The History of Ethylene Oxide

Ethylene oxide is a naturally occurring compound that has played a role in various industries since the 1930s. In the 1940s, it found its way into the medical field, where it was first used as a sterilant by hospitals and the military. However, the early methods of EO sterilization were quite different from what we see with Andersen Sterilizers methods today—larger doses, bulkier equipment, and less refined safety protocols. Over time, advancements in technology and a deeper understanding of EO have led to significant improvements in how it’s used. Today, Andersen has modernized EO sterilization to be safer, more efficient, and environmentally conscious, using smaller doses and low-temperature cycles that are ideal for delicate medical instruments. This evolution has made ethylene oxide one of the most effective sterilization methods in the world of modern healthcare.

EO Timeline

• 1930s

  EO insecticidal use gaining popularity. (Source)

• 1940s

  Registered with EPA as antimicrobial pesticide; early use of EO in hospitals. (Source)

  Used as sterilant by military.(Source)

• 1950s

  Dr. Charles Rush Phillips research spearheads EO’s use to sterilize delicate instruments. The McDonald process was patented for medical devices. (Source)

• 1960s

  Late in the decade, EO became the dominant chemical sterilant in major healthcare facilities.

• 1980s

  OSHA sets EO exposure limits. (Source)

• 1990s

  EO/CFC ban rumors. (Source)

• 2000s

  75% of hospitals using EO to sterilize devices. (Source)

  100% EO (Andersen) has never had a ban proposal. (Source)

• 2008

  Outbreak at 2 hospitals in Highland County, Florida – As many as 70 exposed, 22 dead; legitimate issues with reprocessing. (Source)

• 2012

  Additional outbreaks with hundreds infected and dozens killed.

• 2015
  • LA Times runs expose uncovering CRE outbreak at UCLA – 8 infected, 3 dead, 179 patients exposed. (Source)
  • FDA releases safety warnings about the use of duodenoscopes. (Source)
  • FDA convenes panel of experts to consult on whether current reprocessing standards are adequate. Their conclusion is no. (Source)
  • FDA recommends the use of EO for duodenoscope reprocessing. (Source)
  • World’s first FDA registration for flexible chamber EO sterilizer. (Source)
• 2017

  Renewed cleaning efforts for scopes not enough, triggering the search of most efficient methods by leading hospitals. (Source)

• 2020

  FDA notifies facilities again that gas sterilization has a greater safety margin than HLD.

  November: Andersen receives first and ONLY FDA clearance for terminal sterilization of duodenoscopes and colonoscopes. (Source)

• 2021

  April: Urological endoscopes
  June: Bronchoscopes
  join the list of complex devices that cannot be dependably disinfected. FDA continues to remind facilities that gas sterilization has a greater safety margin than HLD.