[Federal Register Volume 63, Number 215 (Friday, November 6, 1998)]
[Proposed Rules]
[Pages 59917-59921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29566]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. 98N-0786]
General Hospital and Personal Use Devices: Proposed
Classification of Liquid Chemical Sterilants and General Purpose
Disinfectants
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
classify both liquid chemical sterilants intended for use as the
terminal step in processing critical and semicritical medical devices
prior to patient use, and general purpose disinfectants intended to
process noncritical medical devices and equipment surfaces. Under the
proposal, liquid chemical sterilants would be classified into class II
(special controls) and general purpose disinfectants would be
classified into class I (general controls). FDA also proposes to exempt
general purpose disinfectants from the premarket notification
requirements. The agency is publishing in this document the
recommendations of the General Hospital and Personal Use Devices Panel
(the Panel) regarding the classification of these devices. After
considering public comments on the proposed classification, FDA will
publish a final regulation classifying these devices. This action is
being taken to establish sufficient regulatory controls that will
provide reasonable assurance of the safety and effectiveness of these
devices.
DATES: Written comments by February 4, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8913.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Devices Amendments of 1976 (the
1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990
(the SMDA) (Pub. L. 101-629), and the Food and Drug Administration
Modernization Act of 1997 (the FDAMA) (Pub. L. 105-115), established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on 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).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1)
[[Page 59918]]
Received a recommendation from a device classification panel (an FDA
advisory committee); (2) published the panel's recommendation for
comment, along with a proposed regulation classifying the device; and
(3) published a final regulation classifying the device. FDA has
classified most preamendments devices under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until: (1) The device is
reclassified into class I or II; (2) FDA issues an order classifying
the device into class I or II in accordance with new section 513(f)(2)
of the act, as amended by the FDAMA; or (3) FDA issues an order finding
the device to be substantially equivalent, in accordance with section
513(I) of the act, to a predicate device that does not require
premarket approval. The agency determines whether new devices are
substantially equivalent to previously offered devices by means of
premarket notification procedures in section 510(k) of the act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval. Consistent with the act and the
regulations, FDA consulted the Panel, regarding the classification of
the device.
The FDAMA added a new section 510(l) to the act (21 U.S.C. 360(l)).
New section 510(l) of the act provides that a class I device is exempt
from the premarket notification requirements under section 510(k) of
the act, unless the device is intended for a use which is of
substantial importance in preventing impairment of human health or it
presents a potential unreasonable risk of illness or injury. Hereafter,
these are referred to as ``reserved criteria.'' FDA has considered the
general purpose disinfectants in accordance with the reserved criteria
and determine that the devices do not require premarket notification.
Such an exemption permits manufacturers to introduce into commercial
distribution generic types of devices without first submitting a
premarket notification to FDA.
In 1980, when other general hospital and personal use devices were
classified (45 FR 69678 to 69737, October 21, 1980), FDA inadvertently
omitted liquid chemical germicides, such as liquid chemical sterilants
and general purpose disinfectants from the classification process. In
subsequent years, FDA actively regulated only liquid chemical
germicides that were used as accessories to specific class II devices,
such as hemodialyzers. FDA began actively regulating all liquid
chemical germicides in the early 1990's following efficacy testing by
FDA for the Environmental Protection Agency (EPA) and publication of
the 1993 General Accounting Office (GAO) report on Hospital Sterilants
(Ref. 1). Liquid chemical germicides were regulated as accessories to
other devices with the level of regulation applicable coinciding with
the classification of the other devices. FDA also determined that two
categories of liquid chemical germicides existed, liquid chemical
sterilants and general purpose disinfectants.
The first category consists of liquid chemical sterilants which are
intended for use as the terminal step in processing critical and
semicritical medical devices prior to patient use. Semicritical medical
devices contact mucous membranes or nonintact skin during use, while
critical devices contact normally sterile tissue or body spaces.
The second category of liquid chemical germicides consists of
general purpose disinfectants which are intended to process noncritical
medical devices and medical equipment surfaces, and can be used to
preclean or decontaminate critical or semicritical medical devices
prior to terminal sterilization or high level disinfection. Noncritical
medical devices only make topical contact with intact skin of the body.
In addition to being regulated by FDA, certain liquid chemical
germicides are regulated by EPA as pesticides under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). On June 4, 1993, a
memorandum of understanding (MOU) was signed between FDA and EPA (Refs.
3 and 4). The purpose of the MOU was to resolve the confusion and
burden of dual regulation and, at the same time, ensure that the safety
and efficacy requirements of both statutes are met.
In 1996, liquid chemical sterilants used for processing critical
and semicritical medical devices were exempted from the definition of a
pesticide under FIFRA with passage of the Food Quality Protection Act
of 1996 (FQPA) and are no longer regulated by EPA. FDA now has sole
regulatory jurisdiction over liquid chemical sterilants and high level
disinfectants used to process reusable critical and semicritical
medical devices. Regulatory authority over general purpose
disinfectants was not affected by FQPA. Therefore, the MOU remains in
effect for general purpose disinfectants, and the dual regulatory
requirements for these germicides continue until the rulemaking process
for classification of the germicides is completed.
II. Recommendations of the Panel
During a public meeting which was held on July 18, 1995, the Panel
made the following recommendations regarding the classification of
liquid chemical sterilants and general purpose disinfectants.
A. Identification
The Panel recommended that the devices be identified as follows:
A liquid chemical sterilant is a germicide intended for use as the
terminal step in processing critical and semicritical medical devices
prior to patient use. Semicritical devices make contact with mucous
membranes or nonintact skin during use. Critical devices contact
normally sterile tissue or body spaces during use (Refs. 5 and 6).
A general purpose disinfectant is a germicide intended to process
noncritical medical devices and medical equipment surfaces. A general
purpose disinfectant can be used to preclean or decontaminate critical
or semicritical medical devices prior to terminal sterilization or high
level disinfection. Noncritical medical devices only make topical
contact with intact skin of the body (Refs. 5 and 6).
B. Recommended Classification of the Panel
The Panel unanimously recommended that liquid chemical sterilants
be classified into class II. The Panel believed that class II with the
special controls (the 510(k) guidance document (Ref. 2), voluntary
standards, and user information and training) would provide reasonable
assurance of the safety and effectiveness of the devices.
The Panel recommended that general purpose disinfectants be
classified into class I and that the devices should be exempt from the
premarket notification procedures.
C. Summary of Reasons for Recommendation
After reviewing the information provided by FDA, and after
[[Page 59919]]
consideration of the open discussions during the Panel meeting and the
Panel members' personal knowledge of and clinical experience with the
device systems, the Panel gave the following reasons in support of its
recommendations to classify the generic type of liquid chemical
sterilants for use as the terminal step in processing critical and
semicritical medical devices prior to patient use into class II, and
general purpose disinfectants for use in processing noncritical medical
devices and medical equipment surfaces into class I:
1. The Panel believes that liquid chemical sterilants should be
classified into class II because special controls, in addition to
general controls, would be necessary to provide reasonable assurance of
the safety and effectiveness of the devices, and there is sufficient
information to establish special controls to provide such assurance.
2. The Panel believes that general purpose disinfectants should be
classified into class I because general controls would provide
reasonable assurance of the safety and effectiveness of the devices. In
addition to the Panel's recommendation, FDA has considered general
purpose disinfectants in accordance with the reserved criteria of new
section 510(l) of the act and determined that the general purpose
disinfectants do not require premarket notification.
D. Summary of Data Upon Which the Recommendation is Based
The Panel noted that liquid chemical sterilants include peracetic
acid, hydrogen peroxide, chlorine dioxide, and glutaraldehyde. These
substances are used to sterilize or high level disinfect heat sensitive
medical devices such as flexible endoscopes. Toxicity studies have
shown hydrogen peroxide and peracetic acid to be nontoxic,
nonsensitizing and, at most, minimally irritating. In addition, these
chemicals, as well as chlorine dioxide, are used at low concentrations
and readily degrade to nontoxic compounds, such as water and molecular
oxygen (Refs. 7, 8, and 9).
Toxicity studies have shown glutaraldehyde to be a skin, eye, and
respiratory system irritant and a skin sensitizer. Since glutaraldehyde
does not readily degrade, long-term effects of its residue as a skin or
eye irritant are of concern (Refs. 10 and 11). Although some injuries
and deaths have been reported following the use of these chemicals as
sterilants and disinfectants, they have been primarily associated with
failure of the user to follow the manufacturer's directions for use
(Ref. 12).
The Panel noted that general purpose disinfectants include
alcohols, chlorines, iodophors, phenolics, and quaternary ammonium
compounds. The hazards and adverse effects of these substances are well
known (Ref. 8). Toxicity is minimal because these substances are used
at low concentrations on equipment surfaces and noncritical devices
that only contact intact skin during use.
The use of liquid chemical sterilants and general purpose
disinfectants on medical devices is based on the infection control
classification system devised by E. H. Spaulding (Refs. 13 and 14), and
adopted by infection control practitioners, FDA, and the Centers for
Disease Control and Prevention. Spaulding's system is predicated on the
relative risks associated with the use of medical devices. According to
Spaulding's system, devices that contact normally sterile tissues or
body spaces during use are termed critical devices. Critical devices
should be sterilized prior to use.
Devices that contact mucous membranes, which can provide a barrier
to many, but not all microorganisms, are termed semicritical devices.
Semicritical devices should be sterilized prior to use when practical,
or should undergo high level disinfection (a high level disinfectant is
a sterilant used for a shorter contact time and that kills all
microbial pathogens except large numbers of bacterial endospores).
General purpose disinfectants can be used to clean or decontaminate
critical and semicritical devices prior to a terminal sterilization or
high level disinfection process.
E. Risks to Health
The following three risks are associated with the use of germicides
such as liquid chemical sterilants and general purpose disinfectants:
(1) Nosocomial infection, (2) toxicity associated with chemical
exposure, and (3) damage to medical devices.
The formulation of a germicide plays an important role in the
effectiveness of the germicide on the device. If the formulation is
inadequate for its intended use or if the germicide is improperly used,
the sterilization or disinfection process will be ineffective. As a
result, the processed device may serve as a potential vector for the
transmission of infectious microorganisms to the next patient.
In the Federal Register of December 6, 1996 (61 FR 64755), FDA
announced the availability of a draft guidance document entitled
``Draft Guidance on the Content and Format of Premarket Notification
(510(k)) Submissions for Liquid Chemical Germicides'' (Ref. 2). In the
Federal Register of May 22, 1997 (62 FR 28055), FDA extended the period
to comment on the draft guidance until August 20, 1997.
The guidance document suggests that manufacturers of these devices
are to submit, for review and evaluation, microbiological studies
supporting all germicidal claims, and adequate instructions for use.
EPA registration for general purpose disinfectants requires similar
information.
With regard to chemical exposure, health-care workers who process
medical devices with either liquid chemical sterilants or general
purpose disinfectants are potentially exposed to toxic substances
during use of the germicides. In addition, the patient may be exposed
to germicide residues if the device is inadequately rinsed.
Labeling recommendations in the guidance document include warnings
and precautions regarding the proper use and handling of liquid
chemical sterilants and other toxic substances. Additionally, the
guidance document recommends a toxicological assessment of germicide
residues remaining following rinsing. EPA registration of general
purpose disinfectants requires similar information.
Lastly, both liquid chemical sterilants and general purpose
disinfectants may damage medical devices causing them to function
improperly or create areas that cannot be effectively cleaned,
disinfected or sterilized. The guidance document recommends that data
demonstrating device materials compatibility with the liquid chemical
germicides be included in the 510(k).
F. Special Controls
Based on the available information, FDA believes that, in addition
to general controls, the special controls discussed as follows are
adequate to address the risks to health which were identified
previously.
1. The 510(k) guidance document;
2. Voluntary standards; and
3. User information and training.
The guidance document provides 510(k) applicants with specific
directions regarding data and information that should be submitted to
FDA in a 510(k) submission for liquid chemical germicides. The document
incorporates voluntary standards and guidelines from professional
organizations as part of its recommendation for performance testing.
Compliance with the recommendations made in the document for liquid
chemical sterilants is important in preventing nosocomial infections.
[[Page 59920]]
Voluntary standards provide assurance of consistency and uniformity
in germicide effectiveness.
User information and training programs are critical to ensure that
users have full knowledge and assume responsibility for the safe and
effective use of the liquid chemical sterilants.
Adherence to these special controls can provide the user community
a greater assurance of effectiveness and appropriate use in order to
minimize nosocomial infection through improperly sterilized or
disinfected reusable medical devices.
III. Proposed Classification
FDA believes that liquid chemical sterilants should be classified
into class II because special controls, in addition to general
controls, would provide reasonable assurance of the safety and
effectiveness of the devices, and there is sufficient information to
establish special controls to provide such assurance.
FDA believes that general purpose disinfectants should be
classified into class I because general controls under the act and the
EPA registration requirements would provide reasonable assurance of
safety and effectiveness of these products. FDA also believes that
these devices do not meet the reserved criteria of new section 510(l)
of the act and should be exempt from premarket notification
requirements.
IV. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. U.S. General Accounting Office, Report to the Ranking
Minority Member Committee on Government Operations, House of
Representatives, Hospital Sterilants: Insufficient FDA Regulation
May Pose a Public Health Risk, GAO/HRD-93-79, June 1993.
2. FDA, Center for Devices and Radiological Health, Office of
Device Evaluation, ``Draft Guidance on the Content and Format of
Premarket Notification (510(k)) Submissions for Liquid Chemical
Germicides,'' January 1992; revised April 26, 1995.
3. Memorandum of Understanding Between the Food and Drug
Administration, Public Health Service, Department of Health and
Human Services and the Environmental Protection Agency, Notice
Regarding Matters of Mutual Responsibility--Regulation of Liquid
Chemical Germicides Intended for Use on Medical Devices, June 4,
1993.
4. Amendment to the June 4, 1993, Memorandum of Understanding
Between the Food and Drug Administration, Public Health Service,
Department of Health and Human Services and the Environmental
Protection Agency, June 30, 1994.
5. General Hospital and Personal Use Devices Panel, Thirtieth
Meeting, Transcript, July 18, 1995.
6. General Hospital and Personal Use Devices Panel, Thirtieth
Meeting, Summary of Minutes, July 18, 1995.
7. Malchesky, P. S., ``Peracetic Acid and Its Application to
Medical Instrument Sterilization,'' Artificial Organs, vol. 17, no.
3, pp. 147-152, 1993.
8. Block, S. S., ``Peroxygen Compounds,'' Disinfection,
Sterilization, and Preservation, pp. 167-181, Philadelphia, 1991.
9. Dychdala, G. R., ``Chlorine and Chlorine Compounds,''
Disinfection, Sterilization, and Preservation, pp. 131-151,
Philadelphia, 1991.
10. Scott, E. M., and S. P. Gorman, ``Glutaraldehyde,'' in
Disinfection, Sterilization, and Preservation, pp. 596-614,
Philadelphia, 1991.
11. Australian Government Publishing Service, ``Priority
Existing Chemical No.3, Glutaraldehyde,'' pp. 53-62, Canberra, July
1994.
12. Spach, D. H., F. E. Silverstein, and W. E. Stamm,
``Transmission of Infection by Gastrointestinal Endoscopy and
Bronchoscopy,'' Annals of Internal Medicine, vol. 118, no. 2, pp.
117-128, 1993.
13. Spaulding, E. H., ``Role of Chemical Disinfection in the
Prevention of Nosocomial Infections,'' Proceedings of International
Conference on Nosocomial Infections, pp. 247-254, Chicago, 1970.
14. Spaulding, E. H., ``Chemical Disinfection and Antisepsis in
the Hospital,'' Journal of Hospital Research, vol. 9, pp. 5-31,
1972.
V. Environmental Impact
The agency has 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.
VI. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4)). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this proposed rule is consistent with
the regulatory philosophy and principles identified in the Executive
Order. In addition, the proposed rule is not a significant regulatory
action as defined by the Executive Order and so is not subject to
review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed rule classifying these devices
eliminates duplicative registration, and may enable additional small
competitors to enter the marketplace by eliminating the cost of
complying with two sets of requirements, it will impose no significant
economic impact on any small entities. The agency therefore certifies
that this proposed rule, if issued, will not have a significant
economic impact on a substantial number of small entities. In addition,
this proposed rule will not impose costs of $100 million or more on
either the private sector or State, local, and tribal governments in
the aggregate, and therefore a summary statement or analysis under
section 202(a) of the Unfunded Mandates Reform Act of 1995 is not
required.
VII. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
VIII. Submission of Comments and Proposed Dates
Interested persons may, on or before February 4, 1999, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
FDA proposes that any final regulation that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register.
List of Subjects in 21 CFR Part 880
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 880 be amended to read as follows:
[[Page 59921]]
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
1. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Sections 880.6885 and 880.6890 are added to subpart G to read as
follows:
Sec. 880.6885 Liquid chemical sterilants.
(a) Identification. A liquid chemical sterilant is a germicide that
is intended for use as the terminal step in processing critical and
semicritical medical devices prior to patient use. Critical devices
make contact with normally sterile tissue or body spaces during use.
Semicritical devices make contact with mucous membranes or nonintact
skin during use.
(b) Classification. Class II (special controls). (Guidance on the
Content and Format of Premarket Notification (510(k)) Submissions for
Liquid Chemical Germicides, voluntary standards, and user information
and training.)
Sec. 880.6890 General purpose disinfectants.
(a) Identification. A general purpose disinfectant is a germicide
intended to process noncritical medical devices and equipment surfaces.
A general purpose disinfectant can be used to preclean or decontaminate
critical or semicritical medical devices prior to terminal
sterilization or high level disinfection. Noncritical medical devices
make only topical contact with intact skin of the body.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 880.9.
Dated: October 2, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-29566 Filed 11-5-98; 8:45 am]
BILLING CODE 4160-01-F