WASHINGTON, D,C. -- The Food and Drug Administration (FDA) today announced that Adven Medical, Inc., of Lubbock, Texas, and its president, Mark W. Aldana, have signed a consent decree of permanent injunction in which they agree to stop reprocessing and distributing medical devices until Adven corrects its manufacturing problems. Adven was cited by the FDA for failing to adequately reprocess medical devices.
The firm reprocesses different kinds of single-use medical devices, such as catheters, biopsy forceps, sutures, and blood pressure cuffs. Some of these devices have been used on patients. Others are opened but unused or are past their expiration dates. Many hospitals and medical care facilities use reprocessed single-use devices because it is less expensive to clean, disinfect, and re-sterilize them than to purchase new products.
"If firms don't adhere to good manufacturing practice standards for reprocessing medical devices, there is no guarantee that reprocessed devices will be safe and effective," said FDA Commissioner Mark B. McClellan, MD, PhD.
The FDA found numerous violations of the good manufacturing practice requirements of the federal Food, Drug, and Cosmetic Act and its Quality System (QS) regulation during inspections of the firm. Good manufacturing practice requires firms to manufacture medical devices under established quality procedures to ensure that the devices are made and tested according to high standards.
Adven violated FDA's QS regulation by failing to: (1) validate its cleaning, disinfecting, and sterilization processes; (2) adequately establish and maintain procedures to validate medical device designs; (3) establish and maintain procedures to prevent and correct manufacturing problems; and (4) use adequate criteria to ensure that finished devices meet their design specifications.
Adven's history of non-compliance goes back to June 1999 when, under a partnership with FDA, the Texas Department of Health inspected Adven's manufacturing facility. Many of the problems observed in that inspection recurred, along with new problems, in later FDA inspections. Adven failed to correct these problems.
The consent for permanent injunction was filed today in the United States District Court for the Northern District of Texas, Lubbock Division.
Adven will not be allowed to resume reprocessing and distributing medical devices until FDA is satisfied that it has corrected its manufacturing problems.