[Federal Register: June 20, 2002 (Volume 67, Number 119)]
[Proposed Rules]
[Page 41890-41892]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn02-28]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. 01P-0120]
RIN 0910-ZA20
Medical Devices; Needle-Bearing Devices; Request for Comments and
Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this
document to invite interested persons to submit information to assist
the agency in determining what additional actions, if any, the agency
should take to protect healthcare workers from needlestick injuries
from medical devices. FDA is taking this action because it is concerned
about the significant health risk posed by needlestick and other
percutaneous injuries. The agency is also responding to a petition.
DATES: Submit written comments or information by September 18, 2002.
ADDRESSES: Submit written comments or information to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Timothy A. Ulatowski, Center for
Devices and Radiological Health (HFZ-480), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8879.
SUPPLEMENTARY INFORMATION: Blood and other potentially infectious
materials have long been recognized as a potential threat to the health
of employees who are exposed to these materials by percutaneous contact
(penetration of the skin). Injuries from contaminated needles and other
sharps have been associated with the increased risk of disease from
infectious agents. The primary agents of concern are the human
immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C
virus (HCV). (Ref. 1)
I. Previous FDA Actions
FDA has taken several actions to address the risk of sharps
injuries to healthcare workers and others from devices and continues to
monitor this issue.
On April 16, 1992, FDA issued a safety alert warning of
the risk of needlestick injuries from the use of hypodermic needles as
a connection between two pieces of intravenous (IV) equipment. The
safety alert urged that needleless systems or recessed needle systems
be used in place of hypodermic needles to access IV lines. The agency
noted that hypodermic needles should only be used in situations where
there is a need to penetrate the skin. FDA also outlined various device
characteristics that have the potential to reduce the risk of
needlestick injuries.
In March 1995, FDA issued a guidance document entitled
``Supplementary Guidance on the Content of Premarket Notification
[510(k)] Submissions for Medical Devices With Sharps Injury Prevention
[[Page 41891]]
Features.'' This guidance was intended to: (1) Make it easier to
prepare and submit 510(k) applications for devices incorporating a
sharps injury prevention feature so as to encourage the development of
more of those types of devices, (2) promote consistency in the content
of 510(k)s in order to facilitate review by FDA, and (3) guide FDA
review staff in conducting and documenting the review of 510(k)s for
devices with sharps injury prevention features.
On August 9, 1996, FDA issued a guidance document entitled
``MDR Guidance Documents and Exemption-No. 3-Needlesticks and Blood
Exposure-E1996003.'' This guidance document outlined FDA's policy for
determining when an event involving needlesticks and blood exposure is
reportable as a serious injury and when it is reportable as a
malfunction.
On March 2, 2001, FDA issued a guidance document entitled
``Premarket Approval Applications (PMA) for Sharps Needle
Destruction.'' This document provides guidance to manufacturers on the
types of issues and areas of concern that need to be addressed when
submitting a PMA for sharps needle destruction devices intended for use
in healthcare facilities.
FDA has cosponsored several national meetings on
needlestick prevention issues.
FDA has worked with consensus standards development groups
on needleless injectors.
FDA has cleared several hundred devices with needlestick
prevention features.
In February 1999, FDA, in conjunction with the National
Institute for Occupational Safety and Health (NIOSH), the Centers for
Disease Control and Prevention (CDC), and the Occupational Safety and
Health Administration (OSHA), issued a joint safety advisory about
glass capillary tubes.
II. FDA Cooperation With OSHA
FDA also has been working together with OSHA to reduce the risk of
sharps injuries to healthcare workers and others. FDA regulates medical
devices, including those containing sharps under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) (the act). OSHA
maintains authority to regulate workplace controls for the protection
of employees (Refs. 2 and 3).
In the Federal Register of December 6, 1991 (56 FR 64004), OSHA
issued its Bloodborne Pathogens (BBP) Standard (29 CFR 1910.1030). The
standard reflects OSHA's determination that a combination of
engineering and work practice controls, personal protective equipment,
training, medical surveillance, hepatitis B vaccination, signs and
labels, and other requirements would minimize the risk of disease
transmission. FDA provided extensive input and comment to OSHA during
the development of the standard.
On November 6, 2000, President Clinton signed the Needlestick
Safety and Prevention Act (Public Law 106-430). This statute required
OSHA to revise several aspects of the BBP standard within 6 months. In
the Federal Register of January 18, 2001 (66 FR 5318), OSHA published a
final rule amending the BBP standard. The final rule went into effect
on April 18, 2001. Again, FDA provided input and comment to OSHA during
the development of the amended BBP standard.
The amended BBP standard added new requirements to the annual
review and update of a covered employer's exposure control plan.
Specifically, under these new requirements, each covered employer must
document the extent to which it uses, or has considered using, products
that will minimize workplace exposure to needlesticks and other
percutaneous injuries. The annual update and review of each covered
employer's plan must also reflect changes in technology that eliminate
or reduce exposure to bloodborne pathogens and document consideration
and implementation of appropriate commercially available and effective
safer medical devices designed to eliminate or minimize occupational
exposure. Each employer subject to the rule is also required to solicit
input from nonmanagerial employees responsible for direct patient care
who are potentially exposed to injuries from contaminated sharps in the
identification, evaluation, and selection of effective engineering and
work practice controls. The employer must document the solicitation in
the exposure control plan.
III. HRG/SEIU Petition
On March 6, 2001, FDA received and then filed a petition that had
been submitted jointly by Public Citizen's Health Research Group (HRG),
a consumer advocacy group, and the Service Employees International
Union (SEIU). The petition requested that FDA take certain actions to
further reduce the risk of needlestick injuries to healthcare workers.
On September 5, 2001, FDA issued a response to this petition. In its
response, FDA stated that it did not have sufficient information to
take the actions requested by the petitioners, but that FDA would
publish this advance notice of proposed rulemaking inviting interested
persons to submit additional data and information to assist FDA in
determining a proper course of action. The HRG/SEIU petition and FDA's
response are available from the Dockets Management Branch (see
ADDRESSES). In requesting the petition and response, refer to docket
number 01P-0120.
In the following paragraphs, FDA summarizes the actions requested
by HRG and SEIU and invites interested persons to submit additional
data and information to support these actions or any other action that
the commenter may consider appropriate.
A. Banning
The HRG/SEIU petition requested that FDA ban the following:
1. IV catheters, blood collection devices (needles and tube
holders) and blood collection needle sets (``butterfly syringes'') that
do not meet the criteria identified in FDA's April 16, 1992, safety
alert. This safety alert says that needle-bearing devices should have a
fixed safety feature that meets all of the following criteria:
(1) It provides a barrier between the hands and needles after use;
(2) It allows or requires the worker's hands to remain behind the
needle at all times;
(3) It is an integral part of the device, and not an accessory; and
(4) It is in effect before disassembly, if any, and remains in
effect after disposal.
The safety alert also suggests that the device should be simple and
easy to use requiring little training.
2. Glass capillary tubes; and
3. IV infusion equipment that does not use needleless technology or
recessed needles.
The petitioners stated that they identified these particular
devices as devices that should be banned because they meet at least two
of the following three criteria:
(1) Their use creates a high risk of exposure to bloodborne
pathogens,
(2) Their use is common in healthcare today, and
(3) There is currently available FDA-cleared technology to minimize
exposure.
The legal standard to be applied by FDA in deciding whether it is
appropriate to ban a device is set out in section 516 of the act (21
U.S.C. 360f). In short, this section states that FDA may ban a device
if it finds that the device presents a ``substantial deception or an
unreasonable and substantial risk of illness or injury.'' The
regulations implementing section 516 state that, in determining whether
the risk of illness
[[Page 41892]]
or injury is substantial, FDA will need to consider whether the risk
posed by continuing marketing of the device is important, material, or
significant in relation to the benefit to the public health from
continued marketing (21 CFR 895.21(a)(1)).
In its petition response, FDA stated that it did not have
sufficient information to conclude that there is a legal basis for
banning the devices identified in the petition. In support of their
petition, the petitioners refer to occupational exposure data obtained
from the Epinet database coordinated by the University of Virginia
(Ref. 1). The Epinet data show that 52 hospitals with a total average
daily census of 9,681 patients reported 3,180 sharp object injuries in
1998. Syringes accounted for 33 percent of these injuries; needles on
IV lines, 2 percent; butterfly needles, 8 percent; vacuum tube blood
collection needles, 6 percent; IV catheter stylets and glass capillary
tubes, less than 1 percent.
The petition also cited similar data from the Centers for Disease
Control and Prevention (CDC). The CDC reported that, for the period
from June 1995 to July 1999, there were 4,951 sharp object injuries
reported to its surveillance system. Of these reported injuries, 29
percent involved hypodermic needles, 13 percent butterfly needles, 6
percent IV catheter stylets, and 4 percent blood drawing needles. The
petition also stated that 8 percent of exposures with hollow bore
needles were categorized as IV line-related.
Although the petition addressed the number of injuries related to
generic types of devices, it did not show: (1) Which specific devices
were used; (2) how many devices of that type were used during the
relevant time period; (3) what the design characteristics of those
devices were or (4) whether the devices met any or all of the design
criteria listed. In the absence of such information about specific
devices, FDA was unable to conclude that any particular device
presented a ``substantial deception or an unreasonable and substantial
risk of illness or injury.'' FDA invites interested persons to submit
data and information that would provide insight on the basis for
banning one or more of these devices.
B. Performance Standard
The petition requested that FDA issue performance standards based
on the five design criteria identified in the FDA safety alert (listed
in section III.A of this document) following the procedures set forth
in 21 CFR part 861. The petition listed the criteria but did not
discuss how FDA could apply these criteria to specific devices in the
context of a mandatory performance standard; or how such a standard
would provide reasonable assurance of the safety and effectiveness of
these devices.
In its response, FDA stated that it did not have sufficient
information to develop a standard to address the risk of needlestick
injury. FDA believes that these criteria are a good starting point to
develop a standard, but FDA needs additional information to determine
how best to apply these criteria to specific devices in the context of
a standard.
FDA invites interested persons to submit any information or data
addressing the appropriateness of developing a performance standard,
based on these criteria or others. FDA is also prepared to enter into
discussions with any organization that wishes to develop a voluntary
consensus standard for one or more of these devices that FDA may adopt
or recognize in some form.
C. Labeling
Finally, the petition requested that FDA require that the labeling
for ``conventional syringes'' state: ``TO PREVENT POSSIBLE EXPOSURE TO
HIV AND HEPATITIS, DO NOT USE FOR STANDARD BLOOD DRAWS.'' The
petitioners stated that current labeling for syringes does not contain
adequate warning of the hazards that the device presents.
In its response, FDA stated that the information in this statement
is well known to healthcare professionals who use these types of
devices and, therefore, under 21 CFR 801.109(c), FDA would not
ordinarily require such a statement in the labeling. FDA invites
interested persons to comment on whether the proposed labeling
statement or any other labeling requirement is necessary to provide
reasonable assurance of the safety and effectiveness of these devices.
IV. Comments
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments on this document by September
19, 2002. Submit electronic comments to http://www.fda.gov/dockets/
ecomments. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
name of the device and the docket number found in brackets in the
heading of this document. Received comments may be seen in the Dockets
Management Branch 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 (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from Public Citizen, Health Research Group and the
Service Employees International Union (Docket No. 01P-0120) and FDA's
response dated September 5, 2001.
2. Letter from Dr. Michael A. Friedman, Deputy Commissioner for
Operations, Food and Drug Administration, to Charles N. Jeffress,
Assistant Secretary of Labor for Occupational Safety and Health, dated
December 18, 1998.
3. Letter from Charles N. Jeffress, Assistant Secretary of Labor
for Occupational Safety and Health, to Dr. Michael A. Friedman, Deputy
Commissioner for Operations, Food and Drug Administration, dated
February 8, 1999.
Dated: January 31, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15493 Filed 6-19-02; 8:45 am]
BILLING CODE 4160-01-S