Terminal sterilization of medical devices using vaporized hydrogen peroxide: a review of current methods and emerging opportunities

McEvoy, Brian; Rowan, Neil J.

doi:10.1111/jam.14412

Cited by 112 publications

(81 citation statements)

References 96 publications

(110 reference statements)

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“…With hydrogen peroxide established as a biocidal agent since the 1800s and the first uses of the vapor form in sterilization emanating from the late 1970s, VHP is a well-established sterilization method of choice in the healthcare setting for the processing of reusable devices. 3 Furthermore, VHP is used in many other applications, such as room and facility decontamination. 4 The disinfection and sterilization efficacy of hydrogen peroxide in both aqueous and gas form are well documented, 4,5 with the latter form considerably outperforming the liquid system.…”

Section: Vaporized Hydrogen Peroxidementioning

confidence: 99%

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Vaporized Hydrogen Peroxide: A Well-Known Technology with a New Application

McEvoy¹,

Eveland²

2020

Biomedical Instrumentation & Technology

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Hydrogen peroxide has a multitude of uses and the vapor form was first identified as a sterilant in late 1970s. Following a number of developments, vaporized hydrogen peroxide (VHP) became widely adopted in early 90s as a substitute for ethylene oxide (EO) in device and instrument processing and reprocessing in healthcare facilities. Often VHP was hailed as the replacement technology for EO. Because of key limitations such as scale, penetration, and compatibility with packaging materials, adoption to terminal sterilization of single-use devices has not commenced to any significant level. However, recent developments in sterilization chamber design and process development provide new opportunity for consideration. For future products, such as those that require “end of production line sterilization,” such limitations may be reconsidered and overcome. This article describes those challenges and how they have been addressed, with practical examples. The development of global consensus standards and leveraging the well-established knowledge of VHP sterilization with regard to microorganism inactivation and material compatibility will help facilitate wider consideration of VHP technology as a true alternative to EO in certain product applications.

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Section: Vaporized Hydrogen Peroxidementioning

confidence: 99%

“…Industrial VHP sterilization chambers ( Figure 1) are typically one-half to four pallets (35-280 ft 3 ). This is in contrast with large EO chambers, often ranging from 1,000 ft 3 to 2,200 ft 3 .…”

Section: Industrial-scale Vhpmentioning

confidence: 99%

Vaporized Hydrogen Peroxide: A Well-Known Technology with a New Application

McEvoy¹,

Eveland²

2020

Biomedical Instrumentation & Technology

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“…Low temperature (65°C) sterilization methods suitable for 3D printouts include ethylene oxide (EtO) gas and hydrogen peroxide plasma, with the latter technique preferred due to its absence of toxic by-products [4]. Hydrogen peroxide plasma is generated following excitation beyond the gaseous phase and achieves sterility by inducing free-radical formation [5].…”

Section: Introductionmentioning

confidence: 99%

A review of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively

Shea

et al. 2020

3D Print Med

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3D printing in the context of medical application can allow for visualization of patient-specific anatomy to facilitate surgical planning and execution. Intra-operative usage of models and guides allows for real time feedback but ensuring sterility is essential to prevent infection. The additive manufacturing process restricts options for sterilisation owing to temperature sensitivity of thermoplastics utilised for fabrication. Here, we review one of the largest single cohorts of 3D models and guides constructed from Acrylonitrile butadiene styrene (ABS) and utilized intra-operatively, following terminal sterilization with hydrogen peroxide plasma. We describe our work flow from initial software rendering to printing, sterilization, and on-table application with the objective of demonstrating that our process is safe and can be implemented elsewhere. Overall, 7% (8/114 patients) of patients developed a surgical site infection, which was not elevated in comparison to related studies utilizing traditional surgical methods. Prolonged operation time with an associated increase in surgical complexity was identified to be a risk factor for infection. Low temperature plasma-based sterilization depends upon sufficient permeation and contact with surfaces which are a particular challenge when our 3D-printouts contain diffusion-restricted luminal spaces as well as hollows. Application of printouts as guides for power tools may further expose these regions to sterile bodily tissues and result in generation of debris. With each printout being a bespoke medical device, it is important that the multidisciplinary team involved in production and application understand potential pitfalls to ensuring sterility as to minimize infection risk.

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“…Finally, we are testing various procedures for decontaminating and reusing face shields and similar PPE. Preliminary results with ionized hydrogen peroxide sterilization (iHP; TOMI SteraMist™) 10 suggests that PanFab face shields can be successfully sterilized without suffering damage through at least five cycles.…”

Section: Discussionmentioning

confidence: 99%

Rapid prototyping and clinical testing of a reusable face shield for health care workers responding to the COVID-19 pandemic

Mostaghimi

Antonini

Plana

et al. 2020

Preprint

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Due to supply chain disruption, the COVID-19 pandemic has caused severe shortages in personal protective equipment (PPE) for health care professionals. Local fabrication based on 3D printing is one way to address this challenge, particularly in the case of simple products such as protective face shields. As a consequence, many public domain designs for face shields have become available. No clear path exists, however, for introducing a locally fabricated and unapproved product into a clinical setting. In a US health care setting, face shields are regulated by the Food and Drug Administration (FDA); similar policies exist in other countries. We describe a research protocol under which rapid iteration on an existing design, coupled with clinical feedback and real-world testing in an emergency department, allowed a face shield to be implemented by the members of the incident command team at a major academic medical center. We describe our design and testing process and provide an overview of regulatory considerations associated with fabrication and testing of face shields and related products. All designs, materials used, testing protocols, and survey results are reported in full to facilitate the execution of similar face shield efforts in other clinical settings. Our work serves as a case study for development of a robust local response to pandemics and other health care emergencies, with implications for healthcare professionals, hospital administrators, regulatory agencies and concerned citizens.

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Terminal sterilization of medical devices using vaporized hydrogen peroxide: a review of current methods and emerging opportunities

Cited by 112 publications

References 96 publications

Vaporized Hydrogen Peroxide: A Well-Known Technology with a New Application

Vaporized Hydrogen Peroxide: A Well-Known Technology with a New Application

A review of the manufacturing process and infection rate of 3D-printed models and guides sterilized by hydrogen peroxide plasma and utilized intra-operatively

Rapid prototyping and clinical testing of a reusable face shield for health care workers responding to the COVID-19 pandemic

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