Re-processor caught between rock and two FDA offices

By Mark A. DeSorbo

ROCKVILLE, Md.— Although a re-processor of single-use medical devices has agreed to halt production, the president of the Lubbock, Texas-based company says the Food and Drug Administration's (FDA) claim that Adven Medical Inc. failed to properly validate cleaning, disinfecting and sterilization processes is “false and inflammatory.”

Mark W. Aldana, Adven's president and chief executive officer, told CleanRooms that the company can support its claim with pre-market notifications (510ks) containing complete cleaning validation and sterilization protocols and results, which were submitted and cleared by the FDA's Office of Device Evaluation.

“Clearly, if the FDA had any issues regarding cleaning or sterilization validation processes performed at Adven, these issues would have prevented the Office of Device Evaluation from issuing clearance on Adven's pre-market notifications,” Aldana says.

In early August, after months of discussions with the FDA, Aldana signed a consent decree of permanent injunction with the understanding that Adven would stop production while the agency reviewed and confirmed that the re-processor's protocols fell in line with current Good Manufacturing Practices (cGMPs).

A press release issued by the FDA Office of Compliance shortly thereafter indicated Adven agreed to halt production and distribution until it corrects its manufacturing problems, saying numerous cGMP violations were found during inspections.

Specifically, the FDA says Adven violated QS regulations by failing to: Validate its cleaning, disinfecting, and sterilization processes; adequately establish and maintain procedures to validate medical device designs; establish and maintain procedures to prevent and correct manufacturing problems; and use adequate criteria to ensure that finished devices meet their design specifications.

“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,” FDA Commissioner Mark B. McClellan said in the statement.

Attempts by CleanRooms to reach the FDA via telephone and e-mail were unsuccessful.

“Their lawyers came to us and wanted us to sign a consent decree, and allow the FDA to come in and confirm that everything meets their standards,” says Aldana. “We signed the decree as it was in our best interest. We did not know they were going to publish what they said in their press release. It certainly caught us off guard. We do not understand why they are saying this.”

The FDA indicates that some of Adven's reported inadequately-processed devices were used on patients. Other devices were opened, but unused, or are past their expiration dates. No adverse events stemming from the Adven case have been reported by the FDA.

Many hospitals and medical care facilities are now using reprocessed single-use devices because it is less expensive to clean, disinfect, and re-sterilize them than to purchase new products.

According to the FDA guidance, “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals,” issued August 2000, the FDA regulates third-party processors and hospitals that reprocess single-use devices the same way the agency now regulates original equipment manufacturers. (See “FDA's new medical device guidance questioned,” CleanRooms, November 2000, p. 1.)

At the heart of the controversy is a January 2001 audit, which led to another FDA inspection in June 2002, when Adven was issued a 483 for failing to adequately reprocess such medical devices as catheters, biopsy forceps, sutures and blood pressure cuffs.

“We invited the FDA to come back after that January 2001 audit, and they did in June 2002,” says Aldana. “During that audit, we received a 483. We responded to that 483 in July 2002 and again in October 2002, and we had numerous conversations with our compliance officers; they never told us there were any issues associated with our responses.”

In May, FDA attorneys showed up at Adven to discuss the same consent decree that would shut it down three months later. “We were surprised to hear from their lawyers, 11 months later,” Aldana says. “We were reprocessing the entire time, and we had all of it validated.”

Now, he says federal regulators are putting the company through unwarranted “pain and anguish.”

Aldana believes that for the Office of Compliance to say Adven has not properly validated its process is to also say the Office of Device Evaluation “did not properly review Adven's pre-market notifications.”

“There is one office branch conflicting with another office branch,” he adds. “If the Office of Compliance truly believed that Adven Medical was reprocessing without validating its cleaning and sterilization processes, and continued to permit us to reprocess 13 months after the 483 was issued, it raises serious questions concerning the Office of Compliance's competency in regulating the medical device industry.”

If anything, Aldana says the only thing of which Adven is guilty is not presenting cleaning validation and sterilization protocols and results in the format FDA regulators wanted.

“They wanted to see it in the design format,” he says, adding that documentation had since been formatted correctly. “This has nothing to do with the science that is involved with reprocessing medical devices. The science is sound and is all there. We stand by our process and our sterility assurance level of 10-6.”


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