Industry News – Recall of Sterrad 200 Sterilizers
The FDA published an announcement on March 30th that Advanced Sterilization Products (ASP) was recalling its Sterrad® 200 sterilizer. The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
While oil mists can be irritating, a major concern is that there may be hydrogen peroxide vapor in with the oil mists since the OSHA permissible exposure limit for hydrogen peroxide vapor is only 1 ppm (8 hr time weighted average).
A recent letter dated January 23, 2013 from ASP to a customer said that “the vacuum pump in the Sterrad 200 system may cause the emission of a slightly increased level of hydrogen peroxide (H2O2) vapor into the surrounding environment if not regularly serviced or replaced.” The letter goes on to describe one incident where a healthcare worker experienced temporary eye discomfort and throat irritation while in close proximity to the sterilizer, due to emissions caused by failure of an internal filter.
There have been other reports of workers being exposed to hydrogen peroxide vapor and/or oil mist vapor from not only sterrad sterilizers but other brands and models of hydrogen peroxide sterilizer (see for example the FDA’s MAUDE database.)
If you suspect that your sterilizer is emitting hydrogen peroxide vapor, then ensure that all personnel clear the area until the hydrogen peroxide concentrations are within safe limits as indicated by a hydrogen peroxide monitor; and follow the sterilizer manufacturer’s instructions to get the problem corrected. If a hydrogen peroxide monitor is not available, use appropriate PPE and other measures to ensure that workers are not exposed.