Earlier this fall, the Advanced Medical Technology Association (AdvaMed) released a fact sheet on ethylene oxide (EtO) sterilization to refute fallacies about medtech manufacturers’ preferred disinfecting method.
 
“A false emerging narrative suggests ethylene oxide (EtO) sterilization is ‘cheaper, easier, and faster than alternatives and thus preferred,” states the fact sheet, released Nov. 1. “Modern Healthcare called it a ‘relatively cheap process that easily penetrates products, making it an attractive choice for device makers.’”
 
For many device makers, EtO is the only sanitizing option due to product size, shape, design complexity, or material composition. Some materials, in fact, actually degrade under radiation or steam decontamination processes.
 
Consequently, EtO sterilization has gained favor with the medtech industry over the last several decades despite its high costs. AdvaMed’s fact sheet notes that ethylene oxide is “often the most expensive, time consuming, and inefficient” sterilizing method. It’s also a more harmful method for human health, given its designation as a carcinogen by the U.S. Environmental Protection Agency.
 
Emissions from EtO sterilization facilities have prompted concerns and lawsuits from both (neighboring) residents and state and local governments. Eliminating ethylene oxide as a cleaning tool would have disastrous public health consequences, as more than half of all medical devices undergo this method of decontamination. “Elimination of this sterilization technology would introduce the real risks of increased morbidity and mortality,” AdvaMed has stated.
 
ODT’s packaging and sterilization feature delves into the controversy surrounding EtO disinfection as well as the trends and market forces driving the final stages of product development. Elizabeth Sydnor, director of microbiology at Eurofins Medical Device Testing, was among the experts interviewed for this feature; her full input is provided in the following Q&A:
 
Michael Barbella: What kinds of alternative sterilization methods are companies embracing to reduce their dependency on EtO, given the technology’s much-publicized health/environmental risk factors?
Elizabeth Sydnor: Depending on product and packaging material, gamma irradiation, eBeam, and VHP can be considered as an alternative sterilization method. However, a validation of this alternative method would need to completed.
 
Barbella: Where is the packaging/sterilization industry (for orthopedics) headed in the next five years?
Sydnor: Gamma sterilization is commonly used for orthopedic products. However, due to the shortage in Cobalt-60, the industry is considering alternative radiation modalities. In the next five years we will probably begin to see that shift from manufactures and regulatory guidance to support this change.