In a move that evokes memories of the dispute between the FDA and Utah Medical Products (Salt Lake City, Utah), the agency has issued to Shelhigh (Union, New Jersey) a formal written request to recall all of its medical devices from the marketplace, including hospital inventories, because of "sterility concerns."

"Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Daniel Schultz, MD, director, FDA's Center for Devices and Radiological Health. "FDA will continue to provide up-to-date information to patients and physicians about this ongoing public health matter."

Shelhigh devices are used in infants, children and adults. The products include pediatric heart valves, conduits for blood flow, surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings for repairing heart valves, and arterial grafts.

In a response to the FDA, posted on its web site, Shelhigh founder Shlomo Gabbay, MD, said it does not believe the FDA allegations are valid and that the company "has no intention to initiate a recall. The FDA should understand that it must prove its allegations before it can make a request and their newest statements do not provide any further factual support for their claims."

Doug Goldman, director of marketing for Shelhigh told MDD that he is perplexed about FDA's actions. "I think we've been up front [with FDA] about everything the whole time." And he called the agency's 10-week inspection at the company — from his point of view as a 20-year veteran in the medical device industry — "unheard of."

He said such an inspection should take no more than a couple of days to a week, at the most. "It doesn't take 10 weeks, especially for a small company like ours."

Shelhigh is asking FDA to produce its Health Hazard Evaluation (HHE) for review and consideration by Shelhigh, a document that is required in order for the agency to mandate a recall and one which the company said it has yet to receive.

The FDA said that Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates. The company has also been the subject of two previous warning letters.

This latest salvo in a war of words with FDA — that began last month with the seizure by U.S. Marshalls of the company's products at its Union, New Jersey facility at FDA's request (Medical Device Daily, April 19, 2007) — included a posting of questions and answers furnished by the FDA in regards to the seizure and in response to an earlier letter from Shelhigh (MDD, April 24, 2007). In response, Shelhigh issued a release of its own refuting many of FDA's charges.

A sampling, below, makes for interesting reading:

Why did FDA seize Shelhigh's medical devices?

FDA: Under order from U. S. District Court in New Jersey, FDA and U.S. Marshals seized all products and product components at the firm's facility in Union, N.J., after FDA found significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

Shelhigh: The FDA presented its allegations of deficiencies to the U.S. District Court in a unilateral move for which the "significance" will be determined by the evidence. The company provided comprehensive responses in early February and April 2007. It appears that the FDA did not review our responses based on some of the claims in their complaint. Shelhigh believes that it has evidence to contradict FDA allegations and for which ultimately the Federal Court will determine the outcome

Shelhigh claims that the seizure was unwarranted, that there is no evidence that their devices are not sterile, and that they are safe to use.

FDA: Shelhigh devices are intended for use in open-heart surgery for valve replacement; and repair of soft tissue structures during abdominal, pelvic, heart, lung, brain, shoulder, and spine surgery. These devices are permanently implanted into infants, children and adults during surgical procedures. In the complaint filed in federal court, FDA has alleged that Shelhigh's manufacturing processes are deficient in many respects. The company's own records indicate a number of sterility test failures and that the tests and retests were not properly performed. The violative manner in which the products were made increases the likelihood that the products are not sterile and are deficient in other respects. FDA has determined that use of these devices, if not sterile, poses a reasonable probability of serious adverse events or death. We recommend that hospitals and physicians consider using alternate products.

Shelhigh: The FDA claim that Shelhigh records "indicate a number of sterility test failures and that the tests and retests were not properly performed" is misleading at best. At no time during the inspection or through the documentation of FDA observations (FORM FDA 483) did the FDA inspectors indicate that the sterilization method employed by Shelhigh was improper or would fail to produce the desired result. The sterilization method employed by Shelhigh has been validated on numerous occasions and has been included as part of required submissions to the FDA.

The statement continues: The public allegation by the FDA on 17 April, 2007, was the first indication to the firm that the FDA believed the sterilization method to be "improper." Sterility testing of Shelhigh products is performed by an independent International Standards Organization (ISO) certified contract laboratory. Shelhigh sterility testing procedures have been in effect since prior to 2000 and these have been reviewed through numerous FDA inspections of the Shelhigh facility without any indication of concern. For the FDA to now assert that these procedures are in alleged violation of regulations is inaccurate and misleading.

Shelhigh raised another point concerning timing: Why did it take FDA six months to decide seizure was the appropriate action in this case if the alleged problems were so severe?

"During this period of time no reports of adverse incidents have been reported to Shelhigh to support FDA concerns, and none have been received to date," the company said.

"We as a company just frankly, remain baffled as to why [the FDA is] pursuing this," said Goldman. "Our valves have never been shown to be unsterile, ever."

"I just hope that the FDA halts its public posturing and returns to discussions with Shelhigh," Gabbay said.

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