Hydrogen Peroxide (H2O2) Gas Plasma VS Other Low Temperature Sterilization Modalities

Sterilization plays a vital role in patient safety and infection prevention resulting from contaminated medical devices and surgical equipment. As a result of the increasing complexity of medical devices and surgical instruments, traditional sterilization methods, such as the steam sterilization (steam autoclave), have become unsuitable for use on many modern devices. Alternative low-temperature sterilization methods, that could be used on heat and moisture-sensitive instruments and devices, were therefore developed. Ethylene oxide (EtO) is an example one such low-temperature sterilant which is widely used. However, it has several associated drawbacks such as the need for long, costly sterilization cycles and the potential toxicity hazards for patients and staff.

In 1987, a group of scientists in Texas USA, pioneered a novel idea to use hydrogen peroxide (H2O2) for device sterilization and as a result Advanced Sterilization Products (ASP) was formed. Since FDA approval of the STERRAD 100 System in 1993, ASP has been committed to continuously advancing infection prevention technologies through developing a range of first-of-their-kind H2O2 low-temperature sterilizers.

Low-Temperature Sterilization Using Hydrogen Peroxide Gas Plasma

ASP devices use H2O2 gas plasma sterilization to safely and effectively perform terminal sterilization of medical devices and surgical instruments.1 H2O2 is an oxidising agent that kills microorganisms through oxidation of their key cellular components.

A solution of H2O2 and water is delivered into STERRAD™ Systems, and vaporised into gas before entering the sterilization chamber.1 The H2O2 gas plasma, a ‘cloud’ of highly energised species, is generated upon application of a strong electrical field within the chamber.1 These energised species (free radicals) surround the medical devices and surgical instruments and create a biocidal environment, killing any microbial cells present.1 Upon removal of the electrical field, the free radicals lose their energised state and recombine to form oxygen and water.1

Hydrogen Peroxide Gas Plasma Sterilization

h202 gas plasma sterilization
h202 gas plasma sterilization

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).2 It is also known to have a toxic impact on the environment.3

EtO can be absorbed by many materials, with concentrations (1-2%) of unchanged EtO having being measured in sterilized devices.4, 5 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.5, 6 As a result of this absorption, EtO sterilization loads require lengthy periods of aeration, meaning typical sterilization cycles last between 16-17 hours.7, 8

Due to the health, safety and environmental concerns associated with EtO, central sterile supply departments must comply with strict regulations.5 Healthcare facilities using EtO must possess sufficient ventilation and abatement systems and staff must undergo extensive training, in addition to regular health checks.8, 9

FO

FO is a highly toxic, carcinogenic irritant that is also associated with serious health complications.10, 11 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.8, 9

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.5, 13, 14 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.5, 8

H2O2 sterilization loads do not require lengthy aeration periods, meaning that sterilization cycles are typically much shorter than EtO and FO sterilization.7, 14 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.5, 15

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

Low-temperature sterilization modality EtO FO H2O2
Typical cycle length 16–17 hours7 2–3 hours7 24–60 minutes16
Health Risks
Carcinogenic
Acute exposure side effects Vomiting2
Bronchitis2
Irritation of the nose and throat2
Central nervous system depression2
 
Local irritation of mucous membranes10
Malaise and headaches10
Irritation of the nose and throat10
 
Irritation13
Long-term exposure side effects Reproductive disorders2
Cataracts2
Neurological disorders2
Sensitisation, resulting in asthma and contact dermatitis10
Cancer10
Chronic irritation13

References

  1. Advanced Sterilization Products. STERRAD™ 100NX and STERRAD NX™ with ALLClear™ Technology Technical White Paper. AD-190024-01-CT_C-MDR.

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

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

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

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

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

  7. 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.

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

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

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

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

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

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

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

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

AD-220106-01-CT_A-MDR

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