FDA should mandate cleanrooms

FDA should mandate cleanrooms

Lisa A. Karter, Chief Editor

Chief Editor

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The FDA is finally revising its current good manufacturing practices (cGMPs)–which haven`t been revamped since 1978. The agency`s goal is to reduce the number of deaths and injuries that are caused by faulty medical devices.

That`s an honorable and safe goal — saving lives. But the FDA made it clear in its announcement of its new Quality System Regulations that human life must have a price tag.

The FDA has reported that each fatality avoided has an economic value of $5 million and, therefore, projects the monetary value of saving an estimated 36 to 44 lives each year to be $180 million to $200 million. Meanwhile, industry must foot a bill of $81.9 million to implement the new regulations.

The question is, “How many people had to die or were seriously injured before industry decided to implement new rules and regs?” No changes since 1978 seems like an awful lot of wasted lives and foot-dragging from both FDA and industry — especially since contamination control and cleanrooms technology have been around since 1961. It`s quite clear that the value of many human lives were not enough to kick start the industry into action.

What could they have done? Well, how about a lot more contamination control technology. Of course, the new regs only hint at some changes in contamination control. But if the semiconductor industry can manufacture at higher yields with fewer defects using our industry`s technology — then why isn`t the FDA mandating the use of cleanrooms, at least for critical devices such as ventilators?

I hope the FDA will not wait another 12 years before improving its “latest” regulations.


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