U.S. Senate committee recommends FDA assess whether devices require design modifications
THURSDAY, Jan. 14, 2016 (HealthDay News) — More patients than previously estimated contracted life-threatening infections from contaminated medical scopes in recent years, according to a U.S. Senate committee report released Wednesday.
According to the report, at least 250 people developed “superbug” infections in at least 25 outbreaks linked to duodenoscopes. The infections occurred in the United States and three other countries between 2012 and early 2015, the Associated Press reported.
Last year, the U.S. Food and Drug Administration said contaminated duodenoscopes were associated with 142 patient infections. The infections were caused by bacteria that remained on the scopes even after they were cleaned according to manufacturers’ instructions, the AP reported.
A number of legislative and regulatory changes were recommended in the report from the Senate Committee on Health, Education, Labor, and Pensions. It said the FDA should assess whether the devices require design modifications and, if so, have companies make repairs through a phased recall. The committee also said Congress should mandate unique medical device identifiers in insurance claims, electronic health records, and device registries, the AP reported.
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