Lumen claims of the STERRAD 100NX sterilizer: Testing performance limits when processing equipment containing long, narrow lumens

Diab-Elschahawi, Magda; Alexander, Bryce; Bachhofner, Nicole; Koller, Walter

doi:10.1016/j.ajic.2011.01.010

Cited by 8 publications

(6 citation statements)

References 13 publications

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“…Sterilization is dependent upon plasma permeation and direct contact, with confined spaces involving long narrow lumens, for example during the sterilization of endoscopes, being potentially problematic. Under controlled testing however, plasma sterilization eradicated bacteria spores seeded to a depth of 500 mm within 0.7 mm diameter tubing [12]. It is uncertain how hydrogen peroxide plasma will penetrate into narrow lumen (Fig.…”

Section: Discussionmentioning

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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Section: Discussionmentioning

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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show abstract

“…Thus, the chosen PCDs have to be positioned in the most "inaccessible" chamber locations to confirm the efficacy of the sterilization process. 9 To evaluate the sterilization ability of the sterilizer, we considered the following PCD lumen parameters: diameter, length, type of material, and designed shape. In this study, we tested PCDs with lumens of various sizes and designs to determine the worst-case PCD scenarios (Table 3) when process parameters such as temperature, diffusion time, pressure, and sterilant injection volume (Table 2) are varied.…”

Section: Sterilization Performance Depending On Pcd Specifications Un...mentioning

confidence: 99%

“…Geobacillus stearothermophilus (ATCC 7953) is a Gram-positive aerobic bacillus that is found in high-temperature (55–60 °C) environments. In our study, the microorganism was mainly used as an indicator organism to demonstrate the sterilization performance of the vaporized-hydrogen-peroxide-based sterilizers. , The test microorganism was used as a form of a self-contained biological indicator (SCBI) (EZTest, Mesa Labs, Bozeman, MT), wherein a microorganism population of about 2.1 × 10 6 spores is contained in a stainless steel carrier with the diameter of 7.16 mm.…”

Section: Experimental Sectionmentioning

confidence: 99%

“…1,5 Since ethylene oxide (EO) is potentially toxic and leaves behind residues on medical devices, 6−8 hydrogen peroxide gas sterilization has been proposed and developed as the new sterilization technology in the market. 9 With regard to vaporized-hydrogen-peroxide-based sterilization, it becomes essential to understand the diverse parameters that affect the sterilization ability to obtain optimal sterilization performance.…”

Section: Introductionmentioning

confidence: 99%

“…High-temperature sterilization is a traditional method that is effective only for heat-stable medical devices. In this regard, the main limitation of autoclave machines is that they are unusable for sterilizing heat-sensitive materials. , Meanwhile, low-temperature sterilization is essentially required for temperature-dependent medical devices such as complicated minimally invasive surgical products. , The typical kinds of gaseous chemical sterilants for low-temperature sterilization include ethylene oxide and hydrogen peroxide. , Since ethylene oxide (EO) is potentially toxic and leaves behind residues on medical devices, − hydrogen peroxide gas sterilization has been proposed and developed as the new sterilization technology in the market . With regard to vaporized-hydrogen-peroxide-based sterilization, it becomes essential to understand the diverse parameters that affect the sterilization ability to obtain optimal sterilization performance.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of Sterilization Performance for Vaporized-Hydrogen-Peroxide-Based Sterilizer with Diverse Controlled Parameters

et al. 2020

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Hydrogen-peroxide-based low-temperature sterilization is a new sterilization technology for temperature-dependent medical devices. The effect of the process parameters of hydrogen-peroxide-based sterilizer on the sterilization performance of process challenge devices (PCDs) needs to be investigated. Sterilant amount, operating temperature, vacuum pressure, diffusion time, and chamber loading of the sterilizer on the sterilization performance of PCDs were adjusted. Seven PCDs with various morphologies and material containing biological indicators (BI) (EZTest, Geobacillus stearothermophilus) were used to evaluate the sterilization performance. The sterilization success rates of PCDs were 86, 71, and 57% with controlled temperature and pressure, diffusion time, and sterilant volume injection, respectively. The PCD material and structure also obviously affected sterilization performance. The sterilization of PCD A is the least successful for all parameters. Meanwhile, the sterilization of PCD B was influenced by the diffusion time and the sterilant injection volume. PCD B and PCD C were successfully sterilized by controlling the temperature and pressure. The weights and volume of the sterilization loading chamber resulted in a different sterilization performance. Sterilization performances of PCD 1, PCD 2, and PCD 3 were <70, <90, and 100%, respectively. Sterilant volume, sterilant diffusion time, pressure, temperature, PCD types, and chamber loading were proven to be important process parameters of sterilizer that affect the sterilization performance of vaporized-hydrogen-peroxide-based sterilizers.

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Cold atmospheric pressure plasma and decontamination. Can it contribute to preventing hospital-acquired infections?

O’Connor

Cahill²,

Daniels

et al. 2014

Journal of Hospital Infection

103

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Lumen claims of the STERRAD 100NX sterilizer: Testing performance limits when processing equipment containing long, narrow lumens

Cited by 8 publications

References 13 publications

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

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

Evaluation of Sterilization Performance for Vaporized-Hydrogen-Peroxide-Based Sterilizer with Diverse Controlled Parameters

Cold atmospheric pressure plasma and decontamination. Can it contribute to preventing hospital-acquired infections?

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