FDA to investigate cleaning of medical scopes
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The manufacturers of specialized medical scopes in the US have come under the direct scanner of the FDA following a series of life-threatening bacterial outbreaks at U.S. hospitals. The direct issue is how the reusable medical devices are cleaned and disinfected by the hospital authorities.
As a first step forward, the federal authority has ordered such manufacturers to study how the reusable devices are cleaned, after confirming reports of the bacterial outbreaks.
The Food and Drug Administration said Monday that the three companies must submit plans to study how well hospital staffers actually follow instructions for disinfecting the scopes between uses. The agency hopes this information will shed light on a recent spate of infections involving antibiotic-resistant "superbugs" linked to the scopes.
The FDA issued the instructions to Olympus American, Fuji Medical Systems and Hoya Corp. All three companies are based in Japan but do business through U.S. affiliates. Olympus American accounts for 85 percent of the specialized scopes sold in the U.S., according to figures from the FDA.
As a first step forward, the federal authority has ordered such manufacturers to study how the reusable devices are cleaned, after confirming reports of the bacterial outbreaks.
The Food and Drug Administration said Monday that the three companies must submit plans to study how well hospital staffers actually follow instructions for disinfecting the scopes between uses. The agency hopes this information will shed light on a recent spate of infections involving antibiotic-resistant "superbugs" linked to the scopes.
The FDA issued the instructions to Olympus American, Fuji Medical Systems and Hoya Corp. All three companies are based in Japan but do business through U.S. affiliates. Olympus American accounts for 85 percent of the specialized scopes sold in the U.S., according to figures from the FDA.
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