[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]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
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.
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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
