[Federal Register Volume 66, Number 71 (Thursday, April 12, 2001)]
[Rules and Regulations]
[Pages 19028-19046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8932]
[[Page 19027]]
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Part III
Department of Transportation
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Federal Aviation Administration
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14 CFR Parts 121 and 135
Emergency Medical Equipment; Final Rule
Federal Register / Vol. 66, No. 71 / Thursday, April 12, 2001 / Rules
and Regulations
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Parts 121 and 135
[Docket No. FAA-2000-7119; Amendment No. 121-280 and 135-78]
RIN 2120-AG89
Emergency Medical Equipment
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
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SUMMARY: This action responds to the Aviation Medical Assistance Act of
1998 by requiring that air carrier operators carry automated external
defibrillators on large, passenger-carrying aircraft and augment
currently required emergency medical kits. It affects those air carrier
operations for which at least one flight attendant is required and
includes provisions designed to provide the option of treatment of
serious medical events during flight time.
EFFECTIVE DATES: Effective May 12, 2004.
FOR FURTHER INFORMATION CONTACT: Judi Citrenbaum, AAM-210, Aeromedical
Standards, Office of Aviation Medicine, Federal Aviation
Administration, 800 Independence Avenue, SW, Washington, DC 20591,
telephone (202) 267-9689.
SUPPLEMENTARY INFORMATION:
Availability of Final Rules
You can get an electronic copy using the Internet by taking the
following steps:
(1) Go to the search function of the Department of Transportation's
electronic Docket Management System (DMS) Web page http://dms.dot.gov/search).
(2) On the search page type in the last four digits of the Docket
number shown at the beginning of this notice. Click on ``search.''
(3) On the next page, which contains the Docket summary information
for the Docket you selected, click on the final rule.
You can also get an electronic copy using the Internet through
FAA's web page at http://www.faa.gov/avr/armhome.htm. or the Federal
Register's web page at http://www.access.gpo.gov/su_docs/aces/aces140.html.
You can also get a copy by submitting a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW, Washington, DC 20591, or by calling (202) 267-9680. Make
sure to identify the amendment number or docket number of this
rulemaking.
Small Business Regulatory Enforcement Fairness Act
The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996, requires the FAA to comply with small entity requests for
information or advice about compliance with statutes and regulations
within its jurisdiction. Therefore, any small entity that has a
question regarding this document may contact their local FAA official,
or the person listed under FOR FURTHER INFORMATION CONTACT. You can
find out more about SBREFA on the Internet at our site, http://www.faa.gov/avr/arm/sbrefa.htm. For more information on SBREFA, e-mail
us at [email protected].
Background
On May 24, 2000, the Federal Aviation Administration (FAA) issued a
notice (65 FR 33720) proposing that air carrier operators of large,
passenger-carrying aircraft carry automated external defibrillators
(AED's) and augment currently required emergency medical kits (EMK's).
The FAA proposed to make that action applicable to those air carrier
operations for which at least one flight attendant is required. The
objectives of that action can be summarized as follows:
To respond to the Aviation Medical Assistance Act (the
Act), enacted April 24, 1998 [Pub. L. 105-170, 49 U.S.C. 44701], which
directs the FAA to determine whether current minimum requirements for
air carrier crewmember medical emergency training and air carrier
emergency medical equipment should be modified.
To modify, as appropriate, the regulatory requirements for
EMK's in light of advancements in medical technology and treatments,
the increase in passenger enplanements, and the anticipated increase in
the occurrence of inflight medical events.
To require equipment that would provide crewmembers and
passengers who might come forward to assist during an inflight medical
event, more up-to-date treatment options, specifically AED's.
To require flight attendant instruction in cardiopulmonary
resuscitation (CPR) and AED usage.
To require needed modifications to current minimum
equipment and training standards without raising expectation among
passengers or crewmembers about the ability to receive and/or provide
in-flight emergency medical assistance.
To establish a separate subpart under part 121 of Title 14
of the Code of Federal Regulations (14 CFR part 121) that, while not
deviating from established requirements for certain equipment and
crewmember training, would provide greater regulatory flexibility in
making future modifications that may be needed.
To allow those affected air carriers that have not made
emergency medical equipment modifications sufficient time to provide
crewmember instruction and procure medical enhancements.
Comments Received
The FAA received 370 comments on the proposal; 321 from the general
public in support of the proposal, in particular, that AED's be carried
on board passenger-carrying aircraft. Most of these 321 comments are
from family, friends, co-workers, and acquaintances of a 28-year-old
man who, they indicate, died on board an airliner in July 2000. These
comments state that this passenger had been diagnosed with hypertrophic
cardiomyopathy \1\ a few months prior to the flight and that, if an AED
had been on board, it may have saved his life. These commenters express
concern about the welfare of other passengers and state that they want
to promote awareness about checking with an air carrier before booking
a flight to assure the availability of an AED. This incident is of
particular concern to the commenters given the young age and apparent
sound physical condition of the passenger who died. The commenters
state that he had been an accomplished athlete.
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\1\ A primary myocardial disease of unknown cause that is
characterized by a hypertrophied, nondilated, hypercontractile left
ventricle. The annual mortality is 3-5%. The common mode of demise
is sudden cardiac death. (Sudden cardiac death is defined as an
unexpected, unpredictable cessation of effective contractions of the
heart.) Therefore, the primary objectives of treatment are the
amelioration of symptoms, the control of arrhythmias, and the
prevention of sudden death. American Journal of Medical Science;
Sept 1987: pp 191-210]
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For the remaining comments, which are discussed in further detail
below, 25 generally support the proposal but make detailed comments
and/or request modifications; 22 express neither support nor opposition
for the action but provide comments for consideration.
The former (25) comments are from the following:
Aerospace Medical Association (ASMA)
Agilent Technologies (an AED manufacturer)
Air Line Pilots' Association (ALPA)
Air Transport Association (ATA)
[[Page 19029]]
American Heart Association (AHA)
America West
Association of Professional Flight Attendants (APFA)
(representing American Airlines' flight attendants)
Complient (a national training center for the American Heart
Association and the National Safety Council)
Food Allergy Network
Florida International University
International Association of Firefighters
International Association of Machinists and Aerospace Workers,
AFL-CIO
International Brotherhood of Teamsters Airline Division
MedAire, an air carrier medical care provider
Northwest Airlines
Pakistan International Airways
Teamsters Local 2000 (representing Northwest Airlines flight
attendants)
3 private citizens, 4 private physicians, and a volunteer
firefighter
The latter (22) comments are from private physicians, nurses,
flight attendants, the Association of Flight Attendants (AFA), Atlantic
Southeast Airlines, Continental Express (two separate comments), the
Regional Airline Association (RAA), and the Small Business
Administration.
One commenter, identified as a Registered Nurse, is opposed to the
proposal. She indicates, among her other comments, that ``if it is
deemed necessary to be able to administer advanced medical care on any
given flight, then turn this over to flight nurses and/or flight
paramedics who are trained in all aspects of flight medicine/
pathophysiology/flight physiology.''
The Civil Aviation Authority of the Hashemite Kingdom of Jordan
states that it would like to implement the proposal for Jordan Air
Lines.
Discussion of Comments
Because the additional suggestions and requests for further
modifications received from the various commenters are elaborate, for
clarity of discussion the FAA categorizes them specifically as follows:
Automated External Defibrillators
Battery Requirements
Agilent Technologies, an AED manufacturer, comments that the FAA
should state the minimum requirements that AED's and their batteries
must meet to be allowed in the aircraft environment and, in addition,
reference the Flood and Drug Administration's (FDA) requirements for
ensuring the safety and effectiveness of AED's. Agilent states that the
reference in proposed part 121, appendix A to ``FDA-approved AED''
should be changed to ``AED legally marketed in the United States in
accordance with FDA requirements.''
Agilent requests that the FAA add further requirements to the
regulation, specifically that paragraph 2. of the AED section of
proposed part 121, Appendix A read as follows:
2. Demonstrated through compliance with applicable sections of
Technical Standard Order (TSO) requirements or other standards or
testing to meet the following requirements:
(a) The AED does not interfere with the safe operation of other
aircraft equipment.
(b) The AED and its power supply have safety features that
prevent fire and explosion hazards.
(c) The AED is designed such that the AED system does not create
a hazard for occupants of the aircraft cabin.
FAA response: The FAA agrees, and has verified with the FDA, that
the reference to ``FDA-approved AED'' in the proposal should be changed
to ``AED legally marketed in the United States in accordance with FDA
requirements'' in the final rule.
The FAA disagrees that further regulatory requirements for AED's
are needed for this action. As with all equipment carried on board
aircraft the certificate holder must ensure that AED's placed on
aircraft do not interfere with safe operation of the aircraft.
The FAA issued TSO-C142 on April 4, 2000. This TSO prescribes the
minimum FAA performance standard that lithium cells and batteries must
meet to be identified with the applicable TSO marking. The standards of
this TSO apply to lithium cells and batteries intended to provide power
for aircraft equipment including emergency and standby systems. The FAA
intends that any AED powered by lithium batteries placed on an aircraft
on or after April 4, 2000, would have to comply with this TSO.
This requirement, in addition to being approved for aircraft use by
the FDA, is adequate for the purposes of this action.
Servicing/Maintenance
Complient, a national training center for the AHA and the National
Safety Council, suggests that each AED should be serviced twice each
year by a trained service specialist. Also, on-site service should be
provided within 24 hours after each medical event to ensure that proper
AED information and service requirements are met.
FAA response: The FAA disagrees with the comment. As proposed and
adopted, part 121, appendix A requires that AED's be maintained in
accordance with the manufacturer's specifications. The FAA has
determined that this is the best method to meet maintenance
requirements.
Storage
The ALPA recommends that AED's be stored in the cockpit. In its
view, cockpit placement would assure that the flightcrew is well aware
of the presence of an AED. Wtih the AED in the passenger cabin they
state that flight attendants may become so focused on its use that the
cockpit crew will not be notified about in-flight medical events.
Further, the AED is a valuable piece of equipment and will be more
secure in the cockpit.
The AFA states that if AED's are required on aircraft, the devices
should be in locations that are suitable for quick emergency response.
FAA response: The FAA agrees that AED's should be stored in
accessible locations as described under proposed part 121, appendix A.
The FAA does not agree that the devices should be stored in
cockpits. If stored in cockpits, the devices would be less accessible
to flight attendants, crewmembers who will be required to have
instruction in AED usage. Also, as cockpit crew always are to be
notified about in-flight medical events as required under
Sec. 121.417(b)(1), the FAA anticipated that cabin and cockpit crews
will communicate during in-flight medical events.
In addition, just prior to issuing the Notice of Proposed
Rulemaking (NPRM), the FAA was made aware of four separate AED battery
``rupturing'' incidents that had occurred on the ground, including one
incident that occurred on a hangared jet. These ``rupturing'' incidents
occurred in AED's powered by lithium sulfur dioxide batteries.
The extremely energetic materials used in lithium cells, and in
other AED power sources, are not intrinsically safe. Safety concerns
include the possibility of fire, explosion, and the venting of toxic or
flammable gases from any portable power source such as AED batteries.
The FAA determined, therefore, that AED's would have to meet more rigid
standards when carried on aircraft and would be more safely stored in
the passenger cabin rather than the cockpit, more critical to safe
flight operations.
Visual Inspection
The ATA suggests that he FAA clarify that the inspection/marking
requirement under proposed Sec. 121.803(b) does not apply to the visual
inspection of emergency equipment typically
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performed by flight attendants at the start of each new crew shift.
FAA response: The FAA agrees that the inspection/marking
requirement under proposed Sec. 121.803(b) does not apply to visual
inspection. However, as with all emergency equipment, AED's must be
visually inspected by flight attendants as part of routine pre-flight
procedures.
Data Collection
In-Flight Medical Events
The ASMA observes that differences of opinion among the medical
community exist because no comprehensive database describing in-flight
medical events and deaths exists.
The International Association of Machinists and Aerospace Workers,
AFL-CIO, state that, to rely heavily on the data collection only, to
support a rulemaking to provide AED's and related drugs on aircraft
EMK's is ``woefully limited.'' Further, the FAA did not report from the
data collection findings who used the AED's on passengers and whether
any drugs were administered.
The RAA states that the evaluation that was used to justify the
proposal is not representative of the regional fleet since some
regionals are only now equipping some or all in their fleets. Further,
without a study that specifically addresses the effective use of AED's
on regional flights, it questions whether AED's will be used at all.
Contrary to these commenters, the ATA suggests that detailed
reports on in-flight medical events is not needed and that the FAA
should ``discard'' the idea of a supplemental information-gathering
action. According to the ATA, it would be costly and burdensome, data
submitted to the FAA likely will be subject to release under the
Freedom of Information Act, and it will discourage emergency assistance
from volunteer doctors and other health care providers.
FAA response: The FAA does not believe that further studies are
needed for this action at this time. As described in the NPRM, the FAA
has conducted separate and specific studies on in-flight medical
events. (Copies of these studies are on file in this docket.) Very
limited assumptions can be made as a result of most of the studies
conducted by the FAA (as well as outside organizations) on in-flight
medical events and EMK usage for the following reasons: the long-term
outcome of the passenger(s) beyond what occurs on the aircraft
frequently cannot be determined; a passenger's past and subsequent
medical history is a private matter and therefore generally
unavailable. Thus it is typically difficult to assess why or even what
medical event occurred.
When it conducts studies, the FAA is obligated, under the Paperwork
Reduction Act [5 CFR 1320.13], not to overburden entities from which it
is collecting information. Therefore, the FAA typically does not
collect data unless it is absolutely warranted, mandated, and/or
invited. For this action, the Act directed that ``a major air carrier
shall make a good faith effort to obtain, and shall submit quarterly
reports on'' death or threat-of-death incidents occurring on board its
flights. In the data collection that was conducted, up to 15 different
air carriers, carrying approximately 85 percent of U.S. domestic
airline passengers, contributed data throughout the year. As
acknowledged in the NPRM, the data received had multiple limitations
and appeared highly variable. Not all of the air carriers who supplied
data were carrying AED's and/or enhanced EMK's; however, the intent of
the study was, in part, to determine whether AED's (as well as other
enhancements) would have been used had they been available. In that
regard, out of a total of 188 events, an AED was reported as ``not
available'' for 40 events in which they may have been used.
The FAA was able to determine from this data collection that four
passengers who were administered at least one AED shock during flight
survived and continue to survive. In at least two of these incidents
the event occurred right after takeoff. Subsequent to the data
collection, further cases of long-term survival as a result of AED
usage were revealed to the FAA, including cases involving crewmembers,
some on short-haul flights. Because some events occurred right after
takeoff and the flights were diverted back to the airport of departure,
it is apparent that these events can occur regardless of the size of
the aircraft or the length of the flight.
Overall, 156 (of the total 188) events reported some type of
medical assistance being provided on board the flight. The actual
number might have been somewhat lower as it was impossible sometimes to
determine whether a reported paramedic or emergency medical technician
was a passenger or part of the ground response team. Physicians were
reported available on the aircraft for 92 events, nurses for 49 events.
Nitroglycerin and epinephrine were the medications most commonly
reported as being used. Atropine and intravenous (IV) saline were used
on time each.
Because of conclusions that could be made from its most recent data
collection and because the FAA anticipates an increase in in-flight
medical emergencies for the future, the FAA has determined that this
rule is needed now. The FAA will continue to study in-flight medical
emergencies, to consider any recommendations, and to monitor the usage
of the enhancements being made to the EMK's.
Emergency Medical Kits
EMK Containers; Location on the Aircraft; and Quantity Needed
America West Airlines comments that, if the FAA intends to mandate
that the modified EMK be contained in a single container or
compartment, such a requirement should be specified in the rule.
Similarly, the ATA indicates that, because the NPRM does not address
containers for EMK's the final rule should clarify that soft-sided
containers are acceptable. America West Airlines also states that the
placement of the items should be left to air carrier discretion.
Requiring a single container to include the current and new requirement
would require air carriers to retrofit with larger-sized kits,
triggering both material and labor expenses.
Northwest Airlines suggests that language be included in the rule
that would allow airlines to augment their existing EMK's with other
additional specially designated medical kits without reference to any
specific kit nomenclature. These additional kits would have as a
minimum the additional EMK items called out in the NPRM. This
modification would preclude the waste associated with making the
existing EMK obsolete. It should also be noted that the additional
items required under the NPRM will not fit into the existing EMK box
found on Northwest Airlines aircraft.
Pakistan International Airways would like to have the EMK divided
into two types; one for the use of the cabin crew and a second for
physicians travelling abroad.
The RAA comments that regional airplanes do not have the space to
accommodate a larger EMK and that it will be more costly to retrofit a
regional airplane.
FAA response: The FAA disagrees, in part, with these commenters.
The proposal does not specify that the modified EMK be contained in a
single container or in a hard, versus a soft, container. Therefore,
this action does not require a retrofit and should not severely affect
available storage space on an aircraft.
The FAA modifies part 121, appendix A under this action to state
``at least one'' EMK to accommodate certain air
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carriers who may use more than one container or more than one EMK. Some
air carriers, for example, carry a so-called ``basic box'' to meet the
minimum requirements and then also carry their own separate, modified
EMK; some others may be carrying ``grab-and-go kits;'' and the like.
Beyond what is set out in the regulation, the certificate holder may
choose the number and type of kits desired as long as the basic,
minimum EMK requirements are met.
The FAA is aware that many air carriers contract with various
medical kit providers and that these providers use various types of
containerization, (e.g., soft-sided vinyl bags as well as rugged,
double-walled, polyethylene cases.) The choice of which type of EMK,
and whether more than one container may be used to meet the minimum
requirements, is at the air carrier's discretion.
As some air carriers may be using, or need to use, more than one
container to meet the requirements the FAA adds the following paragraph
under part 121, appendix A:
3. If all of the above-listed items do not fit into one
contained, more than one container may be used.
It should be noted that formerly, under existing Sec. 121.309
(b)(4) and to be adopted under Sec. 121.803 (b)(4), an FAA-required EMK
container(s) must be marked as to contents and date of last inspection.
Expiration Date of EMK Medications
America West Airlines suggests that procedures be established to
preserve the shelf life of temperature-sensitive medications. Those
such as lidocaine, if stored in a standard EMK, would require constant
replacement thereby creating additional cost and administrative burden.
FAA response: Currently required EMK medications as well as the
following medications proposed for the EMK's have an expiration date of
approximately 1 year: atropine, bronchodilator inhaler, dextrose,
epinephrine, saline solution, and lidocaine; aspirin, non-narcotic
analgesic, antihistamine, and nitroglycerin tablets.
Under current experience (since 1986) with injectable
antihistamine, dextrose, epinephrine, and nitroglycerin tablets, the
FAA has not found expired medications to be a problem. Therefore, the
FAA does not anticipate that medications will require constant
replacement. If temperature extremes occur on the aircraft or if the
medications have surpassed their expiration date; however, then the
certificate holder should replace them. As has been the case since
first required, EMK's must be inspected periodically according to
schedules developed under operations specifications.
Medications
The following is a list of additional equipment and medication that
commenters suggest the FAA should include in EMK's:
Items Suggested:
AED patient care kit containing a razor and towel
Audio-prompting device
Auto-injector to administer epinephrine
Burn gel
16 French Coude catheter
Connecting tubing, IV Start kit, IV catheters 18g, 20g, 22g,
Atropine 1mg, Epinephrine 1:10,000 1mg and Lidocaine 100 mg
CPR masks fitted with an oxygen inlet and with a standard 15-22-mm
connector available in one average size for adults with additional
sizes for infants and children, equipped with a 1-way valve that
diverts the victim's exhaled gas
Dexamethasone
EKG machine
Endotracheal tube/laryngoscope
Furosemide injection
Glucometer
Glucose gel-administered orally for symptoms of hypoglycemia
Medication for seizure control
Nasal cannulas in sizes appropriate for adult, child, and infant
Pocket masks
Portable oxygen equipment with regulator capable of delivering
between 4 L/min and 12 L/min, including a hose capable of connecting to
a resuscitation face mask, bag-valve mask, and a connecting system for
use with a nasal cannula.
A standardized portable response kit to include an AED, AED
preparation kit, emergency oxygen, first-aid/BBP kits and supplies, and
an audio prompt device.
A manual resuscitation bag-valve that has:
A self-refilling bag
A nonjam valve system allowing for a maximum oxygen inlet flow of
30 L/min
A non-pop-off valve
Standard 15-/22-mm fittings
A system for delivering high concentrations of oxygen through an
ancillary oxygen reservoir
A true nonrebreathing valve
The capability to perform satisfactorily under all common
environmental conditions and extremes of temperature
Stretcher
Torch lights w/spare batteries
Eleven commenters stress the importance of air carriers carrying an
epinephrine auto-injector. Although the FAA currently requires
epinephrine, and proposes to require an additional quantity of it, the
commenters indicate that an auto-injector is far easier and quicker to
use and would be critical when attending to a passenger suffering from
a severe allergic reaction in flight.
FAA response: The FAA disagrees with these commenters. No
commenters provided data (as requested in the NPRM) to confirm that
these suggested additions for the EMK's would be necessary. Also, as
noted in the NPRM, the purpose of the EMK's is to add some medical
options; it is not comprehensive. The certificate holder may carry
additional equipment/medications if deemed appropriate.
Since 1986, all major, passenger-carrying air carriers have been
required to carry epinephrine in on-board EMK's. Part 121, appendix A,
requires two quantities of epinephrine (1:1000) in ``single dose ampule
or equivalent.'' An additional preparation of epinephrine (1:10,000), a
dose that may be used for heart stimulation, proposed under this action
is intended to complement the dosage currently required, which is
intended for use as a treatment for severe, or anaphylactic, allergic
reactions.
The FAA did not propose to require epinephrine auto-injectors
because recent and former studies (on file in the docket) that the FAA
has conducted on in-flight medical events did not reveal a need to make
epinephrine auto-injectors available. These studies did suggest the
need for an oral treatment for allergic reactions, therefore, an oral
antihistamine was included in the NPRM.
The FAA will review this matter in any future considerations of the
EMK contents and for any subsequent regulatory action.
The AHA cautions the FAA to be ``extremely conservative'' when
considering EMK expansion. According to the AHA, the FAA should not
approach expansion of the EMK's from the perspective of simply making
available every drug and medical device ever requested by an in-flight
physician. According to AHA, its international guidelines on CPR and
emergency cardiovascular care have recommended far fewer resuscitation
medications and medical devices than ever before.
[[Page 19032]]
Medications
MedAire comments that consideration should be given to increasing
the quantities of the proposed medications (in particular atropine,
epinephrine, lidocaine) and that supplies needed to administer certain
medications are not being required. For example, saline solution is
included in the recommended kit contents, but no provisions have been
made for an IV catheter, which is essential to administer the fluid.
Also, specific syringe and needle sizes should be required.
FAA response: The FAA disagrees with this comment. The FAA took a
very conservative approach when assigning quantities to proposed
medications given the limited need to use such medications in flight.
In the preamble to the NPRM, it is clear that the FAA intends to
require ``an IV administration kit'' which would include one or more IV
catheters. In the regulatory language under proposed part 121, appendix
A, that intent may have been misunderstood as the words ``1 set'' are
used rather than ``kit.'' Therefore, for clarity, in the final rule,
the FAA moves the word ``set'' from the ``Quantity'' column under
proposed part 121, appendix A and places it after ``IV Admin'' so that
the intent is clear.
The FAA did include recommended, appropriate needle and syringe
sizes in its proposal to part 121, appendix A. Further, the original
language from 1986 (``or sizes necessary to administer required
medications'') was maintained so that the FAA could remain as
descriptive as possible.
Another comment on medications, from the ATA, states that
convenience medications, such as low-strength analgesics, should not be
included in the kit. The kit should be intended for life-threatening
emergencies only, and be opened only in the event of a true emergency
by a ``responding health care provider'' or as directed by a
``qualified health care provider.''
FAA response: The FAA's study entitled ``The Evaluation of In-
Flight Medical Care Aboard Selected U.S. Air Carriers from 1996 to
1997'' (on file in this Docket) reveals that certain convenience
medications, such as an oral antihistamine, a non-narcotic analgesic,
and a bronchodilator inhaler are appropriate for inclusion in air
carrier EMK's. In its study, the FAA found these items to be necessary
additions to the EMK because passengers, especially those with chronic
allergies or asthma, do not always carry them or may inadvertently
leave them in their checked baggage.
Oral antihistamines may prove useful and necessary for attempting
to assist a passenger experiencing severe allergy problems; a non-
narcotic analgesic, to relieve muscle aches and headaches; and a
brochodilator inhaler, to attempt to restore normal breathing in an
asthmatic passenger.
Periodic Review of Appropriate Content
MedAire Inc., an air carrier medical care provider, requests that
the FAA conduct a review of the EMK content every 2 years to ensure
that required drugs continue to meet the AHA Advance Cardiac Life-
Saving guidelines. MedAire indicates that the FAA should establish a
database in order to monitor kit usage and the appropriateness of its
content.
FAA response: The FAA concurs that EMK content must come under
periodic review and the FAA will continue working in close
collaboration with the public in that regard. However, the FAA did not
propose to adopt the AHA Advance Cardiac Life-Saving guidelines and
does not adopt that requirement now.
It should be noted that the AHA, in its comment to the docket,
cautions the FAA to be ``extremely conservative'' when considering
expansion of in-flight EMK's. This is the approach that the FAA has
adopted at this time. This final rule will establish a separate subpart
under part 121 with a view to facilitating short-term issuance of any
needed amendments in the future.
Protective Barrier Devices
According the MedAire, the requirement for protective barrier
devices (e.g., gloves, masks, etc.) can be simplified by allowing
airlines the ability to use those that have been designed for universal
application rather than having to house three different, specific sizes
within the kit.
For items such as airways, resuscitation devices, and CPR masks,
the ATA indicates that, rather than specifying quantity and sizes, the
final rule should simply require that the EMK contain those items
suitable for all air travelers. This change would permit airlines to
select, for example, a universal mask that could fit or be adapted to
all travelers, including infants, children, and adults.
The AFA believes that a face mask is more appropriate than a face
shield. It is concerned that some of the air carriers have chosen to
provide only a face shield. Without the FAA mandating the personal
protective equipment required, some air carriers may choose to continue
to provide this type of barrier device versus a face mask.
The APFA requests that pocket masks be required and made more
accessible. Without a mask, it indicates, flight attendants are
potentially exposed to hepatitis, AIDS, and other diseases. The APFA
recommends that ``grab-and-go parts of acronym-syndrome kits'' be made
``no-go'' items or that each flight attendant be issued a mask and be
required to carry it. Pocket masks also could be attached or made part
of the ``defibrillator kit.''
FAA response: The FAA is not opposed to affected air carriers
carrying airways, CPR masks, and masks for use with self-inflating
manual resuscitation devices designed for universal application,
provided they are carried in quantities of three and provided they are
appropriate for pediatric and small and large adult use. The devices
must, however, be equivalent to those required under the regulation.
The FAA did not propose that any equipment be used but rather that
it be available for possible use if the certificate holder or its
agents (e.g., flight attendants) so choose. Therefore, if different
equipment, in addition to that required is desired then the certificate
holder may provide it.
With the addition of the words ``or equivalent'' after the
requirements for airways, self-inflating resuscitation devices, and CPR
masks under part 121, Appendix A, the final rule is adopted as
proposed.
Quality of EMK's
The Teamsters Local 2000, National Safety and Health Department,
representing Northwest Airlines flight attendants, states that, in many
cases, EMK's include cheap, disassembled parts, with medical equipment
manufacturers taking advantage of the air carriers by placing sub-
standard equipment in the kits purchased by the air carriers. The
applicable regulations specify contents of the EMK but do not make
determinations about their quality. As referenced in the FAA report
published in 1991, and based on a 2-year study of medical kit use, the
poor technical quality of the most frequently used equipment was
revealed. The commenter believes that this aspect of EMK's must be
addressed.
FAA response: The FAA disagrees that it requires or allows EMK's of
poor technical quality. Part 121, appendix A as it currently exists and
as it will be adopted requires an ``approved'' EMK that must contain
``appropriately maintained contents.'' Not maintaining equipment or
carrying sub-standard equipment, therefore, constitutes a violation of
part 121. While the FAA does not endorse or recommend
[[Page 19033]]
equipment suppliers, it is expected that the certificate holders will
procure equipment of appropriate quality.
The available data from the 1991 FAA report entitled ``Response
Capability During Civil Air Carrier In-flight Medical Emergencies''
(filed in this Docket) did not reveal overall poor technical quality of
the EMK. Rather, it revealed one case in which an ``inopertative''
blood pressure cuff was criticized and fewer than five cases in which
better airway equipment was recommended. The FAA believes that the
quality of the equipment required by the regulations is maintained by
routine FAA oversight of air carrier operations.
Usage of EMK's on Regional Air Carriers
The RAA indicates that the proposed enhanced EMK's simply will not
be used in a typical regional operation given the lack of opportunity
and lack of medical guidance needed to use the materials.
FAA response: The FAA disagrees that in-flight medical events will
not occur during regional operations. Cardiac events can occur at any
time, in any place, and to anyone. While professional medical guidance
may not be as readily available or forthcoming on a regional flight, it
is anticipated that certificate holders and its agents will act
appropriately to provide for the safety of the passengers on the
aircraft.
Flight attendants receive instruction in passenger emergency
medical care only to a level that would allow them to attempt care if
appropriate and safe. Under this action, they will need to become
familiar with the modifications being made to the EMK in the event that
care is chosen to be provided or if any other passenger attempts to
assist.
It should be noted that crewmembers have been required, under
existing Sec. 121.417(b)(3)(iv), to be familiar with what is contained
in the EMK. This action does not change that requirement, except to
move the provision under Sec. 121.805(b)(3) and to require
familiarization with the EMK as modified.
If serious medical events do occur in flight, having enhanced
emergency medical equipment available may facilitate the ability to
attempt to assist a passenger.
Flight Operations
EMK's/AED's as ``No-Go'' Items
With the proposed additions to the medical equipment onboard
aircraft and the increased cabin crewmember training, MedAire's
experience indicates that airlines will be using their onboard medical
equipment much more often. Therefore, MedAire comments that
consideration should be given to the airlines allowing them to fly a
passenger flight to a maintenance facility where the equipment/medical
kit can be replaced rather than having them maintain expensive
inventories at every destination. The high cost of this equipment and
stocking requirements would make it difficult for the airlines to
manage the program under a strict ``no-go'' rule. The possibility
exists that a diversion into a non-station airport potentially could
ground an aircraft and strand passengers.
The ATA comments that the FAA needs to clarify the intent of the
words ``unless authorized by the Administrator'' under Sec. 121.803 (a)
that flights are not delayed or canceled unnecessarily. Specifically,
air carriers should not be forced to seek authorization on a case-by-
case basis as the issue arises. The ATA recommends that an airplane
should be permitted to operate in commercial service for a reasonable
period of time (up to 5 days) while an AED is not available, such as
for battery replacement or maintenance or, in the case of an EMK,
required items are replenished. To achieve this, the FAA could allow
conditional FAA Principal Operations Inspector (POI) authorization for
such operations in advance through operations specifications, a Master
Minimum Equipment List provision, or as past of approved AED
maintenance plans.
The APFA recommends that ``grab-and-go kits'' be made ``no-go''
items such that aircraft cannot depart without them unless each flight
attendant is issued a mask and is required to carry it.
FAA response: The FAA agrees, in part, with these comments. In
particular, the ATA's comment that air carriers should not be forced to
seek authorization on a case-by-case basis for flights without EMK's
and/or AED's available.
Under long-standing regulation, existing Sec. 121.309 (a), an
airplane may not be operated unless it is equipped with required
emergency equipment, including EMK's. Therefore, EMK's have always been
considered ``no-go'' items and must be carried as listed by the Master
Minimum Equipment List. ``Grab and go kits,'' as suggested by the APFA,
are not an adequate substitute.
Under Sec. 121.803 (a), as proposed, the FAA carried over the
provisions of Sec. 121.309 (a) but added the words ``unless authorized
by the Administrator.'' The intent of this proposal was to cover
situations in which an AED may be inoperable or not available for
flight; however, the FAA inadvertently extended that provision to all
``emergency medical equipment'' which also would include EMK's. Upon
further review, the FAA has determined that AED's should be, and EMK's
should remain, ``no-go'' items.
To allow an airplane without an EMK or AED to be operated in
commercial service up to 5 days, as ATA suggests is not consistent with
this action. Nor is it consistent to provide conditional POI
authorization through operations specifications, a Master Minimum
Equipment List, or as part of approved AED maintenance plans.
Therefore, until the FAA develops more experience with the enhanced
EMK's and AED's it will continue the current provision under
Sec. 121.309 (a) and will adopt Sec. 121.803(a) without the words
``unless authorized by the Administrator.''
Single Flight Attendant Requirement
Continental Express suggests limiting the applicability of the
proposal to flight operations requiring two, rather than one, flight
attendant. Airplanes with as few as 10 passenger seats are required
under Sec. 121.391 to have a flight attendant. Continental Express
asserts that it is unreasonable to expect a single flight attendant to
attend to a stricken passenger while simultaneously performing the
duties associated with approach and landing.
The International Brotherhood of Teamsters, Airline Division, wants
the rule to explicitly address potential conflicts between existing
regulations and the administration of CPR and/or the provision of any
other first-air/responder care. It must also explicitly provide for
resolution to these conflicts. While common sense may determine that
the flight attendants continue with CPR, the regulations should address
these circumstances. Air carriers and their employees should not have
to be burdened with conflicting rules.
The Teamsters Local 2000 (representing Northwest Airlines flight
attendants) comments that, when medical emergencies occur, compliance
with certain regulations pertinent to cabin crewmembers may become more
challenging.
The RAA indicates that the proposed rule fails to address the
potential safety concerns in having one flight attendant devote time to
attending to a medical event when this flight attendant has regulatory
responsibilities and other passengers. On a regional airline there is
the possibility that a flight attendant could accidentally shock him or
herself. The suggested airborne medical emergency procedures will
subject the flight attendant and other passengers to a greater risk of
injury from airplane
[[Page 19034]]
movement particularly if a flight diversion occurs. In contrast to
these commenters, MedAire believes that the recommendation to include
aircraft with a single cabin crewmember as a part of the ruling is a
sound one.
According to MedAire, since a person must be defibrillated within
10 minutes following cardiac arrest, it becomes impossible for any
aircraft to reach life-saving medical attention in time. Today's single
cabin crewmembers routinely are taught CPR during emergency training.
Defibrillation has become a portion of the basic life support
capability that is embodied within the CPR skill. Just as on any other
aircraft, a flight attendant who is handling a medical emergency must
redirect priorities if another emergency occurs that stands to impact
the lives of others onboard.
FAA response: The FAA disagrees that this action conflicts with
existing regulations as there is no regulation that the certificate
holder or its agents provide care.
As noted previously, the FAA amended Sec. 121.309(d)(1)(ii) under
the ``Commuter Rule'' to require an EMK in airplanes for which a flight
attendant is required. This action transfers that provision to
Sec. 121.803 and expands it to include an AED as well as an EMK. The
FAA bases the determination to continue this requirement on the 5 years
of experience it has had under the regulation and did not find a need
to modify it.
While not a routine occurrence, in-flight medical events, like
other on-board events such as smoke or fire, do affect the ability of
flight attendants to perform their duties. For this reason, unexpected
scenarios, and how to respond to them while maintaining a safe, calm,
and orderly passenger cabin environment, must be trained. But exactly
how to deal with these events is at the discretion of the certificate
holder and its agents.
Size/Seating Capacity of Aircraft Affected
Continental Express indicates that the FAA has not factored
airplane size or route length into its justification and that it
appears that the size of aircraft affected was an arbitrary decision.
The added weight, unit expense, and scarce cabin space may render the
smaller (50 passengers and less) aircraft unlikely candidates for this
rule. It suggests that the applicability of this rule, and others like
it, be driven by passenger seat capacity (a fixed value) versus a
variable weight. Further, Continental Express asserts that the
probability a passenger suffering a medical event while on board a
small airplane operating a short flight segment is much lower than the
probability of a passenger suffering a medical event on a large
airplane, operating a long flight segment.
FAA response: The size of the aircraft affected under this action
was constrained in part by the direction set forth in the Act as
follows:
``(d) Limitation.--The Administrator may not require automatic
external defibrillators on helicopters and on aircraft with a
maximum payload capacity (as defined in section 119.3 of title 14,
Code of Federal Regulations) of 7,500 pounds or less.''
Although there are variables in payload capacity and size of aircraft,
the more than 7,500 pound payload capacity roughly translates to
aircraft with a capacity for 30 passengers.
In 1995, the FAA required one flight attendant as part of the
``Commuter Rule'' [60 FR 65832; December 20, 1995] for this size
aircraft. This rule also required an EMK. Based on its experience, the
FAA has determined that this size aircraft is the size necessary for
EMK's and AED's.
The FAA has no data to indicate that the probability of a passenger
experiencing an in-flight medical event is lower on a small airplane
operating a short-flight segment. The FAA has determined that all
passengers should be treated equally by having, to the extent possible,
the same options for in-flight medical treatment.
Good Samaritan Protection
Seven commenters raise the issue of the applicability of the ``Good
Samaritan'' provision.
A flight attendant indicates that flight attendants need legal
protection under a ``Good Samaritan law'' that would provide them tort
immunity (except in the case of gross negligence). If this is not the
case, this flight attendant points out that he may not respond as
quickly or aggressively as he might otherwise out of fear of being
sued.
The AFA and the Trinity Medical Network, a global emergency medical
evacuation company based in Singapore, propose that letters of
indemnification be given to flight attendants to protect them from
liability.
The International Association of Machinists and Aerospace Workers,
AFL-CIO, appreciates the fact that the Act includes a ``Good
Samaritan'' provision that limits air carriers' liability when
obtaining medically qualified non-employee passengers to assist persons
but questions whether this same protection applies to flight
attendants.
The ALPA recommends that the ``Good Samaritan'' provisions be
clearly stated in the rule itself and should be a specific required
training subject. Knowledge of the ``Good Samaritan'' protection could
positively influence the willingness of a medical professional to step
forward to assist in an in-flight medical emergency.
The International Brotherhood of Teamsters, Airline Division,
observes that the NPRM only briefly touches on legal liability issues
in its background discussion section. Legal liability issues may arise
out of these new requirements and expectations. This liability must not
be placed on the shoulders of the flight attendant or flight deck
crewmember. Crewmembers must be indemnified. At the very least, air
carriers must be required to provide indemnification for their
employees who respond in accordance with air carrier policies and
procedures.
Teamsters Local 2000 (representing Northwest Airlines flight
attendants), reveals that the legal immunity afforded flight attendants
in the use of emergency medical equipment presents a concern. The legal
protection afforded flight attendants must be clearly defined and made
a part of the proposed regulations applicable to crewmember actions in
support of a medical emergency, whether on or off the aircraft (as in
the jetway for example).
FAA response: The FAA disagrees with these commenters. As stated
before, there is no requirement that certificate holders or their
agents provide medical assistance to passengers. If the certificate
holder or its agents voluntarily choose to provide care, the provisions
of the Act will apply. The ``Good Samaritan'' provisions of the Act do
not require further implementation by the FAA. The issues raised by the
commenters are between employees and employers and as such are not
subject to this rulemaking.
Quality Control
Complient suggests that reference to data management criteria
should be provided in the final regulation. It suggests a program to
track and report the details of every in-flight medical event via the
Internet. This process would ensure compliance and allow immediate
access to all quality assurance information.
The AHA concludes that the FAA should implement strong quality
improvement components by establishing close medical review of all uses
of an AED during commercial air travel. This review should include both
appropriate, and perhaps not so appropriate, use of the AED.
[[Page 19035]]
The ASMA and America West Airlines suggest a standardized review
program that would provide an efficient and expeditious process for
monitoring the use and effectiveness of the equipment and medicines and
aid in determining the need for possible future modifications to the
kits.
Complient recommends that the FAA review new technologies that
support the mission and implementation of the ``AED program.''
A private citizen, who does not identify affiliation, observes that
the distribution of technology does not ensure its proper use. A
significant portion of the plan for this distribution should be focused
on proper training for flight attendants and education for the airborne
public.
FAA response: The FAA disagrees with these comments. As discussed
in the NPRM preamble, while the FAA believes that this action is
needed, it is also aware that adding enhancements could be
misinterpreted. The FAA is not establishing a proposal for in-flight
medical care. Passenger expectations regarding the level of medical
care should not unrealistically raised by this action. In-flight
medical assistance will continue to be discretionary to the certificate
holder and its agents. In-flight medical care voluntarily provided must
be regarded as limited emergency treatment with no unrealistic
expectations of favorable outcomes for passengers having medical events
in flight.
While it is not within the purview of the FAA to mandate or
regulate health care, the FAA can require that certain equipment be
available. When equipment is carried on the aircraft, the FAA requires
that airline personnel must be familiar with where it is located and
how it is used. Making the equipment available and having airline
personnel recognize where it is located and how it is used, if so
desired, is the basic intent of this action.
The FAA has long-standing procedures and personnel in place to
assure that all equipment carried on board an aircraft are maintained
and stored properly. The FAA continues this by including AED safety
standards, initial training requirements for crewmembers, and recurrent
training provisions for flight attendants.
Training
Annual vs. Biennial Recurrent Training Hours Needed
MedAire recommends that the FAA adopt, at the very least, an annual
recurrent training requirement, which would tie into the flight
attendants' annual training program.
The AFA states that, until an air carrier adopts the concept of
performance-based standards, the training schedule for AED and CPR
should be conducted every 12 months. It is imperative that the FAA
follow the guidelines set by the American Red Cross and the AHA. These
guidelines best represent the knowledge of training in these areas and
set the minimum recurrent standards that these two organizations have
set. According to the AFA, the last training outline that it received
from these organizations revealed that a training certificate was valid
for 1-year intervals. Therefore, the FAA should follow that guidance.
The International Brotherhood of Teamsters, Airline Division,
concurs that the regulation should require recurrent training annually
rather than every 24 months.
According to the International Association of Machinists and
Aerospace Workers, AFL-CIO, non-medical professionals, such as police
officers and fire fighters most likely are faced with having to use an
AED than are flight attendants and have assistance more readily
available. The huge majority of flight attendants probably will never
face such situations or maybe once in their careers. Receiving
appropriate training every 2 years when they may never have encountered
a real-life situation does not ensure the confidence level that the
rule is assuming.
FAA response: While the FAA recognizes that annual performance
drills would be preferable and applauds those air carriers that conduct
the drills at 1-year intervals, under existing Sec. 121.417 similar
recurrent training is conducted on a 24-month basis. The FAA did not
want to deviate from existing practice by establishing a separate
training schedule.
Blood-Borne Pathogens/Occupational Safety and Health Administration
(OSHA)
The International Association of Machinists and Aerospace Workers,
AFL-CIO, comments that blood-borne pathogens have not been addressed in
the NPRM and that it must be addressed in conjunction with the IV kits.
At the least, the training aspect of dealing with blood-borne pathogens
must be included in this rule.
The International Brotherhood of Teamsters, Airline Division,
remarks that the proposed rule does not address occupational safety and
health risks for flight attendants who potentially may be exposed to
blood-borne pathogens in the performance of their duties. Further, it
does not require enforcement of the OSHA Bloodborne Pathogen Standard
to safeguard against those risks. This standard, and a requirement for
compliance by air carriers, must be incorporated by reference into the
final rule. Such action would demonstrate the FAA's intent to act on
the Memorandum of Understanding recently signed with OSHA.
Teamsters Local 2000 (representing Northwest Airlines flight
attendants), comments that flight attendants must have both the
training and personal protection to take on ``first responder''
responsibilities. Such training must include blood-borne pathogens,
with the current OSHA Bloodborne Pathogen Standard applied to Flight
Attendants to safeguard against the known risks involved. It would be
irresponsible to require AED training and not include CPR and blood-
borne pathogen training as well.
According to the AFA, it is anticipated that the OSHA standard on
blood-borne pathogens will be one of several OSHA standards that will
be proposed as OSHA rules covering flight attendants after an initial
OSHA/FAA team report is completed by December 6, 2000. If the air
carriers are going to be doing training on CPR and in AED usage, OSHA
promulgation of its blood-borne pathogen standard covering flight
attendants should be coordinated to take effect on the same date as
this FAA final rule. This will ascertain that the air carriers have an
obligation to provide training on occupational exposure to blood-borne
pathogens and other potentially infectious materials, in addition to
other protections provided by the standard.
Complient comments that, if employees are trained and designated as
responsible for rendering first-aid or medical assistance as part of
their job duties, they are covered by the protections of the OSHA
standard. It is an OSHA violation if employees who administer first-aid
as a collateral duty are not offered a hepatitis B vaccine. It also
comments that a program of blood-borne pathogen training mandated
annually would provide impetus to conduct at least an annual review of
AED-CPR procedures.
FAA response: Because of the FAA's ongoing review \2\ of blood-
borne pathogens, among other issues, with OSHA, this action does not
include a regulatory reference to blood-borne
[[Page 19036]]
pathogens. The FAA continues to promote awareness of blood-borne
pathogen exposure through guidance material found under Advisory
Circular 120-44; March 9, 1995.
---------------------------------------------------------------------------
\2\ See the First Report of the FAA/OSHA Aviation Safety and
Health Team, dated December 2000, entitled, ``Application of OSHA's
Requirements to Employees on Aircraft in Operation'' on file in this
docket.
---------------------------------------------------------------------------
Guidance Material for FAA Inspectors
The AFA is in favor of FAA inspectors being provided with criteria
to use when approving the training associated with this rule. If the
FAA intends to provide criteria or guidance through another means such
as an Advisory Circular or Handbook Bulletin, this should be stated in
the preamble. These criteria should be made available for public
comment before they are published, within 6 months following the
issuance of the final rule.
FAA response: The FAA developed a Flight Standards Information
Bulletin for Airworthiness, FSAW 98-05, that provides POI's with
information regarding installation and use of medical portable
electronic devices abroad aircraft. Specifically, it familiarizes and
standardizes the carriage, testing, and operational use of AED's aboard
aircraft, and provides policy and guidance concerning this issue.
Typically, the FAA does not issue Advisory Circulars until adoption
of a final rule. Whatever guidance the FAA issues as a result of this
action will be published in the Federal Register for public comment.
On-Line Training Programs
Complient mentions an on-line training program as a means of
ensuring that all flight attendants are properly trained and of
containing initial and recurrent training costs.
FAA response: Flight Standards Handbook Bulletin for Air
Transportation, HBAT 98-09, clarifies and presents guidance for POI's
in responding to operators' requests to substitute home study training
modules for approved traditional classroom training modules. The FAA
POI must ensure that the course of study will effectively duplicate the
classroom training to be replaced. No substitutions are considered for
any flight training, Basic Indoctrination, Initial, Transition, or
Upgrade training. Requests for substitutions to Recurrent,
Requalification, or Refresher training are considered. Only cognitive
or knowledge-based training is eligible for consideration for home
study. Hands-on AED or CPR training would not be possible.
Standardization
The AHA recommends standardizing the ``in-flight'' defibrillation
course'' to a nationally recognized CPR-AED curriculum, such as the
Heartsaver AED course of the AHA, the National Safety Council, or the
American Red Cross. A training curriculum is needed that integrates
both CPR and the use of the AED into a single integrated course.
Further, customize the course for the specialized clinical environment
of in-flight commercial aircraft. It indicates that it has assisted
organizations, such as the recreational ski industry and the cruise-
ship industry, with industry-specific protocols.
According to the AFA, using organizations such as the American Red
Cross and the AHA will give the flying public assurance that training
is being performed to a well-recognized worldwide standard. According
to the AFA, the FAA has a responsibility to set minimum standards and
can do so by looking to the guidelines provided by the national
organizations. The minimum guidelines that these national organizations
set should be the same minimum that the FAA requires.
The AFA supports the concept of ``performance-based training''
rather than specified minimum training hours. The AFA believes that
this approach would mirror the concepts listed in AC 120-54, Advanced
Qualification Program. Each flight attendant should receive a
Certificate of Proficiency upon successfully completing the training,
prior to undertaking in-flight medical event duties. This certification
will enhance the confidence of the flight attendant to perform life-
saving tasks.
The International Brotherhood of Teamsters, Airline Division,
states that the level of flight attendant training varies greatly from
carrier to carrier. In many instances, flight attendants are not
sufficiently trained for the first-aid/first response duties already
assigned to them. Upgrading the equipment on aircraft without
simultaneously upgrading the training requirements for flight
attendants will only exacerbate this problem. At the very least, air
carriers should be required to train flight attendants to a standard
equivalent to that received by other ``flight responders.'' The
standard must be specified in the regulation, not left to the
discretion of the air carriers.
Teamsters Local 2000 (representing Northwest Airlines flight
attendants), would like to see comprehensive first-aid training
requirements, increased programmed hours of instruction/frequency for
CPR, and proficiency requirements.
The ATA concurs with the FAA proposal not to require a specific
number of hours of training.
According to the ATA, the final rule should clarify, however, that
the result of the training is not to ``certify'' the trainee. It should
be explained that the purpose of the training is to ensure that the
trainee has satisfactorily completed the training course. Using terms
such as ``certify'' creates an expectation, if not a legal standard.
According to the ATA, it is extremely important for the text of the
final rule, not just the preamble, to state expressly that it is not
the intention of the FAA to convert flight attendants or flightcrew
into emergency medical personnel. Therefore proposed Sec. 121.801
should have a new paragraph added to read as follows:
Nothing in this subpart is intended to require crewmembers to
provide emergency medical care or to establish a standard of care
for the provision of emergency medical care by crewmembers or air
carriers covered by this subpart.
Further a new Sec. 121.805 (c) should be added to clarify that the
required training is not intended to achieve a level of proficiency
required of emergency medical personnel as follows:
(c) The training required by this section is not intended to
achieve the level of proficiency required to be attained by trained
emergency medical personnel.
Other comments received from individual commenters on the issue of
standardization included the following: Medical training for flight
attendants should be standardized and regulated; the minimal training
that needs to be done is a certified paramedic training program;
involve the Association of Air Medical Services, the Emergency Nurses
Association, and the National Association of Paramedics; staff the
cabin crew with several members certified in basic life support; and
include at least two passenger cabin personnel who are certified in
first-aid and CPR.
FAA response: Given that almost every major air carrier voluntarily
has implemented some form of acceptable and approved training program
for flight attendants on the proposed modified EMK's, including AED's,
the FAA did not propose to standardize ``one-size-fits-all''
requirements. The FAA believes that a specific, recommended course of
standardized training would be overly burdensome. It does recommend,
however, that instruction conform to national programs including those
offered by the AHA or the American Red Cross. But as the provision of
care is up to the certificate holder, it is up to the certificate
holder to decide what program best fits its needs.
[[Page 19037]]
Requiring flight attendants to be certified as first responders
would put more responsibility on them, which is not the intent of this
action. While in some cases, flight attendants may be the first and
only responders to an in-flight medical event, it is up to the
certificate holder to decide what, if any, care will be provided.
Requiring first responder certification would be inconsistent with this
action.
Hands-on drills for medical emergencies are useful to have as an
option for care. But, like other events for which training and drilling
occur (e.g., fire) no certificate is provided.
The FAA concurs that the ATA's recommended amendments to
Secs. 121.801 and 121.805 would serve to clarify the intent of this
action and adopts them, with minor modifications, under the final rule.
Suggested Training for Pilots
Pakistan International Airways believes that cockpit and cabin crew
should be able to institute IV fluids. All cockpit/cabin crew should
acquire basic training in CPR and basic life support.
The ALPA supports having flightcrew members being given initial
training in the AED to include instruction in its proper use. While the
flight attendants generally are the crewmembers who will use the AED,
it also would be beneficial for pilots to be given such training.
FAA response: Although the FAA does not require it, air carriers
are not precluded from providing more extensive training to any
crewmembers, including pilots. The FAA did not require pilot training
on the AED's because it could not foresee, except under rare
circumstance,s that the equipment would be used by pilots during
flight.
Other Comments Received
The following are additional comments received that, because they
did not apply within the categories discussed above, are rendered here
below categorized as ``OTHER COMMENTS RECEIVED.''
Airports
The AHA, the ATA, and a private citizen request that this proposal
be extended to include airport action.
The AHA indicates that the airport programs already implemented
have reported a remarkable level of early success. It urges the FAA to
consider the successes of these current airport public access to
defibrillation programs and reconsider its decision not to act to
advance these successes in other airports.
The ATA states that the NPRM ``does not deal'' with the issue of
whether airports should ``install'' AED's and EMK's. Experience
demonstrates that passengers do have medical emergencies in airports
for which the availability of AED's and EMK's could be beneficial. The
ATA urges the FAA to initiate rulemaking to address this need.
FAA response: The FAA addressed airport medical events under
separate action pursuant to the Act. As indicated in its June 6, 2000,
Notice of Decision [65 FR 35971], the FAA determined that it would not
require the same kind of enhancements at airports.
The FAA conducted a survey and found that most airports are already
well-equipped and have well-trained personnel available to respond to
airport medical events. Data on 130 airports indicate that 108, or 83
percent, have defibrillators, and that 11 airports, or 8.5 percent,
have an off-airport response rate of less than 6 minutes. Thus, 119
airports, or 91.5 percent, have the medical capability to address
medical events including those in which AED's may be of assistance.
In light of the determinations, of the widespread availability of
emergency medical care, including AED's, at or near airports, the FAA
decided not to propose action at airports.
First-Aid Kits
The ATA requests that ammonia inhalants be deleted form the first-
aid kit content as they are an ``archaic modality.'' Attempting to
administer ammonia inhalants to a passenger in Sudden Cardiac Arrest
would waste valuable time. ATA also comments that the requirement to
carry up to four first-aid kits is excessive because multiple uses of
first-aid kits on a single flight are rare. Therefore, only one first-
aid kit per airplane should be required.
FAA response: The focus of this action is on EMK's and not first-
aid kits. The FAA does not address first-aid kits in this action except
to delete an outdated, obsolete (and therefore meaningless) reference
to a Defense Department specification. The commenter's suggestions
regarding first-aid kits cannot be considered because the FAA does not
have data that would warrant removing the requirement to carry ammonia
inhalants and/or reducing the number of first-aid kits required to be
carried.
Ground-Based Medical Advisory Providers
The RAA and MedAire mention the need to have a ground-based medical
advisory provider. MedAire indicates that this service can be a
valuable resource in helping to reduce medical-related diversions. The
RAA indicates that several regional air carriers use these services
but, in every instance, the flightcrew makes the call and not the
flight attendants since air-to-ground phones are not available in the
passenger cabin on regional airplanes.
FAA response: As noted before, certificate holders can add
equipment, including communication links, if they deem the equipment
necessary. The FAA did not propose nor will it require this equipment
as it is up to the certificate holder to provide whatever care the
certificate holder deems appropriate.
New Subpart X Unnecessary
Continental Express comments that, by removing the existing
requirement in part 121, subpart K for EMK's (effective now) and
putting it into new subpart X (effective in 3 years), the EMK
requirement is inadvertently deleted in the interim. Continental
Express finds that creation of a new Subpart X is unnecessary and
cumbersome and that if the FAA intends to establish a separate subpart
for emergency medical equipment only, it also should establish separate
subparts for fire extinguishers, flotation equipment, crash axes, and
megaphones. It suggests incorporating changes to emergency medical
equipment requirements into existing subpart K and changes to
crewmember training into existing subpart N. Otherwise, it can be
construed that the air carriers will be required to provide identical
training to crewmembers under two separate training programs. Also,
removing the requirement in existing subpart K for training in ``other
abnormal situations'' removes training requirements for addressing
situations such as abusive passengers, intoxicated passengers,
passengers who might jeopardize safety, turbulence encounters, and crew
coordination.
FAA response: The requirement to carry an EMK is not deleted in
this action. Section 121.803 (c)(2) as added under new subpart X, will
continue to require an approved EMK; however, air carriers will have 36
months to modify their existing EMK's to meet the new standard. But, as
the rule language could be misread, the FAA adds new paragraph (b)(4)
under Sec. 121.805 and a new paragraph 2. under part 121, appendix A
``Emergency Medical Kits'' to be more explicit.
The requirement for training to accommodate ``other abnormal
situations'' is not deleted; it continues to be found under existing
Sec. 121.421(a)(1)(ii).
[[Page 19038]]
It is not the intent of the FAA to create a need for two separate
training programs to comply with the crewmember training requirements
outlines in Sec. 121.805. It is the intent of the FAA that these
training requirements will be incorporated into each air carriers'
approved training program.
The FAA developed a new subpart X for several reasons. Currently
provisions for emergency medical equipment are dispersed throughout
subparts N and O and, in the course of developing this action, the FAA
determined that it would be more appropriate to incorporate emergency
medical equipment requirements into one subpart. Because existing part
121 sets forth specifications for emergency medical equipment under one
separate appendix (part 121, appendix A), the FAA determined that
regulatory provisions corresponding to these specifications would be
more easily understood set forth under one separate subpart.
Noticing Intent of the Regulation in Airports and in Ticket Jackets
The International Brotherhood of Teamsters, Airline Division,
states that, to provide clear notice to the public of the intent of the
regulation, notice should be posted in airports and in ticket jackets
much the same as is required of security and hazardous materials
information.
FAA response: The FAA disagrees that signage requirements at
airports and notification in passenger ticket jackets is necessary. As
the intent of this action is to provide the certificate holder and its
agents the option of providing in-flight medical assistance, there is
no reason to alert the public by sinage that limited in-flight medical
assistance may be available from the certificate holder.
The FAA has always encouraged the public to seek qualified medical
advice before travelling regarding any medical concerns.
Other Suggested Proposals for This Action
Certain commenters request that the FAA do the following:
Staff flights with medical personnel ready to respond to
medical events.
Limit alcoholic beverages consumed on flights.
Establish a coordinated training program for crewmembers
that would link them to ground EMS.
Establish one centralized school for training flight
attendants.
Have passengers inform air carriers about particular
physical status and/or special dietary needs.
Deny air passage to pregnant women.
Maintain oxygen with a flow regulator in a container
adequate for at least 4 hours on overwater flights.
Require two separate blood-borne pathogen kits (a response
kit and a cleanup kit) containing several items.
FAA response: These suggestions are inconsistent with and beyond
the scope of the FAA's proposal. Commenters desiring these changes can
submit separate petitions to the FAA for consideration of such actions.
Other Suggested Rule Language Changes for This Action
The ATA comments that proposed Sec. 121.805(b)(3) should be deleted
in its entirety. This proposed paragraph merely says, in a different
way, what will be required by proposed Sec. 121.805(b) (1) and (2). If
this provision is not deleted, it should be clarified that the
``handling'' of medical events means only ``responding'' in a general
sense. Also, although the term ``familiarization'' is a carryover from
existing regulations, it is somewhat vague and imprecise when
contrasted with the specific requirements set forth in Sec. 121.805
(b)(1) and (2). If retained, this term should be explained.
The final rule should set forth the compliance date for training in
more direct terms than proposed, ATA states. For example, the final
rule could state:
The training required in this section shall be completed on [36
months after the effective date of the final rule.
The AFA would like the words ``programmed hours of instruction''
added to proposed Sec. 121.805 (b)(4)(iii). Further, proposed
Sec. 121.805 only mentions the word ``instruction'' therefore leaving
the reader with the implication that ``hand-on'' training would not be
required. Not requiring ``hands-on'' training with respect to CPR and
AED usage is not acceptable. Proposed Sec. 121.805 does not mention the
word ``perform'' anywhere in the text of the new sub-paragraph.
FAA Response: The FAA agrees that paragraphs (b)(1), (2), and (3)
of Sec. 121.805 may contain redundancies as proposed and has revised
these paragraphs based on the ATA's comment. These changes are made to
clarify that crewmembers are not expected to know how to use but rather
to be able to recognize, and therefore be familiar with, the content of
the EMK's.
The FAA agrees that it should specify, under Sec. 121.805, the 3-
year timeframe allowed before being required to carry enhanced EMK's
and has added a new paragraph accordingly. The FAA does not a add a
specific compliance date for completing any of the required
instruction. As noted in the NPRM, however, the required instruction
must be completed within 36 months after the effective date and before
compliance is required.
The FAA concurs with the AFA's comment and has revised Sec. 121.805
(b)(4) accordingly. To further clarify the intent of this action, the
FAA deletes references, that may have appeared erroneous, to
Sec. 121.421 (under proposed paragraphs (b)(4)(i) and (ii)) and to
Sec. 121.427 (under proposed paragraphs (b)(4) (iii)).
Reducing the Proposed 3-Year Compliance Date
Teamsters Local 2000 (representing Northwest Airlines flight
attendants) believes that the time has come to directly address the
increase in passengers needing in-flight medical assistance and the
continuing growth of passengers flying with medical conditions who are
more likely to experience an in-flight medical event. From a realistic
viewpoint, the proposed rule changes are long overdue. In fact, the 36-
month compliance date noted for the affected rule is in question, in
that many U.S. air carriers have addressed many of the provisions of
the proposal.
FAA response: Because many of the major air carriers already comply
or will comply with the proposal, the compliance date is an issue
mainly for the regional air carriers. The FAA set a 3-year compliance
date to allow those air carriers that have not made modifications
sufficient time to provide crewmember instruction and procure medical
enhancements.
Use of Equipment by Medical Professionals Only/International Civil
Aviation Organization (ICAO) Standards
The International Association of Machinists and Aerospace Workers,
AFL-CIO, suggests permitting the use of the enhanced equipment only
when qualified medical personnel are on board, or when a ground-to-air
link with qualified medical personnel can be made. This would eliminate
a flight attendant being put in the position of physician.
It also comments that it agrees with ICAO Standards on crew
training and equipment requirements and that the approach of the
proposed rule is ``way beyond the scope'' of the ICAO Standard.
[[Page 19039]]
FAA response: As explained in the NPRM, the FAA acknowledges that
it is unrealistic to expect crewmebers to achieve the same level of
proficiency as emergency medical personnel who perform medical
procedures routinely on a daily basis and that this action only adds
the option of limited in-flight medical assistance. Even in the case of
a threat-of-death, in-flight medical event when on-board medical
assistance is available, the certificate holder and its agents have to
choose what assistance, if any, to provide a stricken passenger. The
FAA does not have the authority, nor is this action intended, to
mandate or regulate health care on board commercial air carriers; it
can only require that the equipment be available.
Because the FAA will be requiring AED's, while ICAO Standards and
Recommended Practices (SARP's) do not, the FAA will exceed ICAO SARP's
for equipment in one area. This action, therefore, does not constitute
a serious difference. The FAA concurs with the ICAO Recommended
Practice that it is preferable that EMK's be used by qualified and
trained personnel but, under U.S. law, it is the certificate holder who
makes that decision. With the advent of medical assistance via radio,
certificate holders may choose to have less qualified personnel use the
EMK to assist stricken passengers under the guidance of ground-based
medical providers.
Alternative Considered
The following are alternatives the FAA could have considered for
this action:
Continue case-by-case approval, without codified
regulations, of voluntary AED carriage for those air carriers who seek
it.
Amend 14 CFR part 91 only and limit the action to
providing authority for air carriers to carry AED's on board aircraft.
Apply the proposal only to those air carriers having a
passenger seating capacity of 51 seats or more and serviced by at least
two flight attendants.
The FAA determined that, absent regulations codified under part
121, none of these options would be fully responsive to the Act and the
majority of the commenters for the following reasons:
Nothing would preclude air carriers from taking AED's off
of aircraft.
Regular maintenance and safe and appropriate usage of
AED's could not be enforced.
Enhanced emergency medical equipment would not be
available on smaller air carriers.
EMK's have been required on aircraft under 51 seats
serviced by just one flight attendant for many years. The FAA could not
justify allowing such aircraft to be exempt from modifications to be
required under part 121.
CPR instruction for flight attendants would not be
required on all passenger-carrying aircraft. CPR, not currently
required, is a necessary adjunct to AED usage as it must be initiated
and continued in the event of any of the following: the AED voice-
prompt indicates ``no shock,'' and a pulse is absent; three AED shocks
are administered to no avail; or the AED malfunctions.
Adopting the final rule as proposed appears to be the most
appropriate FAA option. The data collection conducted as directed under
the Act revealed at least 40 events in which AED's may have been used
had they been available. It also revealed four events in which AED's
were available and used to shock stricken passengers; these passengers
continue to survive today. Subsequent to the data collection, further
FAA investigation reveals that more passengers, and a crewmember, have
had similar experiences.
Many public commenters request that the FAA require more emergency
medical equipment and training than proposed. Because the FAA
determined that these additional modifications would be burden some and
would require supplemental notice for public comment, these requests
could not be considered.
Comments from the Small Business Administration (SBA), the RAA, and
Continental Express address the economic impact of this action on small
entities. These comments are described and analyzed in further detail
directly below.
Summary of Economic Comments
Small Business Administration
The SBA's comment disagrees with the FAA's statement in its NPRM
(preliminary) evaluation that the proposed rule would not have ``a
significant economic impact on a substantial number of small
entities.'' The SBA notes that the FAA's NPRM evaluation estimates that
the rule would impact 60 small air carriers, and cites to the contrary
data from the Bureau of Census to the effect that ``scheduled air
transportation firms totaled 715 employee firms. Of these, 452 firms
have less than 20 employees; 192 firms have between 20 and 499
employees. Taken together, small firms constitute 90 percent of the
industry, not 75 percent. Only 71 firms have 500 or more employee.''
The SBA also finds fault with the FAA's preliminary analysis as it
concerns (a) the threshold of ``significant impact;'' (b) the cost
estimates of AED's, EMK's, and training in terms of their being
disadvantageous to small business in particular.
FAA response: The FAA reviewed its preliminary analysis and now
agrees with the SBA that this rule will have ``a significant economic
impact on a substantial number of small entities,'' according to the
SBA formula. However, the FAA finds that the burden is neither as
significant nor is the number of small entities as substantial as the
SBA presents. As shown in Table A of the Regulatory Flexibility
Analysis (see page 22 of the Final Rule Regulatory Evaluation on file
in the Docket), this rule will impact 28 small businesses. Of these, 17
will be significantly impacted. A full discussion of the impact of this
rule on these small businesses is provided in the Regulatory
Flexibility Analysis. This section of the final rule Regulatory
Evaluation also details the procedure by which the 28 small air
carriers were identified. As noted in the Regulatory Flexibility
Analysis section of the Regulatory Evaluation on file in the Docket,
the FAA used the Fleet PCTM database product maintained by
Back Associates, Inc., first to identify all the rule-designated
airplanes (those with maximum payloads greater than 7,500 pounds) that
are active or inactive (for example, undergoing maintenance checks)
used in civil aviation by U.S. operators, and then to match the
airplanes with their operators. The resulting data were further pared
down to eliminate cargo operations, non-part 121 operations, businesses
that have 1,500 or more employees, businesses that are owned as
subsidiaries by other businesses, and businesses that are decertified
or are otherwise operationally dormant. This approach ensured that the
FAA would not omit any affected, certificated air carrier.
The group of small air carriers that resulted from this process is
volatile. Within this group, between September, 1998 and September,
2000:
DOT certificated six airlines to start operations;
DOT recertificated a previously dormant airline;
DOT decertificated four airlines, three for dormancy and
one for cause; and three airlines were in Chapter 11 (reorganization)
bankruptcy.
For this analysis, all the newly certificated airlines and the re-
certificated airline were assumed to be subject to this rule. In August
1999, one
[[Page 19040]]
of thre three bankrupt airline emerged from the Chapter 11 bankruptcy
of its parent company. Because it had not suspended its operations
during bankruptcy, because it is a non-subsidiary, and because it
reported financial data to the FAA, it is included in this analysis as
subject to this rule.
As shown in Table A of the section on Regulatory Felxibility (see
page 22 of the final rule Regulatory Evaluation, on file in the Docket)
the FAA determined that only 28 carriers \3\ with no more than 1,500
employees are certificated by the FAA to conduct operations subject to
this rule.
---------------------------------------------------------------------------
\3\ In December, 2000, one of the small carriers included in
this group suspended operations and sought Chapter 11 bankruptcy
protection. This analysis does not reflect that event.
---------------------------------------------------------------------------
The FAA's estimate of this rule's average initial burden on these
small business carriers is $43,301. In no case is this amount more than
one percent of any carrier's annual operating revenue, even though for
this analysis, the FAA assumes that these carriers will bear all the
initial cost of compliance in the first year of effectiveness, rather
than spread the costs over the first 36 months of effectiveness, as the
rule permits. The follow-on burdens of operation and upkeep were
ignored in this analysis because (a) they are much smaller than the
initial costs, (b) the financial data are limited, and (c) this carrier
size category displays short business life spans. However, because 17
of these carriers reported negative net operating revenue for the
immediately preceding reporting period (generally, which ended June 30,
2000), the FAA reasoned that these 17 could not pay the costs of
compliance from current net revenue. The FAA concludes this rule will
have ``a significant impact'' on these 17 carriers. The FAA's final
estimate of AED costs is $3,140, ready for use in flight. This estimate
was produced by combining the list price of the device with prices
known to have been paid by air carriers already in voluntary
compliance. The FAA's attenpts to learn vendor discount policy resulted
in the information that such policy was confidential, that a discount
could be given on as small an order as one AED, and that other factors,
such as early or prominent adoption, also account for discounts. Thus,
the FAA can make no conclusive statement on the availability of
discounts on AED's.
For this final rule Regulatory Evaluation, based on comments,
updates, and clarifications, the FAA also revised its estimates of
costs of AED's, EMK's and training from the values noted by SBA. The
FAA agrees with the SBA that the costs of complying with the rule will
fall disproportionately on small carriers, because 90 percent of the
affected air carrier industry (based on revenue passenger miles) is
known to already have initiated voluntary compliance. This 90 percent
includes all but one of the major air carriers and many of them small
airlines, will bear the burden of compliance with this rule when it
becomes effective.
In clarifying earlier comments to the FAA, one of the two major
vendors of AED's noted that discounts had been given on orders as small
as a single unit. This vendor noted that early or prominent adopters
were as likely as volume buyers to be given discounts.
Regional Airline Association
The RAA's comments include suggestions that the applicability of
the rule be limited to operations that require at least two flight
attendants, and that further study be devoted to the feasibility of use
of AED's and enhanced EMK's on airplanes typically operated by RAA
members.
FAA response: This FAA response replies only to the economic and
not to the physical or operational feasibility implications of this
rule, which the FAA already has discussed above. Table B of the
Regulatory Flexibility Analysis (see page 28 of the Regulatory
Evaluation, on file in the Docket), shows that of 185 RAA members, only
28 will be impacted by this rule. Fifteen of the 28 are subsidiaries of
larger businesses. Nine more non-subsidiary air carriers have code-
sharing or other affiliation arrangements with other, larger
businesses.
One thousand two hundred and fifty-nine airplanes of the total
fleet of airplanes operated by these 28 air carriers will be subject to
this rule. Only 132 of these airplanes offer 51 or more seats and thus
require two or more attendants. The FAA has no reason to believe that
the population of passengers on the 30-50 seat airplanes operated by
RAA members is different in terms of its medical needs than the
passengers on the 627,956 American Airlines departures equipped with
AED's on which AED use was studied in 1997-1999. Thus the FAA believes
that similar benefits would be generated on flights by RAA members and
by American Airlines, when those flights are operated subject to this
rule. Because the FAA in its regulatory evaluation determined this rule
to be cost-beneficial, the FAA believes that applying this rule only to
132 of the 1,259 affected airplanes operated by RAA members would be
likely to be less cost-beneficial than applying it to all.
Continental Express
As above, this response addresses only specific economic comments.
Continental Express provides very detailed cost estimates of its burden
of complying with the rule. The Continental Express comment extends
item cost estimates for AED's, EMK's, and training, to its fleet and to
its staff of attendants.
FAA response: Generally, the FAA accepted Continental Express's
cost breakdown structure categories and incorporated them into its
final rule evaluation. The FAA did not accept all of its estimates of
item cost.
The FAA believes that its estimate more closely resembles actual
industry practice than Continental Express' estimate. The FAA's
procedure (shown in Tables 2, 3, and 4 of the Regulatory Evaluation, on
file in the Docket) tracked the provisions of the rule that allow each
carrier 36 months to bring its existing fleet and staff into
compliance. Thus, the FAA estimated costs separately for each of the 10
years of the period of analysis including 2001 through 2011 and
discounted each annual total to its present value. In contrast,
Continental Express provides 10-year lump sum totals.
The FAA's estimate also differed from Continental Express' in
distinguishing between the existing fleet of airplanes that require
only to have their EMK's brought up to enhanced status (1,194 airplanes
at $155 each) and those newly added airplanes added annually at 4.1
percent growth rate to the fleet from 2001 (49) through 2011 (70 at
$514 each).
The FAA accepted Continental Express' assertion of the need to
annually train the attendants who must be hired to replace those lost
through attrition at the annual rate of 20 percent. The FAA used the
same elements and rates of cost that Continental Express provided for
its training cost estimate, but the FAA believes this training is
better characterized as taking one day instead of two. Thus, the FAA
maintains Continental Express' training cost of 4 hours of flight pay
credit per day of training cost of 4 hours of flight pay credit per day
of training at $28 per hour, but applies it to one day. The FAA retains
the Continental Express estimate of $94 per night for lodging for one
night, but applies the estimate of $32.40 per diem allowance to only
one day.
The FAA reduced Continental Express' estimate of $3,500 per AED to
$3,000 to reflect prices known to have been paid by air carriers. The
FAA
[[Page 19041]]
retained Continental Express' estimate of $140 for installation. The
FAA departed from Continental Express' estimate of $30 to enhance
existing EMK's, and continued to rely on its NPRM cost of $155 for
enhancement only for the fleet in existence at the base year, 2000. For
the new airplanes to be added annually afterward, the FAA used the list
price of $514 for the bottom-of-the-line enhanced EMK. In summary, to a
great extent, the FAA incorporated Continental Express' economic
comments into its estimate.
However, as the FAA shows in Table B of the Regulatory Flexibility
Analysis (on file in the Docket), and also as reported on the Form 10K
report filed for the year 1999 by Continental Airlines, Inc., with the
Securities and Exchange Commission of the United States, Continental
Express is a wholly-owned subsidiary of Continental Airlines, Inc.,
which already has initiated voluntary compliance with this rule. This
relationship implies that the cost burden presented by Continental
Express would be borne by its parent, Continental Airlines, Inc., in a
manner similar to that in which other parent corporations, such as AM
Corp., Inc., already bear the cost of voluntarily equipping their
wholly-owned subsidiaries, such as American Airlines, Inc., and
American Eagle Holding Company (American Eagle) Inc., to comply with
this rule.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), the FAA has determined that there are no requirements for
information collection associated with this proposed rule.
International Compatibility
In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to review International
Civil Aviation Organization (ICAO) Standards and Recommended Practices
(SARP's) and to comply to the maximum extent possible.
ICAO Standard (Annex 6, Part 1, Chapter 6, Section 6.2.2) states
that airplanes shall be equipped with ``accessible and adequate medical
supplies appropriate to the number of passengers the aeroplane is
authorized to carry.'' ICAO Recommended Practice (Annex 6, Part 1,
Chapter 6, Section 6.2.2) states that medical supplies should comprise
``one or more first-aid kids'' and ``a medical kit for the use of
medical doctors or other qualified persons in treating in-flight
medical emergencies for aeroplanes authorized to carry more than 250
passengers.'' Attachment B to this Recommended Practice lists, in part,
the ``typical contents'' of first-aid kits and emergency medical kits.
Part 121, Appendix A, as currently drafted, complies with those
ICAO SARO's insofar as first-aid kits and emergency medical kits are
required to be carried. Part 121, Appendix A does not include all ICAO-
recommended emergency medical kit items under ICAO Attachment B,
however, and does not specify who is authorized to use the emergency
medical kit.
The FAA has added to the emergency medical kits those items
warranted for inclusion as a result of its study entitled ``The
Evaluation of In-Flight Medical Care Aboard Selected U.S. Air Carriers
from 1996 to 1997'' and those items necessary to support AED protocol.
The FAA concurs with the recommendation that emergency medical kits be
used by qualified and trained personnel only. Adding such a requirement
to part 121, however, would involve defining the various medical
specialties and, perhaps, limiting access to the extent that the only
person available to assist on a flight might not be included.
ICAO Standard (under Annex 6, Part 1, Chapter 12, Section 12.4)
states, in part, that cabin attendants shall complete training programs
that ensure that each person is ``drilled and capable in the use of
emergency and life-saving equipment required to be carried, such as * *
*, first-aid kits.'' Existing Secs. 121.417 and 121.805 comply with
these ICAO guidelines.
ICAO SARPS do not address AED usage on aircraft.
Executive Order 12866 and DOT Regulatory Policies and Procedures
Executive Order 12866, Regulatory Planning and Review, directs the
FAA to assess both the costs and benefits of a regulatory change. We
are not allowed to propose or adopt a regulation unless we make a
reasoned determination that the benefits of the intended regulation
justify its costs. Our assessment of this proposal indicates that its
economic impact is minimal.
Economic Evaluation, Regulatory Flexibility Determination, Trade Impact
Assessment, and Unfunded Mandates Assessment
Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 requires agencies to analyze the
economic impact of regulatory changes on small entities. Third, the
Trade Agreements Act (19 U.S.C. section 2531-2533) prohibits agencies
from setting standards that create unnecessary obstacles to the foreign
commerce of the United States. In developing U.S. standards, this Trade
Act requires agencies to consider international standards and, where
appropriate, that they be the basis of U.S. standards. Fourth, the
Unfunded Mandates Reform Act of 1995 requires agencies to prepare a
written assessment of the costs, benefits and other effects of proposed
or final rules that include a Federal mandate likely to result in the
expenditure by State, local or tribal governments, in the aggregate, or
by the private sector, or $100 million or more, in any one year
(adjusted for inflation).
In conducting these analyses, the FAA has determined that this
rule: (1) Has benefits which do justify its costs, is not a
``significant regulatory action'' as defined in the Executive Order but
is ``significant'' as defined in DOT's Regulatory Policies and
Procedures; (2) will have a significant impact on a substantial number
of small entities; (3) has a minimal impact on international trade; and
(4) does not impose an unfunded mandate on state, local, or tribal
governments, or on the private sector. These analyses, available in the
Docket, are summarized below.
The Evolution of the Estimates of Benefits and Costs
While this final rule evaluation derives directly from the NPRM
evaluation, the cost estimates are lower and the benefits estimates are
higher for the final rule than for the NPRM. The reasons for these
differences are as follows:
The extent of voluntary compliance by affected carriers
has increased since the NPRM was issued. The carriers known to have
initiated voluntary compliance account for about 90 percent of revenue
passenger miles flown by carriers subject to this final rule. Thus,
this analysis applies only to those carriers not now in voluntary
compliance;
The increased extent of voluntary compliance reduced the
base year fleet and staff estimates for non-complying carriers from
2,600 to 1,194 airplanes, and from 54,400 to 25,500 attendants;
The final rule evaluation assumed currently non-complying
carriers would take the full 36 months allowed by the rule to equip
their existing airplanes and to train their existing attendants;
Reviewing, updating, and clarifying the comments to the
NPRM resulted in
[[Page 19042]]
the upward revision of the costs of some items, including training and
the fully enhanced EMKs, and in its downward revision of the costs of
the AEDs; and
Review of a study published in the October 26, 2000 New
England Journal of Medicine resulted in revising the estimated ten-year
forecasts of averted (statistical) fatalities upward from 55 to 94.8.
The Estimate of Benefits
Quantifiable Benefits
The FAA estimate of the total benefits is based principally on the
findings of a study based on American Airlines operations and published
in the New England Journal of Medicine October 26, 2000. Considering
only those passengers flying on carriers not already in voluntary
compliance, the FAA expects the number of fatalities averted because of
this rule becoming effective will total to 95 over the 10-year period
of analysis that includes 2001 through 2010. This total compares to the
55 of the NPRM evaluation.
Based on the $2,700,000 value of an averted fatality, the total
quantifiable safety benefit over the ten year period of analysis is
about $176.8 million dollars, when discounted at seven percent annually
to its present (year 2000) value as prescribed by OMB. Viewed over 10
years, this discounted value converts to uniform annual benefits of
about $25.2 million dollars.
Unquantifiable Benefits
The FAA has identified but has not attempted to quantify benefits
from the availability of enhanced EMK's, and also from the use of AED's
apart from the benefits of defibrillation. Incidental to their use in
defibrillation, AED's detect and provide electrocardiographic (EKG's)
parameters of passenger/patients. Properly interpreted by a passenger/
physician, these EKG's possibly can rule out the necessity for
diverting a flight, as otherwise might be determined prudent absent a
properly interpreted EKG readout. Further, the availability of on-board
enhanced EMK's for use by a passenger/physician could rule out the
necessity of diverting a flight. Because flight diversions are costly,
their reduction is a benefit, but the FAA has not attempted to quantify
it.
The Estimate of Costs
The comments to the NPRM resulted in the FAA's upward revision of
the costs of some items, including AED's, enhanced EMK's and training.
For example, the vendor's list price of $514 for the entry-level EMK
was determined to be a more accurate reflection of carriers' costs than
was the NPRM estimate. The FAA estimate of initial training costs was
raised from its NPRM value of $151 to $238.40. The new estimate
reflects partial acceptance of the costs provided by a commenter who
postulated 2 days of initial training at $384. The FAA estimate applies
that commenter's cost elements over 1 day of training. For this final
rule evaluation, a 20 percent annual attrition rate among attendants
was included in the computation of training costs. The cost of a
defibrillator was decreased from its NPRM $3,500 list price to $3,000,
reflecting reports of actual pricing. Installation costs of $140 were
added to this acquisition cost. The annual operational cost of the
current generation of AED batteries and pads was increased to $157.50
from $100 as clarified and updated by a vendor/commenter.
For AED's EMK's and training, this final rule evaluation assumes
each affected carrier not already in voluntary compliance will spread
fleet complianace over the full 36 months allowed by the rule. This
means that for AED's and enhanced EMK's the base year 2000 fleet of
1,194 airplanes will be brought to compliance at the rate of one third
of this fleet or 398 airplanes per year. In like manner, the base year
complement of about 25,500 attendants to be trained will be trained at
8,481 per year until all are trained.
These estimates also incorporated new airplanes and new attendants
assumed to be added annually in step with FAA estimates of industry
growth. Finally, this estimate included one-half day of recurrent
training at 2-year intervals.
The FAA totaled all the expected costs over the 10-year period
including 2001 through 2010 (the period of analysis) of this regulatory
proposal. The present value of this cost stream was calculated using a
discount factor of seven percent annually.
The FAA's estimates of the costs of this final rule are as follows:
AEDs....................................................... $5,759,129
Enhanced EMKs.............................................. 1,692,184
Training................................................... 8,848,821
Fuel weight penalty........................................ 319,860
------------
Total................................................ 16,619,994
Uniform Annual Cost over ten years......................... 2,366,687
Benefits/Costs Comparison
Discounted to their present (year 2000) value, the benefits of this
rule are about $176.8 million. The present value of the total costs of
this rule is about $16.6 million dollars. Viewed over the 10-year
period of analysis, the comparison of uniform costs and benefits is
about $25.2 million dollars annually for benefits and about $2.4
million dollars annually for costs. This final rule is cost beneficial.
Regulatory Flexibility Determination
The Regulatory Flexibility Act of 1980 (RFA) was enacted by
Congress to ensure that small entities (small business and small not-
for-profit government jurisdictions) are not unnecessarily and
disproportionately burdened by Federal regulations. The RFA, which was
amended March 1996, requires regulatory agencies to review rules to
determine if they have ``a significant economic impact on a substantial
number of small entities.'' The Small Business Administration defines
small entities to be those airlines with 1,500 or fewer employees for
the air transportation industry.
For this final rule, the small entity group of interest is drawn
from among those air carriers that are certificated by the FAA to
operate under 14 CFR part 121, and which have 1,500 or fewer employees.
The final rule specifically applies to the use by such carriers of
airplanes that have maximum payloads of more than 7,500 pounds and
more. Although this rule also encompasses air carriers certificated to
operate under 14 CFR part 135, the rule as it regards them includes
only a non-substantive editorial change, with no economic impact. Thus
for operators certificated under 14 CFR part 135, the economic impact
of this final rule on such carriers is negligible.
The FAA determined this final rule will have a significant economic
impact on a substantial number of small entities. Twenty-eight small
business air carriers will feel the impact of this rule. To ensure that
the estimated burden of these small carriers would not be understated,
the FAA assumed they would undertake to comply with the rule within 1
year, instead of the 3 allowed. In no case was the actual burden
estimated to be greater than one percent of annual operating income.
However, because 17 of these carriers had negative net operating income
for the year that ended June 30, 2000, the FAA stipulates that these
carriers cannot meet the costs of this rule out of their operating
income.
International Trade Impact Assessment
The Trade Agreement Act of 1979 prohibits Federal agencies from
engaging in any standards or related activities that create unnecessary
obstacles to the foreign commerce of the United States. Legitimate
domestic
[[Page 19043]]
objectives, such as safety, are not considered unnecessary obstacles.
The statute also requires consideration of international standards and
where appropriate, that they be the basis for U.S. standards. In
addition, consistent with the Administration's belief in the general
superiority and desirability of free trade, it is the policy of the
Administration to remove or diminish to the extent feasible, barriers
to international trade, including both barriers affecting the export of
American goods and services to foreign countries and barriers affecting
the import of foreign goods and services into the United States.
In accordance with the above statute and policy, the FAA has
assessed the potential effect of this final rule and has determined
that it will have little or no effect on trade-sensitive activities.
U.S. carriers that have voluntarily upgraded their emergency medical
equipment account for a majority of the U.S.-flag international
service. The FAA believes that the popularity among U.S. carriers of
the provisions of this rule extends to foreign carriers in
international flights to and from the United States. The FAA is aware
that many foreign carriers carry AEDs on flights to and from the United
States. Among those of which the FAA is aware are the following: Aegean
Airlines; Air Canada; Air Zimbabwe; British Airways; Cathay Pacific;
Emirates Airlines; Finnair; Iberia; Malev; Quantas; Swiss Air; Varig;
And Virgin Atlantic.
Final Unfunded Mandates Assessment
The Unfunded Mandates Reform Act of 1995 (the Act.), enacted as
Pub. L. 104-4 on March 22, 1995, is intended, among other things, to
curb the practice of imposing unfunded Federal mandates on States,
local, and tribal governments.
Title II of the Act requires each Federal agency to prepare a
written statement assessing the effects of any Federal mandate in a
proposed or final agency rule that may result in a $100 million or more
expenditure (adjusted annually for inflation) in any one year by State,
local, and tribal governments, in the aggregate, or by the private
sector; such a mandate is deemed to be a ``significant regulatory
action.''
This final rule does not contain such a mandate. Therefore, the
requirements of Title II of the Unfunded Mandates Reform Act of 1995 do
not apply.
Executive Order 13132, Federalism
The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, or the
relationship between the national Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. Therefore, we determined that this final rule does not have
federalism implications.
Environmental Analysis
FAA Order 1050.1D defines FAA actions that may be categorically
excluded from preparation of a National Environmental Policy Act (NEPA)
environmental impact statement. In accordance with FAA Order 1050.1D,
appendix 4, paragraph 4(j), this rulemaking action qualifies for a
categorical exclusion.
Energy Impact
The energy impact of the notice has been assessed in accordance
with the Energy Policy and Conservation Act (EPCA) Pub. L. 94-163. as
amended (42 U.S.C. 6362) and FAA Order 1053.1. It has been determined
that the final rule is not a major regulatory action under the
provisions of the EPCA.
List of Subjects
14 CFR Part 121
Air carriers, Aircraft, Airmen, Alcohol abuse, Aviation safety,
Charter flights, Drug abuse, Drug testing, Reporting and recordkeeping
requirements, Safety, Transportation.
14 CFR Part 135
Aircraft, Airmen, Aviation safety, Reporting and recordkeeping
requirements.
The Amendment
In consideration of the foregoing, the Federal Aviation
Administration amends parts 121 and 135 of Title 14, Code of Federal
Regulations (14 CFR parts 121 and 135) as follows:
PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL
OPERATIONS
1. The authority citation for part 121 continues to read as
follows:
Authority: 49 U.S.C. 106(g), 40113, 40119, 44101, 44701-44702,
44705, 44709-44711, 44713, 44716-44717, 44722, 44901, 44903-44904,
44912, 46105.
2. Amend Sec. 121.303 by revising paragraphs (b) and (d)(2) to read
as follows:
Sec. 121.303 Airplane instruments and equipment.
* * * * *
(b) Instruments and equipment required by Secs. 121.305 through
121.359 and 121.803 must be approved and installed in accordance with
the airworthiness requirements applicable to them.
* * * * *
(d) * * *
(2) Instruments and equipment specified in Secs. 121.305 through
121.321, 121.359, 121.360, and 121.803 for all operations, and the
instruments and equipment specified in Secs. 121.323 through 121.351
for the kind of operation indicated, wherever these items are not
already required by paragraph (d)(1) of this section.
* * * * *
Sec. 121.309 [Amended]
3. Amend Sec. 121.309 by removing and reserving paragraph (d).
4. Amend Sec. 121.323 by revising the introductory text to read as
follows:
Sec. 121.323 Instruments and equipment for operations at night.
No person may operate an airplane at night under this part unless
it is equipped with the following instruments and equipment in addition
to those required by Secs. 121.305 through 121.321 and 121.803:
* * * * *
5. Amend Sec. 121.325 by revising the introductory text to read as
follows:
Sec. 121.325 Instruments and equipment for operations under IFR or
over-the-top.
No person may operate an airplane under IFR or over-the-top
conditions under this part unless it is equipped with the following
instruments and equipment, in addition to those required by
Secs. 121.305 through 121.321 and 121.803:
* * * * *
6. Amend Sec. 121.415 by revising paragraph (a)(3) to read as
follows:
Sec. 121.415 Crewmember and dispatcher training requirements.
(a) * * *
(3) For crewmembers, emergency training as specified in
Secs. 121.417 and 121.805.
* * * * *
Sec. 121.417 [Amended]
7. Amend Sec. 121.417 by removing and reserving paragraphs
(b)(2)(ii) and (b)(3)(iv).
8 Amend Sec. 121.427 by revising paragraph (b)(2) to read as
follows:
Sec. 121.427 Recurrent training.
* * * * *
(b) * * *
(2) Instruction as necessary in the subjects required for initial
ground training by Sec. Sec. 121.415(a) and 121.805,
[[Page 19044]]
as appropriate, including emergency training (not required for aircraft
dispatchers).
* * * * *
9. Amend part 121 by adding subpart X to read as follows:
Sec.
Subpart X--Emergency Medical Equipment and Training
121.801 Applicability.
121.803 Emergency medical equipment.
121.805 Crewmember training for in-flight medical events.
Subpart X--Emergency Medical Equipment and Training
Sec. 121.801 Applicability.
This subpart prescribes the emergency medical equipment and
training requirements applicable to all certificate holders operating
passenger-carrying airplanes under this part. Nothing in this subpart
is intended to require certificate holders or its agents to provide
emergency medical care or to establish a standard of care for the
provision of emergency medical care.
Sec. 121.803 Emergency medical equipment.
(a) No person may operate a passenger-carrying airplane under this
part unless it is equipped with the emergency medical equipment listed
in this section.
(b) Each equipment item listed in this section--
(1) Must be inspected regularly in accordance with inspection
periods established in the operations specifications to ensure its
condition for continued serviceability and immediate readiness to
perform its intended emergency purposes;
(2) Must be readily accessible to the crew and, with regard to
equipment located in the passenger compartment, to passengers;
(3) Must be clearly identified and clearly marked to indicate its
method of operation; and
(4) When carried in a compartment or container, must be carried in
a compartment or container marked as to contents and the compartment or
container, or the item itself, must be marked as to date of last
inspection.
(c) For treatment of injuries, medical events, or minor accidents
that might occur during flight time each airplane must have the
following equipment that meets the specifications and requirements of
appendix A of this part:
(1) Approved first-aid kits.
(2) In airplanes for which a flight attendant is required, an
approved emergency medical kit.
(3) In airplanes for which a flight attendant is required, an
approved emergency medical kit as modified effective April 12, 2004.
(4) In airplanes for which a flight attendant is required and with
a maximum payload capacity of more than 7,500 pounds, an approved
automated external defibrillator as of April 12, 2004.
Sec. 121.805 Crewmember training for in-flight medical events.
(a) Each training program must provide the instruction set forth in
this section with respect to each airplane type, model, and
configuration, each required crewmember, and each kind of operation
conducted, insofar as appropriate for each crewmember and the
certificate holder.
(b) Training must provide the following:
(1) Instruction in emergency medical event procedures, including
coordination among crewmembers.
(2) Instruction in the location, function, and intended operation
of emergency medical equipment.
(3) Instruction to familiarize crewmembers with the content of the
emergency medical kit.
(4) Instruction to familiarize crewmembers with the content of the
emergency medical kit as modified on April 12, 2004.
(5) For each flight attendant--
(i) Instruction, to include performance drills, in the proper use
of automated external defibrillators.
(ii) Instruction, to include performance drills, in cardiopulmonary
resuscitation.
(iii) Recurrent training, to include performance drills, in the
proper use of an automated external defibrillators and in
cardiopulmonary resuscitation at least once every 24 months.
(c) The crewmember instruction, performance drills, and recurrent
training required under this section are not required to be equivalent
to the expert level of proficiency attained by professional emergency
medical personnel.
10. Revise Appendix A to part 121 as follows:
Appendix A to Part 121--First Aid Kits and Emergency Medical Kits
Approved first-aid kits, at least one approved emergency medical
kit, and at least one approved automated external defibrillator
required under Sec. 121.803 of this part must be readily accessible
to the crew, stored securely, and kept free from dust, moisture, and
damaging temperatures.
First-aid Kits
1. The minimum number of first aid kits required is set forth in
the following table:
------------------------------------------------------------------------
No. of
No. of passenger seats first-aid
kits
------------------------------------------------------------------------
0-50......................................................... 1
51-150....................................................... 2
151-250...................................................... 3
More than 250................................................ 4
------------------------------------------------------------------------
2. Except as provided in paragraph (3), each approved first-aid
kit must contain at least the following appropriately maintained
contents in the specified quantities:
------------------------------------------------------------------------
Contents Quantity
------------------------------------------------------------------------
Adhesive bandage compresses, 1-inch.......................... 16
Antiseptic swabs............................................. 20
Ammonia inhalants............................................ 10
Bandage compresses, 4-inch................................... 8
Triangular bandage compresses, 40-inch....................... 5
Arm splint, noninflatable.................................... 1
Leg splint, noninflatable.................................... 1
Roller bandage, 4-inch....................................... 4
[[Page 19045]]
Adhesive tape, 1-inch standard roll.......................... 2
Bandage scissors............................................. 1
------------------------------------------------------------------------
3. Arm and leg splints which do not fit within a first-aid kit
may be stowed in a readily accessible location that is as near as
practicable to the kit.
Emergency Medical Kits
1. Until April 12, 2004, at least one approved emergency medical
kit that must contain at least the following appropriately
maintained contents in the specified quantities:
------------------------------------------------------------------------
Contents Quantity
------------------------------------------------------------------------
Sphygmomanometer............................... 1
Stethoscope.................................... 1
Airways, cropharyngeal (3 sizes)............... 3
Syringes (sizes necessary to administer 4
required drugs).
Needles (sizes necessary to administer required 6
drugs).
50% Dextrose injection, 50cc................... 1
Epinephrine 1:1000, single dose ampule or 2
equivalent).
Diphenhydramine HC1 injection, single dose 2
ampule or equivalent.
Nitroglycerin tablets.......................... 10
Basic instructions for use of the drugs in the 1
kit.
protective nonpermeable gloves or equivalent... 1 pair
------------------------------------------------------------------------
2. As of April 12, 2004, at least one approved emergency medical
kit that must contain at least the following appropriately
maintained contents in the specified quantities:
------------------------------------------------------------------------
Contents Quantity
------------------------------------------------------------------------
Sphygmonanometer............................... 1
Stethoscope.................................... 1
Airways, oropharyngeal (3 sizes): 1 pediatric, 3
1 small adult, 1 large adult or equivalent.
Self-inflating manual resuscitation device with 1:3 masks
3 masks (1 pediatric, 1 small adult, 1 large
adult or equivalent).
CPR mask (3 sizes), 1 pediatric, 1 small adult, 3
1 large adult, or equivalent.
IV Admin Set: Tubing w/ 2 Y connectors......... 1
Alcohol sponges............................ 2
Adhesive tape, 1-inch standard roll 1
adhesive.
Tape scissors.............................. 1 pair
Tourniquet................................. 1
Saline solution, 500 cc........................ 1
Protective nonpermeable gloves or equivalent... 1 pair
Needles (2-18 ga., 2-20 ga., 2-22 ga., or sizes 6
necessary to administer required medications).
Syringes (1-5 cc, 2-10 cc, or sizes necessary 4
to administer required medications).
Analgesic, non-narcotic, tablets, 325 mg....... 4
Antihistamine tablets, 25 mg................... 4
Antihistamine injectable, 50 mg, (single dose 2
ampule or equivalent).
Atropine, 0.5 mg, 5 cc (single dose ampule or 2
equivalent).
Aspirin tablets, 325 mg........................ 4
Bronchodilator, inhaled (metered dose inhaler 1
or equivalent).
Dextrose, 50%/50 cc injectable, (single dose 1
ampule or equivalent).
Epinephrine 1:1000, 1 cc, injectable, (single 2
dose ampule or equivalent).
Epinephrine 1:10,000, 2 cc, injectable, (single 2
dose ampule or equivalent).
Lidocaine, 5 cc, 20 mg/ml, injectable (single 2
dose ampule or equivalent).
Nitroglycerin tablets, 0.4 mg.................. 10
Basic instructions for use of the drugs in the 1
kit.
------------------------------------------------------------------------
3. If all of the above-listed items do not fit into one
container, more than one container may be used.
Automated External Defibrillators
At least one approved automated external defibrillator, legally
marketed in the United States in accordance with Food and Drug
Administration requirements, that must:
1. Be stored in the passenger cabin.
2. Meet FAA Technical Standard Order requirements for power
sources for electronic devices used in aviation as approved by the
Administrator.
3. Be maintained in accordance with the manufacturer's
specifications.
PART 135--OPERATING REQUIREMENTS: COMMUTER AND ON-DEMAND OPERATIONS
AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT
12. The authority citation for part 135 continues to read as
follows:
Authority: 49 U.S.C. 106(g), 44113, 44701-44702, 44705, 44709,
44711-44713, 44715-44717, 44722.
13. Amend Sec. 135.177 by revising paragraph (a)(1) to read as
follows:
Sec. 135.177 Emergency equipment requirements for aircraft having a
passenger seating configuration of more than 19 passengers.
(a) * * *
[[Page 19046]]
(1) At least one approved first-aid kit for treatment of injuries
likely to occur in flight or in a minor accident that must:
(i) Be readily accessible to crewmembers.
(ii) Be stored securely and kept free from dust, moisture, and
damaging temperatures.
(iii) Contain at least the following appropriately maintained
contents in the specified quantities:
------------------------------------------------------------------------
Contents Quantity
------------------------------------------------------------------------
Adhesive bandage compresses, 1-inch............ 16
Antiseptic swabs............................... 20
Ammonia inhalants.............................. 10
Bandage compresses, 4-inch..................... 8
Triangular bandage compresses, 40-inch......... 5
Arm splint, noninflatable...................... 1
Leg splint, noninflatable...................... 1
Roller bandage, 4-inch......................... 4
Adhesive tape, 1-inch standard roll............ 2
Bandage scissors............................... 1
Protective nonpermeable gloves or equivalent... 1 pair
------------------------------------------------------------------------
* * * * *
Issued in Washington, DC, on April 6, 2001.
Jane F. Garvey,
Administrator.
[FR Doc. 01-8932 Filed 4-11-01; 8:45 am]
BILLING CODE 4910-13-M