[Federal Register: September 8, 2005 (Volume 70, Number 173)]
[Proposed Rules]
[Page 53326-53328]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se05-15]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. 2001P-0120 (Formerly Docket No. 01P-0120)]
Medical Devices; Needle-Bearing Devices; Withdrawal of Advance
Notice of Proposed Rulemaking
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of an advance notice of proposed rulemaking (ANPRM)
concerning needle-bearing devices. FDA is concerned about the
significant health risk posed by needlestick and other percutaneous
injuries but FDA believes that the actions it has taken and continues
to take along with the actions taken by the Occupational Safety and
Health Administration (OSHA) are addressing the issue adequately at
this time.
DATES: The ANPRM published at 67 FR 41890 (June 20, 2002), is withdrawn
as of September 7, 2005.
ADDRESSES: Responses to petitions and references may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or on the Internet at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Devices and
Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-827-2974.
SUPPLEMENTARY INFORMATION:
I. Background
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 ``HRG/SEIU petition''). The HRG/SEIU 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 an ANPRM inviting
interested persons to submit additional data and information to assist
FDA in determining a proper course of action.
In the Federal Register of June 20, 2002 (67 FR 41890), FDA
published an ANPRM on this topic. FDA invited interested persons to
submit comments on the HRG/SEIU petition and other matters related to
needlestick prevention by September 18, 2002. FDA received more than 50
written and electronic comments from a wide variety of individuals and
organizations.
II. HRG/SEIU Petition
The following is a brief summary of the HRG/SEIU petition. The
petition and FDA's response are available from the Division of Dockets
Management (see ADDRESSES). In requesting the petition and response,
refer to docket number 2001P-0120.
A. Banning
The HRG/SEIU petition requested that FDA ban the following:
1. Intravenous (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.
B. Performance Standard
The HRG/SEIU petition requested that FDA issue performance
standards based on the five design criteria identified in the FDA
safety alert following the procedures set forth in 21 CFR part 861.
C. Labeling
Finally, the HRG/SEIU 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.
III. Comments
A. Banning
A few comments supported the ban proposed in the HRG/SEIU petition.
One of these comments submitted three studies that showed a significant
decrease in needlesticks when safety devices were used. In their
comment, HRG objected to FDA's conclusion in the petition response that
there was insufficient information to relate injuries to specific
devices so as to justify banning them. HRG suggested that FDA should
make a greater effort to extract the data from its own records to
support a ban. Many comments opposed a ban. Several of these comments
suggested that the criteria for banning a device under section 516 of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360f)
were not met. Many of the comments suggested that a ban would create a
critical shortage of necessary devices.
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. 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 or injury is
substantial, FDA will need to consider whether the risk posed by
continued 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 response to the HRG/SEIU petition, 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
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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 HRG/SEIU 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 has not received any information since
publication of the ANPRM that would lead it to reach a different
conclusion.
B. Performance Standards
Many of the comments expressed a willingness to participate in the
development of a performance standard for needle-bearing devices. Many
of these same comments and other comments, however, expressed doubt as
to whether a standard could be developed because of the wide range of
devices and technologies. No comments proposed any specific parameters
for such a standard. FDA has consulted with some standard development
organizations. The representatives of these groups expressed some
willingness to work with FDA to develop a standard but also
acknowledged the difficulty of developing a standard to address so many
different devices. FDA will continue to work with these standard
development groups to determine if one or more useful standards could
be developed.
C. Labeling
Some comments suggested that the labeling statement for
conventional syringes proposed in the HRG/SEIU petition may be useful.
Many comments suggested that the labeling statement was unnecessary.
In its response to the HRG/SEIU petition, FDA stated that the
information in the proposed 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 has not found anything in the comments to suggest a
different conclusion.
D. National Association for the Primary Prevention of Sharps Injuries
List
The National Association for the Primary Prevention of Sharps
Injuries (NAPPSI) requested that FDA post on its Web site and
disseminate NAPPSI's Safety Device List. This list includes sharps
injury prevention devices. Several comments supported this proposal.
FDA is in favor of health care professionals having access to
information that will help them choose safer medical devices. However,
FDA believes that it would be difficult to ensure that NAPPSI's Safety
Device List was up to date at all times. FDA, nevertheless, encourages
health care professionals and others to make use of whatever
information is available to choose safe devices.
E. The OSHA Bloodborne Pathogens Standard
Several comments suggested that the OSHA Bloodborne Pathogens (BBP)
standard, together with the actions that FDA has been taking, provides
sufficient protection.
FDA 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.). 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 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
this 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.
IV. Conclusion
FDA has cleared several hundred devices with needlestick prevention
features. FDA continues to work with manufacturers to assist in the
clearance of devices with needle-free technology or needlestick
prevention features.
On November 12, 2002, FDA issued a guidance document entitled
``Needlesticks Medical Device Reporting Guidance for User Facilities,
Manufacturers, and Importers.'' This guidance document outlines 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 continues to work with health care professionals
on educational issues concerning the safe use of needle-bearing
devices.
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As noted previously, FDA is working with consensus standards
development groups to determine whether standards could be developed to
address the issue of needlesticks related to medical devices.
FDA believes that these actions, in conjunction with the actions
taken by OSHA under its BBP standard, are sufficient to address the
risk of needlestick injuries related to the use of needle-bearing
medical devices. FDA, therefore, does not intend to take any of the
specific actions requested in the HRG/SEIU petition at this time and is
withdrawing the ANPRM published in the Federal Register of June 20,
2002.
V. References
The following references have been placed on display in the
Division of Dockets Management (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. 2001P-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: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17733 Filed 9-7-05; 8:45 am]
BILLING CODE 4160-01-S