[Federal Register Volume 60, Number 119 (Wednesday, June 21, 1995)]
[Proposed Rules]
[Pages 32406-32420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15086]




[[Page 32405]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Parts 895 and 897



Medical Devices; Performance Standards for Electrode Lead Wires and 
Banning of Unprotected Electrode Lead Wires; Proposed Rule

  Federal Register / Vol. 60, No. 119 / Wednesday, June 21, 1995 / 
Proposed Rules   

[[Page 32406]] 


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 895 and 897

[Docket No. 94N-0078]

Medical Devices; Proposed Performance Standards for Electrode Lead 
Wires and Proposed Banning of Unprotected Electrode Lead Wires

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to 
establish a performance standard for electrode lead wires. The agency 
is taking this action because it has determined that a performance 
standard is needed to prevent hazardous electrical connections between 
patients and electrical power sources. FDA is also proposing to make 
unprotected electrode lead wires a banned device upon the effective 
date of the standard for the device. FDA has determined that 
unprotected electrode lead wires and patient cables present an 
unreasonable and substantial risk of illness or injury, and that the 
risk cannot adequately be corrected or eliminated by labeling or a 
change in labeling.

DATES: Written comments by September 5, 1995. Written requests for 
changes in classification of the device before July 21, 1995. FDA is 
proposing that any final regulation promulgating a performance standard 
and banning the devices that do not meet the standard be effective 1 or 
3 years, depending on the device type, after publication of any final 
rule based on this proposal.

ADDRESSES: Submit written comments and requests for changes in the 
classification to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Marquita B. Steadman, Center for 
Devices and Radiological Health (HFZ-84), Food and Drug Administration, 
2094 Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 145.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 19, 1994 (59 FR 26352), FDA 
published an advance notice of proposed rulemaking (ANPRM) and 
announced the need for further FDA action to address this problem. In 
that ANPRM, FDA described various regulatory actions it had taken since 
the first reported incidents in 1985 of exposed male connector pins of 
electrode lead wires being inserted into either alternating current 
(AC) power cords or a wall outlet, rather than into the patient cable 
that connects to the monitor. The ANPRM also described actions to 
various organizations, such as the former Emergency Care Research 
Institute (ECRI), and outside standard setting bodies have taken to 
prevent electrode lead wires from being connected to electrical power 
sources. A summary of these actions is provided later in this section. 
In the ANPRM, FDA stated that: ``despite efforts to eliminate the risk, 
unprotected electrode lead wires and patient cabling systems are still 
distributed by some manufacturers as replacements for existing 
equipment, and may also be interchangeable among various medical 
devices.'' (See 59 FR 26532 at 26353.) In the ANPRM, FDA further 
announced that it, in conjunction with the Health Industry 
Manufacturers Association and the American Hospital Association (AHA), 
was sponsoring a public conference entitled ``Unprotected Patient 
Cables and Electrode Lead Wires.'' The conference was held on July 15, 
1994, and provided a forum for device users, manufacturers, and other 
health professionals to offer and to hear comments for FDA's 
consideration during the rulemaking process.
    The need for FDA action to resolve the potential hazard of 
unprotected electrode lead wires and patient cables used with medical 
devices was further emphasized in a letter dated August 2, 1994, to FDA 
Commissioner David A. Kessler, from the Honorable Ron Wyden, then 
Chairman, U.S. House of Representatives, Committee on Small Business, 
Subcommittee on Regulation, Business Opportunities, and Technology 
(Ref. 1). In that letter, Mr. Wyden stated that ``shocks, burns, and 
electrocutions occur despite warnings issued by the FDA to hospitals, 
manufacturers, and others.'' Specifically, Mr. Wyden wrote that:

    Hospitals have been told to purchase and use only protected 
wires and cables. They have also been told to remove unprotected 
equipment and to alert staff members to possible hazards to 
patients.
    Manufacturers have been encouraged to modify their designs to 
prevent lead wires from being inserted into electrical outlets.
    Despite warnings and other communications, some manufacturers 
still distribute to hospitals unprotected lead wires as replacements 
for deteriorated equipment.
    It is clear that regulatory action, as well as additional 
education and training is needed to stop the slow but steady flow of 
children (and adults) who are burned or electrocuted.

    FDA's records of incidents with unprotected electrode lead wires 
and patient cables reveal the following: Between 1985 and 1994, 24 
infants or children received ``macro-shock'' (large, externally applied 
currents) from electrode lead wires or cables, including 5 children who 
died by electrocution (Ref. 2). The most recent death (1993), which 
occurred in a hospital, involved a 12-day old infant. The apnea monitor 
involved in the incident had been sold with safety protected electrode 
lead wires and patient cable, but an unprotected patient cable from 
another manufacturer of an ECG monitor and unprotected prewired 
electrodes from a third manufacturer were being used when the infant 
was electrocuted.
    There are reports of injuries associated with unsafe electrode lead 
wires and patient cables involving medical devices other than apnea 
monitors (Ref. 3). In 1986, for example, a death occurred when the ECG 
lead wires were plugged into an infusion pump power cord in a hospital 
environment. Similarly, in 1990, a death occurred when a neonatal 
monitor's electrode lead wires were inserted into a pulse oximeter 
power cord. FDA has received additional reports of similar events that 
resulted in electrical shocks, burns, and possible brain damage to 
patients. In response to the death and electrical burns that occurred 
in 1985, FDA issued an alert to home-use apnea monitor manufacturers, 
home user support organizations, and apnea monitor users, announcing, 
among other things, the agency's intent to embark on a cooperative 
effort with industry and the medical profession to resolve the problem 
of potential electrical connection between patients and electrical 
power sources. FDA also requested each home-use apnea monitor 
manufacturer to evaluate its device for potential electrode lead wire 
and patient cable hazards and, when necessary, to consider design 
changes to preclude insertion of electrode lead wire connectors into AC 
power cords and outlets. In addition to issuing the alert, the Center 
for Devices and Radiological Health's July 1985 ``Medical Devices 
Bulletin'' was devoted in great part to publicizing the unprotected 
electrode lead wire hazard.
    Since 1985, FDA has not cleared for marketing any home-use apnea 
monitor that features an unprotected electrode lead wire and patient 
cable configuration. For all apnea monitors cleared for marketing since 
1989, FDA has required a protective electrode lead [[Page 32407]] wire 
and cable design, whether or not the device was intended for home use. 
Despite these efforts, some hospitals continue to use older units, or 
electrode lead wires and patient cables from other devices, which do 
not have the protective electrode lead wire and cable design. Even with 
the new models, as evidenced by the 1993 incident, it may be possible 
to switch patient cables and/or electrode lead wires, thereby creating 
a hazard.
    On September 3, 1993, FDA issued a safety alert to hospital 
administrators, risk managers, and pediatric department directors, 
warning them that the use of unprotected electrode lead wires with an 
apnea monitor may be dangerous to the patient, and may be in violation 
of section 518(a) of the act (21 U.S.C. 360h(a)) (Ref. 4). FDA included 
in the alert a number of recommendations to help prevent these 
accidents. FDA also sent all apnea monitor manufacturers a notification 
letter under section 518(a) of the act (Ref. 5).
    Section 518(a) of the act authorizes the agency to issue an order 
to assure that adequate notification is provided in an appropriate 
form, by the means best suited under the circumstances involved, to all 
health professionals who prescribe or use a particular device and to 
any other person who should properly receive such notification, in 
order to eliminate an unreasonable and substantial harm to the public 
health when no other practicable means is available under the act to 
eliminate such risk. FDA stated that, for these devices, notification 
should include replacement of unprotected electrode lead wires and 
patient cables, and that a warning label should be permanently affixed 
to all monitors stating that unprotected electrode lead wires and 
patient cables should not be used with the device because inappropriate 
electrical connections may pose an unreasonable risk of adverse health 
consequences or death. FDA also requested manufacturers of all apnea 
monitors to cease further distribution of unprotected electrode lead 
wires and patient cables. On September 20, 1993, FDA issued a similar 
letter to all known third-party manufacturers of patient cables and 
electrode lead wires (Ref. 6).
    On December 28, 1993, FDA issued a Public Health Advisory to 
hospital nursing directors, risk managers, and biomedical/clinical 
engineering departments for distribution to all units in their 
hospitals and outpatient clinics, as well as to home health care 
providers and suppliers affiliated with those facilities, advising them 
of the hazards associated with use of electrode lead wires with 
unprotected male connector pins (Ref. 7). In the Public Health 
Advisory, FDA expanded the scope of its September 3, 1993, apnea 
monitor safety alert to include all devices using patient electrodes. 
FDA noted that, even though manufacturers have changed the design of 
their devices to minimize the potential hazard, some facilities are 
still using older models that make it possible for staff to switch 
patient cables and/or lead wires, thus creating a hazard. FDA 
recommended various precautions to prevent the use of unsafe lead wires 
and patient cables.
    Manufacturers of devices other than apnea monitors that utilize 
patient electrodes, e.g., ECG, have been encouraged by various 
organizations to modify their electrode lead wires so that they cannot 
be inserted into AC power cords or outlets. For example, in February 
1987 and May 1993, ECRI issued hazard reports concerning electrical 
shock hazards from unprotected electrode lead wires and patient cables. 
Further, standards-setting bodies have developed various standards, 
both in draft and final form, that have the same goal in mind--safety 
requirements for patient electrode lead wires.
    IEC has proposed an amendment to IEC 601-1, the safety standard for 
electromedical equipment, requiring that electrode lead wires be unable 
to make contact with hazardous voltages. This amendment was approved 
and published in March 1995.
    The Underwriters Laboratories (UL) adopted IEC 601-1 by issuing its 
standard 2601-1. It became effective on August 31, 1994. This standard 
supersedes UL 544 (referenced in the ANPRM). In adopting the IEC 
standard, UL included a deviation that requires that patient electrodes 
be designed to avoid connection to electrical power sources. (See UL 
2601-1, Medical Electrical Equipment Part 1: General Requirements for 
Safety.) The UL standard states in the rationale section that ``this is 
a basic safety concern prompted by recent accidents involving patient 
injury, including infant deaths. Patients were accidently being 
connected to hazardous circuits while being connected to applied parts 
of medical equipment, such as an apnea monitor.'' FDA has been advised 
that it is possible that UL will modify its requirement to be 
equivalent to the one included in the proposed amendment to IEC 601-1.
    There is also a German DIN standard for touch proof connectors for 
electromedical applications. This design standard was also referenced 
in the ANPRM and states that it was developed because of the accidents 
that occurred with infants in 1985 and 1986.
    The National Fire Protection Agency (NFPA) is also proposing a 
standard for patient electrode lead connectors. FDA has received 
information that even though it is voluntary, this NFPA standard will 
be adopted by many States and municipalities as a mandatory standard 
for health care facilities. Further, this standard is referenced by the 
Joint Commission on Health Care Organizations.
    Finally, the Association for the Advancement of Medical 
Instrumentation (AAMI) is developing a standard that covers cables and 
patient lead wires for surface electrocardiographic monitoring in 
cardiac monitors applications. The draft standard addresses safety and 
performance of cables and lead wires with the added purpose of 
encouraging the availability of lead wires that are interchangeable for 
ECG monitoring applications. The standard defines a safe (no exposed 
metal pins) common interface at the cable yoke and lead wire connector. 
The draft standard is currently being balloted by AAMI and undergoing 
public review for acceptance as an American National Standard.
    FDA believes that industry also recognizes the importance of 
addressing this hazard. In response to FDA's alert letter in June 1985, 
manufacturers voluntarily began to redesign their electrode lead wires 
and patient cables for home apnea monitors. And more recently, many 
firms have taken voluntary action to recall electrode lead wires with 
unprotected exposed metal pins and/or unprotected patient cables. Apnea 
monitor firms are replacing their male pin lead wires and associated 
cables with safety cable systems, usually free of charge, while others 
are making adapters and warning labels available. Some device 
manufacturers have ceased supplying unprotected electrode lead wires.

II. Highlights of the Proposal

    This rule proposes to establish a performance standard that FDA 
believes will eliminate the risk of electrode lead wires being inserted 
or otherwise manipulated so as to make contact with live parts of a 
power outlet or separable power cord. This standard would apply to all 
medical devices that use patient-connected electrode lead wires.
    FDA is proposing a 1- or 3-year effective date for any final 
regulation based on this proposed promulgation of a performance 
standard. Devices that would be subject to the 1-year effective date 
are those devices that present the [[Page 32408]] greatest potential 
risk of harm as demonstrated by use in environments where accidental 
inappropriate connections could reasonably be anticipated, and by 
frequent use of the devices and frequent connections of electrode lead 
wires. Devices subject to the 1-year effective date would also include 
devices that have been the subject of reported adverse events, and 
those that can be reasonably anticipated to be the subject of adverse 
events. Devices that would be subject to the 3-year effective date are 
those devices that do not satisfy the criteria for the 1-year effective 
date but also utilize unprotected electrode lead wires. The agency is 
also proposing to ban devices that do not meet the standard on its 
effective date.

III. The New Framework

    As noted in the ANPRM, FDA recognizes that despite the many efforts 
described above, the potential risks presented by the continued use of 
unprotected electrode lead wires and patient cabling systems still 
exist. In order to eliminate these risks completely, the agency is 
proposing to establish a performance standard that would apply to all 
medical devices that use patient-connected electrode lead wires.
    In reaching this decision, the agency reviewed several standards 
that are in various stages of development before deciding to propose to 
establish its own. FDA decided not to adopt these standards for this 
proposal because some of them were too restrictive or not restrictive 
enough for application to all devices. In addition, it would cause 
unnecessary delay in FDA's handling of this matter to obtain the 
appropriate clearances for the adoption of an existing standard. FDA 
believes, however, that devices that meet the IEC, AAMI, and NFPA 
standards for protected electrode lead wire and cable configurations 
would also meet FDA's proposed standard.
    The agency believes that firms whose devices would be subject to 
the proposed performance standard will begin adapting existing products 
to the standard, or modify ``new devices'' to conform them to the 
standard, if they have not already done so, before the effective date 
of the standard. This would be consistent with Congress' admonition 
that ``stockpiling of nonconforming devices is discouraged, since 
standards will apply to all devices in commercial channels on their 
effective date.'' (See H. Rept. 853, 94th Cong., 2d sess. 30; see also 
45 FR 7474, February 1, 1980, final standards regulations.)
    FDA is publishing a list of devices utilizing patient contacting 
electrodes that would be subject to the 1- or 3-year phase-in process 
of the performance standard. FDA reserves the right, upon proper 
notification to interested parties, to amend this list at any time. FDA 
believes the proposed effective dates are reasonable and consistent 
with the congressional intent in enacting section 514 of the act, as 
well as with comments at the public conference.
    To ensure a full adherence to the standard by both new and existing 
products in commercial distribution and use, the agency is also 
proposing to ban all devices that do not meet the standard on its 
effective date.

IV. Performance Standard

    The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629) 
prescribes changes to the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 321-394), as amended, that improve the regulation of 
medical devices and strengthen the Medical Device Amendments of 1976 
(the 1976 amendments), which established a comprehensive framework for 
the regulation of medical devices.
    The SMDA amended section 513 of the act (21 U.S.C. 360c) to 
redefine class II as the class of devices that is or will be subject to 
special controls, and amended section 514 of the act (21 U.S.C. 360d) 
to simplify the requirements for establishing performance standards. 
Section 513 of the act states that the ``special controls * * * shall 
include performance standards for a class II device if the Secretary 
determines that a performance standard is necessary to provide 
reasonable assurance of the safety and effectiveness of the device.'' 
The legislative history of the SMDA states that:

by simplifying the process for establishing performance standards, 
and by allowing the Secretary discretion to employ such standards as 
one of a variety of additional controls to assure the safety and 
effectiveness of Class II devices, performance standards will become 
valuable tools to regulate those devices for which they are most 
needed.

(S. Rept. 513, 101st Cong., 2d sess. 19 (1990).)
    Under this proposal, this mandatory standard would apply to all 
electrode lead wires, and would be phased-in over a period of 3 years. 
Proposed Sec. 897.12(a) and (b) contain lists of devices that would be 
subject to the performance standard, with the applicable effective 
dates of the standard.

A. The Proposed Standard

    FDA proposes the following mandatory performance standard for 
patient-connected electrode lead wires. Any lead wire intended to 
provide electrical contact between a patient and any medical device 
shall be protected such that the connector at the lead wire end that is 
distal to the patient cannot make conductive contact with an AC 
electrical power source (e.g., wall receptacle, power cord plug).

B. Findings

    Unprotected electrode lead wires and patient cabling systems have 
been associated with burns and electrocutions. The fact that these 
injuries and deaths occurred in both homes and hospitals emphasizes the 
need to address this problem on a wider scale. Until all unprotected 
electrode lead wires and patient cables are out of the user 
environment, the potential hazard exists. FDA believes that a proactive 
approach warranted to address this potential hazard adequately.
    Despite repeated efforts to eliminate the serious hazard they pose, 
the production and use of unprotected electrode lead wires continue. 
Although many firms are taking corrective action, others continue to 
supply users with unprotected electrode lead wires, and users continue 
to request and use them. Therefore, to eliminate the serious risks to 
health presented by these devices, FDA is proposing that all devices 
featuring patient connected electrode lead wires be redesigned or 
adapted to prevent the risk by the end of a 3-year period.

C. Opportunity to Request a Change in Classification

    In accordance with section 514(b)(1)(B)(iii) of the act and 
Sec. 860.132, FDA is offering interested persons an opportunity to 
request a change in the classification of any device that would be 
subject to the proposed standard, based on new information relevant to 
its classification. Any proceeding to reclassify a device will be in 
accordance with section 513(e) of the act.
    A request for a change in the classification of a device that uses 
electrode lead wires is to be in the form of a reclassification 
petition containing information required by Sec. 860.123 (21 CFR 
860.123), including new information relevant to the classification of 
the device, and shall, under section 514(b)(1)(B) of the act, be 
submitted before July 21, 1995.
    The agency advises that, to ensure timely filing of any such 
petition, any [[Page 32409]] request should be submitted to the Dockets 
Management Branch (address above) and not to the address provided in 
Sec. 860.123(b)(1). If a timely request for a change in the 
classification is submitted, FDA will, by August 21, 1995, and after 
consultation with the appropriate FDA advisory committee and by an 
order published in the Federal Register, either deny the request or 
initiate a change in the classification of the device in accordance 
with section 513(e) of the act and 21 CFR 860.130.
    In accordance with section 515(c)(1)(D) of the act (21 U.S.C. 
350e(c)(1)(D)) any class III device for which a PMA is filed would be 
required to include information showing that the device is in 
compliance with the standard.

D. The Proposed Effective Date

    Section 861.36 (21 CFR 861.36) states that:

    A regulation establishing * * * a performance standard will set 
forth the date upon which it will take effect. To the extent 
practical, consistent with the public health and safety, such 
effective date will be established so as to minimize economic loss 
to, and disruption or dislocation of, domestic and international 
trade. (See also section 514(b)(3)(B) of the act.)

    FDA has determined that the cost of converting or adapting unsafe 
electrode lead wire configurations in order to comply with the proposed 
standard is manageable because the standard will be phased in over a 1- 
or 3-year period. Furthermore, FDA believes that this cost is 
justifiable given the severity of the adverse events that have occurred 
and those that may reasonably be anticipated.

V. Banning Action

    The SMDA amended section 516 of the act (21 U.S.C. 360f), which 
authorizes FDA to ban any device intended for human use if FDA finds, 
based on all available data and information, that such device presents 
a ``substantial deception'' or an ``unreasonable and substantial risk 
of illness or injury'' that FDA finds cannot be, or has not been, 
corrected or eliminated by labeling or a change in labeling.
    The Report by the Committee on Interstate and Foreign Commerce on 
the amendments (House Report) stated that:

    By using the term substantial, the Committee intends that the 
Secretary make a determination that the deception or risk incurred 
through the continued marketing of such a device is important, 
material, or significant. In determining that the device is 
deceptive, it is not necessary that the Secretary find that there 
was intent to mislead users of the device. Nor is actual proof of 
deception of or injury to an individual required.

(H. Rept. 853, 94th Cong., 2d sess. 19 (1976).)
    The legislative history of the amendments further stated that:

    A finding that a device presents the requisite degree of 
deception or risk is made `on the basis of all available data and 
information', including information which the Secretary may obtain 
under other provisions of the proposed legislation, and information 
which may be supplied by the manufacturer in response to the 
proceeding relating to the safety, effectiveness, or labeling of the 
device.

(Id. at 19.)
    Under the SMDA, FDA may initiate a proceeding to ban a device, 
based upon available data and information, without first consulting 
with a device panel. In addition, the SMDA no longer requires that the 
agency afford interested persons an opportunity for an informal hearing 
before proposing a regulation to ban a device. (See Section 18(d) of 
the SMDA; and also 21 CFR 895.20.) FDA believes, that the conference 
held on July 15, 1994, was an appropriate forum for interested parties 
to express their views on the agency's options for a proposed course of 
action. Further, the ANPRM solicited comments on alternative solutions 
to the removal of all unprotected electrode lead wires from the market, 
such as banning them under part 895 (21 CFR part 895). FDA considered 
the conference transcript, as well as the written comments submitted in 
response to the ANPRM, before determining that a banning action is 
warranted. For all these reasons, the agency has decided that an 
informal hearing is not necessary before proceeding with the proposal. 
Moreover, this document provides interested persons with an additional 
opportunity to provide comments on the agency's proposed actions.
    FDA is aware that in response to the section 518(a) letters it 
issued last year, many firms conducted voluntary recalls of unprotected 
electrode lead wires to correct the labeling on these devices. However, 
FDA has determined that the continued marketing of unprotected 
electrode lead wires and patient cables, no matter how they are 
labeled, presents an unreasonable and substantial risk of illness or 
injury to individuals, and provides no benefit to the public health 
that is not provided by protected electrode lead wires and patient 
cables. Use of unprotected electrode lead wires has resulted in, and 
can be expected to continue to result in, serious adverse consequences 
or death because the devices are inherently dangerous when used in a 
reasonably foreseeable, albeit inappropriate, manner. There are no 
labeling requirements that can reliably prevent inappropriate 
connections of unprotected electrode lead wires and, thus, unprotected 
electrode lead wires cannot be safely marketed for the device's 
intended purposes. Accordingly, FDA has not proposed a change in device 
labeling. Indeed, labeling warnings are meaningless when unprotected 
electrode wires are available to preschool children or individuals with 
limitations such as vision problems, mental retardation, or other 
cognitive impairments. Further, labeling is often an inadequate 
solution in certain hospital settings where health care professionals 
find themselves in busy, stressful situations in which they may not be 
provided with, or could inadvertently overlook, instructions.
    Therefore, FDA is proposing to ban unprotected electrode lead wires 
in order to prohibit their further introduction into commerce and to 
expedite the removal of these devices from commercial distribution and 
use, thereby preventing any further or unreasonable and substantial 
risk of illness or injury. Based on the public comments received to 
date, FDA believes that the proposed 1- or 3-year effective dates would 
provide a reasonable transition time with minimal economic disruption.
    FDA notes that, even though current law requires that hospitals and 
other users of medical devices report problems such as serious injuries 
and deaths, that law did not become effective until late 1991. 
Therefore, there has probably been an underreporting of the deaths and 
serious injuries attributable to unprotected patient electrode lead 
wires and cables.
VI. Summary and Analysis of Comments and FDA'S Response

    The agency received 19 written comments from manufacturers, 
distributors, user facilities, trade associations, and a consultant in 
response to the ANPRM. A summary of the written comments and oral 
testimony from the conference is provided below:
    1. In general, several comments expressed their appreciation to FDA 
for allowing them to express their views to the agency on this 
important public health issue. A few comments noted that the July 
conference was an excellent forum for the exchange of ideas on a 
subject that is of concern to all manufacturers and users of medical 
instrumentation. One comment encouraged FDA to increase its use of 
[[Page 32410]] forums of this type because they lead to a better 
understanding of issues that are relevant to industry. A few comments 
stated that they were in favor of safety systems for all devices that 
directly connect electrodes to patients. Other comments supported the 
concept of banning the use and production of unprotected electrode lead 
wires, provided the ban was implemented over a period of time to allow 
manufacturers to convert to protected electrode lead or cable sets, and 
for users to budget for and adapt to the change.
    FDA has utilized the information gleaned from the July conference 
and the written comments submitted in response to the ANPRM in 
determining the most appropriate regulatory approach to address the 
risks associated with the continued use of unprotected electrode lead 
wires and patient cabling systems. The agency is proposing to establish 
a performance standard for patient-connected electrode lead wires, and 
also to ban devices that do not meet the standard on its effective 
date. However, FDA is proposing a phase-in of any final rule based on 
this proposal for up to a 3-year period, depending on the device type. 
Based on the public comments received to date, FDA believes that the 
proposed effective dates provide a reasonable transition period for 
both new and existing products in commercial distribution and use.
    2. Some comments noted that interchangeability with various devices 
was an attractive feature of unprotected lead sets. Indeed, several 
comments noted that the straight male (0.80'') single pin and 
corresponding socket are a de facto standard. Several comments noted 
that this interchangeability feature helps to contain costs. Another 
comment noted that single lead wire electrodes are lightweight, which 
makes them good for use on small patients like neonates. Furthermore, 
because of their light weight, there is an increased probability that 
the lead will stay on the patient.
    Interchangeability of pin-style lead wires was one of the factors 
leading to FDA's decision to propose this performance standard and ban. 
FDA believes that protected patient-connected electrode lead wires, if 
properly designed, can provide the same advantages that have been 
offered by unprotected electrode lead wires.
    3. At the conference it was reported that an advantage to using 
unprotected electrode lead wires is the ability to clean the contacts 
of the lead wires, both for the electrical connection because of the 
oxidation of the connections and also from the standpoint of infection 
control. Another advantage noted was the ability to disconnect 
electrode lead wires from one cable and connect them into other cable 
assemblies while the patient is being transported from unit to unit. 
Other comments noted that standardized protected electrode lead wire 
and patient cable interfaces, if properly designed, can provide the 
same advantages as unprotected electrode lead wires.
    FDA agrees that standardized cable and electrode lead wire 
interfaces, if properly designed, can provide the same advantages as 
unprotected electrode lead wires.
    4. One comment stated that hospitals are being forced to stock many 
different cables and electrode lead wires to meet the needs of various 
types of equipment and, as a result, it makes staff training more 
difficult and creates complex problems when patients move from one area 
of the hospital to another.
    FDA recognizes that in a highly complex setting, such as a 
hospital, there are numerous questions that arise such as when to 
change the electrode lead wires, when to change the cables, or when to 
interchange cables. FDA believes that its proposed standard will 
eliminate the risk of injury or death when such decisions are made 
because all electrode lead wires used in the hospital setting, 
regardless of which device they are being used with, will be protected. 
FDA encourages design engineers to standardize protected electrode lead 
wires as much as practicable to permit appropriate interchangeability 
among device types.
    5. One comment noted that many devices (for example, devices that 
are no longer being manufactured) cannot be modified economically to 
accept a protected electrode. Another comment stated that at least 20 
to 50 percent of all devices in use either cannot be converted or are 
not worth converting because the manufacturer is out of business or the 
device is obsolete. This comment states that such devices would need to 
be discarded and replaced with new equipment.
    FDA is not aware of any devices that are no longer being 
manufactured and are in use today that will be unable to accept 
protected electrode lead wires with proper design modification. 
Further, to date, FDA has not been presented with any data showing that 
firms would be unable to economically redesign their electrode lead 
wires in accordance with the phase-in approach set forth in this 
proposal. To the contrary, the evidence in the record demonstrates that 
a phase-in of up to 3 years would allow sufficient time for such a 
conversion. For example, at the conference it was reported that 
clinical engineers from 33 States who responded to an independent 
survey stated that they could eliminate 90 percent of their 
nonprotected electrode lead wire and cables in about 2 years. Further, 
it was reported that studies conducted by AHA and the American Society 
for Electroneurodiagnostic Technologists (ASET) concluded that it would 
take a minimum of approximately 2 years to phase-in any conversion for 
existing electroneurodiagnostic instrumentation and electrode lead 
wires to a new gender configuration. This 2-year timeframe, according 
to a representative from ASET, was based on the financial impact that 
any change would have on the average diagnostic laboratory. This 
representative further believed that, with an extended compliance date 
for the diagnostic laboratory setting, the cost would be spread out 
over a larger fiscal period, making it easier for smaller laboratories 
to absorb the increased cost of services.
    6. At the conference it was suggested that use of adapter blocks 
would be an inexpensive alternative to address the unprotected 
electrode lead wire problem. However, this comment noted that adapters 
are detachable.
    FDA recognizes that certain adapters are not failure proof and can 
be removed, posing the same hazard as an unprotected product. FDA is 
seeking a permanent solution to the problem. If an adapter is used, it 
should be designed to prevent removal by the user.
    7. One comment noted that the use of unprotected electrode lead 
wires is preferable to use of an intermediate adapter because adapters 
introduce a second electrical connection between the device and the 
electrode, and some devices (for example, electroencephalograms 
(EEG's)) are very susceptible to noise that may be generated by this 
additional connection.
    FDA acknowledges that, if improperly designed, any extra connection 
that is made between the electrodes on the patient and the recorder has 
the potential of causing interference in the recording. However, FDA 
believes that significant interference could be prevented by proper 
design of the connector. Further, FDA believes that, in order to comply 
with the proposed standard, adapters would have to be designed so as to 
prevent their removal of the adapter by the user.
    8. A few comments noted that certain devices, such as 
transcutaneous electrical nerve stimulators (TENS), Holter, and 
telemetry, may not permit conversion from unprotected to protected 
electrode leads unless the [[Page 32411]] device is retrofitted by an 
adapter and, in some cases, redesigned by the original equipment 
manufacturer. Several other comments noted that diagnostic instruments 
cannot accept redesigned electrode connections without modifying the 
device.
    FDA believes that if devices cannot accept safety lead sets 
currently available, modifications can be made to the design of the 
lead, and may also be necessary for the device with which the lead is 
intended to be used. Indeed, one comment noted that modification kits 
will be available to permit the use of protected electrode lead wires 
on certain devices that currently cannot accept them.
    As noted at the conference, the electrode lead wires for TENS, 
Holter, and other event monitors may migrate into other clinical areas. 
Indeed, FDA believes that the same is true for all electrode lead 
wires, including those intended for diagnostic use. Therefore, FDA is 
proposing that all unprotected electrode lead wires be redesigned or 
adapted to prevent the risk to health presented by these devices.
    It should be noted that certain battery powered devices (e.g., 
Holter monitors, TENS, biofeedback devices) are proposed for Phase 1 
implementation. If battery powered, these devices do not pose a direct 
electrical hazard. However, FDA is concerned about their unsupervised 
use outside a clinical setting, and the potential hazard presented when 
their pin-style electrode lead wires are connected to a patient instead 
of to a device. Based on previous adverse experiences with home-use 
apnea monitors, FDA believes it prudent to require early conversion of 
these other home-use devices, and is proposing to include them in Phase 
1.
    9. A trade association stated that it is not aware of any device 
that inherently cannot accept a redesigned, protected electrode lead. 
As noted in response to the comment above, FDA believes that if current 
devices cannot accept safety lead sets currently available, 
modifications can be made to the design of the lead, and may also be 
necessary for the device with which the lead is intended to be used. 
Indeed, one comment noted that modification kits will be available to 
permit the use of protected electrode lead wires on certain devices 
that currently cannot accept them.
    10. Some hospitals and other providers contended that immediately 
replacing devices or parts would be too costly and logistically 
difficult. One comment stated that the cost of converting to protected 
electrode lead wires and patient cables would increase the costs of 
medical care. In contrast, one comment stated that the conversion cost 
to health care providers would not be unreasonably high given the 
potential loss of life if unprotected electrode lead wires continue to 
remain available. A few user facilities noted that unprotected 
electrode lead wires are not only less expensive than protected 
electrode leads, but they also have several additional advantages for 
hospitals, i.e., light in weight, and a standard size and shape 
(allowing the hospital to use the wires for multiple purposes). These 
facilities believe that the unprotected electrode lead wire problem 
will resolve itself in time because, as replacements are needed, safer 
leads will be ordered.
    FDA believes that a long-term ``natural'' phaseout is an 
unacceptable solution to the problem. Indeed, one manufacturer of 
electrode lead wires reported that it continues to fill requests for 
unprotected lead wires, and does not anticipate any decrease in such 
requests. One comment estimated that 1.5 million unprotected electrode 
lead wires and patient cables are manufactured and distributed annually 
in the United States either for new use or as replacement products, and 
10 to 40 million unprotected electrode lead wires and patient cables 
are currently in circulation. Moreover, FDA believes that any 
``natural'' phaseout that might occur, would take much longer than is 
reasonable and necessary. FDA believes that a proactive approach is 
necessary to address this potential hazard adequately. Therefore, to 
eliminate the serious risks to health presented by these devices, FDA 
is proposing that all devices featuring patient-connected unprotected 
lead wires be redesigned or adapted in order to eliminate the risk by 
the end of a 3-year period.
    11. A few comments stated that the cost of converting unsafe cables 
to safe cables is manageable. One comment noted that the manufacturing 
of electrode lead wires with protected pins, such as pins meeting DIN 
42 802, costs only a few cents more than manufacturing lead wires with 
unprotected pins. In addition, this comment continued, the cost of the 
jacks that fit into the equipment is also consistent with the costs of 
the 2-millimeter pin jack. This comment concluded that any additional 
costs for new equipment are not significant compared to the cost of 
retrofitting equipment in the field. This comment believed that 
retrofitting would require significant changes to cases and printed 
circuit boards, and is not warranted in light of the frequency and 
nature of the accidents that have occurred.
    FDA believes that the cost of converting or adapting unsafe 
electrode lead wire configurations to safe electrode lead wire 
configurations meeting its proposed standard is manageable because the 
agency will be phasing in its standard over a 1- to 3-year period. 
Furthermore, FDA believes that this cost is justifiable given the 
nature of the adverse events reported and those that may be reasonably 
anticipated if these devices were to remain available.
    12. Several comments noted that the cost of converting to protected 
electrode lead wires will be greater for devices that will have to be 
completely redesigned to accommodate safe connections when electrode 
lead wires are directly inserted into them.
    As noted above, FDA believes that this cost is justifiable and will 
be manageable given the availability of permanent adapter blocks and 
the range of time FDA is proposing for adherence to the standard.
    13. One comment noted that the likelihood that nonmedical electrode 
lead wires and patient cables would be substituted for medical uses is 
virtually nonexistent. Another comment noted that no data are available 
indicating the extent of such substitution.
    FDA has seen no data describing the extent of substitution of 
nonmedical electrode lead wires and patient cables for protected 
medical electrode lead wires and patient cables.
    14. Some manufacturers claimed that substitution of unprotected 
electrode lead wires and patient cables can be avoided if the equipment 
is used properly and adequate warnings and instructions are provided 
with all devices. On the other hand, some users claimed that the reason 
why electrode lead wires and patient cables are misused is the poor 
design of the devices.
    Although FDA recognizes that user education and training are 
essential to the proper use of all devices, including unprotected 
electrode lead wires, a variety of additional factors are involved when 
improper electrical connections are made. One of these factors is the 
cognitive ability of the operator, e.g., sibling, caregiver, or parent, 
at the time of an incident, and another factor is the environment in 
which the device is being used. It is worth noting that, in the Chicago 
hospital incident discussed earlier, the health care professional had 8 
years of prior experience. Therefore, FDA believes that the most 
effective solution to the unprotected electrode lead wire problem is a 
change in the design of the device. [[Page 32412]] 
    15. Several comments stated that there is a need for electrical 
safety education specific to patient cables and electrode lead wires 
for all personnel who come in contact with them in the patient care 
setting.
    FDA agrees with this comment.
    16. Several comments stated that there are certain areas of a 
hospital that present a higher risk than others for inappropriate 
electrical connections. These comments mentioned intensive care units 
(ICU's), cardiac care units (CCU's), and emergency rooms as examples of 
high risk areas because many times people in those areas are under 
stress or fatigued, and events are happening extremely quickly. Another 
comment noted that what was clear regarding reported deaths and macro-
shocks from unprotected electrode lead wires was that there were no 
known reports involving adults. Therefore, this comment continued, the 
obvious conclusion is that neonatal ICU's, nurseries, and pediatric 
units where infants are cared for in a hospital should be the first 
priority in terms of engineering controls and education. The next areas 
that should be focused on are ICU's, CCU's, and possibly operating 
rooms. Finally, the comment concluded, areas using diagnostic devices 
clearly should be addressed last because of the expense of conversion 
and the unique attributes of that environment, including the fact that 
operators are trained, there are very few transactions, things are done 
in a linear fashion, and there is no risk of improper connections by 
parents, which was the cause of some of the reported incidents. A trade 
association added that, in any procedure-based area in a hospital, 
e.g., the catheter lab, the probability of a problem occurring with a 
single bare-pin lead electrode and a female end of a power cord is 
diminished.
    FDA has considered the environments where these devices are used, 
the frequency with which they are used and the reported and reasonably 
anticipated potential adverse events in determining whether specific 
devices should be subject to either the 1- or the 3-year effective date 
of the standard.
    FDA believes that, even though current law requires that hospitals 
and other users of medical devices report serious injuries and deaths, 
there probably has been underreporting of deaths and serious injuries 
caused by unprotected patient electrode lead wires. FDA believes that 
most of the deaths, particularly those involving infants, probably have 
been reported to FDA. However, the agency believes that some injuries, 
that could be related to these devices, including serious injuries, 
probably have not been reported.
    17. Many comments stated that the risk analysis and the history of 
incidents involving ECG and apnea monitoring equipment support a need 
for a performance standard for these devices. One comment at the 
conference noted that intraoperative EEG monitoring equipment should be 
included in any FDA regulatory action because the leads used with this 
equipment are similar to those used with the ECG and apnea monitoring.
    FDA believes that all unprotected electrode lead wires present a 
risk for patients connected to them and, therefore, would be subject to 
the proposed performance standard and ban.
    18. One comment suggested that new devices should be required to 
have a permanently wired cord. In contrast, another comment noted that 
hardwiring the modular power cord to the equipment is a poor 
alternative in light of the costs and logistical feasibility of this 
action. The modular power cord, this comment continued, is inherently 
safe and is a standard across the entire industry base. This comment 
believes that the problem is not the power cords, but rather the lead 
wires and the lack of training of the individuals using them.
    FDA believes that hardwiring the power cord to the monitor is not a 
solution to the hazard presented by an exposed male pin. FDA's proposed 
actions, therefore, focus on the unprotected electrode lead wire, where 
an inappropriate connection can be made.
    19. One comment recommended changing the ECG monitoring color codes 
for lead placement to avoid duplication with those used for the power 
cord.
    FDA believes that a color change is not the most appropriate and 
direct solution to the problem. As noted above, several factors play a 
role in an improper connection.
    20. During the conference it was stated that the detached power 
cord was the primary source for all of the incidents involving macro-
shocks and deaths associated with unprotected lead wires. Furthermore, 
it was noted that there have been no accidents in the home, resulting 
in either injuries or deaths, since 1987. All of the accidents that 
have occurred since then have occurred in a hospital setting.
    As noted in comment 18, FDA believes that the characteristics of 
the power cord can not eliminate the hazard presented by an exposed 
male pin. Therefore, FDA's proposed actions focus on the unprotected 
electrode lead wires. Since 1985, unprotected electrode lead wires have 
been associated with burns and electrocutions in both homes and 
hospitals. Therefore, FDA does not believe that the focus of its 
proposed actions should be limited to a specific environment. FDA has 
considered the intended environments of use, however, in determining 
when the proposed requirements would be applicable to a particular 
device.
    21. Several comments objected to the notion that one standard could 
be appropriate for electrode lead wires and patient cables used in 
multiple diagnostic procedures because the performance attributes are 
different.
    FDA believes that the proposed standard provides enough flexibility 
for manufacturers to design safety leads that take into account the 
type of diagnostic procedure involved, the physical characteristics of 
each examination and operating room, as well as each physician's or 
technician's personal preference for use of the diagnostic instrument 
on the patient. Hence, FDA has determined that one performance standard 
would be appropriate for all electrode types.
    22. Several comments recommended that a risk-based assessment of 
the unprotected electrode lead problem should be a component of any FDA 
action. Devices that present the greatest risk should be given the 
greatest attention.
    FDA has determined that all devices that use electrode lead wires 
should be subject to the proposed performance standard and ban. 
However, FDA has decided to phase-in its proposed requirements to allow 
sufficient flexibility for all devices that use unprotected electrode 
lead wires to be converted. As noted in the response to comment 20, FDA 
considered risk in determining when the proposed requirements would be 
applicable to a particular device.
    23. One comment stated that lead wire connectors should not have 
exposed metal that can be connected to a ground or power source, either 
foreign or domestic.
    FDA agrees. Therefore, its proposed standard attempts to achieve 
this goal.
    24. Several comments stated that a performance standard should be 
focused on line-powered devices and, even more specifically, on apnea 
monitoring and ECG devices, for which there have been reported adverse 
incidents. One comment added that other devices should not be required 
to change to protected electrode lead wires until they are shown to 
present a risk to patients.
    FDA is proposing to apply its standard to all devices featuring 
[[Page 32413]] electrode lead wires. As noted earlier, limiting the 
standard to certain devices would not eliminate the risk of 
interchanging unprotected electrode lead wires with protected electrode 
lead wires. Further, FDA considered the reported and reasonably 
anticipated potential adverse events in determining whether a device 
should be subject to the 1- or 3-year effective date.
    25. One comment noted that FDA should adopt a safety standard such 
as UL 544 in lieu of a performance or design standard, such as AAMI's. 
Several other comments asserted that FDA should establish a performance 
standard. Another comment suggested that, if a general patient safety 
standard is desired, the language of the UL standard would suffice. 
This standard, the comment continued, permits the use of unprotected 
electrode lead wires and cables so long as the overall design of the 
system prevents exposing the patient to main power. If a performance 
standard specific to electrode lead wires and cables is desired, then 
it would be appropriate to establish a standard that requires that all 
electrical connections that can be manually opened be designed so that 
insertion into AC power sockets is not possible.
    FDA believes that its proposed performance standard sufficiently 
addresses the hazard to be prevented, while providing design engineers 
flexibility in determining how to accomplish that goal.
    26. Some comments noted that a performance standard across device 
type is viable assuming that manufacturers are given a reasonable time 
to convert to this performance standard. One comment argued that 
existing devices should be permitted to be ``grandparented'' in.
    FDA is requiring that both new and existing devices be subject to 
the standard. FDA believes that its phase-in approach will provide 
sufficient time for conversion and is consistent with the statutory 
requirements with respect to applicability of a performance standard. 
Therefore, there will be no ``grandparenting'' of existing equipment.
    27. One comment expressed the view that standards committees which 
are currently in place are best prepared to address the unique 
requirements of various devices, and that existing standards 
organizations, such as AAMI, should be encouraged to increase emphasis 
in this area. Indeed, in the conference it was noted, for example, that 
the IEC has developed at least four standards for connectors for 
specific devices.
    FDA encourages standards organizations to continue their efforts in 
this area. However, as stated earlier in this proposal, these are 
voluntary standards, and the agency has determined that a mandatory 
standard is necessary to adequately address the risk to health 
presented by unprotected electrode lead wires. The agency has used 
these standards in developing its proposed mandatory performance 
standard. FDA believes that the proposed standard achieves the goal of 
the existing standards--to eliminate the risk of patient-connected 
electrode lead wires being inserted or otherwise manipulated so as to 
make contact with live parts of a power outlet or separable power cord.
    28. During the conference a concern was raised that, if FDA were to 
require a protected environment, equipment currently in place could no 
longer be used. This comment stated that some equipment lasts more than 
10 years. Therefore, it was the comment's recommendation that protected 
electrode lead wires and cables be required to work with devices in 
place today.
    FDA agrees with this comment. FDA encourages design engineers to 
consider the ``useful life'' of the existing devices subject to this 
proposal when determining how to convert from an unprotected electrode 
lead wire and patient cable configuration to a protected configuration.
    29. Several comments recognized that requiring that only new 
equipment be changed would not adequately solve the problem.
    FDA believes that, until all unprotected electrode lead wires are 
off the market, the potential hazard still exists. Therefore, to ensure 
full adherence to the performance standard by all unprotected electrode 
lead wires currently in commercial distribution or those already sold 
to the ultimate user, FDA is proposing to ban all devices not meeting 
the performance standard on its effective date.
    30. A couple of comments supported the concept of banning the use 
and production of unprotected electrode lead wires. These comments 
recommended that such a ban be implemented over a period of time to 
allow manufacturers to convert to protected electrode lead or cable 
sets, and to allow users to budget for and adapt to the change. 
Comments varied with respect to the timeframe in which they believed 
the ban should be applied. One comment believed that full conversion 
should be required after approximately 18 months. Another comment noted 
that an immediate ban would result in interruption in hospital service 
and increased costs. Another comment noted that a total phaseout could 
be accomplished in 2 years.
    FDA is proposing to phase-in the ban in the same manner as the 
performance standard. Thus, the ban would apply on the effective date 
of the standard.
    31. One comment opposed to banning stated that such an action would 
shut down many areas of a hospital until the equipment could be 
converted.
    As noted earlier, the proposed ban would be phased in over a 1- and 
3-year period. This gradual phase-in would allow hospitals to take 
appropriate measures to convert or adapt existing equipment and thereby 
minimize, if not eliminate, the potential shortage of certain devices 
in the hospital.
    32. One comment stated that a performance standard would probably 
not prevent substitution or removal of offending cables and leads that 
are being used with products that have already been shipped.
    FDA believes that its proposed dual regulatory approach of a 
performance standard and ban for new and existing products would 
prevent further use of devices already shipped. As stated previously, 
both the standard and the ban would apply to all devices subject to 
these actions on the effective date. Any device not in compliance with 
these requirements would be adulterated in accordance with section 
501(e) of the act (21 U.S.C. 351(e)) and/or section 501(g) (21 U.S.C. 
351(g)).
    33. One comment stated that FDA should identify cable manufacturers 
not registered with the agency, or who have not filed 510(k)'s and take 
compliance action against them.
    FDA agrees with this comment, and has examined the regulatory 
status of many cable and lead wire manufacturers and contract 
manufacturers during the past year. FDA will continue to monitor firms 
that have not registered and/or listed, or submitted 510(k)'s, with the 
agency. FDA invites further information regarding any manufacturer 
believed to be in violation of these requirements.
    34. A few comments noted that FDA should require that any device 
for which a new 510(k) is filed meet safety requirements (UL, IEC, 
AAMI).
    As discussed previously, FDA considered adoption of a voluntary 
standard e.g., UL, IEC, AAMI, to address the unprotected electrode lead 
wire hazard, but decided instead to initiate the regulatory process for 
developing a mandatory performance standard for patient-connected 
electrode lead wires. If a final rule is promulgated establishing this 
standard and banning devices that do not meet the standard on its 
effective date, it will be applicable to [[Page 32414]] both new 
devices and existing products in commercial distribution and use.
    35. A request was made that FDA control third-party suppliers 
(manufacturers of cables and lead wires) by requiring 510(k)'s from 
them.
    A third party supplier that manufactures cable and lead wires is 
subject to the requirements of section 510(k) if that supplier also 
distributes the cables and lead wires. (See 21 CFR 807.85 for a 
discussion of exemptions from premarket notification requirements.)
    36. Some comments questioned how device modifications from an 
unprotected electrode lead wire and patient cable configuration to a 
protected configuration will be handled by the Center for Devices and 
Radiological Health's Office of Device Evaluation (ODE). These comments 
noted that, if protected electrode leads were required on equipment, 
the change would have to be processed through the premarket 
notification process (510(k) process), which could result in a delay.
    In a document entitled ``Notification of Implementation of Lead 
Wires and Patient Cable Changes to Safe Configurations,'' dated 
February 15, 1995, ODE stated that, for devices reviewed through the 
510(k) process, information regarding device modification to the 
protected configuration should be submitted as an addendum to the 
existing premarket notification file. FDA noted that, in the interest 
of public health, it is not requiring a new 510(k) and/or prior 
clearance if the only change being made is to a protected 
configuration. For devices reviewed through the premarket approval 
process, a modification from an unprotected electrode lead wire and 
patient cable configuration to a protected configuration may also be 
implemented without prior clearance by FDA. FDA stated that, for these 
devices, information regarding device modifications to the protected 
configuration should be provided in the next annual report to the 
premarket approval application. In both instances, FDA stated that, 
within 90 days of the receipt of the information, it will notify 
parties of any concerns it may have with the proposed safe 
configuration design. Otherwise, no response will be provided. Please 
refer to this ODE document, which is available from the Division of 
Small Manufacturers Assistance (HFZ-220), Food and Drug Administration, 
1350 Piccard Dr., Rockville, MD 20850, 301-443-6597 or 1-800-638-2041, 
prior to making your submission.
    37. A trade association recommended the use of a guidance document 
in lieu of a new regulation or mandatory standard concerning protected 
cable and lead sets.
    FDA has been recommending, advising, and warning about the hazard 
presented by unprotected electrode lead wires for 10 years. FDA has 
decided that firmer regulatory action is warranted.

VII. Enforcement

    FDA's statutory authority to issue performance standards is derived 
from section 514 of the act. Section 701(a) of the act (21 U.S.C. 
371(a)) authorizes FDA to promulgate binding regulations for the 
efficient enforcement of the act. Weinberger v. Hynson, Westcott & 
Dunning, Inc., 412 U.S. 609 (1973); see also Weinberger v. Bentex 
Pharmaceuticals Inc., 412 U.S. 645, 653 (1973); National Assn. of 
Pharmaceuticals Manufacturers v. FDA, 637 F.2d 877 (2d Cir. 1981); 
National Confectioners Assn. v. Califano, 569 F.2d 690 (D.C. Cir. 
1978); National Nutritional Foods Assn. v. Weinberger, 512 F.2d 688 (2d 
Cir.), cert. denied, 423 U.S. 827 (1975). Section 519(a) of the act (21 
U.S.C. 360i(a)) also authorizes the agency to issue regulations 
requiring manufacturers of devices to maintain and provide records to 
ensure that devices are not adulterated, misbranded, unsafe, or 
ineffective. FDA's performance standards for medical devices are 
substantive regulations with the force and effect of law. See United 
States v. Undetermined Quantities of Various Articles of Device * * * 
Proplast II, 800 F. Supp. 499, 502 (S.D. Tex. 1992); United States v. 
789 Cases * * * Latex Surgeons' Gloves, 799 F. Supp. 1275, 1287 (D.P.R. 
1992).
    Section 501(e) of the act deems a device to be adulterated, and 
thus prohibited from commerce, if it is a device subject to a 
performance standard established under section 514 of the act, unless 
such device is in all respects in conformity with such standard. 
Introduction into interstate commerce of a device that fails to comply 
with the requirements established by section 514 of the act is a 
prohibited act under section 301(a) of the act (21 U.S.C. 331(a)), and 
the agency will use its enforcement powers to deter noncompliance. 
Persons who violate section 301 of the act may be subject to injunction 
pursuant to section 302(a) of the act (21 U.S.C. 332(a)). In addition, 
any person responsible for violating section 301 of the act may be 
subject to civil penalties under section 303(f) of the act (21 U.S.C. 
333(f)) and criminal prosecution under section 303(a) of the act.
    Section 501(g) of the act deems a device to be adulterated, and 
thus prohibited from commerce, if it is a banned device. Section 
304(a)(2) of the act (21 U.S.C. 334(a)(2)) authorizes seizure of any 
adulterated device at any time. In any action involving devices, 
section 709 of the act (21 U.S.C. 379a) establishes a statutory 
presumption of interstate commerce for any device in commerce. 
Consequently, once FDA makes a device a banned device, in subsequent 
regulatory proceedings to remove the device from commerce, the 
Government need show only that the device has been banned; the 
Government is not required to cite evidence in court to establish any 
of the elements usually necessary to prove that the device is 
adulterated and should be condemned.
VIII. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(6) 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.

IX. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 final 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. The provisions of the proposed rule, including the 
establishment of a performance standard and ban of the applicable 
devices not meeting the standard, are consistent with the industry's 
response to the hazard presented by medical devices that use 
unprotected electrode lead wires. Indeed, efforts have already begun to 
convert to unprotected electrode lead wire and patient cable 
configurations either by redesigning new equipment or permanently 
affixing adapters to [[Page 32415]] existing products. The industry has 
commented that this conversion to protected electrode lead wires and 
patient cables could occur over a maximum of 2 years. FDA's proposal, 
if implemented, would be phased in over a 3-year period. This proposed 
phase-in would further minimize the costs associated with such a 
conversion. For these reasons, the agency certifies that the proposed 
rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

X. Request for Comments

    Interested persons may, on or before September 21, 1995, submit to 
the 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 is soliciting comments on all aspects of this proposal, and 
specifically requests comments on the following issues:
    (1) Cost of converting or adapting unsafe electrode lead wire 
configurations to safe electrode lead wire configurations that meet the 
proposed requirements in this document. Please provide the source of 
your estimates.
    (2) The list of devices subject to the proposed performance 
standard and ban, and their respective effective dates for compliance.
    (3) The potential for cutaneous electrodes to be interchanged with 
various medical equipment.
    (4) Test methods, if any, that should be included in the proposed 
mandatory standard.

XI. 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. Letter to FDA Commissioner David A. Kessler from Ron Wyden, then 
Chairman, U.S. House of Representatives, Committee on Small Business, 
Subcommittee on Regulation, Business Opportunities, and Technology, 
dated August 2, 1994.
    2. Information from FDA's medical device reporting (MDR) data base, 
Rockville, MD.
    3. Information from FDA's medical device reporting (MDR) data base, 
Rockville, MD.
    4. ``FDA Safety Alert: Unsafe Patient Lead Wires and Cables,'' 
FDA's September 3, 1993, Safety Alert.
    5. Section 518(a) notification letter to apnea monitor 
manufacturers, September 3, 1993.
    6. Section 518(a) notification letter to patient cable and lead 
wire manufacturers, September 20, 1993.
    7. FDA Public Health Advisory: Unsafe Electrode Lead Wires and 
Patient Cables Used With Medical Devices, December 28, 1993.

List of Subjects

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

21 CFR Part 897

    Administrative practice and procedure, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and the 
Public Health Service Act and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that Title 21, Chapter I 
of the Code of Federal Regulations be amended as follows:

PART 895--BANNED DEVICES

    1. The authority citation for 21 CFR part 895 continues to read as 
follows:

    Authority: Secs. 502, 516, 518, 519, 701 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352, 360f, 360h, 360i, 371).

    2. Section 895.105 is added to subpart B to read as follows:


Sec. 895.105  Unprotected electrode lead wire.

    (a) Definition. A lead wire that is intended to provide electrical 
contact between a patient and any medical device and that has a 
connector that is not protected at the end distal to the patient, i.e., 
the connector at the lead wire end that is distal to the patient is 
capable of making conductive contact with an alternating current 
electrical power source (e.g., wall receptacle, power cord plug).
    (b) Applicability. Devices utilizing unprotected patient connected 
electrode lead wires shall be banned as of the date set forth in 
paragraph (c) of this section.
    (c) Effective date. The effective date for the ban of devices 
utilizing unprotected patient-connected electrode lead wires as defined 
in paragraph (a) of this section shall be as follows:
    (1) For the following devices, the effective date for which 
compliance is required is (insert date 1 year after date of publication 
of the final rule):

      Listing of Devices for Which Compliance is Required Effective     
    [Insert date 1 year after date of publication of the final rule]    
------------------------------------------------------------------------
              Product      CFR                                          
   Phase       code      section      Class           Device name       
------------------------------------------------------------------------
1.........  73 BZQ       868.2375  II          Monitor, Breathing       
                                                Frequency.              
1.........  73 FLS       868.2375  II          Monitor (Apnea Detector),
                                                Ventilatory Effort.     
1.........  74 DPS       870.2340  II          Electrocardiograph.      
1.........  74 DRG       870.2910  II          Transmitters and         
                                                Receivers, Physiological
                                                Signal, Radiofrequency. 
1.........  74 DRK       870.5300  III         DC-Defibrillator, High   
                                                Energy, (Including      
                                                Paddles).               
1.........  74 DRO       870.5550  III         Pacemaker, Cardiac,      
                                                External Transcutaneous 
                                                (Noninvasive).          
1.........  74 DRQ       870.2060  II          Amplifier and Signal     
                                                Conditioner, Transducer 
                                                Signal.                 
1.........  74 DRR       870.2050  II          Amplifier and Signal     
                                                Conditioner,            
                                                Biopotential.           
1.........  74 DRT       870.2300  II          Monitor, Cardiac         
                                                (Including              
                                                Cardiotachometer and    
                                                Rate Alarm).            
1.........  74 DRW       870.2350  II          Adaptor, Lead Switching, 
                                                Electrocardiograph.     
1.........  74 DRX       870.2360  II          Electrode,               
                                                Electrocardiograph.     
1.........  74 DSA       870.2900  II          Cable, Transducer and    
                                                Electrode, Patient,     
                                                (Including Connector).  
1.........  74 DSB       870.2770  II          Plethysmography,         
                                                Impedance.              
1.........  74 DSH       870.2800  II          Recorder, Magnetic Tape, 
                                                Medical.                
1.........  74 DSI       870.1025  III         Detector and Alarm,      
                                                Arrhythmia.             
1.........  74 DSJ       870.1100  II          Alarm, Blood Pressure.   
1.........  74 DSK       870.1110  II          Computer, Blood Pressure.
[[Page 32416]]
                                                                        
1.........  74 DSR       870.3850  III         Stimulator, Carotid Sinus
                                                Nerve.                  
1.........  74 DTE       870.3600  III         Pulse Generator,         
                                                Pacemaker, External.    
1.........  74 DXG       870.1435  II          Computer, Diagnostic,    
                                                Preprogrammed, Single-  
                                                Function.               
1.........  74 DXH       870.2920  II          Transmitters and         
                                                Receivers,              
                                                Electrocardiograph,     
                                                Telephone.              
1.........  74 DXJ       870.2450  II          Display, Cathode-Ray     
                                                Tube, Medical.          
1.........  74 DXK       870.2330  II          Echocardiograph.         
1.........  74 DXN       870.1130  II          System, Measurement,     
                                                Blood Pressure,         
                                                Noninvasive.            
1.........  74 DYC       870.2400  II          Vectorcardiograph.       
1.........  74 JOQ       870.1750  II          Generator, Pulse,        
                                                Pacemaker, External     
                                                Programmable.           
1.........  74 KRC       870.2370  II          Tester, Electrode,       
                                                Surface,                
                                                Electrocardiographic.   
1.........  74 KRE       870.3640  II          Analyzer, Pacemaker      
                                                Generator Function,     
                                                Indirect.               
1.........  74 KRG       870.3700  III         Programmer, Pacemaker.   
1.........  74 LDD       870.5300  II          DC-Defibrillator, Low-   
                                                Energy, (Including      
                                                Paddles).               
1.........  74 LDF       870.3680  II/III      Electrode, Pacemaker,    
                                                Temporary.              
1.........  74 LIW      .........  II          Fibrillator, AC.         
1.........  74 LOR      .........  ..........  Resuscitator, Trans-     
                                                Telephonic.             
1.........  74 LOS       870.2340  II          System, ECG Analysis.    
1.........  74 LPA      .........  III         System, Esophageal       
                                                Pacing.                 
1.........  74 LPD      .........  III         System, Pacing,          
                                                Antitachycardia.        
1.........  78 LIL      .........  ..........  Monitor, Penile          
                                                Tumescence.             
1.........  78 KPN       876.2040  II          Alarm, Enuresis.         
1.........  78 KPI       876.5320  II          Stimulator, Electrical,  
                                                Nonimplanted, for       
                                                Incontinence.           
1.........  84 GWF       882.1870  II          Stimulator, Electrical,  
                                                Evoked Response.        
1.........  84 GWK       882.1845  II          Conditioner, Signal,     
                                                Physiological.          
1.........  84 GWL       882.1835  II          Amplifier, Physiological 
                                                Signal.                 
1.........  84 GWN       882.1460  II          Nystagmograph.           
1.........  84 GXY       882.1320  II          Electrode, Cutaneous.    
1.........  84 GXZ       882.1350  II          Electrode, Needle.       
1.........  84 GYE       882.1855  II          System, Telemetry,       
                                                Physiological Signal.   
1.........  84 GZI       882.5810  II          Stimulator,              
                                                Neuromuscular, External 
                                                Functional.             
1.........  84 GZJ       882.5890  II          Stimulator, Nerve,       
                                                Transcutaneous, for Pain
                                                Relief.                 
1.........  84 GZO       882.1540  II          Device, Galvanic Skin    
                                                Response Measurement.   
1.........  84 HCC       882.5050  II          Device, Biofeedback.     
1.........  84 HCJ       882.1560  II          Device, Skin Potential   
                                                Measurement.            
1.........  84 JXE       882.1550  II          Device, Nerve Conduction 
                                                Velocity Measurement.   
1.........  84 JXK       882.5800  III         Stimulator, Cranial      
                                                Electrotherapy for      
                                                Speech Disorder.        
1.........  84 LIH      .........  ..........  Interferential Current   
                                                Therapy.                
1.........  86 HLZ       886.1220  II          Electrode, Corneal.      
1.........  86 HMC       886.1510  II          Monitor, Eye Movement.   
1.........  86 HLL       886.1510  II          Monitor, Eye Movement.   
1.........  89 IKD       890.1175  I           Cable, Electrode (for Use
                                                With Diagnostic Physical
                                                Medicine Devices).      
------------------------------------------------------------------------

  (2) For the following devices, the effective date for which 
compliance is required is (insert date 3 years after date of 
publication of the final rule):

      Listing of Devices for Which Compliance is Required Effective     
    [Insert date 3 years after date of publication of the final rule]   
------------------------------------------------------------------------
              Product      CFR                                          
   Phase       code      section      Class           Device name       
------------------------------------------------------------------------
2.........  73 KOI       868.2775  II          Stimulator, Nerve,       
                                                Peripheral, Electrical. 
2.........  74 DQH       870.2310  II          Cardiograph, Apex        
                                                (Vibrocardiograph).     
2.........  74 DQK       870.1425  II          Computer, Diagnostic,    
                                                Programmable.           
2.........  74 DQX       870.1330  II          Wire, Guide, Computer.   
2.........  74 DTA       870.3720  II          Tester, Pacemaker        
                                                Electrode Function.     
2.........  74 DTC       870.3630  II          Analyzer, Pacemaker      
                                                Generator Function.     
2.........  74 DTD       870.3620  III         Adaptor, Lead, Pacemaker.
2.........  74 KRI       870.4200  I           Accessory Equipment,     
                                                Cardiopulmonary Bypass. 
2.........  74 LIX      .........  ..........  Aid, Cardiopulmonary     
                                                Resuscitation.          
2.........  76 LYD      .........  III         Stimulator,              
                                                Electromagnetic Bone    
                                                Growth for Dental Use.  
2.........  78 MII      .........  ..........  System, Gallbladder      
                                                Thermal Ablation.       
2.........  78 LNL      .........  ..........  Stimulator, Electrical,  
                                                for Sperm Collection.   
2.........  78 LST      .........  ..........  Device, Erectile         
                                                Dysfunction (only       
                                                Cavonsometry).          
2.........  78 KDO       876.1500  II          Rongeur, Hot Cystoscopic.
2.........  78 EXQ       876.1620  II          Cystometer, Electrical   
                                                Recording.              
2.........  78 FAP       876.1620  II          Cystometric (CO2) on     
                                                Hydraulic Device.       
2.........  78 FEN       876.1620  II          Device, Hydraulic        
                                                Cystometric.            
2.........  78 EXS       876.1800  II          Urinometer, Electrical   
                                                (only with              
                                                electromyography (EMG)  
                                                electrodes).            
[[Page 32417]]
                                                                        
2.........  78 EXY       876.1800  II          Uroflowmeter (only with  
                                                EMG electrodes).        
2.........  78 FHC       876.4300  II          Adaptor to the Cord, for 
                                                Transurethral Surgical  
                                                Instrument.             
2.........  78 FGW       876.4300  II          Clamp, Electrical.       
2.........  78 FBJ       876.4300  II          Cord, Electric for       
                                                Transurethral Surgical  
                                                Instrument.             
2.........  78 FHZ       876.4300  II          Desiccator,              
                                                Transurethral.          
2.........  78 FAS       876.4300  II          Electrode,               
                                                Electrosurgical, Active,
                                                Urological.             
2.........  78 FEH       876.4300  II          Electrode, Flexible      
                                                Suction Coagulator.     
2.........  78 KGE       876.4300  II          Forceps, Biopsy,         
                                                Electric.               
2.........  78 FDB       876.4300  II          Plate, Patient.          
2.........  78 FDI       876.4300  II          Snare, Flexible.         
2.........  78 FDJ       876.4300  II          Snare, Rigid Self-       
                                                Opening.                
2.........  78 FFI       876.4300  II          System, Alarm,           
                                                Electrosurgical.        
2.........  78 FAR       876.4300  II          Unit, Electrosurgical.   
2.........  78 KNS       876.4300  II          Unit, Electrosurgical    
                                                (and Accessories).      
2.........  78 FDL       876.4300  II          Wristlet, Patient Return.
2.........  78 EZL       876.5130  II          Catheter, Balloon        
                                                Retention Type.         
2.........  79 GEI       878.4400  II          Device, Electrosurgical, 
                                                Cutting and Coagulation 
                                                and Accessories.        
2.........  79 JOS       878.4400  II          Electrode,               
                                                Electrosurgical.        
2.........  84 GWQ       882.1400  II          Electroencephalograph.   
2.........  84 GXC       882.5940  III         Device, Electroconvulsive
                                                Therapy.                
2.........  84 GXS       882.1610  II          Monitor, Alpha.          
2.........  84 GYC       882.1310  II          Electrode, Cortical.     
2.........  84 GZK       882.1340  II          Electrode,               
                                                Nasopharyngeal.         
2.........  84 GZL       882.1330  II          Electrode, Depth.        
2.........  84 GZN       882.1825  III         Rheoencephalograph.      
2.........  84 HCB       882.5235  II          Device, Adverse          
                                                Conditioning.           
2.........  85 HII       884.5940  III         Stimulator, Vaginal,     
                                                Muscle, Powered, for    
                                                Therapeutic Use.        
2.........  86 HLT       886.1640  II          Preamplifier, Ophthalmic.
2.........  86 HQR       886.4100  II          Apparatus,               
                                                Electrocautery, Radio   
                                                Frequency.              
2.........  86 HQO       886.4115  II          Unit, Cautery, Thermal.  
2.........  86 HRO       886.4250  II          Unit, Electrolysis,      
                                                Ophthalmic.             
2.........  86 HQC       886.4670  II          System,                  
                                                Phacofragmentation.     
2.........  86 HQE       886.4150  II          Instrument, Vitreous     
                                                Aspiration & Cutting.   
2.........  87 KQX       888.1500  I           Goniometer, AC-Powered.  
2.........  87 LBB       888.1240  II          Dynamometer, AC-Powered. 
2.........  87 LOF      .........  III         Stimulator, Bone Growth, 
                                                Noninvasive.            
2.........  87 LWB      .........  III         Stimulator, Functional   
                                                Neuromuscular,          
                                                Scoliosis.              
2.........  89 EGJ       890.5525  III         Device, Iontophoresis,   
                                                Other Uses.             
2.........  89 KTB       890.5525  II          Device, Iontophoresis,   
                                                Specific Uses.          
2.........  89 IKN       890.1375  II          Electromyograph,         
                                                Diagnostic.             
2.........  89 IKP       890.1225  II          Chronaximeter.           
2.........  89 IKT       890.1385  II          Electrode, Needle,       
                                                Diagnostic              
                                                Electromyograph.        
2.........  89 IMG       890.5860  II/III      Stimulator, Ultrasound   
                                                and Muscle, for Use in  
                                                Applying Therapeutic    
                                                Deep Heat.              
2.........  89 IPF       890.5850  II          Stimulator, Muscle,      
                                                Powered.                
2.........  89 ISB       890.1850  II          Stimulator, Muscle,      
                                                Diagnostic.             
2.........  89 LPQ       890.5860  II/III      Stimulator, Ultrasound   
                                                and Muscle.             
2.........  89 MBN      .........  III         Stimulator, Muscle,      
                                                Powered, Invasive.      
2.........  89 MKD      .........  III         Stimulator, Functional   
                                                Walking Neuromuscular,  
                                                Noninvasive.            
2.........  90 LNH       892.1000  II          System, Imaging, Nuclear 
                                                Magnetic Resonance.     
------------------------------------------------------------------------

  3. New part 897 is added to read as follows:

PART 897--PERFORMANCE STANDARD FOR PATIENT-CONNECTED ELECTRODE LEAD 
WIRES

Sec.
897.10  Applicability.
897.11  Performance standard.
897.12  Effective date.

    Authority: Secs. 501, 502, 513, 514, 530-542, 701, 704 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360c, 
360d, 360gg-360ss, 371, 374); secs. 351, 361 of the Public Health 
Service Act (42 U.S.C. 262, 264).


Sec. 897.10  Applicability.

    Devices utilizing electrode lead wires intended to be connected to 
patients shall be subject to the standard set forth in section 897.11.


Sec. 897.11  Performance standard.

    Any lead wire intended to provide electrical contact between a 
patient and any medical device shall be protected such that the 
connector at the lead wire end that is distal to the patient cannot 
make conductive contact with an alternating current electrical power 
source (e.g., wall receptacle, power cord plug).


Sec. 897.12  Effective date.

    The effective date for compliance with the standard set forth in 
897.11(a) shall be as follows:
    (a) For the following devices the effective date for which 
compliance is required is (insert date 1 year after date of publication 
of the final rule):

                                                                        
[[Page 32418]]
      Listing of Devices for Which Compliance is Required Effective     
    [Insert date 1 year after date of publication of the final rule]    
------------------------------------------------------------------------
              Product      CFR                                          
   Phase       code      section      Class           Device name       
------------------------------------------------------------------------
1.........  73 BZQ       868.2375  II          Monitor, Breathing       
                                                Frequency.              
1.........  73 FLS       868.2375  II          Monitor (Apnea Detector),
                                                Ventilatory Effort.     
1.........  74 DPS       870.2340  II          Electrocardiograph.      
1.........  74 DRG       870.2910  II          Transmitters and         
                                                Receivers, Physiological
                                                Signal, Radiofrequency. 
1.........  74 DRK       870.5300  III         DC-Defibrillator, High   
                                                Energy (Including       
                                                Paddles).               
1.........  74 DRO       870.5550  III         Pacemaker, Cardiac,      
                                                External Transcutaneous 
                                                (Noninvasive).          
1.........  74 DRQ       870.2060  II          Amplifier and Signal     
                                                Conditioner, Transducer 
                                                Signal.                 
1.........  74 DRR       870.2050  II          Amplifier and Signal     
                                                Conditioner,            
                                                Biopotential.           
1.........  74 DRT       870.2300  II          Monitor, Cardiac         
                                                (Including              
                                                Cardiotachometer and    
                                                Rate Alarm).            
1.........  74 DRW       870.2350  II          Adaptor, Lead Switching, 
                                                Electrocardiograph.     
1.........  74 DRX       870.2360  II          Electrode,               
                                                Electrocardiograph.     
1.........  74 DSA       870.2900  II          Cable, Transducer and    
                                                Electrode, Patient      
                                                (Including Connector).  
1.........  74 DSB       870.2770  II          Plethysmograph,          
                                                Impedance.              
1.........  74 DSH       870.2800  II          Recorder, Magnetic Tape, 
                                                Medical.                
1.........  74 DSI       870.1025  III         Detector and Alarm,      
                                                Arrhythmia.             
1.........  74 DSJ       870.1100  II          Alarm, Blood Pressure.   
1.........  74 DSK       870.1110  II          Computer, Blood Pressure.
1.........  74 DSR       870.3850  III         Stimulator, Carotid Sinus
                                                Nerve.                  
1.........  74 DTE       870.3600  III         Pulse Generator,         
                                                Pacemaker, External.    
1.........  74 DXG       870.1435  II          Computer, Diagnostic,    
                                                Preprogrammed, Single-  
                                                Function.               
1.........  74 DXH       870.2920  II          Transmitters and         
                                                Receivers,              
                                                Electrocardiograph,     
                                                Telephone.              
1.........  74 DXJ       870.2450  II          Display, Cathode-Ray     
                                                Tube, Medical.          
1.........  74 DXK       870.2330  II          Echocardiograph.         
1.........  74 DXN       870.1130  II          System, Measurement,     
                                                Blood Pressure, Non-    
                                                invasive.               
1.........  74 DYC       870.2400  II          Vectorcardiograph.       
1.........  74 JOQ       870.1750  II          Generator, Pulse,        
                                                Pacemaker, External     
                                                Programmable.           
1.........  74 KRC       870.2370  II          Tester, Electrode,       
                                                Surface,                
                                                Electrocardiographic.   
1.........  74 KRE       870.3640  II          Analyzer, Pacemaker      
                                                Generator Function,     
                                                Indirect.               
1.........  74 KRG       870.3700  III         Programmer, Pacemaker.   
1.........  74 LDD       870.5300  II          DC-Defibrillator, Low-   
                                                Energy (Including       
                                                Paddles).               
1.........  74 LDF       870.3680  II/III      Electrode, Pacemaker,    
                                                Temporary.              
1.........  74 LIW      .........  II          Fibrillator, AC.         
1.........  74 LOR      .........  ..........  Resuscitator, Trans-     
                                                Telephonic.             
1.........  74 LOS       870.2340  II          System, ECG Analysis.    
1.........  74 LPA      .........  III         System, Esophageal       
                                                Pacing.                 
1.........  74 LPD      .........  III         System, Pacing,          
                                                Antitachycardia.        
1.........  78 LIL      .........  ..........  Monitor, Penile          
                                                Tumescence.             
1.........  78 KPN       876.2040  II          Alarm, Enuresis.         
1.........  78 KPI       876.5320  II          Stimulator, Electrical,  
                                                Nonimplanted, for       
                                                Incontinence.           
1.........  84 GWF       882.1870  II          Stimulator, Electrical,  
                                                Evoked Response.        
1.........  84 GWK       882.1845  II          Conditioner, Signal,     
                                                Physiological.          
1.........  84 GWL       882.1835  II          Amplifier, Physiological 
                                                Signal.                 
1.........  84 GWN       882.1460  II          Nystagmograph.           
1.........  84 GXY       882.1320  II          Electrode, Cutaneous.    
1.........  84 GXZ       882.1350  II          Electrode, Needle.       
1.........  84 GYE       882.1855  II          System, Telemetry,       
                                                Physiological Signal.   
1.........  84 GZI       882.5810  II          Stimulator,              
                                                Neuromuscular, External 
                                                Functional.             
1.........  84 GZJ       882.5890  II          Stimulator, Nerve,       
                                                Transcutaneous, for Pain
                                                Relief.                 
1.........  84 GZO       882.1540  II          Device, Galvanic Skin    
                                                Response Measurement.   
1.........  84 HCC       882.5050  II          Device, Biofeedback.     
1.........  84 HCJ       882.1560  II          Device, Skin Potential   
                                                Measurement.            
1.........  84 JXE       882.1550  II          Device, Nerve Conduction 
                                                Velocity Measurement.   
1.........  84 JXK       882.5800  III         Stimulator, Cranial      
                                                Electrotherapy for      
                                                Speech Disorder.        
1.........  84 LIH      .........  ..........  Interferential Current   
                                                Therapy.                
                                                                        
                                                                        
[[Page 32419]]
                                                                        
1.........  86 HLZ       886.1220  II          Electrode, Corneal.      
1.........  86 HMC       886.1510  II          Monitor, Eye Movement.   
1.........  86 HLL       886.1510  II          Monitor, Eye Movement.   
------------------------------------------------------------------------

  (b) For the following devices the effective date for which 
compliance is required is (insert date 3 years after date of 
publication of the final rule):

      Listing of Devices for Which Compliance is Required Effective     
    [Insert date 3 years after date of publication of the final rule]   
------------------------------------------------------------------------
              Product      CFR                                          
   Phase       code      section      Class           Device name       
------------------------------------------------------------------------
2.........  73 KOI       868.2775  II          Stimulator, Nerve,       
                                                Peripheral, Electrical. 
2.........  74 DQH       870.2310  II          Cardiograph, Apex        
                                                (Vibrocardiograph).     
2.........  74 DQK       870.1425  II          Computer, Diagnostic,    
                                                Programmable.           
2.........  74 DQX       870.1330  II          Wire, Guide, Computer.   
2.........  74 DTA       870.3720  II          Tester, Pacemaker        
                                                Electrode Function.     
2.........  74 DTC       870.3630  II          Analyzer, Pacemaker      
                                                Generator Function.     
2.........  74 DTD       870.3620  III         Adaptor, Lead, Pacemaker.
2.........  74 KRI       870.4200  I           Accessory Equipment,     
                                                Cardiopulmonary Bypass. 
2.........  74 LIX      .........  ..........  Aid, Cardiopulmonary     
                                                Resuscitation.          
2.........  76 LYD      .........  III         Stimulator,              
                                                Electromagnetic Bone    
                                                Growth for Dental Use.  
2.........  78 MII      .........  ..........  System, Gallbladder      
                                                Thermal Ablation.       
2.........  78 LNL      .........  ..........  Stimulator, Electrical,  
                                                for Sperm Collection.   
2.........  78 LST      .........  ..........  Device, Erectile         
                                                Dysfunction (only       
                                                Cavonsometry).          
2.........  78 KDO       876.1500  II          Rongeur, Hot Cystoscopic.
2.........  78 EXQ       876.1620  II          Cystometer, Electrical   
                                                Recording.              
2.........  78 FAP       876.1620  II          Cystometric (CO2) on     
                                                Hydraulic Device.       
2.........  78 FEN       876.1620  II          Device, Hydraulic        
                                                Cystometric.            
2.........  78 EXS       876.1800  II          Urinometer, Electrical   
                                                (only with EMG          
                                                electrodes).            
2.........  78 EXY       876.1800  II          Uroflowmeter (only with  
                                                EMG electrodes).        
2.........  78 FHC       876.4300  II          Adaptor to the Cord, for 
                                                Transurethral Surgical  
                                                Instrument.             
2.........  78 FGW       876.4300  II          Clamp, Electrical.       
2.........  78 FBJ       876.4300  II          Cord, Electric for       
                                                Transurethral Surgical  
                                                Instrument.             
2.........  78 FHZ       876.4300  II          Desiccator,              
                                                Transurethral.          
2.........  78 FAS       876.4300  II          Electrode,               
                                                Electrosurgical, Active,
                                                Urological.             
2.........  78 FEH       876.4300  II          Electrode, Flexible      
                                                Suction Coagulator.     
2.........  78 KGE       876.4300  II          Forceps, Biopsy,         
                                                Electric.               
2.........  78 FDB       876.4300  II          Plate, Patient.          
2.........  78 FDI       876.4300  II          Snare, Flexible.         
2.........  78 FDJ       876.4300  II          Snare, Rigid Self-       
                                                Opening.                
2.........  78 FFI       876.4300  II          System, Alarm,           
                                                Electrosurgical.        
2.........  78 FAR       876.4300  II          Unit, Electrosurgical.   
2.........  78 KNS       876.4300  II          Unit, Electrosurgical    
                                                (and Accessories).      
2.........  78 FDL       876.4300  II          Wristlet, Patient Return.
2.........  78 EZL       876.5130  II          Catheter, Balloon        
                                                Retention Type.         
2.........  79 GEI       878.4400  II          Device, Electrosurgical, 
                                                Cutting and Coagulation 
                                                and Accessories.        
2.........  79 JOS       878.4400  II          Electrode,               
                                                Electrosurgical.        
2.........  84 GWQ       882.1400  II          Electroencephalograph.   
2.........  84 GXC       882.5940  III         Device, Electroconvulsive
                                                Therapy.                
2.........  84 GXS       882.1610  II          Monitor, Alpha.          
2.........  84 GYC       882.1310  II          Electrode, Cortical.     
2.........  84 GZK       882.1340  II          Electrode,               
                                                Nasopharyngeal.         
2.........  84 GZL       882.1330  II          Electrode, Depth.        
                                                                        
                                                                        
[[Page 32420]]
                                                                        
2.........  84 GZN       882.1825  III         Rheoencephalograph.      
2.........  84 HCB       882.5235  II          Device, Adverse          
                                                Conditioning.           
2.........  85 HII       884.5940  III         Stimulator, Vaginal,     
                                                Muscle, Powered, for    
                                                Therapeutic Use.        
2.........  86 HLT       886.1640  II          Preamplifier, Ophthalmic.
2.........  86 HQR       886.4100  II          Apparatus,               
                                                Electrocautery, Radio   
                                                Frequency.              
2.........  86 HQO       886.4115  II          Unit, Cautery, Thermal.  
2.........  86 HRO       886.4250  II          Unit, Electrolysis,      
                                                Ophthalmic.             
2.........  86 HQC       886.4670  II          System,                  
                                                Phacofragmentation.     
2.........  86 HQE       886.4150  II          Instrument, Vitreous     
                                                Aspiration & Cutting.   
2.........  87 KQX       888.1500  I           Goniometer, AC-Powered.  
2.........  87 LBB       888.1240  II          Dynamometer, AC-Powered. 
2.........  87 LOF      .........  III         Stimulator, Bone Growth, 
                                                Noninvasive.            
2.........  87 LWB      .........  III         Stimulator, Functional   
                                                Neuromuscular,          
                                                Scoliosis.              
2.........  89 EGJ       890.5525  III         Device, Iontophoresis,   
                                                Other Uses.             
2.........  89 KTB       890.5525  II          Device, Iontophoresis,   
                                                Specific Uses.          
2.........  89 IKN       890.1375  II          Electromyograph,         
                                                Diagnostic.             
2.........  89 IKP       890.1225  II          Chronaximeter.           
2.........  89 IKT       890.1385  II          Electrode, Needle,       
                                                Diagnostic              
                                                Electromyograph.        
2.........  89 IMG       890.5860  II/III      Stimulator, Ultrasound   
                                                and Muscle, for Use in  
                                                Applying Therapeutic    
                                                Deep Heat.              
2.........  89 IPF       890.5850  II          Stimulator, Muscle,      
                                                Powered.                
2.........  89 ISB       890.1850  II          Stimulator, Muscle,      
                                                Diagnostic.             
2.........  89 LPQ       890.5860  II/III      Stimulator, Ultrasound   
                                                and Muscle.             
2.........  89 MBN      .........  III         Stimulator, Muscle,      
                                                Powered, Invasive.      
2.........  89 MKD      .........  III         Stimulator, Functional   
                                                Walking Neuromuscular,  
                                                Noninvasive.            
2.........  90 LNH       892.1000  II          System, Imaging, Nuclear 
                                                Magnetic Resonance.     
------------------------------------------------------------------------

  Dated: June 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-15086 Filed 6-20-95; 8:45 am]
BILLING CODE 4160-01-P