Ethylene Oxide is a sterilant chemical often used in healthcare sterile processing and medical device manufacture. Ethylene Oxide is flammable, toxic, and a known carcinogen. Know the facts for process management and safety.
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Applications for Ethylene Oxide (EtO) Gas Sterilization:
- Medical device manufacturing
- Low temperature steriliztion process for medical instruments
- Low temperature sterilization process for medical packs
Regulations/ Guidelines for Ethylene Oxide
Exposure limits and guidelines when using ethylene oxide have been set by a number of national agencies including the following:
OSHA: Occupational and Safety Health Administration
OSHA Permissible Exposure Limit (PEL) : 1.0 ppm (8 Hr TWA)
-Duties: Employers have a duty to provide a safe work environment and employees have a duty to work safely.
-Hazard Communication Regulation, suppliers (labels, safety data sheets), Employers (facilities, work practices, training and personal protective equipment) to enable the safe use of the chemicals
NIOSH: National Institute of Occupational Safety and Health
NIOSH Immediately Dangerous to Life and Health (IDLH) : 800 ppm
JC: Joint Commission
Joint Commission Standard EC.02.02.01
: American Conference of Government Industrial Hygienist
ACGIH Threshold Limit Values TLV : 1.0 ppm (8 Hr TWA)
OSHA Hazard Communications 29 CFR 1910.1200
AAMI : Association for the Advancement of Medical Instrument
AAMI ST:41:1999 and ST:58:2013
UK HSE : United Kingdom Health & Safety Executive
UK HSE Long-Term : 5 ppm
Mexico: 1 ppm (8 Hr TWA)
It is highly recommended to use a combination of continuous fixed area monitoring and portable area monitoring to find danger zones throughout any facility that uses Ethylene Oxide.
Continuous fixed area monitoring is recommended in the following areas:
Near concentrated EtO sterilizers, storage areas, dilution lines, and pump stations
Any area where employees have experienced symptoms or known risks are present for exposure
Portable monitoring is recommended as checks needed on Ethylene Oxide throughout the day.
Important to note: Ethylene Oxide sterilizers can leak, so you may experience different levels per day. The same goes for sprayers that put off different levels of sanatation per day. Make sure to incorporate vapor monitoring into you QC and safety program. Monitoring will be used to access real-time exposure to hydrogen peroxide sterilization on a daily basis. Facilities can use these monitors to improve work practices, optimize engineering controls and/or add PPE as needed to ensure the safe use of Ethylene Oxide.
At a minimum, chemical-resistant gloves (Neoprene) and splash-proof eye protection should be worn.
Adding a face shield is appropriate if working with larger quantities.
Concentrated Ethylene Oxide should only be handled in well-ventilated areas.
Prolonged exposure, or exposure above OELs may require the use of a suitable respirator. If a respirator is used, it should be full face to protect eyes.
Storage In Healthcare
Since use cartridges, no more than one day supply and < 12 cartridges near Ethylene Oxide sterilizer. Cartridges should be stored in approved flammable cabinet that must be actively vented and monitored to prevent a build up of EtO gas.
EtO use often requires permitting, dedicated ventilation, emissions control and special training. Consult appropriate regulations and standards for guidance.
EtO Spill Control
Since EtO is a gas under normal conditions, any spills or leaks will rapidly vaporize and will be removed by ventilation. EtO should only be used in well ventialted areas, typically 10 air exchanges per hour (see local regulations). In the event of a leak, it is important to take measure to prevent worker exposure. Emissions regulations may also apply.