[Federal Register Volume 63, Number 145 (Wednesday, July 29, 1998)]
[Notices]
[Pages 40533-40534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0448]


Guidance on the Performance Standard for Electrode Lead Wires and 
Patient Cables; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance on the Performance 
Standard for Electrode Lead Wires and Patient Cables.'' The guidance 
document provides information on the electrocution hazard posed by 
unprotected patient electrical connectors. This guidance is intended to 
help affected parties understand the steps needed to achieve compliance 
with the performance standard for electrode lead wires and patient 
cables.

DATES:  Written comments concerning this guidance must be received by 
October 27, 1998.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance entitled ``Guidance on the Performance 
Standard for Electrode Lead Wires and Patient Cables'' to the Division 
of Small Manufacturers

[[Page 40534]]

Assistance, Center for Devices and Radiological Health (HFZ-220), Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 301-443-8818. See the  
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.

    Submit written comments on this guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Steward Crumpler, Center for Devices 
and Radiological Health (HFZ-340), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-4659.

SUPPLEMENTARY INFORMATION:

I. Background

     FDA is announcing the availability of a document entitled`` 
Guidance on the Performance Standard for Electrode Lead Wires and 
Patient Cables.'' This guidance document addresses the implementation 
of the Performance Standard for Electrode Lead Wires and Patient 
Cables. This standard was issued to address the electrocution hazard 
posed by unprotected patient electrical connectors. Since May 11, 1998, 
electrode lead wires or patient cables intended for use with any of the 
following devices have been required to comply with the standard:
    1. Breathing frequency monitors,
    2. Ventilatory effort monitors (Apnea detectors),
    3. Electrocardiographs (ECG's),
    4. Radio frequency physiological signal transmitters and receivers,
    5. Cardiac monitors,
    6. Electrocardiograph electrodes (including pre-wired ECG 
electrodes),
    7. Patient transducer and electrode cables (including connectors),
    8. Medical magnetic tape recorders (e.g. Holter monitors),
    9. Arrhythmia detectors and alarms,
    10. Telephone Electrocardiograph transmitters and receivers.
    Manufacturers and users have an additional 2 years to prepare for 
the second phase of implementation of the standard. Beginning on May 9, 
2000, any electrode lead wire or patient cable lead intended for use 
with any medical device must comply with the standard.
    The performance standard incorporates the specific requirements of 
international standard, IEC-60601, clause 56.3(c), which requires leads 
to be constructed in such a manner as to preclude patient contact with 
hazardous voltages or, for certain devices, contact with electrical 
ground. Design changes and labeling changes need to be considered by 
manufacturers and importers of the devices referenced previously.
    Adapters can be used to convert devices already in the marketplace 
so they can accept electrode wires and patient cables that comply with 
the new performance standard.
    This guidance document represents the agency's current thinking on 
the performance standard for electrode lead wires and patient cables. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the applicable statute, regulations, or 
both. The agency has adopted good guidance practices (GGP's) (62 FR 
8961, February 27, 1997), which set forth the agency's policy for the 
development, issuance and use of guidance documents. This is a Level 1 
guidance document in accordance with the GGP's. The guidance document 
was made available on the World Wide Web (WWW) in March 1998 in order 
to provide guidance before the May 11, 1998, effective date of the 
first phase of implementation. Due to the risk of serious injury or 
death associated with the use of unprotected electrode leads and 
patient cables, this guidance is being implemented while the agency 
receives public input.

II. Comments

    Interested persons may, on or before October 27, 1998, submit to 
the Dockets Management Branch (address above) written comments 
regarding this guidance document. 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. The guidance document and received comments may be 
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    In order to receive the ``Guidance on the Performance Standard for 
Electrode Lead Wires and Patient Cables'' via your fax machine, call 
the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 
from a touch-tone telephone. At the first voice prompt press 1 to 
access DSMA Facts, at second voice prompt press 2, and then enter the 
document number (1197) followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the WWW. The Center for Devices and Radiological Health (CDRH) 
maintains an entry on the WWW for easy access to information including 
text, graphics, and files that may be downloaded to a personal computer 
with access to the Web. Updated on a regular basis, the CDRH home page 
includes the ``Guidance on the Performance Standard for Electrode Lead 
Wires and Patient Cables,'' device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at ``<a href="http://ww.fda.gov/
cdrh">http://ww.fda.gov/
cdrh</a>''.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA home page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general 
information, or arrow down for specific topics.

    Dated: July 17, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-20240 Filed 7-28-98; 8:45 am]
BILLING CODE 4160-01-F