If you've been following medical news, you may have come across this unsettling little update: Medical device implants don't always undergo human trials before being allowed on the market.
A study in the Archives of Internal Medicine revealed some of the most critical medical devices aren't subjected to clinical studies before they are approved for human use. Also revealed was that the Food and Drug Administration's most urgent recalls in recent years involved "high-risk" devices that had gone to market without undergoing clinical trials or inspections. Many of these devices had been approved through a process called 510(k), which requires no human trials. An alarming number of these recalls involved cardiovascular devices like defibrillators and stents. Other urgently recalled devices went on the market without any FDA oversight because the agency considered them to pose no risk.
The new study put the spotlight on recalls of Class III devices, which support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. The law requires Class III devices to undergo pre-market approvals that mandate proper clinical trials—similar to those required for drugs. But in the last two decades, a scant one percent of all medical devices have gone through this rigorous process.
Some believe the FDA lacks the staff or budget to perform pre-market reviews on most of the new devices submitted each year. The cost to companies for a thorough FDA review is over $200,000; a 510(k) review runs just over $4,000.
As many as 112.6 million devices have been recalled in the last five years. In response, the FDA has proposed a major revamping of medical device regulations. In addition, the Institute of Medicine is working on a comprehensive report, commissioned by the FDA, on identifying the problems inherent with current medical device regulations.
For an added perspective, check out this video:
Alex A. Kecskes has written hundreds of published articles on health/fitness, "green" issues, TV/film entertainment, restaurant reviews and many other topics. As a former Andy/Belding/One Show ad agency copywriter, he also writes web content, ads, brochures, sales letters, mailers and scripts for national B2B and B2C clients. Please see more of his blogs and view additional job postings on Nexxt.
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