Medtech manufacturers Boston Scientific (Marlborough, MA) and 3M Health Care (St. Paul, MN), along with sterilization companies and industry associations, warn that an EPA draft conclusion stating that ethylene oxide (EO) can cause cancer in humans could, if finalized, seriously disrupt the availability of life-saving medical devices. EO is one of the primary forms of medical device sterilization, used to process more than 56% of all medical devices, according to industry estimates. "Restricting the use of EO as a viable sterilization method would severely impact the availability of approximately 32 million devices sterilized annually, many of which are life-saving," notes Boston Scientific in comments submitted to the EPA's Science Advisory Board (SAB).
The SAB's Chemical Assessment Advisory Committee (CAAC) met on Nov. 18 to 20 to evaluate the Integrated Risk Information System (IRIS) draft assessment of the carcinogenic effects of inhaled EO. In 1985, the EPA concluded that EO was a probable human carcinogen, and it has been trying to update this assessment since 1998, according to Bloomberg BNA.
Specifically, the EPA's primary goal in regards to the revised draft assessment is to examine the cancer risks of low exposure concentrations of EO and to estimate the cancer risk of occupational exposure to EO, writes Med Device Online. The agency's secondary goal is to review the accuracy, objectivity, and transparency of the revised draft.