[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Proposed Rules]
[Pages 5750-5753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3019]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 67, No. 26 / Thursday, February 7, 2002 / 
Proposed Rules  

[[Page 5750]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 01N-0339]


Medical Devices; Proposed Classification for Medical Washer and 
Medical Washer-Disinfector

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
classify the medical washer and medical washer-disinfector intended for 
general medical purposes to clean and dry surgical instruments, 
decontaminate or disinfect anesthesia equipment, hollowware, and other 
medical devices into class II (special controls). Elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of a 
guidance document that FDA intends to use as the special control for 
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: Submit written or electronic comments by May 8, 2002. See 
section VII of this document for the proposed effective date of a final 
rule based on this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20857. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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 Device Amendments of 1976 (the 
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 
(the SMDA) (Public Law 101-629), and the Food Drug Administration 
Modernization Act of 1997 (the FDAMA) (Public Law 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) 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 of the regulations (21 CFR part 807).
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures (510(k)), 
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 with the 
General Hospital and Personal Use Devices Panel (the Panel), an FDA 
advisory committee regarding the classification of the medical washers 
and medical washer-disinfectors.
    Medical washers intended for general medical purposes to clean and 
dry surgical instruments, anesthesia equipment, hollowware, and other 
medical devices, and medical washer-disinfectors intended additionally 
to decontaminate or disinfect medical devices were in commercial 
distribution prior to May 28, 1976, the date of the Medical Device 
Amendment to the act. Medical washers and medical washer-disinfectors 
are considered medical devices within the meaning of section 201(h) of 
the act (21 U.S.C. 321(h)). Although they were legally marketed medical 
devices, the medical washers and medical washer-disinfectors were not 
included among the devices that were classified in 1980 by the Panel. 
Because the medical washers and medical washer-disinfectors are not 
dedicated to a single type of device, FDA has not considered them as 
accessories to classified medical devices. Although FDA has classified 
several generic types of washers and washer-disinfectors by regulation, 
medical washers and medical washer-disinfectors intended for general 
medical purposes to reprocess a variety of devices have not been 
classified by regulation and are therefore considered as unclassified 
devices.
    Prior to June 1998, it was unclear to regulated industry whether 
the unclassified medical washers and medical washer-disinfectors were 
devices subject to the 510(k) requirements of the act. On June 2, 1998, 
FDA published on the Center for Devices and Radiological Health (CDRH)

[[Page 5751]]

Internet site the document entitled ``Guidance Document for Washers and 
Washer-Disinfectors Intended for Processing Medical Devices,'' which 
clarified their regulatory status at that time. FDA informed industry 
that these devices were subject to the 510(k) requirements of the act; 
that FDA would have a Panel meeting for the purpose of classifying 
these devices; and that FDA would provide guidance on the types of 
information to be included in a submission. The Panel was convened on 
September 14, 1998. In the Federal Register of November 5, 1998 (63 FR 
59794), FDA announced the availability of the draft guidance and 
invited interested persons to comment on the guidance.
    FDA has classified the following generic types of washers and 
washer-disinfectors that were in commercial distribution prior to May 
28, 1976, by regulation. Washers and washer-disinfectors intended to 
process only ``general purpose articles,'' such as laboratory 
glassware, pipettes, bottles, and containers, although considered as 
medical devices, are treated by FDA as ``general purpose'' articles 
exempt from registration under Sec. 807.65(c) and from the 510(k) 
requirements of the act.
    Washers labeled only to wash and sanitize body waste receptacles, 
such as bedpans, have been classified as class I devices under 21 CFR 
880.6800 (washers for body waste receptacles) and are exempt from the 
510(k) requirements of the act (subject to the limitations on 
exemptions found in Sec. 880.9 (21 CFR 880.9)).
    Ultrasonic cleaners, which are intended to clean medical 
instruments by emission of high frequency soundwaves, and any cleaning 
solution intended for use with the ultrasonic cleaners, have been 
classified as class I devices under 21 CFR 880.6150 and are exempt from 
510(k) requirements of the act (subject to the limitations on 
exemptions found in Sec. 880.9).
    Products used in the cleaning and disinfection of rigid gas 
permeable and soft (hydrophilic) contact lenses are classified as class 
II devices under 21 CFR 886.5918 and 886.5925, respectively.
    FDA considers washers, washer-disinfectors, or disinfectors 
intended solely for the processing of flexible endoscopes as 
accessories to endoscopes. Under the definition of a medical device, an 
accessory to a medical device is itself considered a medical device and 
is regulated in the same class as the associated medical device. 
Therefore, endoscope washers, endoscope washer-disinfectors, or 
endoscope disinfectors are considered in the same class as endoscopes 
under 21 CFR 876.1500. Endoscopes and accessories are class II devices.

II. Recommendation of the Panel

    During a public meeting, which was held on September 14, 1998, the 
Panel made the following recommendation regarding the classification of 
the general use washers and washer-disinfector. ``General use'' was the 
identifying terminology used at the time of Panel deliberations.

A. Identification

    The Panel recommended that the device be identified as follows: A 
general use washer or washer-disinfector is a device intended for 
medical purposes to clean, decontaminate or disinfect, and dry surgical 
instruments, anesthesia equipment, hollowware and other medical 
devices. A general use washer or washer-disinfector can be equipped 
with electromechanical control systems or with microprocessor control 
systems and may have one or more cleaning and decontamination/
disinfection cycles for a variety of medical devices. The device can be 
a free standing, single or double door unit or a wall recessed, pass-
through unit with spray arms, nozzles, and adapters for directing fluid 
flow onto the external and internal surfaces of the medical devices. It 
may also have accessory inserts, such as specialized trays and racks, 
for processing a wide variety of instruments. The washer or washer-
disinfector may clean, decontaminate or disinfect, and dry medical 
devices using preset cycles with defined-contact parameters. The 
cleaning phase may automatically dilute and dispense the cleaning agent 
or may require the user to dilute and add the cleaning agent manually. 
In some instances, manual precleaning of patient exposed devices may be 
necessary before placing them in the general use washer or washer-
disinfector because of complex device designs or because of heavy 
soiling of the medical devices. The disinfection phase may be either a 
thermal process using heated water or steam or a chemical process using 
a liquid chemical germicide.

B. Recommended Classification of the Panel

    The Panel unanimously recommended that the general use washer and 
washer-disinfector be classified into class II. The Panel believed that 
special controls in addition to the general controls would provide 
reasonable assurance of the safety and effectiveness of the device. The 
Panel recommended the following as special controls: FDA guidance, 
voluntary consensus standards, and user information/education.

C. Summary of Reasons for Recommendation

    The Panel considered the information provided by FDA and industry, 
open discussions during the Panel meeting, and their clinical 
experience with the device in making their recommendation. The Panel 
then voted that general use washers and washer-disinfectors that are 
intended for medical purposes to clean, decontaminate or disinfect, and 
dry medical devices should be classified into class II. The Panel 
believed that special controls, in addition to general controls, would 
provide reasonable assurance of the safety and effectiveness of the 
device, and that there was sufficient information to establish special 
controls to provide such assurance.

D. Summary of Data Upon Which the Recommendation is Based

    The Panel discussed a proposal to classify the general use washers 
and washer-disinfectors according to their intended use into two 
classes. Devices with cleaning as the only intended use would be placed 
in class I, whereas devices that are intended to be used for both 
cleaning and disinfection would be placed in class II. The Panel, 
however, noted that most of these devices would be placed in central 
services departments of healthcare facilities and believed that the 
majority of the devices would be intended for use as a washer-
disinfector system rather than for use as a washer. The Panel 
recognized that a wide variety of medical devices, such as surgical 
instruments, anesthesia equipment, hollowware, and many other medical 
devices, are processed in these general use washers and washer-
disinfectors and it is extremely difficult to dissociate the cleaning 
process from the disinfection process. Consequently, the Panel rejected 
the option of classifying the device intended only for washing as a 
class I device. The Panel recommended that the general use washers and 
washer-disinfectors, whether intended only for cleaning or intended for 
both cleaning and disinfection, be classified as class II.
    The Panel acknowledged that those washers and washer-disinfectors 
already classified by regulation, such as washers for body waste 
receptacles, washers for general purpose articles, such as laboratory 
glassware, ultrasonic cleaners, washers and washer-disinfectors for 
flexible endoscopes, and contact lens cleaners, would not be affected 
by this classification.

[[Page 5752]]

E. Risks to Health

    The Panel identified the following risks associated with the use of 
these devices: (1) Potential for increased risk of nosocomial 
infections; if general use washers and washer-disinfectors fail to 
process medical devices adequately, the medical device may serve as a 
potential vector for infection; (2) damage to medical devices if the 
cycle parameters or the liquid chemical germicide are incompatible with 
the medical device; damaged devices may fail to function or have areas 
that cannot be reprocessed effectively; (3) exposure of patient and 
healthcare users to chemical residues; if a liquid chemical germicide 
is used during the disinfection step, healthcare users and patients can 
be exposed to toxic residues if the rinse cycles are inadequate; (4) 
healthcare user exposure to toxic fumes from liquid chemical germicides 
or burns caused by exposure to hot water/steam used in the disinfection 
step; (5) electrical hazards; (6) electro-magnetic interference with 
the electronic components resulting in firmware failures; and (7) 
software failures.

F. Special Controls

    In the Federal Register of November 5, 1998 (63 FR 59794), FDA 
announced the availability of the draft guidance document entitled 
``Guidance on the Content and Format of Premarket Notification [510(k)] 
Submissions of Washers and Washer-Disinfectors.'' The draft guidance 
outlines the recommended testing to support the intended use of these 
devices. It recommends physical performance testing demonstrating that 
the general use washers and washer-disinfectors meet and maintain 
parameter specifications for each cycle. The draft guidance also 
provides information on the types of microbicidal performance testing 
to support the intended level of disinfection. In addition, it contains 
recommendations for residue testing, software documentation, and 
electrical and electromagnetic compatibility. The guidance includes 
recommendations on the types of information that should be included in 
the labeling for the general use washers and washer-disinfectors to 
provide the user with sufficient information for the proper use of 
these devices. FDA reviewed the comments on the draft guidance and has 
revised the guidance. Elsewhere in this issue of the Federal Register, 
FDA is announcing the availability of the guidance document that FDA 
intends to use as the special control for these devices (the special 
control guidance document).
    Although the Panel recommended voluntary consensus standards as a 
special control when classifying the ``general use'' washers and 
washer-disinfectors, as they were termed at the time of Panel 
deliberations, there are currently no voluntary consensus design or 
performance standards specific to the ``general use'' washers and 
washer-disinfectors. There are more general applicable voluntary 
consensus standards, e.g., electrical safety standards. In the future, 
when voluntary standards are adopted for ``general use'' washers and 
washer-disinfectors, they can be incorporated in the FDA special 
control guidance document.
    User information and education is critical to ensure that the users 
have full knowledge and can assume responsibility for the safe and 
effective use of the general use washers and washer-disinfectors. The 
Panel recommended user information and education as a special control. 
The FDA special control guidance document describes the type of 
information that should be made available to users of the ``general 
use'' washers and washer-disinfectors. The special control guidance 
document can be amended as the information and educational needs are 
updated.

III. Proposed Classification

    FDA believes that in order to reduce the potential for confusion, 
the identification terms ``general use'' washer and ``general use 
washer-disinfector'' as recommended by the Panel should be changed to 
``medical washer'' and ``medical washer-disinfector.'' The new terms 
will distinguish these devices from ``general purpose article'' washers 
and washer-disinfectors that are exempt from 510(k) requirements. FDA 
also believes that decontamination and disinfection are distinct 
intended uses that require FDA to distinguish washers from washer-
disinfectors in classification descriptions.
    FDA concurs with the Panel that the medical washers and washer-
disinfectors 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 device, and there is 
sufficient information to establish special controls to provide such 
assurance.
    As the Panel initially considered, FDA believes that the medical 
washer can be exempt from 510(k) requirements and that some medical 
washer-disinfectors can also be exempted from 510(k) requirements 
depending on intended use. The medical washer-disinfector intended to 
clean and high level disinfect medical devices should be subject to 
510(k) requirements because the reusable devices subject to a high 
level disinfection process may pose a high risk of infection and other 
serious sequelae if the washer-disinfector is unsafe or ineffective. 
The medical washer-disinfector intended to clean and provide low or 
intermediate level disinfection can be exempt from 510(k) requirements 
because the reusable devices subject to low or intermediate 
disinfection pose a relatively lower risk of infection and other 
serious sequelae if the washer-disinfector is unsafe or ineffective.

IV. 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.

V. 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 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 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. Manufacturers of these devices are already subject 
to 510(k) requirements. Some of these devices will now be exempt from 
the 510(k) requirement. The guidance will not add significantly to the 
information FDA presently requires in a 510(k). Therefore, FDA has 
determined that this proposed rule will impose little or no additional 
economic impact on any

[[Page 5753]]

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 to section 202(a) of the Unfunded 
Mandates Reform Act of 1995 is not required.

VI. Submission of Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this proposal 
by May 8, 2002. 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.

VII. Proposed Dates

    FDA proposes that any final regulation based on this proposal 
become effective 30 days after its publication in the Federal Register.

VIII. References

    The following reference has 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. Transcript of General Hospital and Personal Use Devices Panel 
of the Medical Devices Advisory Committee Meeting, September 14, 
1998.

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 as follows:

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 880.6991 and 880.6992 are added to subpart G to read as 
follows:


Sec. 880.6991  Medical washer.

    (a) Identification. A medical washer is a device that is intended 
for general medical purposes to clean and dry surgical instruments, 
anesthesia equipment, hollowware and other medical devices.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Medical Washers and Medical 
Washer-Disinfectors.'' The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec. 880.9.


Sec. 880.6992  Medical washer-disinfector.

    (a) Identification. A medical washer-disinfector is a device that 
is intended for general medical purposes to clean, decontaminate, 
disinfect, and dry surgical instruments, anesthesia equipment, 
hollowware, and other medical devices.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Medical Washers and Medical 
Washer-Disinfectors.'' Medical washer-disinfectors that are intended 
only to clean, and provide low or intermediate level disinfection and 
dry surgical instruments, anesthesia equipment, hollowware, and other 
medical devices are exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to Sec. 880.9.

    Dated: August 24, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-3019 Filed 2-6-02; 8:45 am]
BILLING CODE 4160-01-S