[Federal Register Volume 59, Number 96 (Thursday, May 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12154]


[[Page Unknown]]

[Federal Register: May 19, 1994]


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Part IV





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Ch. I




Medical Devices; Performance Standards for Electrode Lead Wires; 
Requests for Comments and Information; Public Conference; Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Ch. I

[Docket No. 94N-0078]

 
Medical Devices; Performance Standards for Electrode Lead Wires; 
Requests for Comments and Information; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; notice of public 
conference.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
intent to establish special controls, including the promulgation of 
performance standards, for medical devices that use electrode lead 
wires. The agency is taking this action because it has determined that 
special controls are needed to prevent hazardous electrical connections 
between patients and electrical power sources. FDA is also announcing a 
public conference on this advance notice of proposed rulemaking 
(ANPRM). FDA will consider any comments or other information received 
in response to this ANPRM and information gleaned from the conference 
when proposing the special controls for devices using electrode lead 
wires.

DATES: Written comments by August 17, 1994. The public conference will 
be held on July 15, 1994, from 8:30 a.m. to 5 p.m. To register for the 
conference, please contact Sociometric, Inc. (address below) by June 
24, 1994.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857. The public conference will be held at the Sheraton 
Washington Hotel, 2660 Woodley Rd. NW., Washington, DC 20008.

FOR FURTHER INFORMATION CONTACT:
    Regarding the ANPRM: Marquita B. Steadman, Center for Devices and 
Radiological Health (HFZ-84), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4765.
    Regarding the conference: Kathy Pointer, Sociometric, Inc., 8308 
Colesville Rd., suite 550, Silver Spring, MD 20910, 301-608-2151 or 
301-608-3542 (facsimile).

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's Center for Devices and Radiological Health (CDRH) issued an 
alert letter in June 1985 to manufacturers, home user support 
organizations, and apnea monitor users, announcing that CDRH had 
received reports of one death and two electrical burns that occurred 
when unsupervised children plugged the male connector pins of the 
electrode lead wires from a home apnea monitor system into either 
alternating current (AC) power cords or a wall outlet, rather than into 
the patient cable which connects to the monitor (Ref. 1). In that 
letter, the agency announced its intention to embark on a cooperative 
effort with industry and the medical profession to resolve the problem 
of potential electrical connection between patients and electrical 
power sources. FDA also requested each manufacturer to evaluate its 
device for potential electrode lead wire and patient cable hazards and, 
when necessary, to consider design changes to preclude insertion of 
lead wire connectors into AC power cords and outlets. In response, 
manufacturers voluntarily began to redesign their electrode lead wires 
and patient cables for home apnea monitors. In addition to issuing the 
alert letter, CDRH's July 1985 Medical Devices Bulletin (a periodic 
publication that is distributed to the healthcare community and 
manufacturers) was devoted in great part to publicizing the lead wire 
hazard (Ref. 2).
    Since 1985, FDA has cleared for marketing only those home use apnea 
monitors with patient cables and lead wires designed to prevent unsafe 
electrical connections. This protective design has also been required 
for all apnea monitors cleared for marketing since 1989, whether or not 
they were intended for home use. Nonetheless, some hospitals continue 
to use older units, or lead wires and patient cables from other 
devices, which do not have the protective design. Even with the new 
models, it may be possible for staff to switch patient cables and/or 
lead wires, thereby creating a hazard.
    On August 25, 1993, a 12-day old infant being monitored for apnea 
was electrocuted in a hospital, in Chicago, IL. FDA's investigation of 
the incident confirmed that the patient electrode lead wires were 
unprotected. Specifically, the male connector pins were not protected 
to prevent unsafe electrical connections. Although the infant apnea 
monitor involved in that incident had been sold with safety protected 
lead wires and patient cable, an unprotected patient cable from another 
manufacturer and unprotected lead wires from a third manufacturer were 
being used when the infant was electrocuted.
    In response to this incident, on September 3, 1993, FDA issued a 
safety alert to hospital administrators, risk managers, and pediatric 
department directors, warning them that the use of unsafe electrode 
lead wires with an apnea monitor may be dangerous to the patient, and 
may be in violation of section 518(a) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360h(a)) (Ref. 3). FDA included in 
the alert a number of recommendations to help prevent these accidents.
    On that same day, FDA also sent all apnea monitor manufacturers a 
notification letter under section 518(a) of the act (Ref. 4). Section 
518(a) of the act authorizes the agency to require that notification be 
provided when it is necessary to eliminate an unreasonable risk of 
substantial harm to the public health and when no other practicable 
means is available under the act to eliminate such risk. FDA determined 
that manufacturer notification under section 518(a) of the act to all 
hospitals, clinics, distributors, and suppliers of apnea monitors was 
necessary to eliminate the unreasonable risk of harm to infants and 
other apnea monitor patients from unprotected lead wires and patient 
cables. FDA stated that notification should include replacement of 
unprotected lead wires and patient cables, and that a warning label 
should be permanently affixed to all monitors stating that unprotected 
lead wires and patient cables should not be used with the device 
because inappropriate electrical connections may pose an unreasonable 
risk of adverse health consequences or death. FDA also requested 
manufacturers of all apnea monitors to cease further distribution of 
unprotected lead wires and patient cables. On September 20, 1993, FDA 
issued a similar letter to all known manufactures of patient cables and 
lead wires (Ref. 5).
    FDA also has received reports of injuries associated with unsafe 
lead wires and patient cables involving medical devices other than 
apnea monitors (Ref. 6). In 1986, for example, a death resulted in a 
hospital from electrocardiogram (ECG) lead wires being plugged into an 
infusion pump power cord. Similarly, in 1990, a death occurred when 
neonatal monitor lead wires were inserted into a pulse oximeter power 
cord. FDA has received additional reports of similar events that 
resulted in electrical shocks and burns to patients. The agency also 
has received reports of ECG monitor lead wires being inserted into 
power sources, causing patient injuries. Finally, FDA has received one 
report of patient shock involving an electroencephalograph cable.
    Manufacturers of devices other than apnea monitors that utilize 
patient electrodes, e.g., ECG, have been encouraged by various 
organizations to modify their lead wires so that they cannot be 
inserted into AC power cords or outlets. In February 1987 and May 1993, 
the Emergency Care Research Institute (ECRI) issued hazard reports 
concerning electrical shock hazards from unprotected lead wires and 
patient cables in its publication ``Health Devices'' (Ref. 7). On July 
15, 1991, the Underwriters Laboratories (UL) amended its Standard for 
Medical and Dental Equipment (UL 544) to require patient-connected lead 
wires to be designed to avoid connection to electrical power sources. 
This requirement became effective on December 1, 1991 (Ref. 8). In 
March 1993, the International Electrotechnical Commission (IEC) 
published a standard for ECG machines, including a safety requirement 
for leads (601-2-25) (Ref. 9). The IEC, as well as the Association for 
the Advancement of Medical Instrumentation (AAMI), are in the process 
of developing a standard for all leads. There is also an existing 
German standard (DIN 42 802) which has been adopted by some U.S. 
manufacturers in their design of safety protected lead wires (Ref. 10).
    On December 28, 1993, FDA issued a Public Health Advisory to 
hospital nursing directors, risk managers, and biomedical/clinical 
engineering departments for distribution to all units in their 
hospitals and outpatient clinics, as well as to home health care 
providers and suppliers affiliated with those facilities, advising them 
of the hazards associated with use of electrode lead wires with 
unprotected male connector pins. (Ref. 11). In the Public Health 
Advisory, FDA expanded the scope of its September 3, 1993, apnea 
monitor safety alert to include all devices using patient electrodes. 
FDA noted that, even though manufacturers have changed the design of 
their devices to minimize the potential hazard, some facilities are 
still using older models that make it possible for staff to switch 
patient cables and/or lead wires, thus creating a hazard. FDA 
recommended various precautions to prevent the use of unsafe lead wires 
and patient cables.

II. Revisions Under Consideration

    In accordance with section 513(a) of the act (21 U.S.C. 360c(a)), 
FDA has classified medical devices intended for human use into one of 
three regulatory classes, i.e., class I, general controls; class II, 
special controls; and class III, premarket approval. Classification 
depends on the extent of control necessary to assure the safety and 
effectiveness of each device. Apnea monitors, as well as many other 
medical devices that use patient electrodes, are classified into class 
II. Class II devices are devices for which general controls by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness of the device, and for which there is sufficient 
information to establish special controls to provide such assurance 
(see 21 CFR 860.3(c)(2)). Possible special controls include the 
issuance of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines (including 
guidelines for the submission of clinical data in premarket 
notification submissions in accordance with section 510(k) of the act 
(21 U.S.C. 360(k)), recommendations, and other appropriate actions as 
FDA deems necessary to provide such assurance. (See section 
513(a)(1)(B) of the act.)
    The agency recognizes that, despite efforts to eliminate the risk, 
unprotected lead wires and patient cabling systems are still 
distributed by some manufacturers as replacements for existing 
equipment, and may also be interchangeable among various medical 
devices. In order to reduce the risks to health presented by these 
devices, the agency is considering establishing special controls for 
devices that use lead wires. The agency believes these controls should 
include, but not be limited to, the development of a performance 
standard.
    FDA believes that the development of a performance standard is 
necessary to reduce or eliminate the hazards of unprotected lead wires 
and patient cables. The DIN standard is a design, rather than a 
performance, standard, and may be too restrictive for application to 
all devices. While the proposed AAMI and IEC standards for all leads 
are more general, they are not yet completed. Therefore, the agency is 
considering establishing a standard that resembles the UL standard. The 
agency will consider other standards, however, that are finalized 
before completion of this rulemaking process. FDA is also considering 
revising CDRH's Office of Device Evaluation's ``blue book'' to reflect 
the agency's policy of not clearing for marketing unprotected male pins 
that may be used with any device with patient electrodes.
    FDA is soliciting comments on the issuance of a performance 
standard that would eliminate the risk of burns and death associated 
with placing an unprotected electrode lead wire directly into a power 
source.
    FDA is soliciting comments on all aspects of this ANPRM, and 
specifically requests comments on the following issues:
    1. The current extent of manufacturing, distribution, and use of 
unprotected patient cables and electrode lead wires as replacement 
products.
    2. Advantages, if any, of using unprotected electrode lead wires 
with particular medical devices.
    3. The devices, if there are any, that cannot accept redesigned 
electrode lead wires or patient cables.
    4. Cost to manufacturers and the user community to convert to 
protected electrode lead wires and patient cables for all medical 
devices.
    5. Extent of substitution, if any, of unprotected nonmedical 
electrode lead wires and patient cables, for use as medical device 
electrode lead wires and patient cables.
    6. Essential components of a performance standard for lead wires 
and patient cables.
    7. Viability of applying a performance standard across device 
types.
    8. Alternative solutions to the removal of all unprotected 
electrode lead wires from the market, such as banning them under 21 CFR 
part 895.

III. Public Conference

    FDA, the Health Industries Manufactures Association, and the 
American Hospital Association are sponsoring a public conference 
entitled ``Unprotected Patient Cables and Electrode Lead Wires'' to be 
held on July 15, 1994. The purpose of the conference is to: (1) Focus 
attention on medical devices that use unprotected electrode lead wires; 
(2) bring together patient cable and lead wire manufacturers, device 
manufactures, distributors, users, and purchasers to facilitate 
understanding of the electrode lead wire problem and possible 
solutions, including the development of performance standards, and the 
announcement of new regulatory policy for all devices that use patient 
electrodes; (3) solicit industry and user input concerning FDA's 
intention to develop a new regulatory framework for devices that use 
patient electrodes; (4) identify the extent of existing and potential 
design and user problems, including design applicability for specific 
devices; and (5) identify the economic impact of the proposed solutions 
to these problems.

IV. Comments

    FDA is particularly interested in comments from inventors, patient 
cable and lead wire manufacturers, device manufacturers, purchasers, 
and users of devices that use electrode lead wires. Comments from other 
interested individuals or groups are also welcome. FDA advises that, 
under 21 CFR 10.30(d), any comments submitted in response to this 
document will be included under the docket number found in brackets in 
the heading of this document.
    Interested persons may, on or before August 17, 1994, submit to the 
Dockets Management Branch (address above), written comments regarding 
this ANPRM. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

V. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. Form letter from FDA to manufacturers, home user support 
organizations, and apnea monitor users, June 1985.
    2. Center for Devices and Radiological Health's Medical Devices 
Bulletin, July 1985.
    3. FDA's September 3, 1993, Safety Alert.
    4. Section 518(a) notification letter to apnea monitor 
manufacturers, September 3, 1993.
    5. Section 518(a) notification letter to patient cable and lead 
wire manufacturers, September 20, 1993.
    6. Information from FDA's medical device reporting (MDR) data 
base.
    7. ECRI's publications, ``Health Devices Alert,'' February, 
1979, ``Health Devices,'' May 1993.
    8. Underwriters Laboratories' Standard for Safety Medical and 
Dental Equipment (UL 544).
    9. International Electrotechnical Commissions' Safety 
Requirements for Medical Electrical Equipment (IEC Standard 601-1; 
601-2-25).
    10. German DIN Standard 42 802.
    11. FDA Public Health Advisory: Unsafe Electrode Lead Wires and 
Patient Cables Used With Medical Devices, December 28, 1993.

    Dated: May 12, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-12154 Filed 5-18-94; 8:45 am]
BILLING CODE 4160-01-F