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March 16, 1998
Dear Medical Device Manufacturer or Importer:
This letter is to remind you of your obligation to comply with the Performance Standard for Electrode Lead Wires and Patient Cables (Code of Federal Regulations, Chapter 21, Part 898), which becomes effective for certain devices on May 11, 1998. Enclosed for your information are copies of a final guidance document regarding this standard, as well as a copy of the final rule, and excerpts from the referenced international standard, IEC 60601-1. The agency is accepting comments on the guidance document, as it is being implemented. A forthcoming Notice of Availability in the Federal Register will provide instructions for submitting your comments on the guidance document to the agency.
For further information regarding compliance with the Performance Standard for Electrode Lead Wires and Patient Cables, please contact Stewart Crumpler in the Office of Compliance at 301-594-4659, or via FAX at 301-594-4672.
Sincerely yours, | |
Lillian J. Gill | |
Director | |
Office of Compliance | |
Center for Devices and | |
Radiological Health |
This document is intended to provide guidance. It represents the Agency's current thinking on implementation of 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 requirements of the applicable statute, regulations, or both.
Document issued on: March 9, 1998
After the close of the initial comment period, comments and suggestions may be submitted at any time for Agency consideration to Stewart Crumpler, Office of Compliance, 2098 Gaither Road, Rockville, Maryland 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Stewart Crumpler at (301) 594-4659, or via FAX at (301) 594-4672.
Additional Copies: World Wide Web/CDRH home page http://www.fda.gov/cdrh
The Performance Standard for Electrode Lead Wires and Patient Cables, found in Title 21 Code of Federal Regulations (CFR), part
898, was published in the Federal Register on May 9, 1997 [62
FR 25497]. The performance standard becomes effective for certain
devices on May 11, 1998.
This guidance document represents the agency's initial thinking
on implementation of the performance standard for electrode lead
wires and patient cables. This guidance 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. Due to
the public health risks associated with the use of unprotected
electrode lead wires and patient cables, the agency is accepting
public input while the guidance is being implemented.
The performance standard was promulgated to address the electrocution
hazard posed by unprotected patient electrical connectors. Copies
of the final rule are also available through the Division of Small
Manufacturers Assistance via Facts-on-Demand at 800-899-0381,
or 301-827-0111, or from the CDRH Web Page at:
http://www.fda.gov/cdrh/comp/fr0509af.html
or
http://www.fda.gov/cdrh/comp/fr0509ap.pdf
This is the first mandatory medical device performance standard,
and it is being implemented in two phases. Beginning on May 11,
1998, all electrode lead wires or patient cables intended for
use with any of the following devices must comply with the standard:
Replacement electrode lead wires and patient cables that are intended
for use with any of the above listed devices must also comply
with the performance standard beginning on May 11, 1998. The
ten devices included in this first phase of implementation are
those which pose the greatest potential hazard (e.g., those with
reported macroshock deaths or injuries, and certain cardiac monitoring
devices used outside healthcare facilities).
By reference, the performance standard incorporates the specific
requirements of the international standard, IEC 60601-1, subclause
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). Specific tests
for compliance include conductive contact with a flat conductive
surface, conductive contact with the inside of a socket connector,
and conductive contact when plugged into an electrical (mains)
socket or power cord. While it cannot be posted to the CDRH Web
Page, single copies of the referenced IEC subclause, with test
criteria and rationale, are available to affected manufacturers
on request, from the Office of Compliance at the telephone or
FAX numbers listed at the end of this guidance document.
Compliance is determined by the design of the electrode lead wire
at the end remote from the patient. Most (if not all) single
pole, exposed pin lead wires (regardless of size) and some exposed
multi-pin connectors are non-compliant with this standard. The
Center is aware of various lead wire designs that do comply, including
recessed sockets, recessed or shielded pins, and shielded multi-pin
connectors. To meet the standard, a compliant patient cable must
be compatible with a compliant lead wire. Questions regarding
the compliance status of specific electrode lead wire and patient
cable configurations should be directed to the Office of Compliance,
at the telephone or FAX numbers listed at the end of this guidance
document.
As stated in the preamble to the final rule, design changes and
labeling changes made to comply with this performance standard
will not require submission of a new premarket notification (510(k)). However, for devices cleared through a premarket approval, information describing the design and labeling changes should be included in the firm's next annual report. Supporting documentation
for design changes should also be maintained in the design history
file for the device, and will be subject to FDA inspection.
Manufacturers and users have an additional two years to prepare
for implementation of the second phase of the standard. Beginning
on May 9, 2000, any electrode lead wire or patient cable intended
for use with any medical device must comply with the performance
standard. During this two year transition period, applicability
of the performance standard will be determined by the stated intended
use of the electrode lead wire or patient cable, and by circumstances
surrounding its promotion, advertising and marketing. To assure
compliance with the performance standard after the effective date,
manufacturers and their representatives are expected to exercise
due diligence in assessing their customers' intended use of replacement
electrode lead wires and patient cables marketed for use with
existing devices. While not required, manufacturers may also
wish to add a statement to their labeling noting compliance with
the FDA performance standard (21 CFR, part 898), in order to assist
users in selection and management of their electrode lead wires
and patient cables. During the transition period, it will also
be important to educate customers regarding proper selection of
electrode lead wires and patient cables, and to avoid labeling
that could be misconstrued regarding intended use. For example,
prewired "ECG" electrodes are currently used for many
purposes. However, beginning on May 11, 1998, any pre-wired electrodes
labeled for "ECG" use must comply with the performance
standard.
Continued availability of compatible electrode lead wires and
patient cables for existing devices is a concern for the user
community. It is anticipated that relatively inexpensive adapters
will be available and can be used to economically convert existing
devices already in the marketplace to accept compliant electrode
lead wires and patient cables. However, the performance standard
also accounts for the possibility that there may be circumstances
where adapters are not feasible. In such circumstances, the manufacturer
may request a variance or exemption from compliance with the standard.
Criteria and procedures for submission of a variance/exemption
may be found in 21 CFR, section 898.14, and 21 CFR, section 10.30.
For further information regarding compliance with the Performance
Standard for Electrode Lead Wires and Patient Cables, please contact
Stewart Crumpler in the Office of Compliance at 301-594-4659,
or via FAX at 301-594-4672.
Updated 3/17/1998