According to the FDA, post approval changes to the STERIS SYSTEM 1 Processor can be dangerous to both patients and healthcare workers. The STERIS SYSTEM is a low heat medical sterilizer. The FDA did not specify the modifications made to the device. There have been reports of STERIS SYSTEM malfunctions that could cause or contribute to patient infections. The FDA has also received reports of injuries, such as burns, suffered by healthcare workers operating the system. According to the FDA, it did not approve the changes made to the system by the manufacturer STERIS.
In May 2008, the FDA sent a warning notification to STERIS, but was dissatisfied with the company’s efforts to switch customers to other sterilizer products. Healthcare facilities are urged to transition from potentially defective STERIS SYSTEM products to legal alternatives as soon as possible. The FDA sent a letter to healthcare facility administrators indicating that infections caused by improperly sterilized devices may be difficult to link to the cleaner.
According to the product manager for the STERIS SYSTEM, the company has discontinued new sales of the particular device at issue. STERIS is based in Mentor, Ohio.