ASP Warns of Exposure to Residual Hydrogen Peroxide in Sterilizer Load

Advanced Sterilization Products (ASP), the manufacturer of the Sterrad hydrogen peroxide (H2O2) gas plasma sterilizer, the market leader in gas sterilization in healthcare; issued a letter recently to hospital risk managers warning them that hydrogen peroxide residues may be found in the sterilization load.

The letter warned that the residual hydrogen peroxide may be present if users fail ‘to comply with Sterrad System User’s guide with regard to device compatibility, weight limitations, volume limitations and recommended materials.’ ASP provides materials compatibility data, for example, it is well known that cellulose products (paper) cannot be used with a hydrogen peroxide vapor sterilizer because the cellulose will absorb the hydrogen peroxide [Sterrad 200 Users Manual].

Over the last few years there have been many reports in the FDA MAUDE database of workers getting chemical burns to their hands and elsewhere as a result of contact with residual liquid hydrogen peroxide, especially after an aborted load. Some cases are listed below:

  • The user facility reported that after a completed cycle an employee removed a pack from the sterilizer and “burned” her hand (2013)
  • An experienced healthcare worker experienced H2O2 contact while removing a load from a sterrad 100nx sterilizer completed cycle (2010).
  • The customer reported that a healthcare worker experienced H2O2 contact while retrieving a processed package from the sterrad 100s sterilizer after a completed cycle.(2010)
  • The customer reported that an experienced healthcare worker experienced a skin reaction while removing instruments from a tray of a completed sterrad nx cycle. (2010)
It is noteworthy that while there were many cases in 2010 and before, but there has been a sharp reduction in reported cases since then. It appears that ASP has recognized residual hydrogen peroxide exposure to be a problem and have successfully taken steps to reduce it, including the letter referenced at the beginning of this article.
Similar residual hydrogen peroxide exposure issues have been found with the Steris V-Pro, the second largest hydrogen peroxide vapor sterilizer in the US, as illustrated by the examples below (all 2013).
  • The user facility reported that a worker who opened sterile pack in operating room received chemical burns to hands and thighs.
  • The user facility reported that after a completed cycle, an employee went to retrieve instruments from the sterilizer and experienced discoloration to her hands.
  • The user facility reported that after a completed cycle an employee removed a peel pack and liquid contacted her finger… causing a small blister.
  • The user facility reported an employee experienced a chemical burn on their hand when operating the V-Pro sterilizer.

We applaud ASP for their efforts to keep users of their equipment safe and hope that all manufacturers of chemical sterilization equipment will take measures to reduce worker exposure to these hazardous chemicals.

Skin contact with hydrogen peroxide is but one potential route to hydrogen peroxide exposure. In addition to the efforts from the sterilizer manufacturers, user facilities should take appropriate measures to reduce exposure to hydrogen peroxide or other sterilant chemicals. These measures include engineering controls such as adequate air turnovers, and dedicated exhaust, a continuous gas monitor for the sterilant chemical to provide a warning in case the gas or vapor concentration approaches or exceeds safe levels. Lastly, it is essential to develop good work practices for the safe use of chemicals and train people how to use sterilants safely and what to do in the event that there is a leak.