[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Proposed Rules]
[Pages 11140-11151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04578]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2016-N-0400]
General and Plastic Surgery Devices; Reclassification of Blood
Lancets
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed order.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
proposing to reclassify the following three types of blood lancets used
to puncture skin to obtain a drop of blood for diagnostic purposes from
class I (general controls) exempt from premarket notification into
class II (special controls) and subject to premarket review: Single use
only blood lancets with an integral sharps injury prevention feature,
single use only blood lancets without an integral sharps injury
prevention feature, and multiple use blood lancets for single patient
use only. FDA is identifying proposed special controls for these types
of blood lancets that we believe are necessary to provide a reasonable
assurance of safety and effectiveness. FDA is also proposing to
reclassify multiple use blood lancets for multiple patient use from
class I (general controls) exempt from premarket notification into
class III (premarket approval). FDA is proposing the reclassification
of these four types of blood lancets on its own initiative based on new
information.
DATES: Submit either electronic or written comments on the proposed
order by June 1, 2016. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 (PRA) by April 4, 2016, (see
the ``Paperwork Reduction Act of 1995'' section of this document). See
section X of the SUPPLEMENTARY INFORMATION section of this document for
the proposed effective date of any final order that may publish based
on this proposal.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a
[[Page 11141]]
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-0400 for ``General and Plastic Surgery Devices;
Reclassification of Blood Lancets.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit comments on information collection issues to the Office of
Management and Budget (OMB) in the following ways:
Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
[email protected]. All comments should be identified with the
title, ``General and Plastic Surgery Devices; Reclassification of Blood
Lancets.''
FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G422, Silver Spring, MD 20993-0002, 301-796-6524;
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71,
Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as
amended, established a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories (classes) of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
Section 513(a)(1) of the FD&C Act defines the three classes of
devices. Class I devices are those devices for which the general
controls of the FD&C Act (controls authorized by or under section 501,
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h,
360i, or 360j) or any combination of such sections) are sufficient to
provide reasonable assurance of safety and effectiveness; or those
devices for which insufficient information exists to determine that
general controls are sufficient to provide reasonable assurance of
safety and effectiveness or to establish special controls to provide
such assurance, but because the devices are not purported or
represented to be for a use in supporting or sustaining human life or
for a use which is of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury, are to be regulated by general controls (section
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for
which general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, but for which there
is sufficient information to establish special controls to provide such
assurance, including the promulgation of performance standards,
postmarket surveillance, patient registries, development and
dissemination of guidelines, recommendations, and other appropriate
actions the Agency deems necessary to provide such assurance (section
513(a)(1)(B) of the FD&C Act). Class III devices are those devices for
which insufficient information exists to determine that general
controls and special controls would provide a reasonable assurance of
safety and effectiveness, and are purported or represented for a use in
supporting or sustaining human life or for a use which is of
substantial importance in preventing impairment of human health, or
present a potential unreasonable risk of illness or injury (section
513(a)(1)(C) of the FD&C Act). Under section 513(d)(1) of the FD&C Act,
devices that were in commercial distribution before the enactment of
the 1976 amendments, May 28, 1976 (generally referred to as
``preamendments devices''), are classified after FDA: (1) Receives a
recommendation from a device classification panel (an FDA advisory
committee); (2) publishes the panel's recommendation for comment, along
with a proposed regulation classifying the device; and (3) publishes a
final regulation classifying the device. FDA has classified most
preamendments devices under these procedures.
Devices that were not in commercial distribution before May 28,
1976 (generally referred to as ``postamendments devices'') are
classified automatically by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval, unless and until: FDA reclassifies
the device into class I or II; or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
[[Page 11142]]
device that does not require premarket approval. The Agency determines
whether new devices are substantially equivalent to previously marketed
devices by means of premarket notification procedures in section 510(k)
of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21
CFR part 807). A person may market a preamendments device that has been
classified into class III through premarket notification procedures
without submission of a PMA until FDA issues a final order under
section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket
approval.
On July 9, 2012, Congress enacted the Food and Drug Administration
Safety and Innovation Act (FDASIA). Section 608(a) of FDASIA amended
section 513(e) of the FD&C Act, changing the reclassification process
from rulemaking to administrative order. Section 513(e)(1) of the FD&C
Act sets forth the process for issuing a final order. Specifically,
prior to the issuance of a final order reclassifying a device, the
following must occur: Publication of a proposed order in the Federal
Register, a meeting of a device classification panel described in
section 513(b) of the FD&C Act, and consideration of comments to a
public docket. The proposed reclassification order must set forth the
proposed reclassification and a substantive summary of the valid
scientific evidence concerning the proposed reclassification, including
the public health benefits of the use of the device, and the nature and
incidence (if known) of the risk of the device. (See section
513(e)(1)(A)(i) of the FD&C Act.)
Section 513(e)(1) provides that FDA may, by administrative order,
reclassify a device based on ``new information.'' FDA can initiate a
reclassification under section 513(e) or an interested person may
petition FDA. The term ``new information,'' as used in section 513(e)
of the FD&C Act, includes information developed as a result of a
reevaluation of the data before the Agency when the device was
originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos v.
United States Dep't of Health, Educ. & Welfare, 587 F.2d 1173, 1174 n.1
(D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell
v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical
science.'' (See Upjohn v. Finch, 422 F.2d at 951.) Whether data before
the Agency are past or new data, the ``new information'' to support
reclassification under section 513(e) must be ``valid scientific
evidence,'' as defined in section 513(a)(3) of the FD&C Act and 21 CFR
860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C.
Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.
1985), cert. denied, 474 U.S. 1062 (1985).)
II. Regulatory History of the Device
Blood lancets were classified in part 878 (21 CFR part 878) in a
final rule published in the Federal Register on June 24, 1988 (53 FR
23856) that classified 51 general and plastic surgery devices. This
1988 rule classified blood lancets into class I (general controls).
These devices were grouped with other devices under ``Manual surgical
instrument for general use'' in Sec. 878.4800 (21 CFR 878.4800). At
the time, blood lancets had been in common use in medical practice for
many years, and FDA believed that general controls were sufficient to
provide reasonable assurance of the safety and effectiveness of those
devices. The rule was amended on April 5, 1989 (54 FR 13826) to clarify
that manual surgical instruments for general use made of the same
materials as used in preamendment devices were exempt from premarket
notification 510(k) review.
On December 7, 1994, FDA further amended the classification when it
published a final rule in the Federal Register (59 FR 63005) that
exempted 148 class I devices from premarket notification, with
limitations. Blood lancets were one of those devices. FDA determined
that manufacturers' submissions of premarket notifications were
unnecessary for the protection of the public health and that FDA's
review of such submissions would not advance its public health mission.
On August 26, 2010, FDA and the Centers for Disease Control and
Prevention (CDC) issued a joint initial communication warning that the
use of fingerstick devices (blood lancets) to obtain blood from more
than one patient posed a risk of transmitting bloodborne pathogens. The
communication was updated on November 29, 2010 (Ref. 1). FDA's
communication update, ``Use of Fingerstick Devices on More Than One
Person Poses Risk for Transmitting Bloodborne Pathogens: Initial
Communication: Update 11/29/2010'' stated that ``[o]ver the past 10-15
years, the CDC and FDA have noted a progressive increase in reports of
bloodborne infection transmission (primarily hepatitis B virus [HBV])
resulting from the shared use of fingerstick and POC [or `Point of
Care'] blood testing devices.'' FDA and CDC recommended, among other
things, that health care professionals and patients never use a blood
lancet for more than one person.
On November 29, 2010, FDA published a guidance entitled ``Guidance
for Industry and Food and Drug Administration Staff; Blood Lancet
Labeling'' (75 FR 73107) (Ref. 2). This guidance includes labeling
recommendations to address concerns that both health care providers and
patients may be unaware of the serious adverse health risks associated
with using the same blood lancet for assisted withdrawal of blood from
more than one patient, even when the blood lancet blade is changed for
each blood draw. FDA recommends in the guidance that all blood lancets
be labeled for use only on a single patient. FDA recommends in the
guidance that a statement limiting use to a single patient should also
appear on the label attached to the device, if possible. The guidance
was for immediate implementation. When final, this order will supersede
this labeling guidance.
On June 26, 2013, FDA held a meeting of the General and Plastic
Surgery Devices Panel of the Medical Devices Advisory Committee (the
Panel) to discuss the potential reclassification of blood lancets (Ref.
3). The Panel discussed new scientific information (see section VII of
this document), the risks to health from blood lancets, whether blood
lancets should be reclassified or remain in class I, and possible
special controls for these devices if reclassified into class II. The
Panel agreed that general controls were not sufficient to provide a
reasonable assurance of safety and effectiveness of any of the four
types of blood lancets (the four types are explained in section III).
The Panel believed that because multiple use blood lancets for multiple
patient use presented a potential unreasonable risk of illness or
injury, and insufficient information existed to establish special
controls for these devices, they should be reclassified into class III.
The Panel recommended that all other blood lancet devices be
reclassified into class II (special controls). FDA is not aware of new
information since this Panel meeting that would provide a basis for a
different recommendation or findings.
III. Device Description
A blood lancet is used to puncture the skin to obtain small blood
specimens for testing blood glucose, hemoglobin, and
[[Page 11143]]
other blood components. Some blood lancets are used with POC blood
testing devices, such as blood glucose meters and Prothrombin Time and
International Normalized Ratio (PT/INR) anticoagulation meters. Today,
probably the most common use for a blood lancet is in diabetes
monitoring. These devices are used in both home and professional health
care settings. Only a small blood sample is needed for testing of blood
glucose level. The blood sample is dropped onto a test strip and
inserted into a blood glucose meter for results.
FDA has identified four subsets of blood lancets:
1. A single use only blood lancet with an integral sharps injury
prevention feature is a disposable blood lancet intended for a single
use that is comprised of a single use blade attached to a solid, non-
reusable base (including an integral sharps injury prevention feature)
that is used to puncture the skin to obtain a drop of blood for
diagnostic purposes. The integral sharps injury prevention feature
allows the device to be used once and then renders it inoperable and
incapable of further use;
2. A single use only blood lancet without an integral sharps injury
prevention feature is a disposable blood lancet intended for a single
use that is comprised of a single use blade attached to a solid, non-
reusable base that is used to puncture the skin to obtain a drop of
blood for diagnostic purposes;
3. A multiple use blood lancet for single patient use only is a
multiple use capable blood lancet intended for use on a single patient
that is comprised of a single use blade attached to a solid, reusable
base that is used to puncture the skin to obtain a drop of blood for
diagnostic purposes; and
4. A multiple use blood lancet for multiple patient use is a
multiple use capable blood lancet intended for use on multiple patients
that is comprised of a single use blade attached to a solid, reusable
base that is used to puncture the skin to obtain a drop of blood for
diagnostic purposes.
IV. Proposed Reclassification
A. Single Patient Use Only Blood Lancets
FDA is proposing to reclassify the following three subsets of blood
lancets from class I (general controls) exempt from premarket review to
class II (special controls) and subject to premarket review: (1) Single
use only blood lancets with an integral sharps injury prevention
feature, (2) single use only blood lancets without an integral sharps
injury prevention feature, and (3) multiple use blood lancets for
single patient use only. FDA believes that general controls by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness for these devices, and that there is sufficient
information to establish special controls to provide such assurance.
The Food and Drug Administration Modernization Act (FDAMA) (Pub. L.
105-115) added section 510(m) to the FD&C Act. Section 510(m) of the
FD&C Act provides that a class II device may be exempted from the
premarket notification requirements under section 510(k) of the FD&C
Act, if the Agency determines that premarket notification is not
necessary to assure the safety and effectiveness of the device. The
Agency does not intend to exempt these devices from premarket
notification (510(k)) submission as allowed under section 510(m) of the
FD&C Act. FDA believes premarket notification is necessary for these
devices to provide a reasonable assurance of safety and effectiveness.
B. Multiple Patient Use Blood Lancets
FDA is proposing that a fourth subset of blood lancets, multiple
use blood lancets for multiple patient use, be reclassified from class
I (general controls) without premarket review to class III (premarket
approval). FDA believes that insufficient information exists to
determine that general controls and special controls would provide a
reasonable assurance of safety and effectiveness for these devices,
which present a potential unreasonable risk of illness or injury (see
section 513(a)(1)(C) of the FD&C Act).
Elsewhere in this issue of the Federal Register, FDA is proposing
to require the filing of a PMA or notice of completion of a product
development protocol (PDP) for these devices, which will be finalized
only if FDA reclassifies multiple use blood lancets for multiple
patient use to class III.
FDA continues to believe that multiple use blood lancets for use in
multiple patients present significant risks to public health.
Specifically, multiple patient use blood lancets pose a risk of
transmission of bloodborne pathogen infections, including HBV and
hepatitis C. Bloodborne pathogens may be transmitted between patients
by blood or blood products taken from a patient with a transmissible
infection. FDA believes that certain design characteristics would be
required to help mitigate these risks. For example, multiple use blood
lancets for use in multiple patients would need to be designed to allow
for rigorous, thorough cleaning plus a disinfection or sterilization
process capable of reduction of bloodborne pathogens to a clinically
acceptable level between each use in a different patient in order to be
safe for this intended use. The cleaning and disinfection/sterilization
process to be used to render a multiple use blood lancet safe for use
in multiple patients would need to be effective in spite of potential
health care provider noncompliance with manufacturer's Instructions for
Use. More importantly, the multiple use blood lancet for use in
multiple patients would need to be designed such that repeat operation
of the device is not possible until the device has been thoroughly
cleaned and disinfected, using validated processes, by the health care
user. Such a mechanism is necessary to prevent health care providers,
especially those working in facilities that provide relatively little
staff education or supervision, such as assisted living facilities
(ALF), from failing to comply with manufacturer recommendations
regarding rendering multiple patient use blood lancets safe for use in
more than one patient. Therefore, the safety of the multiple use blood
lancets for multiple patients, especially the effectiveness of their
design and reprocessing instructions to render the device safe for use
on more than one patient and the ability of health care providers to
follow these instructions completely, must be rigorously demonstrated,
independently of any other blood lancet. Because blood lancets for use
on multiple patients present a potential unreasonable risk of illness
or injury and insufficient information exists for FDA to determine that
special controls would provide reasonable assurance of safety and
effectiveness of the device, the Agency believes that these devices
should be reclassified into class III.
V. Public Health Benefits and Risks to Health
As required by section 513(e)(1)(A)(I) of the FD&C Act, FDA is
providing a substantive summary of the valid scientific evidence
regarding the public health benefit of blood lancets, and the nature
and, if known, the incidence of the risk of the devices. Since the
1990s, because of outbreaks of HBV infections associated with blood
lancets and meters used in blood glucose monitoring, CDC and FDA have
recommended that blood lancets should be limited to one individual's
use (Refs. 1 and 4 to 6). Nevertheless, there have been continuing
reports of bloodborne pathogen transmission from the shared use of
blood lancets. Improper use of blood lancets can endanger public
health, and FDA is concerned about the persistent risk of transmission
of
[[Page 11144]]
hepatitis and other bloodborne pathogens when blood lancets are used to
obtain blood from more than one patient in health care settings.
Certain bloodborne pathogens, such as HBV, are very stable at ambient
temperatures and HBV infected patients, who often lack clinical
symptoms of hepatitis, can have high concentrations of HBV in their
blood or body fluids, thus serving as unsuspected sources of the
infectious agent available for transmission to other patients when
blood lancets are misused (Refs. 7 to 32).
These findings were discussed by the June 26, 2013, General and
Plastic Surgery Devices Panel. The Panel agreed that the risks to
health identified in this section are applicable to blood lancet
devices, particularly the risk of cross-contamination between patients
when the same lancet is used on multiple patients (Ref. 3).
After considering the information discussed by the Panel and in
published literature, as well as medical device reports relating to
blood lancets, and reported outbreaks of various bloodborne pathogen
infections, FDA believes that the risks to health associated with the
use of blood lancets are (1) bloodborne pathogen transmission, (2)
sharp object injuries, (3) local tissue infections, and (4) adverse
tissue reaction (not infection). The June 26, 2013, Panel also believed
that these were the risks for the device (Ref. 3).
A. Bloodborne Pathogen Transmission
Bloodborne pathogens such as HBV, hepatitis C virus, and
potentially any other pathogen present in the bloodstream of a patient
can be transmitted from one patient to another by the following
mechanisms:
Reuse of the same lancet blade to draw blood from more
than one patient or
Failure/inability to adequately clean the base of a
multiple use blood lancet resulting in the blood contamination of the
next ``new'' lancet blade when blood is drawn from more than one
patient.
B. Sharp Object Injuries
The blade of a blood lancet device is designed to pierce the skin
and draw blood. Except when the used lancet blade is immediately and
automatically covered by a sharps safety feature, which renders the
blade inaccessible, the exposed sharp blade of a blood lancet presents
a puncture hazard to anyone coming in contact with it. Blade exposure
can result due to either the lack of a sharps safety feature or device
breakage.
C. Local Tissue Infections
Human skin always carries a population of bacteria and often fungi
(normal skin flora), which causes no problem for the host when skin is
intact. However, puncture injuries to the skin by sharp objects such as
blood lancet blades can carry these microbes into the normally sterile
tissue below the skin. Such injuries have the potential to cause local
skin/soft tissue infections.
D. Adverse Tissue Reaction (Not Infection)
Tissue contact with some materials, metals, and material colorants
can cause skin inflammation, irritation, or exanthems (rashes). These
reactions may be due to either hypersensitivity to a specific compound/
metal or to a non-specific reaction.
VI. Summary of Reasons for Reclassification
FDA believes that blood lancets for use on a single patient only
should be reclassified into class II because special controls, in
addition to general controls, can be established to provide reasonable
assurance of safety and effectiveness of the device. FDA further
believes that blood lancets for use on multiple patients should be
reclassified into class III because multiple patient use blood lancets
present a potential unreasonable risk of illness or injury and
insufficient information exists for FDA to determine that special
controls would provide reasonable assurance of safety and effectiveness
of the device.
The June 26, 2013 reclassification Panel recommended that single
patient blood lancets be reclassified into class II and multiple
patient blood lancets into class III. The Panel did not believe that
general controls alone were sufficient to ensure the safety and
effectiveness of blood lancets. The Panel believed that special
controls could be established to provide reasonable assurance of the
safety and effectiveness of single use blood lancets, with and without
integral sharps injury prevention features, and multiple use lancets
for single patients, but that special controls could not be established
to provide reasonable assurance of safety and effectiveness for
multiple use lancets for multiple patients. Hence, the Panel agreed
that blood lancets for use on a single patient only should be
reclassified into class II (special controls), and multiple use lancets
for multiple patients should be reclassified into class III (premarket
approval).
VII. Summary of Data Upon Which the Reclassification Is Based
FDA uses the bloodborne pathogens definition in 29 CFR
1910.1030(b). Bloodborne pathogens, such as HBV, may be transmitted
between patients by blood and certain body fluids (Ref. 32). Since HBV-
infected patients, who often lack clinical symptoms of hepatitis, have
high concentrations of HBV in their blood and HBV is stable at ambient
temperatures, transmission of HBV may result from exposure to equipment
that has not been adequately disinfected or by the misuse of ``single
use only'' medical devices (e.g., needles and syringes) (Ref. 33).
The history of recognized bloodborne pathogen transmission by blood
lancets may have started in 1923 when an outbreak of jaundice occurred
in the Goteborg Hospital diabetic clinic in Sweden, which was described
by Schmid, et al. (Ref. 10). All patients had blood drawn for glucose
testing from their ear lobes by a spring-activated ``Schnepper''
device, which was cleaned ``perfunctorily'' between uses. As a result,
26 clinic patients developed jaundice. Outbreaks of hepatitis in
English diabetic patients were described by Graham in 1938 (Ref. 11)
and by Droller in 1945 (Ref. 12). In both of these outbreaks, venous
blood for glucose measurement was drawn using syringes that were only
chemically disinfected between uses while the needles were boiled;
cleaning procedures were not mentioned in the reports. Syringes and
needles are now single-use-only devices because the procedures used to
reprocess these devices many years ago have long been recognized to be
inadequate, resulting in outbreaks of hepatitis transmission (Ref. 10).
There were also two case reports, in 1985 and 1997, of the transmission
of HBV infection due to sharing personal use blood lancets for home
glucose monitoring with one other person who already had HBV. One
report was from the United States and one was from Hungary (Refs. 13
and 14). In addition, Mendez et al. reported a 75-year-old patient with
diabetes who died of acute hepatitis, whose only risk factor for HBV
infection appeared to be her diabetic care at a local outpatient
facility where she had repeated fingersticks for blood glucose
monitoring (Ref. 15).
During the 1990s, several bloodborne pathogen transmission issues
led to CDC and FDA involvement. In 1990, CDC learned of a nosocomial
outbreak of HBV transmission due to the use of a spring-loaded lancet
device whose disposable platform was not removed
[[Page 11145]]
and discarded after each use of the device while it was used for the
care of multiple patients (Ref. 4).\1\ CDC reported this outbreak to
FDA; FDA then issued a safety alert warning users of the precautions
needed for the safe use of this device (Ref. 5). This was the first
reported outbreak of HBV transmission associated with the use of a
blood lancet device in the United States (Refs. 5 and 7).
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\1\ Hepatitis B and hepatitis C infections, as well as other
bloodborne infections such as HIV infection, are reported to State
health departments and, by them, to CDC; FDA does not usually
receive such reports directly from health care facilities or
personnel, even when a medical device has transmitted the infection.
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CDC's outbreak investigation revealed that a patient who had
diabetes and also a chronic HBV infection caused by a relatively rare
viral subtype was admitted to the outbreak ward in 1989. Twelve of the
23 patients who acquired HBV after admission to the same ward as the
chronic HBV source patient were serotyped, and all were found to have
the same viral subtype causing their HBV infections. The first
nosocomially infected patient had a very long-term stay on the ward and
so served as a source of transmission to other patients over a period
of 12 months. Twenty of the 23 outbreak patients had diabetes; they and
the three other case-patients all experienced numerous POC fingerstick
blood draws with the same type of blood lancet while hospitalized on
the outbreak ward. The implicated blood lancet device included a
disposable platform to stabilize the patient's finger; the single use
lancet blade penetrated a hole in that platform to reach the patient's
skin. Half the ward nursing staff who performed fingersticks with this
lancet acknowledged not changing the device platform with each use of
the lancet. A similar outbreak of hepatitis transmission was reported
in 1990 in France in which a similar blood lancet device was
implicated. Douvin et al. (Ref. 8) reported that examination of the
device implicated in the French outbreak showed visible blood
contamination of the lancet platform in 24 percent of studied uses of
that device. Shier et al. (Ref. 9) reported in 1993 that the use of
another spring-loaded lancet device in a volunteer study of blood
glucose levels resulted in visible blood contamination on 29 percent of
the device end caps. This device was intended for ``personal'' use
only.
As a result of the 1990 outbreak of HBV transmission due to blood
lancet use in the United States, FDA and CDC recommended that spring-
loaded blood lancet devices should have only single use only
``platforms'' as well as single use only blades; the devices were to be
cleaned and disinfected per the manufacturer's instructions (Refs. 4
and 5). The 1990 FDA Safety Alert also advised ``Devices [blood
lancets] without a removable platform should only be used with one
patient in the hospital or outpatient setting. After the patient is
discharged, the device may be reused only if it is disinfected
according to the manufacturer's instructions. If there are no
instructions for disinfection, the device should be discarded.''
Since 1990, the incidence of diabetes mellitus has increased
significantly in the United States, especially in adults aged 65-79
(Refs. 34 and 35). At the same time, clinical practice in the care of
these patients increasingly emphasized the need for improved blood
glucose level control, resulting in the increased use of POC blood
glucose monitoring both in health care facilities and at home (Refs. 36
to 38). Unfortunately, along with the increased incidence of diabetes
has come a progressive increase in the reports of bloodborne infection
transmission (primarily HBV), resulting from the shared use of
fingerstick and POC blood testing devices (Ref. 1). In 2011, the CDC
reported that 25 of 29 outbreaks of HBV infection occurring in long-
term care facilities since 1996 involved adults with diabetes receiving
assisted blood glucose monitoring (Ref. 39).
In 1997, CDC reported two outbreaks of HBV transmission, one in a
nursing home in Ohio and one in a hospital in New York City (NYC) (Ref.
16). Two different blood lancet devices were used at the two sites.
However, both lancet devices included the use of an ``end cap'' that
came in contact with patient skin. This was a separate, individual use
component of the lancet device used in Ohio; the nursing home was
reusing both the lancet and the cap for multiple patients. The end cap
was a part of the disposable, single use only lancet blade assembly in
the device used in NYC. The exact mechanism of blood transmission was
not entirely clear in the NYC setting; staff claimed they had discarded
the end cap after each use. CDC postulated that either blood-
contaminated nurses gloves worn for the care of multiple patients or
the pen-like lancet-holding device itself might have been the source of
the blood cross-contamination of the lancet. A similar outbreak was
reported by Quale et al. in 1998 from a hospital in New York (Ref. 17).
The recognition of 3 cases of nosocomially acquired HBV infection
resulted in an investigation that uncovered another 11 cases. Reuse by
hospital staff of a disposable lancet end cap with the lancet in
multiple patients was identified as the probable cause of hepatitis
cross-transmission to patients; contamination of the lancet wound from
blood on unchanged gloves worn by nurses during collection of blood
samples from multiple patients may also have contributed to the
nosocomial transmission of HBV in this outbreak.
CDC reviewed the incidence of reported outbreaks of HBV and
hepatitis C infection in nonhospital health care settings between 1998
and 2008 and noted a significant increase in such nosocomial
transmission of bloodborne pathogens (Refs. 18 to 21). N.D. Thompson et
al. identified 33 outbreaks of nosocomial hepatitis transmission in
nonhospital health care settings (Ref. 18). Of these 33 outbreaks, 15
were found to be due to blood glucose monitoring in long-term care
facilities. Only half of these outbreak investigations were published
in the scientific literature; the others were recognized by health
department investigations and reports to CDC. In 9 of the 15 outbreaks
of nosocomial hepatitis in patients with diabetes, blood lancet devices
were shared among multiple patients. In two additional outbreaks,
lancets were not noted to be shared, but blood-soiled glucose meters
were stored together with lancets without cleaning/disinfection of the
devices and gloves were not regularly changed between each patient.
These failures of proper infection control practice could have led to
blood contamination of individual blood lancets in these two
facilities.
N.D. Thompson et al. also investigated blood glucose monitoring
practices in long-term care facilities in Pinellas County, FL, in 2007
and found that 22 percent of the participating facilities that used
reusable fingerstick devices used them in multiple patients (Ref. 22).
Patel et al. reported in 2009 on the efforts of the Virginia Department
of Health to improve blood glucose monitoring practices in ALFs in
Virginia (Ref. 23). This effort followed two separate outbreaks of HBV
infections in two ALFs. In those outbreaks, one of the three acutely
symptomatic initial patients died of HBV infection. Of 68 patients
undergoing blood glucose monitoring in these 2 facilities, a total of
11 patients acquired HBV infection. Both facilities used reusable blood
lancets to obtain blood from multiple patients and did not clean or
disinfect them between uses. The Virginia Department of Health then
mailed an educational packet on safe blood glucose monitoring practices
to all ALFs (640) in the State. A random sample of
[[Page 11146]]
ALFs was contacted after the educational intervention and invited to
participate in a survey to evaluate the response to the educational
packet. The results found that 16 percent of the facilities that used
lancets to monitor blood glucose levels were still using these devices
to obtain blood from multiple patients.
Y.G. McIntosh et al. investigated outbreaks of nosocomial HBV
transmission in four ALFs between 2009 and 2011 and found that in all
four facilities, pen-style lancets were used to obtain blood for
glucose monitoring from multiple patients even though two facilities
provided each patient with dedicated ``single patient use only pen-
style lancets'' according to their policies (Ref. 24). Z. Moore et al.
reported another outbreak of nosocomial HBV transmission in an ALF in
North Carolina in 2010 in which blood lancet devices were shared among
multiple patients. Six of the eight elderly patients who acquired acute
HBV in this outbreak died from complications of hepatitis (Ref. 25).
M.K. Schaefer et al. surveyed a stratified, random sample of ambulatory
surgery centers (ASCs) in three volunteer states in 2009 (Ref. 26). Of
the 53 ASCs that performed blood glucose monitoring, 11 (21 percent)
reused pen-style blood lancets on multiple patients and 17 (32 percent)
also failed to clean and disinfect blood glucose meters after each use.
Thompson and Schaefer reported the analysis of four outbreaks of
nosocomial HBV in ALFs in 2009-2010 (Ref. 27). One was also reported
separately by Z. Moore et al. (Ref. 24). Two of the three other
outbreaks occurred in Virginia and one in Florida; these 3 outbreaks
resulted in 21 new patients acquiring acute HBV. In two of the three
facilities, use of reusable blood lancets to draw blood from multiple
patients was observed or reported. The third facility denied that it
permitted the sharing of reusable lancets. However, used lancets and
glucose meters were stored together, along with clean supplies; visible
blood contamination was observed on several glucose meters and one
reusable lancet by the investigator. Thompson and Schaefer also
reported in their paper on two patient notification campaigns resulting
from the misuse of reusable blood lancets with preloaded lancet
cartridges, intended and cleared only for single patient use, which
were used to obtain blood from multiple patients. One episode involved
a community health center and was reported when personnel noted that
the lancet blades were not retracting properly, which might have
resulted in blade use for more than one patient. The second episode
occurred at a community health fair in which physician assistant
students were offering diabetes screening. During the fair, the
students realized that the lancet blades had not been advanced properly
so that each patient received a new blade. The first episode exposed
283 patients to a contaminated lancet blade; the second incident
exposed approximately 60 patients. The results of the patient
notification studies were not reported.
As a result of this significant increase in such nosocomial
transmission of bloodborne pathogens, on August 26, 2010, FDA and the
CDC issued a Safety Communication (Ref. 1) and a Clinical Reminder
(Ref. 6), respectively, warning that the use of blood lancets to obtain
blood from more than one patient risks the transmission of bloodborne
pathogen infections from one patient to other patients. Both FDA and
CDC recommended that blood lancets should never be used to obtain blood
from more than one patient. In addition, the Centers for Medicare and
Medicaid Services issued a Survey and Certification Memorandum for
Point of Care Devices and Infection Control in Nursing Homes
identifying the use of blood lancet devices for more than one patient
as an infection control standards deficiency (Ref. 40). On November 29,
2010, FDA issued ``Guidance for Industry and Food and Drug
Administration Staff: Blood Lancet Labeling,'' which provided guidance
for lancet manufacturers on the labeling of all blood lancets,
including those capable of reuse, as ``single patient use only''
devices (Ref. 2).
In 2012, another outbreak of acute HBV was reported in an ALF in
Virginia (Ref. 28). The source patient had been recently transferred
from another ALF where she had acquired nosocomial HBV infection from
the shared use of blood lancets for multiple patients (Ref. 24). This
ALF also reused blood lancets to obtain blood from multiple patients
for glucose monitoring. This dangerous practice resulted in two new
nosocomial HBV infections in this ALF.
Outbreaks of hepatitis transmission due to use of blood lancets to
draw blood from more than one patient for blood glucose monitoring have
not been limited to the United States. In 2001, Desenclos et al.
described an outbreak of nosocomial hepatitis C transmission in an
inpatient ward for children with cystic fibrosis and diabetes in a
French hospital in 1994-1995 (Ref. 29). Blood glucose monitoring was
done by the nursing staff for the patients with cystic fibrosis as well
as for the patients with diabetes using a spring-loaded lancet with a
disposable platform to stabilize the finger. These devices were shared
among patients between 1986 and 1992 during repeated admissions to the
inpatient unit. After 1992, patients were supposed to use only their
own lancet devices for blood glucose monitoring. The retrospective
prevalence of prior hepatitis C infection was found to be 58 percent in
patients with cystic fibrosis and 17 percent in patients with diabetes
in 1994. At the time (1994), the prevalence of antibody to hepatitis C
in the general public in France was 1.1 percent. The patients with
cystic fibrosis had more frequent and longer admissions to the
inpatient ward and more of the exposed cystic fibrosis patients (66.7
percent) were screened for hepatitis C infection than were the patients
with diabetes admitted to the inpatient ward during the exposure period
(39.5 percent). These factors may have influenced the apparent
difference in hepatitis C transmission in these two groups of exposed
patients.
In 2005, De Schrijver et al. described an outbreak of acute HBV
infection in a nursing home in Antwerp (Ref. 30). The initial report of
a fulminant case of acute HBV infection in an 83-year-old resident of
the home resulted in an investigation that identified acute HBV
infection in another four patients there. Four of the five acutely
infected patients had diabetes and received assisted blood glucose
sampling by the nursing home staff. The two blood lancet models used in
the facility (one each in two sections) were used to obtain blood from
multiple patients. The device platforms were not disposable. The
lancets were washed only when blood was visible on the device and they
were not disinfected. Nurses did not routinely wash their hands or wear
gloves when obtaining blood. Two of the five patients with acute
nosocomial HBV died of their infections.
In 2008, Gotz et al. reported the investigation of two cases of
acute HBV infection among patients at a nursing home in the Netherlands
(Ref. 31). The nursing home stay of these two patients overlapped with
that of a patient with known chronic HBV infection. Early in this time
period, the nursing home changed the lancet device used for glucose
monitoring from a spring-loaded device with a disposable platform (used
for multiple patients) to a device with a rotating drum dispensing new
lancet blades, which was also used to draw blood from multiple
patients, although it was labeled for single patient use only. This
device was used for about a month until the staff realized that active
rotation of the drum was occasionally forgotten, resulting in the reuse
of a lancet blade on more than one patient.
[[Page 11147]]
The new device was then removed from the facility and the spring-loaded
lancet was returned to use. The two patients with acute HBV received
blood glucose monitoring as did the source patient with chronic HBV,
sometimes on the same day. Two other patients who also received blood
glucose monitoring escaped infection. The investigators stated that
they believed the rotating lancet drum device was likely the means of
transmission of HBV infection between patients.
In 2011, Duffell et al. reported on the investigations of five
reports of HBV transmission in community health care settings in the
United Kingdom (Ref. 32). All of the nine initially reported patients
with HBV had diabetes and were receiving blood glucose monitoring.
Further investigation identified another 12 patients with acute HBV
infection. The care settings in which hepatitis transmission occurred
were described as a ``private residential home'' (one patient),
``nursing and residential home'' (one patient), ``private nursing and
residential home'' (one patient) and ``local care home'' (two
patients). Eleven of the 21 acutely infected patients had symptomatic
HBV; 7 of these patients died, 5 due to the HBV infection. All of the
care sites in which acute HBV transmission occurred were using blood
lancets intended for single patient use only; these devices were either
routinely or occasionally used for multiple patients. One facility also
used a single glucometer for multiple patients and did not clean or
disinfect it between patients. The authors also noted that information
reported on patients found to have acute HBV infection between 1990 and
2003 identified only four patients with blood glucose monitoring as a
possible risk factor; one of these patients was infected as a result of
in-hospital transmission from another patient on the same ward,
although details were not provided. Between 2004 and 2006, the 9
patients described previously in this document were reported and
investigation led to the discovery of an additional 12 cases of health
care-related HBV transmission due to the improper use of blood lancets
during patient blood glucose monitoring.
VIII. Special Controls
FDA believes that the special controls identified in the paragraphs
that follow--in addition to general controls--are necessary to provide
reasonable assurance of safety and effectiveness for this device when
it is for single patient use only. Special controls were discussed at
the June 26, 2013, reclassification Panel (Ref. 3). The Panel agreed
that the special controls as presented would provide a reasonable
assurance of safety and effectiveness for these devices, emphasizing in
discussions the need for adequate labeling for these devices. FDA
believes that the special controls proposed for single use only blood
lancets with an integral sharps injury prevention feature in Sec.
878.4850(a)(2), in addition to the general controls, mitigate the risks
to health discussed in section V and are necessary to provide
reasonable assurance of safety and effectiveness.
Table 1 depicts how each risk to health would be mitigated by the
proposed special controls.
Table 1--Health Risks and Mitigation Measures for Single Use Only Blood
Lancet With an Integral Sharps Injury Prevention Feature
------------------------------------------------------------------------
Identified risk Mitigation measure
------------------------------------------------------------------------
Bloodborne pathogen transmission....... Design characteristics.
Mechanical performance testing.
Labeling.
Sharp object injuries.................. Design characteristics.
Mechanical performance testing.
Labeling.
Local tissue infection................. Labeling.
Sterilization.
Adverse tissue reaction (not infection) Biocompatibility.
------------------------------------------------------------------------
FDA believes that the special controls proposed for single use only
blood lancets without an integral sharps injury prevention feature in
proposed in Sec. 878.4850(b)(2), in addition to the general controls,
mitigate these risks to health discussed in section V and are necessary
to provide reasonable assurance of safety and effectiveness.
Table 2 depicts how each risk to health would be mitigated by the
proposed special controls.
Table 2--Health Risks and Mitigation Measures for Single Use Only Blood
Lancet Without an Integral Sharps Injury Prevention Feature
------------------------------------------------------------------------
Identified risk Mitigation measure
------------------------------------------------------------------------
Bloodborne pathogen transmission....... Design characteristics.
Mechanical performance testing.
Labeling.
Sharp object injuries.................. Design characteristics.
Mechanical performance testing.
Labeling.
Local tissue infection................. Labeling.
Sterilization.
Adverse tissue reaction (not infection) Biocompatibility.
------------------------------------------------------------------------
[[Page 11148]]
FDA believes that the special controls proposed for multiple use
blood lancets for single patient use only in proposed Sec.
878.4850(c)(2), in addition to the general controls, mitigate these
risks to health discussed in section V and are necessary to provide
reasonable assurance of safety and effectiveness.
Table 3 depicts how each risk to health would be mitigated by the
proposed special controls.
Table 3--Health Risks and Mitigation Measures for Multiple Use Blood
Lancet for Single Patient Use Only
------------------------------------------------------------------------
Identified risk Mitigation measure
------------------------------------------------------------------------
Bloodborne pathogen transmission....... Design characteristics.
Mechanical performance testing.
Labeling.
Sharp object injuries.................. Design characteristics.
Mechanical performance testing.
Labeling.
Local tissue infection................. Labeling.
Sterilization.
Validated cleaning and
disinfection.
Adverse tissue reaction (not infection) Biocompatibility.
------------------------------------------------------------------------
IX. The Proposed Order
FDA is issuing this proposed order to reclassify the following
three types of blood lancets used to puncture skin to obtain a drop of
blood for diagnostic purposes from class I (general controls) exempt
from premarket notification into class II (special controls) and
subject to premarket review: (1) Single use only blood lancets with an
integral sharps injury prevention feature, (2) single use only blood
lancets without an integral sharps injury prevention feature, and (3)
multiple use blood lancets for single patient use only. FDA is
identifying proposed special controls for these types of blood lancets,
as identified in section VIII of this document, that are necessary to
provide a reasonable assurance of safety and effectiveness. FDA is also
proposing to reclassify multiple use blood lancets for multiple patient
use from class I (general controls) exempt from premarket notification
into class III (premarket approval).
X. Effective Date
FDA proposes that any final order based on this draft order become
effective on its date of publication in the Federal Register.
Blood lancets for single patient use only that have not
been offered for sale prior to the effective date of the final order,
or have been offered for sale but are required to submit a new 510(k)
under 21 CFR 807.81(a)(3): Manufacturers would have to obtain 510(k)
clearance before marketing their devices after the effective date of
the order. If a manufacturer markets such a device without receiving
510(k) clearance, then FDA would consider taking action against such a
manufacturer under its usual enforcement policies.
Blood lancets for single patient use only that have been
offered for sale prior to the effective date of the final order, and do
not already have 510(k) clearance: FDA does not intend to enforce
compliance with the 510(k) requirement or special controls until 180
days after the effective date of the final order. After that date, if a
manufacturer continues to market such a device but does not have 510(k)
clearance or FDA determines that the device is not substantially
equivalent or not compliant with special controls, then FDA would
consider taking action against such manufacturer under its usual
enforcement policies.
For blood lancets for single patient use that have prior 510(k)
clearance, FDA would accept a new 510(k) and would issue a new
clearance letter, as appropriate, indicating substantial equivalence
and special controls compliance. These devices could serve as
predicates for new devices. These clearance letters would be made
publicly available in FDA's 510(k) database, and compliance with
special controls at the time of clearance would be stated in the
publically available 510(k) Summary posted in this database. Since many
blood lancets for single patient use are non-prescription (``over the
counter'') devices, FDA believes that our public database is a
transparent tool allowing consumers to confirm that their devices have
been submitted under a new 510(k) and demonstrated conformance to
applicable special controls. Elsewhere in this issue of the Federal
Register, FDA is proposing to require the filing of a PMA or notice of
completion of a PDP for multiple use blood lancets for multiple patient
use, which will be finalized only if FDA reclassifies these devices
into class III.
XI. Analysis of Environmental Impact
We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
XII. Paperwork Reduction Act of 1995
This proposed order refers to previously approved information
collections found in FDA regulations. The collections of information in
21 CFR part 807, subpart E, have been approved under OMB control number
0910-0120. The collections of information in 21 CFR part 801 have been
approved under OMB control number 0910-0485. The collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073. The collections of information in 21 CFR part 814,
subparts B and E, have been approved under OMB control number 0910-
0231.
The labeling provisions in proposed Sec. 878.4850(a)(2)(vi),
(b)(2)(vi), and (c)(2)(vii) are not subject to review by OMB because
they do not constitute a ``collection of information'' under the PRA.
Rather, the following labeling: (1) ``For use only on a single patient.
Discard the entire device after use.''; (2) ``For use only on a single
patient. Disinfect reusable components according to manufacturer's
instructions between each use.''; (3) ``Used lancet blades must be
discarded safely after a single use.''; (4) ``Warning: Not intended for
more than one use. Do not use on more than one patient. Improper use of
blood lancets can increase the risk of inadvertent transmission of
bloodborne pathogens, particularly in settings where multiple patients
are tested.'';
[[Page 11149]]
and (5) ``Warning: Do not use on more than one patient. Improper use of
blood lancets can increase the risk of inadvertent transmission of
bloodborne pathogens, particularly in settings where multiple patients
are tested. The cleaning and disinfection instructions for this device
are intended only to reduce the risk of local use site infection; they
cannot render this device safe for use for more than one patient.'' are
a ``public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)).
XIII. Codification of Orders
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) as amended requires FDA to issue final orders rather
than regulations, FDASIA also provides for FDA to revoke previously
issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, under section 513(e)(1)(A)(i), as
amended by FDASIA, in the proposed order, we are proposing to revoke
the requirements in Sec. 878.4800 related to the classification of
blood lancets as class I devices and to codify the reclassification of
subsets of blood lancets into class II or class III in Sec. 878.4850.
XIV. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. U.S. Food and Drug Administration (FDA), ``Use of Fingerstick
Devices on More Than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication'' (August 26, 2010) and
``Update'' (November 29, 2010), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm234889.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
2. U.S. Food and Drug Administration, ``Guidance for Industry and
Food and Drug Administration Staff: Blood Lancet Labeling''
(November 29, 2010), available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm234577.htm.
3. FDA's General and Plastic Surgery Devices Panel transcript and
other meeting materials for the June 26, 2013, meeting are available
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm.
4. Centers for Disease Control and Prevention (CDC). ``Nosocomial
Transmission of Hepatitis B Virus Associated With a Spring-Loaded
Fingerstick Device--California'', MMWR Morbidity and Mortality
Weekly Report, 1990; 39 (35):610-613. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00001743.htm)
5. Food and Drug Administration (FDA), ``Safety Alert Medical
Devices; Hepatitis B Transmission via Spring-Loaded Lancet Devices''
(August 28, 1990), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm241809.htm.
6. Centers for Disease Control and Prevention (CDC), ``CDC Clinical
Reminder Use of Fingerstick Devices on More Than One Person Poses
Risk for Transmitting Bloodborne Pathogens'', available at http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
7. Polish, L., C. Shapiro, F. Bauer, et al., ``Nosocomial
Transmission of Hepatitis B Virus Associated With the Use of a
Spring-Loaded Fingerstick Device'', New England Journal of Medicine,
1992; 326 (11):721-725.
8. Douvin, C., D. Simon, H. Zinelabidine, et al., ``An Outbreak of
Hepatitis B in an Endocrinology Unit Traced to a Capillary Blood
Sampling Device'', New England Journal of Medicine, 1990; 322:57-58.
9. Shier, N., J. Warren, M. Torabi, et al., ``Contamination of a
Fingerstick Device'', New England Journal of Medicine, 1993;
328:969-970.
10. Schmid, R., ``History of Viral Hepatitis: A Tale of Dogmas and
Misinterpretations'', Journal of Gastroenterology and Hepatology,
2001; 16(7):718-722.
11. Graham, G., ``Diabetes Mellitus: A Survey of Changes in
Treatment During the Last Fifteen Years'', The Lancet, 1938 2:1-7.
12. Droller, H., ``An Outbreak of Hepatitis in a Diabetic Clinic'',
British Medical Journal, 1945; 1(4400):623-625.
13. Stapleton, J., and S. Lemon, ``Transmission of Hepatitis B
During Blood Glucose Monitoring'', Journal of the American Medical
Association 1985; 253:3250.
14. Farkas K and G Jermendy. ``Transmission of Hepatitis B Infection
During Home Blood Glucose Monitoring'', Diabetic Medicine, 1997;
14:263.
15. Mendez, L., K.R. Reddy, R.A. Di Prima, et al., ``Fulminant
Hepatic Failure Due to Acute Hepatitis B and Delta Co-Infection:
Probable Bloodborne Pathogen Transmission Associated With a Spring-
loaded Fingerstick Device'', American Journal of Gastroenterology,
1991; 86:895-897.
16. Centers for Disease Control and Prevention (CDC), ``Nosocomial
Hepatitis B Virus Infection Associated With Reusable Fingerstick
Blood Sampling Devices--Ohio and New York City, 1996'', MMWR
Morbidity and Mortality Weekly Report, 1997; 46(10):217-221.
(Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00046679.htm.)
17. Quale, J.M., D. Landman, B. Wallace, et al.,
``D[eacute]j[agrave] vu: Nosocomial Hepatitis B Transmission and
Fingerstick Monitoring'', The American Journal of Medicine, 1998;
105;296-301.
18. Thompson, N.D., J. Perz, A. Moorman, et al., ``Nonhospital
Health Care-Associated Hepatitis B and C Virus Transmission: United
States, 1998-2008'', Annals of Internal Medicine, 2009; 150:33-39.
19. Khan, A.J., S.M. Cotter, B. Schulz, et al., ``Nosocomial
Transmission of Hepatitis B Virus Infection Among Residents With
Diabetes in a Skilled Nursing Facility'', Infection Control and
Hospital Epidemiology, 2002; 23:313-318.
20. Centers for Disease Control and Prevention (CDC), ``Transmission
of Hepatitis B Virus Among Persons Undergoing Blood Glucose
Monitoring in Long-Term-Care Facilities--Mississippi, North
Carolina, and Los Angeles County, California, 2003-2004'', MMWR
Morbidity and Mortality Weekly Report, 2005; 54(09):220-223.
(Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5409a2.htm.)
21. Thompson, N.D. and J.F. Perz, ``Eliminating the Blood: Ongoing
Outbreaks of Hepatitis B Virus Infection and the Need for Innovative
Glucose Monitoring Techniques'', Journal of Diabetes Science and
Technology, 2009; 3(2):283-288.
22. Thompson, N.D., V. Barry, K. Alelis, et al., ``Evaluation of the
Potential for Bloodborne Pathogen Transmission Associated With
Diabetes Care Practices in Nursing Homes and Assisted Living
Facilities, Pinellas County'', Journal of the American Geriatrics
Society, 2010; 58:914-918.
23. Patel, A.S., M.B. White-Comstock, D. Woolard, et al.,
``Infection Control Practices in Assisted Living Facilities: A
Response to Hepatitis B Virus Infection Outbreaks'', Infection
Control and Hospital Epidemiology, 2009; 30:209-214.
24. Centers for Disease Control and Prevention (CDC), ``Multiple
Outbreaks of Hepatitis B Virus Infection Related to Assisted
Monitoring of Blood Glucose Among Residents of Assisted Living
Facilities--Virginia, 2009-2011'', MMWR Morbidity and Mortality
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List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 878 be amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Amend Sec. 878.4800 by revising paragraph (a) to read as follows:
Sec. 878.4800 Manual surgical instrument for general use.
(a) Identification. A manual surgical instrument for general use is
a nonpowered, hand-held, or hand-manipulated device, either reusable or
disposable, intended to be used in various general surgical procedures.
The device includes the applicator, clip applier, biopsy brush, manual
dermabrasion brush, scrub brush, cannula, ligature carrier, chisel,
clamp, contractor, curette, cutter, dissector, elevator, skin graft
expander, file, forceps, gouge, instrument guide, needle guide, hammer,
hemostat, amputation hook, ligature passing and knot-tying instrument,
knife, mallet, disposable or reusable aspiration and injection needle,
disposable or reusable suturing needle, osteotome, pliers, rasp,
retainer, retractor, saw, scalpel blade, scalpel handle, one-piece
scalpel, snare, spatula, stapler, disposable or reusable stripper,
stylet, suturing apparatus for the stomach and intestine, measuring
tape, and calipers. A surgical instrument that has specialized uses in
a specific medical specialty is classified in separate regulations in
parts 868 through 892 of this subchapter.
* * * * *
0
3. Add Sec. 878.4850 to subpart E to read as follows:
Sec. 878.4850 Blood lancets.
(a) Single use only blood lancet with an integral sharps injury
prevention feature--(1) Identification. A disposable blood lancet
intended for a single use that is comprised of a single use blade
attached to a solid, non-reusable base (including an integral sharps
injury prevention feature) that is used to puncture the skin to obtain
a drop of blood for diagnostic purposes. The integral sharps injury
prevention feature allows the device to be used once and then renders
it inoperable and incapable of further use.
(2) Classification. Class II (special controls). The special
controls are:
(i) The design characteristics of the device must ensure that the
structure and material composition are consistent with the intended use
and must include a sharps injury prevention feature;
(ii) Mechanical performance testing must demonstrate that the
device will withstand forces encountered during use and that the
integral sharps injury prevention feature will irreversibly disable the
device after one use;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility testing must demonstrate the sterility of the
device;
(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of
the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of
the device.
(C) Instructions on cleaning and disinfection of the skin to be
pierced.
(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(1) For those devices intended for health care settings, labeling
must address the health care facility use of these devices, including
how these lancets are to be used with personal protective equipment,
such as gloves.
[[Page 11151]]
(2) For those devices intended for use in the home, labeling must
be written so that it is understandable to lay users.
(vi) Labeling must also include the following statements,
prominently placed:
(A) ``For use only on a single patient. Discard the entire device
after use.''
(B) ``Warning: Not intended for more than one use. Do not use on
more than one patient. Improper use of blood lancets can increase the
risk of inadvertent transmission of bloodborne pathogens, particularly
in settings where multiple patients are tested.''
(b) Single use only blood lancet without an integral sharps injury
prevention feature--(1) Identification. A disposable blood lancet
intended for a single use that is comprised of a single use blade
attached to a solid, non-reusable base that is used to puncture the
skin to obtain a drop of blood for diagnostic purposes.
(2) Classification. Class II (special controls). The special
controls are:
(i) The design characteristics of the device must ensure that the
structure and material composition are consistent with the intended use
and address the risk of sharp object injuries and bloodborne pathogen
transmissions;
(ii) Mechanical performance testing must demonstrate that the
device will withstand forces encountered during use;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility testing must demonstrate the sterility of the
device;
(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of
the device.
(B) Handwashing instructions for the user before and after use of
the device.
(C) Instructions on cleaning and disinfection of the skin to be
pierced.
(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(1) For those devices intended for health care settings, labeling
must address the health care facility use of these devices, including
how these lancets are to be used with personal protective equipment,
such as gloves.
(2) For those devices intended for use in the home, labeling must
be written so that it is understandable to lay users.
(vi) Labeling must also include the following statements,
prominently placed:
(A) ``For use only on a single patient. Discard the entire device
after use.''
(B) ``Warning: Not intended for more than one use. Do not use on
more than one patient. Improper use of blood lancets can increase the
risk of inadvertent transmission of bloodborne pathogens, particularly
in settings where multiple patients are tested.''
(c) Multiple use blood lancet for single patient use only--(1)
Identification. A multiple use capable blood lancet intended for use on
a single patient that is comprised of a single use blade attached to a
solid, reusable base that is used to puncture the skin to obtain a drop
of blood for diagnostic purposes.
(2) Classification. Class II (special controls). The special
controls are:
(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually
or by triggering a blade storage unit to discard the used blade and
reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the
intended use and address the risk of sharp object injuries and
bloodborne pathogen transmissions; and allow for validated cleaning and
disinfection;
(ii) Mechanical performance testing must demonstrate that the
device will withstand forces encountered during use;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility testing must demonstrate the sterility of the
device;
(v) Validation testing must demonstrate that the cleaning and
disinfection instructions are adequate to ensure that the reusable
lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of
the device.
(B) The Environmental Protection Agency (EPA) registered
disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of
the device.
(D) Instructions on cleaning and disinfection of the skin to be
pierced.
(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the
reusable blood lancet base between uses to minimize contamination or
damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(1) For those devices intended for health care settings, labeling
must address the health care facility use of these devices, including
how these lancets are to be used with personal protective equipment,
such as gloves.
(2) For those devices intended for use in the home, labeling must
be written so that it is understandable to lay users.
(vii) Labeling must also include the following statements,
prominently placed:
(A) ``For use only on a single patient. Disinfect reusable
components according to manufacturer's instructions between each use.''
(B) ``Used lancet blades must be safely discarded after a single
use.''
(C) ``Warning: Do not use on more than one patient. Improper use of
blood lancets can increase the risk of inadvertent transmission of
bloodborne pathogens, particularly in settings where multiple patients
are tested. The cleaning and disinfection instructions for this device
are intended only to reduce the risk of local use site infection; they
cannot render this device safe for use for more than one patient.''
(d) Multiple use blood lancet for multiple patient use--(1)
Identification. A multiple use capable blood lancet intended for use on
multiple patients that is comprised of a single use blade attached to a
solid, reusable base that is used to puncture the skin to obtain a drop
of blood for diagnostic purposes.
(2) Classification. Class III (premarket approval).
Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04578 Filed 3-2-16; 8:45 am]
BILLING CODE 4164-01-P