- OSHA Healthcare Advisor - http://blogs.hcpro.com/osha -

Quick IC tips on FDA recommendations for the Steris System 1 processor

By now you’ve likely heard about the Food and Drug Administration (FDA) warning urging users of the STERIS System 1 Processor (SS1) to find an alternative method [1]. If you don’t have a replacement processor, you should take measures to find one as soon as possible.

The FDA said it “received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections.” However infections are particularly difficult to trace back to the SS1, and may go unreported. The FDA has also received reports of injuries to healthcare workers, including burns from exposure to the sterilant solution.

Healthcare facilities should seek acceptable alternatives to SS1 as soon as possible, according to FDA recommendations. For now, the FDA does not “expect to take action against healthcare facilities solely because they are now using SS1s,” but facilities are required to report suspected device-related deaths, and the FDA may take enforcement action against a facility that fails to submit a report.

From a practical standpoint you are probably asking yourself, what should I do right now?

Your first step is to contact manufacturers of the devices that are disinfected in the SS1 and find out what alternate chemicals are recommended by the manufacturer. Fortunately most instruments can still be disinfected or sterilized manually using a liquid process, but as many of you know that is a much longer process. Your manufacturer will have the specifics concerning how long you should soak the instruments.

Remember, the amount of time equipment should soak depends upon both the device that is sterilized and the sterilant used. Be sure to account for both variables.

The trick is to find the accommodating chemical, notify all staff members of the change, and adjust work schedules to accommodate the extra workload. In high volume facilities this is particularly difficult, and may require additional staff members to help with the transition, but it’s imperative to maintain patient safety and sound infection prevention practices.

In the long run your facility should look into replacing the SS1 with an AER (automated reporcessor) sooner rather than later for those who are reprocessing a high volume of equipment.