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Kaiser Daily Health Policy Report
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[Dec 12, 2005]
The Washington Post recently published a series that examined the issues related to the use of reprocessed medical devices in hospitals. Summaries appear below.
- "Hospitals Save Money, But Safety Is Questioned": The article examines how more hospitals nationwide have begun to use reprocessed medical devices to reduce costs, despite warnings from manufacturers against the practice. According to the Post, hospitals, which do not have to inform patients when they use reprocessed medical devices, maintain that the practice is cost-effective and "poses no threat to patients because the instruments are cleaned with such care that they are as good as new." FDA, which regulates the use of reprocessed medical devices but "devotes few resources to overseeing" the practice, in 2004 began to require hospitals to report malfunctions in reprocessed devices, the Post reports. However, based on current data, "it is impossible to compare" how often medical devices malfunction in their first and subsequent uses, according to the Post (Klein [1], Washington Post, 12/11).
- "The Consequences of Cuts": The article examines the story of a nine-year-old boy in Britain who died after part of a medical device "accidentally lodged itself inside his oxygen tube," which the hospital had reused (Klein [2], Washington Post, 12/11).
- "Reused Devices Attract Entrepreneurs, Scrutiny": The article examines efforts by FDA to regulate the reprocessed medical device industry. Although FDA officials maintain that the agency has made "good progress in regulating" the industry, they have acknowledged "shortcomings" in oversight efforts, the Post reports. FDA, which requires companies to register and obtain approval for each medical device that they seek to reprocess, has "occasionally found those reprocessors in violation of good manufacturing practices" and has barred them from the industry," according to the Post. However, the Post reports, FDA "was unaware that some of those same players have re-entered the business." FDA officials maintain that the agency "relies too heavily on doctors to voluntarily report problems with faulty medical devices" and does not have a "routine or standard inspection schedule" for companies that reprocess medical devices, according to the Post (Klein, Washington Post, 12/12).
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