New “FDA-Compliant” Patient Lead Cord Systems
On May 9, 2000, a new federal performance standard (law) goes into effect regarding patient lead cords. The law, its application, and the dates of application have been confusing. We asked the FDA for clarification and only through recent correspondence (April 3, 2000) have they clarified the law. (click here for FDA response)
Please note in the letter that the law applies to the lead cords only, not to the devices. What this means is that all “old-style” lead cords (cords that have unshrouded pins distal from the patient) will actually be illegal to ship to us or by us. We have, in the past, asked that you always return the lead cords with your device to properly diagnose problems. Based on the new law, this will not be possible. Please do not send in your “old-style” leads! (click here if you want to see the FDA’s response!)
All devices and patient lead cords shipped after May 1, 2000 from Rich-Mar will be compliant with the new law.
A. For all devices manufactured or sold to the end customer after May 1, 1999, Rich-Mar Corporation will provide all kits at no cost. Yes, free. (Well sort of…this will be done via charge and credit invoices.)
B. For all devices still in warranty (specifically premium and extended warranties), Rich-Mar will cover all service charges and return shipping.
If you wish, Rich-Mar will be happy to install the adapter kits here for an $85.00 service fee. (Yes, if your device is under warranty, this fee will be waived—see “B” above. If your device was manufactured or sold after May 1, 1999, the kit cost will also be waived.)
"Like-new factory modifications" are available on some devices for additional costs. Contact Rich-Mar for more information.
See the FDA link below for more information
1. FDA Letter Regarding Compliance ("FDAreply.pdf" 19 KB)
2. Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables.
(http://www.fda.gov/cdrh/comp/fr0509af.html).
3. 21CFR Part 898 Performance Standard for Lead Cords. ("898.pdf" 140 KB)
See Part 898 on page 21 of this PDF document. |
