“ASP's actions violated the law and put patients at unnecessary risk for infection,” Steve Silberman, director of compliance at the FDA Center for Devices and Radiological Health, said in a statement.
Last year, ASP announced two recalls affecting a product called the Cyclesure 24 Biological Indicator, which is used to make sure that medical equipment sterilized using ASP's Sterrad low-temperature cleaning machines is free of bacteria, fungi and viruses.
FDA inspectors, according to a civil complaint last July, uncovered evidence that the company sold the Cyclesure 24 tests with 15-month expiration dates even though ASP's internal studies had not established the product's safe shelf life was that long.
After the issue was discovered, ASP shortened the shelf life of the Cyclesure indicators to six months. The company also recalled all lots of the products manufactured between February 2008 and December 2011.
Dirty endoscopes used during colon cancer screenings, for example, have been implicated in the transmission of hepatitis C and many types of bacteria, according to ASP's own website.
However, FDA officials noted that misbranded products in themselves presented a low risk of infection, because the biological tests are one of three methods used to ensure the sterility of endoscopes and surgical instruments.
Asked for comment, a company spokesperson said by e-mail: “This settlement resolves the administrative complaint for civil money penalties and does not constitute an admission of liability or fault by Advanced Sterilization Products or the two named ASP executives. ASP is pleased to have resolved this matter with FDA.”
The statement said healthcare workers can continue using the Cyclesure biological indicator as directed.
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