"Detention Without Physical Examination of Electrode Lead Wires and Patient Cables That Do Not Comply With the Applicable Performance Standard"

A performance standard was promulgated for electrode lead wires and patient cables to assure their safe use.

As of May 9, 2000, this standard applies to all electrode lead wires and patient cables used with all devices unless there is a specific variance or exemption issued by CDRH. Those shipments of electrode lead wires and patient cables, which do not conform to this standard, should be placed under detention without physical examination and subsequently refused entry if not brought into compliance.

Once evidence is provided that the electrode lead wires and patient cables comply with this standard (or an approved variance or exemption), they will be removed from the Red List of this alert. A list of approved variances and exemptions will be posted on the CDRH web site at www.fda.gov/cdrh.

Districts may detain entries of those shipments of patient cables and lead wires from manufacturers listed on this alert. These entries should be detained until evidence is submitted which overcomes the appearance of a violation. (Such evidence may include conducting fieldexams, as well as providing the Affirmation of Compliance Code (A of C Code = LWC), documentation such as photographs, certificates of compliance from the manufacturer, etc.).

If districts have questions about the reliability of submitted documentation the district should contact CDRH, Office of Compliance, Division of Enforcement III, for guidance.

Shipments of patient cables and electrode lead wires which have been physically examined and found to be non-compliant with the standard should be detained and subsequently refused entry if not brought into compliance. A recommendation should be submitted to place the firm/product on detention without physical examination under this alert.

Recommendations for detention without physical examination should be sent to the Division of Import Operations and Policy (DIOP) (HFC-170), which has direct reference authority for detention without physical examination for these devices. A copy of the recommendation should also be sent to Stewart Crumpler, CDRH/Office of Compliance, Division of Enforcement III.

Manufacturers and importers who have been listed on this alert should be encouraged to contact CDRH to discuss bringing future shipments into compliance. General questions or requests for guidance regarding the new performance standard should be directed to CDRH, HFZ-340.

Patient Cables and Electrode Lead Wires

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects, in conformity with such standard. [Adulteration -Section 501(e)]."

OASIS charge code - FAILS STD