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Article: MDRs required though device no longer made.(Food and Drug Administration investigated Medical Device Reporting at Hospital for Special Surgery)(Brief Article)
- Article from:
- Inspection Monitor
- Article date:
- April 1, 1999
CopyrightCOPYRIGHT 1999 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Hospital for Special Surgery, New York, NY, New York District.
A January 1998 audit of the Hospital for Special Surgery (HSS) showed that FDA expected continuing Medical Device Reporting (MDR) com-pliance although the hospital had stopped making hip, elbow and knee implants.
According to the recently released EIR, which was accompanied by a recall report, HSS began making standard orthopedic devices in 1988. It stopped producing standard devices in 1992 and custom devices in 1996. These custom items were distributed only to HSS and, in some cases, affiliated institutions in New York City.
However, the hospital was not registered as a device ...