AUG. 12–LUBBOCK, Texas – A medical device reprocessor has agreed to halt work until it corrects problems in its manufacturing process, according to the Food and Drug Administration.
Adven Medical Inc. and its president, Mark W. Aldana, signed an agreement that was filed Thursday in federal district court in Lubbock, the FDA said.
The FDA said it would have to approve Adven’s manufacturing processes before it can resume refurbishing devices and shipping them to hospitals and doctors’ offices.
Adven reprocesses catheters, biopsy forceps, sutures and blood-pressure cuffs that have been used or have passed their expiration dates. Many hospitals and other facilities use reprocessed devices because they are cheaper than new ones.
The FDA said inspections beginning in June 1999 turned up violations of federal regulations on good practices for reprocessing companies, including failing to validate its sterilization process.