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China to Crack Down on Medical Device Makers

Mar 21, 2008 | Parker Waichman LLP

China will revoke the licenses of those manufacturers producing unqualified medical devices that cause disastrous results, according to a draft on the administration of medical device recalls.  The Chinese government will assign compulsory recalls and levy penalties of three times the amount of the medical device value to those manufacturers which do not voluntarily recall products that pose a potential safety hazard.

According to the rules, medical device producers should maintain minutes on the handling of recalled products and report to the regulator of the Food and Drug Administration.  Also, when destroying unqualified medical devices, producers must have a drug regulator on hand to witness the process.  Manufacturers should closely track and handle recalled, embedded medical devices and bear relevant expenses resulting from the process.  The administration regulations were drafted by the State Food and Drug Administration, which was just incorporated into the Ministry of Health when it concluded its annual session of the National People's Congress.

Meanwhile, in the United States, researchers from the University of California, San Francisco (UCSF) argued that medical devices are not subject to the same rigorous review process as pharmaceuticals and this needs to change to improve health outcomes.  The team found once a device receives US Food and Drug Administration (FDA) approval, an independent technology review could help identify which devices are beneficial.  According to the team, this data would improve health professionals' awareness of "the potential promise and pitfalls of new technology.”  Feldman, professor of medicine at UCSF said, "These days, patients are asking their doctors for the newest technologies from genetic tests to specific radiation treatments and many physicians don't know where to turn for the latest evidence-based information.  Sometimes, the only information out there is what the manufacturer provides."

The UCSF analysis evaluated the federal review process, how devices come to market, how scientific literature reports on clinical trials involving medical devices, and the effectiveness of independent review boards in improving a technology's medical benefit.   Out of thousands of medical technology applications submitted annually to the FDA, less than 100 undergo the scrutiny required for new drugs.  Most new applications are approved through an expedited FDA process that considers new devices similar to those already approved.  Also, the FDA relies on manufacturers and clinical investigators to initiate recalls and failure reports when a technology is not beneficial or is potentially harmful to patients.

"FDA approval should be the start of the process toward clinical application, not the end," Feldman said. "Physicians and patients just aren't aware of the limitations of the FDA process of initial assessment and oversight of new medical technologies.  Assessments by objective entities are a necessary addition to FDA approval, so that deficiencies in clinical evidence, and patient safety issues that may arise after approval, are recognized before widespread adoption into clinical practice."   The purpose of independent review organizations is to provide transparent, objective evaluations, Feldman said.  Eventually, the authors suggest, independent review boards should summarize their findings into uncomplicated take-home messages that patients can easily find on their own.


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