Sterilization is crucial in preventing infections caused by contaminated medical devices. With the increasing complexity of these devices, traditional methods like steam autoclaving are no longer suitable. 
Consequently, alternative low-temperature sterilization methods have been developed, specifically for heat and moisture-sensitive instruments and devices.
One widely-used method is ethylene oxide (EtO) sterilization. However, it has drawbacks such as long and expensive sterilization cycles, as well as potential toxicity hazards for both patients and staff.

Learn how H2O2 Gas Plasma Sterilization works, here.
 

H₂O₂ Gas Plasma Technology Versus EtO and Formaldehyde gas (FO) Sterilization

Sterilization using H2O2 gas plasma offers a safer, more efficient alternative to other commonly used low-temperature sterilization methods, such as EtO and FO.

EtO

EtO is a toxic, carcinogenic sterilant which has been shown to cause serious health complications following both acute and long-term exposure (Table 1).1 It is also known to have a toxic impact on the environment.2

EtO can be absorbed by many materials, with concentrations (1-2%) of unchanged EtO having being measured in sterilized devices.3, 4 This poses a risk of exposing patients to toxic residues of EtO and its breakdown products, potentially leading to complications such as burns and allergic reactions.4, 5 As a result of this absorption, EtO sterilization loads require lengthy periods of aeration, meaning typical sterilization cycles last between 16-17 hours.6, 7

Due to the health, safety and environmental concerns associated with EtO, central sterile supply departments must comply with strict regulations.4 Healthcare facilities using EtO must possess sufficient ventilation and abatement systems and staff must undergo extensive training, in addition to regular health checks.7, 8

FO

FO is a highly toxic, carcinogenic irritant that is also associated with serious health complications.9, 10 Due to its toxicity, sterilization departments must adhere to strict safety regulations to limit exposure to staff and implement safety measures, such as using dedicated room ventilation.7, 8

Hydrogen Peroxide Gas Plasma Sterilization vs EtO and FO

In comparison to EtO and FO, H2O2 is a non-carcinogenic, non-mutagenic sterilant, which is broken down into non-toxic by-products (water and oxygen) when used as a gas plasma.4, 12, 13 Patients and staff are therefore protected from being exposed to unnecessary health risks. Due to the lack of toxic emissions, H2O2 low-temperature sterilizers avoid many of the regulatory and safety requirements associated with EtO and FO sterilization methods.4, 7

H2O2 sterilization loads do not require lengthy aeration periods, meaning that sterilization cycles are typically much shorter than EtO and FO sterilization.6, 13 As such, instrument and device turnaround is typically quicker with H2O2 low-temperature sterilization, reducing the need for large, costly surgical inventories and resulting in improved workflow efficiency in sterilization departments.4, 14

The table below compares the cycle lengths and health risks associated with each of the three main low temperature sterilization methods.

Low-temperature sterilization modalityEtOFOH2O2
Health Risks
Typical cycle length16–17 hours62–3 hours524–60 minutes13
Carcinogenic✓✓✕
Acute exposure side effectsVomiting1
Bronchitis1
Irritation of the nose and throat1
Central nervous system depression1
 		Local irritation of mucous membranes9
Malaise and headaches9
Irritation of the nose and throat9
 		Irritation12
Long-term exposure side effectsReproductive disorders1
Cataracts1
Neurological disorders1		Sensitisation, resulting in asthma and contact dermatitis9
Cancer9		Chronic irritation12

References

  1. Agency for Toxic Substances & Disease Registry. Medical Management Guidelines for Ethylene Oxide.

  2. Environmental Protection Agency. Hazardous Air Pollutants: Ethylene Oxide.

  3. World Health Organization. Concise International Chemical Assessment Document 54: Ethylene Oxide. 2003.

  4. Advanced Sterilization Products. Now is the right time to go EtO free. AD-140114-01-CT_D-MDR

  5. Ari S, Caca I, Sahin A, et al. Toxic anterior segment syndrome subsequent to pediatric cataract surgery. Cutan Ocul Toxicol 2012;31:53-7.

  6. Kanemitsu K, Imasaka T, Ishikawa S, et al. A comparative study of ethylene oxide gas, hydrogen peroxide gas plasma, and low-temperature steam formaldehyde sterilization. Infect Control Hosp Epidemiol 2005;26:486-9.

  7. World Health Organisation. Decontamination and Reprocessing of Medical Devices for Health-care Facilities. 2016.

  8. Adler S, Scherrer M, Daschner FD. Costs of low-temperature plasma sterilization compared with other sterilization methods. J Hosp Infect 1998;40:125-34.

  9. Agency for Toxic Substances & Disease Registry. Medical Management Guidelines for Formaldehyde.

  10. Occupational Safety and Health Administration. OSHA FactSheet - Formaldehyde. 2011.

  11. Agency for Toxic Substances & Disease Registry. Medical Management Guidelines for Hydrogen Peroxide.

  12. Advanced Sterilization Products. STERRAD™ Systems with ALLClear™ Technology Product Brochure. AD-160029-01-CT_D-MDR

  13. Muscarella LF. Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes. BMJ Open Gastroenterol 2019;6:e000282.

  14. Advanced Sterilization Products. STERRAD™ 100NX with ALLClear™ Technology Data Sheet AD-AD-160028-01-CT_D-MDR

AP-2400578-01-1

Disclaimer

The content of this website is aimed exclusively at healthcare professionals (HCPs) and not at the general public. Please confirm by clicking below that you are a healthcare professional, duly authorized to practice in your field. ASP EMEA declines all responsibility in case of unauthorized consultation.