[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