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News / January 19, 2022
The Association for the Advancement of Medical Instrumentation (AAMI) developed a new technical information report (TIR) to help reduce the risks associated with chemicals and sterilants used in reprocessing medical devices. This is an important safety issue for all healthcare personnel involved with reprocessing medical devices. According to the CDC, the injury rate for healthcare workers is higher than most other industries.1
Commercially available sterilants and chemical disinfectants are used daily in healthcare facilities to destroy a broad range of disease-causing organisms found in and on reusable medical devices. Their use is especially prevalent on devices that are heat sensitive and cannot be placed in a steam sterilizer.
“All chemical sterilants and disinfectants are potentially hazardous to the processing professionals who use them,” said Janet Prust, chair of AAMI’s Chemical Sterilants Hospital Practices Working Group (AAMI ST/WG 61). “While not necessarily lethal to humans in normal work practices, these chemicals carry significant occupational risk for damage to the lungs, eyes, and skin, as well as other health hazard–related injuries.”2
Occupational diseases among reprocessing personnel have been associated with use of several commercially approved disinfectants (i.e., formaldehyde, glutaraldehyde, and chlorine). To reduce the risk to your reprocessing personnel, precautions should always be used to minimize exposure to these disinfectants. Such precautions should include approved gloves, barrier gowns, eye wear and proper ventilation. (3-5)
Another risk associated with the use of chemical disinfectants is asthma and reactive airway diseases. These can occur in sensitized persons exposed to any airborne irritant that can trigger a reaction, including germicides. Asthma and reactive airway diseases can occur at levels below the levels currently regulated by OSHA. The best way to control this potential risk is through the elimination of the chemical. This can be done by switching to another disinfectant that the worker is not sensitive to or by simply relocating of the worker to another area.
“More facilities are moving away from glutaraldehyde and choosing OPA or hydrogen peroxide solutions for faster disinfection times and fewer rinses, as well as to reduce staff safety concerns around glutaraldehyde exposure. Other considerations when selecting a high-level disinfectant include transducer compatibility (check your manufacturer’s IFU), contraindications, ventilation requirements and recommended re-use periods.” 6
The TIR from AAMI (AAMI TIR67:2018, Promoting safe practices pertaining to the use of sterilant and disinfectant chemicals in health care facilities) “was developed to help managers of departments using sterilant and disinfectant chemicals find and understand the pertinent regulatory information related to the safe use of these chemicals and provide general information on risk analysis and chemical safety.”7
According to AAMI, “TIR67 summarizes regulations, standards, and recommendations from the Food and Drug Administration, Occupational Safety and Health Administration, and Environmental Protection Agency, as well as describing relevant consensus standards.”8
TIR67 fulfills a longstanding industry need. Specifically, prior to its publication, it was very difficult and time consuming for healthcare workers to get good, useful information from all of the various sources and agencies listed above. TIR67 represents the single, best source for CS/SPD departments and department managers to get the most current regulations, information and requirements from these various regulatory agencies.
“It’s really helpful to have all of this information in a single document with the relevant regulation references that will help managers know the requirements for the specific chemicals used in their department,” Prust said. “I believe it will allow employers and department managers to more effectively ensure employees handling these hazardous chemicals are provided with the right information, proper training, and the appropriate work tools for a safer environment.”9
In order to better protect you and your fellow CS/SPD reprocessing personnel from the dangers associated with sterilants and disinfectant chemicals, go to www.aami.org and order a copy of AAMI ST79 for your facility today.
1 NIOSH [2018]. Current U.S. Workforce Data by NORA sector. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health.
2 AAMI News, August, 2018
3 Weber DJ, Rutala WA. Occupational risks associated with the use of selected disinfectants and sterilants. In: Rutala WA, ed. Disinfection, sterilization, and antisepsis in healthcare. Champlain, New York: Polyscience Publications, 1998:211-26.
4 Hansen KS. Occupational dermatoses in hospital cleaning women. Contact Dermatitis 1983; 9:343-51
5 Melli MC, Giorgini S, Sertoli A. Sensitization from contact with ethyl alcohol. Contact Dermatitis 1986; 14:315.
6 Nadeau K. Connecting the dots, removing the spots. HPN November 20, 2017
7 AAMI News, August, 2018
8 Op. Cite.
9 Op. Cite.
