Every time you go to a hospital for, say, throat surgery, there are many different instruments that the surgeon will use to, say, excise some polops on your larynx. With the millions of surgeries performed in the U.S., that can add up to a lot of plastic or metal that would need to be disposed of - a big waste in the eyes of many. These instruments, or Single-Use Devices (SUDs), can sometimes be reused, so long as they have been properly sterilized and cleaned, of course.
Way back when, most instruments, no matter what they were made of, would be reused - sterilized somehow and then brought back into the hospital. Then in the 1970s, more instruments were being made of plastic and there was a general societal push toward disposable items, including medical instruments. While there were some neat innovations, this also lead to fuller dumps and landfills and a lot of waste. In the '80s, hospitals again started to look at reusing instruments to cut down on costs and waste.
Which is all well and good - I'm a huge proponent of recycling and consider my office to be fairly "green" (I send the printer cartridges back in, recycle all newspaper, envelopes and paper in the office, try to use non-toxic cleansers, etc.). But it does make one a bit squeamish to think that perhaps that dental bur or scalpel wasn't quite laved properly before reuse.
In 1999, the FDA got into the game, and started issuing guidance on what instruments would need to submit 510k applications in order to be reused (and there is a nifty FDA Reuse webpage). These generally were items that would be used for dental work (lots of exposure to blood vessels and chance of infection) or invasive surgical instruments. Also, in 2002, Pres. Bush signed the Medica Device User Fee and Modernization Act of 2002 (MDUFMA), which not only set new fees and implemented a scheme for third-party inspections of Class II and III device manufacturers, but also established the new regulatory requirements for the reprocessing of SUDs.
The list of categories of SUDs that are required to have 510k's be submitted in order to obtain the FDA's approval for reprocessing those devices and reusing them can be found here in List I (about half-way down the webpage). There were also many devices that had already received 510k approval, but still had to submit validation data showing that the reprocessing procedure actually did resterilize the SUDs. That list is also on this page in List II.
The FDA recently issued a summary of the results from their review of the applications they'd received by the deadline. Unfortunately, the press release was a bit lacking in detail and only states that about 25% of the applications were not satisfactory and the devices cannot be used. That's a rather scary statistic, and makes me glad that the FDA is looking into this issue. The last thing anyone would want would be the reuse of, say, an angioballoon that isn't properly sterilized (or heck, I wouldn't even want a dental bur to be reused that still has germs on it).
As a last note on the subject, the FDA will be conducting a public meeting on the MDUFMA on Nov. 18. Check here for details if you wish to attend.
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