Vaporized Hydrogen Peroxide Gains Support as Low‐Temperature Sterilization Method

• Published in: AORN journal Vol. 120; no. 3; pp. P1 - P4
• Main Author: Fischer, Lindsay
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.09.2024
• Subjects: Departments; Health care networks; Health risk assessment; Health risks; Heat; Hospitals; Humans; Hydrogen peroxide; Hydrogen Peroxide - administration & dosage; Medical device industry; Medical equipment; Methods; Nurses; Occupational safety; Perioperative; Pollutants; Radiation; Sterilization - methods; Sterilization - standards; Surgery; Temperature; Volatilization; United States > US; Pennsylvania
• ISSN: 1878-0369; 0001-2092; 1878-0369
• DOI: 10.1002/aorn.14213

Manufacturers have routinely used irradiation technologies or gaseous ethylene oxide (EO) to sterilize heat-sensitive products.2 When filing a premarket submission for critical and semicritical devices to the FDA, companies must demonstrate that their product has an adequate sterilization process that effectively eliminates all microbial life, including spores.1 By giving manufacturers a new validated way to effectively sterilize their products, this recategorization will allow these manufacturers to move away from EO use.3 Amber Wood, MSN, RN, CNOR, CIC, FAPIC, senior perioperative practice specialist at AORN, explained, "industrial EO sterilization is associated with environmental concerns, and it is important to find alternative sterilization methods. Along with VHP, other Established Category A methods include dry heat, EO, moist heat or steam, and radiation through gamma or electron beam.1,3 Each of these techniques are effective at sterilizing certain devices.1,3 However, because different devices have varying levels of complexity, material type, and heat sensitivity, the same methods cannot be used for all of them.3 For example, steam sterilization, which is quick and nontoxic, typically requires a temperature of at least 121° C-which endoscopes and surgical devices with delicate components cannot withstand.3,4 Dry heat can be an effective method, but takes more time than steam sterilization, and the temperatures are still too high for some devices, particularly those with plastic and rubber.3 Radiation, which is a low-temperature method like EO and VHP, has the advantage of short processing times, good penetration capabilities, and the ability to process a different range of doses and densities; however, its prolonged exposure can be potentially lethal, and its use can produce ozone gas.3 EO as a Public Health Risk According to the FDA, EO is the most popular modality for sterilizing industrial medical devices in the United States.1 Approximately 50% (20 billion) of purchased devices requiring sterilization are sterilized with EO.1 However, there is evidence that exposure to EO is associated with adverse health outcomes.5 The Environmental Protection Agency (EPA) has stated that EO poses a significant health risk to those who live near facilities that emit EO and to those who encounter EO-treated medical equipment in the hospital setting.5 Historically, the risks associated with EO were not always considered significant.5 The method was once previously known as a "potentially hazardous air pollutant. "5 However, today, it is recognized as a known human carcinogen.5 In March 2024, the EPA published the final amendments to air toxic standards for EO commercial sterilization facilities.6 The amendments clarify that EO is a significant contributor to air toxicity and a potent cancer-causing air pollutant.6 As of 2024, any commercial sterilizer that uses EO must follow the National Emissions Standards for Hazardous Air Pollutants.6 Through these actions, the EPA intends to reduce EO emissions by 90% nationwide.6 Broadening VHP Use In comparison to EO, VHP is a nontoxic and time-efficient method that does not leave harmful residuals on devices.3 Like EO, VHP is a lowtemperature sterilant that is able to permeate most materials, and it can also inactivate prions.3 When concentrated, VHP becomes a strong agent for the advanced oxidation process, which uses reactive species, such as hydroxyl radicals, to break down a range of organic and inorganic matter, including microorganisms.2,4 Vaporized hydrogen peroxide is suited to sterilize polymeric materials, which can be found in many medical instruments, including endoscopes.4 It is considered safer than other gaseous oxidizing agents because it easily degrades into oxygen and water,4 and it is also considered advantageous because it can sterilize products in less than one hour.4 Healy emphasized that the FDA's recognition of VHP will allow its use to become more widespread. Many health care professionals are already familiar with certain equipment that use VHP and have used low-temperature sterilization systems to provide terminal sterilization of medical devices and surgical equipment used in sterile processing departments, ORs, and ambulatory surgery centers.2 Ruth Kravetz, chief technician of the sterile processing department at Forbes Hospital in Monroeville, Pennsylvania, which is part of the Allegheny Health Network, explained that the shorter process time with VHP is an advantage in the hospital setting.