Almost Sterile Is Not Sterile Enough

Posted By John Coletti || 11-Dec-2009

You know all those surgical tools and medical instruments, such as endoscopes and bronchoscopes, at doctors’ offices and hospitals? You probably also know they need to be properly sterilized to prevent infections and such. Unfortunately, there aren’t exactly a ton of sterilizers on the market, and one that is used by many hospitals, System 1 by Steris, has been slapped by the Food and Drug Administration with a warning NOT to use it.

The FDA apparently first raised concerns about System 1 back in 2001. Now it has removed its “safe and effective” label from System 1 units and is advising hospitals and doctors against using the sterilizer. The FDA first approved the System 1 sterilizer some two decades ago, but Steris, the FDA argues, has made such modifications to the sterilizer in the past 20 years that the current unit is not the same as the one the FDA approved. The FDA has received a number of complaints about the sterilizer.

Steris defends its System 1 sterilizer and insists there is nothing wrong with it. The company is telling customers to continue using System 1 while it seeks re-approval from the FDA. This runs counter to agreements made by Steris to the FDA in which Steris agreed to support customers in a switch to other sterilizers.

The FDA concedes that the number of reported injuries is minimal in proportion to the number of System 1 units in use, but an FDA warning is an FDA warning. Let’s hope this issue gets resolved quickly and efficiently!