The History of Ethylene Oxide

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.