[Federal Register Volume 59, Number 96 (Thursday, May 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12154]
[[Page Unknown]]
[Federal Register: May 19, 1994]
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Part IV
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Ch. I
Medical Devices; Performance Standards for Electrode Lead Wires;
Requests for Comments and Information; Public Conference; Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Ch. I
[Docket No. 94N-0078]
Medical Devices; Performance Standards for Electrode Lead Wires;
Requests for Comments and Information; Public Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking; notice of public
conference.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intent to establish special controls, including the promulgation of
performance standards, for medical devices that use electrode lead
wires. The agency is taking this action because it has determined that
special controls are needed to prevent hazardous electrical connections
between patients and electrical power sources. FDA is also announcing a
public conference on this advance notice of proposed rulemaking
(ANPRM). FDA will consider any comments or other information received
in response to this ANPRM and information gleaned from the conference
when proposing the special controls for devices using electrode lead
wires.
DATES: Written comments by August 17, 1994. The public conference will
be held on July 15, 1994, from 8:30 a.m. to 5 p.m. To register for the
conference, please contact Sociometric, Inc. (address below) by June
24, 1994.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857. The public conference will be held at the Sheraton
Washington Hotel, 2660 Woodley Rd. NW., Washington, DC 20008.
FOR FURTHER INFORMATION CONTACT:
Regarding the ANPRM: Marquita B. Steadman, Center for Devices and
Radiological Health (HFZ-84), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-4765.
Regarding the conference: Kathy Pointer, Sociometric, Inc., 8308
Colesville Rd., suite 550, Silver Spring, MD 20910, 301-608-2151 or
301-608-3542 (facsimile).
SUPPLEMENTARY INFORMATION:
I. Background
FDA's Center for Devices and Radiological Health (CDRH) issued an
alert letter in June 1985 to manufacturers, home user support
organizations, and apnea monitor users, announcing that CDRH had
received reports of one death and two electrical burns that occurred
when unsupervised children plugged the male connector pins of the
electrode lead wires from a home apnea monitor system into either
alternating current (AC) power cords or a wall outlet, rather than into
the patient cable which connects to the monitor (Ref. 1). In that
letter, the agency announced its intention 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 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
lead wire connectors into AC power cords and outlets. In response,
manufacturers voluntarily began to redesign their electrode lead wires
and patient cables for home apnea monitors. In addition to issuing the
alert letter, CDRH's July 1985 Medical Devices Bulletin (a periodic
publication that is distributed to the healthcare community and
manufacturers) was devoted in great part to publicizing the lead wire
hazard (Ref. 2).
Since 1985, FDA has cleared for marketing only those home use apnea
monitors with patient cables and lead wires designed to prevent unsafe
electrical connections. This protective design has also been required
for all apnea monitors cleared for marketing since 1989, whether or not
they were intended for home use. Nonetheless, some hospitals continue
to use older units, or lead wires and patient cables from other
devices, which do not have the protective design. Even with the new
models, it may be possible for staff to switch patient cables and/or
lead wires, thereby creating a hazard.
On August 25, 1993, a 12-day old infant being monitored for apnea
was electrocuted in a hospital, in Chicago, IL. FDA's investigation of
the incident confirmed that the patient electrode lead wires were
unprotected. Specifically, the male connector pins were not protected
to prevent unsafe electrical connections. Although the infant apnea
monitor involved in that incident had been sold with safety protected
lead wires and patient cable, an unprotected patient cable from another
manufacturer and unprotected lead wires from a third manufacturer were
being used when the infant was electrocuted.
In response to this incident, on September 3, 1993, FDA issued a
safety alert to hospital administrators, risk managers, and pediatric
department directors, warning them that the use of unsafe electrode
lead wires with an apnea monitor may be dangerous to the patient, and
may be in violation of section 518(a) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 360h(a)) (Ref. 3). FDA included in
the alert a number of recommendations to help prevent these accidents.
On that same day, FDA also sent all apnea monitor manufacturers a
notification letter under section 518(a) of the act (Ref. 4). Section
518(a) of the act authorizes the agency to require that notification be
provided when it is necessary to eliminate an unreasonable risk of
substantial harm to the public health and when no other practicable
means is available under the act to eliminate such risk. FDA determined
that manufacturer notification under section 518(a) of the act to all
hospitals, clinics, distributors, and suppliers of apnea monitors was
necessary to eliminate the unreasonable risk of harm to infants and
other apnea monitor patients from unprotected lead wires and patient
cables. FDA stated that notification should include replacement of
unprotected lead wires and patient cables, and that a warning label
should be permanently affixed to all monitors stating that unprotected
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 lead wires and patient cables. On September 20, 1993, FDA
issued a similar letter to all known manufactures of patient cables and
lead wires (Ref. 5).
FDA also has received reports of injuries associated with unsafe
lead wires and patient cables involving medical devices other than
apnea monitors (Ref. 6). In 1986, for example, a death resulted in a
hospital from electrocardiogram (ECG) lead wires being plugged into an
infusion pump power cord. Similarly, in 1990, a death occurred when
neonatal monitor lead wires were inserted into a pulse oximeter power
cord. FDA has received additional reports of similar events that
resulted in electrical shocks and burns to patients. The agency also
has received reports of ECG monitor lead wires being inserted into
power sources, causing patient injuries. Finally, FDA has received one
report of patient shock involving an electroencephalograph cable.
Manufacturers of devices other than apnea monitors that utilize
patient electrodes, e.g., ECG, have been encouraged by various
organizations to modify their lead wires so that they cannot be
inserted into AC power cords or outlets. In February 1987 and May 1993,
the Emergency Care Research Institute (ECRI) issued hazard reports
concerning electrical shock hazards from unprotected lead wires and
patient cables in its publication ``Health Devices'' (Ref. 7). On July
15, 1991, the Underwriters Laboratories (UL) amended its Standard for
Medical and Dental Equipment (UL 544) to require patient-connected lead
wires to be designed to avoid connection to electrical power sources.
This requirement became effective on December 1, 1991 (Ref. 8). In
March 1993, the International Electrotechnical Commission (IEC)
published a standard for ECG machines, including a safety requirement
for leads (601-2-25) (Ref. 9). The IEC, as well as the Association for
the Advancement of Medical Instrumentation (AAMI), are in the process
of developing a standard for all leads. There is also an existing
German standard (DIN 42 802) which has been adopted by some U.S.
manufacturers in their design of safety protected lead wires (Ref. 10).
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. 11). 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.
II. Revisions Under Consideration
In accordance with section 513(a) of the act (21 U.S.C. 360c(a)),
FDA has classified medical devices intended for human use into one of
three regulatory classes, i.e., class I, general controls; class II,
special controls; and class III, premarket approval. Classification
depends on the extent of control necessary to assure the safety and
effectiveness of each device. Apnea monitors, as well as many other
medical devices that use patient electrodes, are classified into class
II. Class II devices are devices for which general controls by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness of the device, and for which there is sufficient
information to establish special controls to provide such assurance
(see 21 CFR 860.3(c)(2)). Possible special controls include the
issuance of performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines (including
guidelines for the submission of clinical data in premarket
notification submissions in accordance with section 510(k) of the act
(21 U.S.C. 360(k)), recommendations, and other appropriate actions as
FDA deems necessary to provide such assurance. (See section
513(a)(1)(B) of the act.)
The agency recognizes that, despite efforts to eliminate the risk,
unprotected 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. In order to reduce the risks to health presented by these
devices, the agency is considering establishing special controls for
devices that use lead wires. The agency believes these controls should
include, but not be limited to, the development of a performance
standard.
FDA believes that the development of a performance standard is
necessary to reduce or eliminate the hazards of unprotected lead wires
and patient cables. The DIN standard is a design, rather than a
performance, standard, and may be too restrictive for application to
all devices. While the proposed AAMI and IEC standards for all leads
are more general, they are not yet completed. Therefore, the agency is
considering establishing a standard that resembles the UL standard. The
agency will consider other standards, however, that are finalized
before completion of this rulemaking process. FDA is also considering
revising CDRH's Office of Device Evaluation's ``blue book'' to reflect
the agency's policy of not clearing for marketing unprotected male pins
that may be used with any device with patient electrodes.
FDA is soliciting comments on the issuance of a performance
standard that would eliminate the risk of burns and death associated
with placing an unprotected electrode lead wire directly into a power
source.
FDA is soliciting comments on all aspects of this ANPRM, and
specifically requests comments on the following issues:
1. The current extent of manufacturing, distribution, and use of
unprotected patient cables and electrode lead wires as replacement
products.
2. Advantages, if any, of using unprotected electrode lead wires
with particular medical devices.
3. The devices, if there are any, that cannot accept redesigned
electrode lead wires or patient cables.
4. Cost to manufacturers and the user community to convert to
protected electrode lead wires and patient cables for all medical
devices.
5. Extent of substitution, if any, of unprotected nonmedical
electrode lead wires and patient cables, for use as medical device
electrode lead wires and patient cables.
6. Essential components of a performance standard for lead wires
and patient cables.
7. Viability of applying a performance standard across device
types.
8. Alternative solutions to the removal of all unprotected
electrode lead wires from the market, such as banning them under 21 CFR
part 895.
III. Public Conference
FDA, the Health Industries Manufactures Association, and the
American Hospital Association are sponsoring a public conference
entitled ``Unprotected Patient Cables and Electrode Lead Wires'' to be
held on July 15, 1994. The purpose of the conference is to: (1) Focus
attention on medical devices that use unprotected electrode lead wires;
(2) bring together patient cable and lead wire manufacturers, device
manufactures, distributors, users, and purchasers to facilitate
understanding of the electrode lead wire problem and possible
solutions, including the development of performance standards, and the
announcement of new regulatory policy for all devices that use patient
electrodes; (3) solicit industry and user input concerning FDA's
intention to develop a new regulatory framework for devices that use
patient electrodes; (4) identify the extent of existing and potential
design and user problems, including design applicability for specific
devices; and (5) identify the economic impact of the proposed solutions
to these problems.
IV. Comments
FDA is particularly interested in comments from inventors, patient
cable and lead wire manufacturers, device manufacturers, purchasers,
and users of devices that use electrode lead wires. Comments from other
interested individuals or groups are also welcome. FDA advises that,
under 21 CFR 10.30(d), any comments submitted in response to this
document will be included under the docket number found in brackets in
the heading of this document.
Interested persons may, on or before August 17, 1994, submit to the
Dockets Management Branch (address above), written comments regarding
this ANPRM. 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.
V. 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. Form letter from FDA to manufacturers, home user support
organizations, and apnea monitor users, June 1985.
2. Center for Devices and Radiological Health's Medical Devices
Bulletin, July 1985.
3. FDA's September 3, 1993, Safety Alert.
4. Section 518(a) notification letter to apnea monitor
manufacturers, September 3, 1993.
5. Section 518(a) notification letter to patient cable and lead
wire manufacturers, September 20, 1993.
6. Information from FDA's medical device reporting (MDR) data
base.
7. ECRI's publications, ``Health Devices Alert,'' February,
1979, ``Health Devices,'' May 1993.
8. Underwriters Laboratories' Standard for Safety Medical and
Dental Equipment (UL 544).
9. International Electrotechnical Commissions' Safety
Requirements for Medical Electrical Equipment (IEC Standard 601-1;
601-2-25).
10. German DIN Standard 42 802.
11. FDA Public Health Advisory: Unsafe Electrode Lead Wires and
Patient Cables Used With Medical Devices, December 28, 1993.
Dated: May 12, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-12154 Filed 5-18-94; 8:45 am]
BILLING CODE 4160-01-F
