Cause of Device-Related Incident
Device factors

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; CSR / Materials Management; Facilities Engineering

Device Factors
Device failure

Document Type
User Experience Network (UEN) reports

External Factors
*Not stated

Mechanism of Injury or Death
Burn (electrical, thermal, chemical); Exposure to hazardous gas

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

Medical Gas Cylinders [16-501]; Sterilizing Units, Ethylene Oxide [13-740]

Minimizing EtO Exposure When Changing Gas Cylinders

User Experience Network™ [Health Devices Jul-Aug 1989;18(7-8):290]


On removing an EtO hose while changing a 140 lb ethylene oxide (EtO) gas cylinder, two staff members were sprayed with EtO from a failed shut-off valve. Apparently, the valve failed to close when it was screwed completely down to the OFF position, resulting in a leak. How can exposure to EtO be minimized from such failures, which are unpredictable?


While we recognize that shut-off valve failures can happen, this is the first such report that we have received. We do not believe that such incidents occur frequently. However, we recommend that the following precautions and actions be taken whenever an EtO cylinder is changed or other maintenance activity is conducted in which EtO exposure is possible:

  1. Employees must always wear a suitable respirator. The type of respirator required can be determined by referring to the OSHA EtO Standard C.F.R. § 1910.1047, which defines respirator requirements based on previous exposure monitoring levels. The complete standard can be found in Title 29 Code of Federal Regulations (C.F.R.). A full-facepiece respirator will also provide effective eye protection.
  2. Employees must wear an impermeable coverall and heavy neoprene rubber work gloves to prevent skin contact. We recommend disposable suits; however, if reusable coveralls are used, they must be replaced or repaired when they become torn or damaged. Clean garments must be provided to ensure adequate protection.
  3. In case of an EtO leak, immediately exit the area and alert all employees in the department to evacuate the premises. Re-enter the area only when wearing a self-contained, air-supplied respirator. Other types of respirators may be adequate for tank changing; however, they may not provide adequate protection during an uncontrolled release of EtO. Contaminated clothing and shoes should be immediately removed and discarded in compliance with federal and state hazardous waste disposal guidelines. Contaminated clothing should be removed while under an emergency deluge shower. All persons exposed to EtO in this type of incident should be examined by a physician as detailed in the OSHA EtO Standard.


  • Medical Gas Cylinders [16-501]
  • Sterilizing Units, Ethylene Oxide [13-740]

Cause of Device-Related Incident

Device factor: Device failure

Mechanism of Injury or Death

Burn (chemical); Exposure to hazardous gas

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