Low-temperature Hydrogen Peroxide Gas Plasma Research Articles

Monitoring the Effective Sterilization of Low-Temperature Hydrogen Peroxide Gas Plasma Sterilizers in 58 Hospitals - 22 PLADs, China, June 2015-December 2019.

What is already known on this topic?Hydrogen peroxide sterilizeation is widely used for luminal devices. However, the low penetrability of the sterilant is of major concern.What is added by this report?This report investigated the effective sterilization of low-temperature hydrogen peroxide gas plasma sterilizers and compared the applicability of different biological monitoring methods based on medical luminal devices.What are the implications for public health practice?It is recommended to use a biological process challenge device for monitoring the sterilization of luminal devices with low-temperature hydrogen peroxide gas plasma sterilizers.

Decontamination of N95 masks for re-use employing 7 widely available sterilization methods.

The response to the COVID-19 epidemic is generating severe shortages of personal protective equipment around the world. In particular, the supply of N95 respirator masks has become severely depleted, with supplies having to be rationed and health care workers having to use masks for prolonged periods in many countries. We sought to test the ability of 7 different decontamination methods: autoclave treatment, ethylene oxide gassing (ETO), low temperature hydrogen peroxide gas plasma (LT-HPGP) treatment, vaporous hydrogen peroxide (VHP) exposure, peracetic acid dry fogging (PAF), ultraviolet C irradiation (UVCI) and moist heat (MH) treatment to decontaminate a variety of different N95 masks following experimental contamination with SARS-CoV-2 or vesicular stomatitis virus as a surrogate. In addition, we sought to determine whether masks would tolerate repeated cycles of decontamination while maintaining structural and functional integrity. All methods except for UVCI were effective in total elimination of viable virus from treated masks. We found that all respirator masks tolerated at least one cycle of all treatment modalities without structural or functional deterioration as assessed by fit testing; filtration efficiency testing results were mostly similar except that a single cycle of LT-HPGP was associated with failures in 3 of 6 masks assessed. VHP, PAF, UVCI, and MH were associated with preserved mask integrity to a minimum of 10 cycles by both fit and filtration testing. A similar result was shown with ethylene oxide gassing to the maximum 3 cycles tested. Pleated, layered non-woven fabric N95 masks retained integrity in fit testing for at least 10 cycles of autoclaving but the molded N95 masks failed after 1 cycle; filtration testing however was intact to 5 cycles for all masks. The successful application of autoclaving for layered, pleated masks may be of particular use to institutions globally due to the virtually universal accessibility of autoclaves in health care settings. Given the ability to modify widely available heating cabinets on hospital wards in well-resourced settings, the application of moist heat may allow local processing of N95 masks.

Is plasma sterilization the modality of choice of sterilization today for endourological procedures such as ureterorenoscopy and retrograde intrarenal surgery? A single-center retrospective evaluation of 198 patients.

Introduction:The prevalence of infective complications among patients undergoing Retrograde Intrarenal Surgery (RIRS) for renal stone is 1.7%-18%, including fever, Systemic Inflammatory Response Syndrome (SIRS) and sepsis. The infectious complications of RIRS can be minimised by strict aseptic precautions and plasma sterilization. The Sterrad Next Generation (Sterrad NX) System, a low-temperature sterilizer represents the next generation of low-temperature hydrogen peroxide gas plasma sterilizers. This study was conducted to evaluate the efficacy of plasma sterilization among patients undergoing ureterorenoscopy (URS) and RIRS. The primary endpoint of this study was incidence of septicemia or related complications. Till date, there is no study on the incidence of infection rate in RIRS in relation to a specific mode of sterilization.Material and Methods:This is a retrospective study comprising of 198 patients undergoing URS and/or RIRS. The parameters studied were incidence of post-operative fever, Systemic Inflammatory Response Syndrome (SIRS), pyelonephritis or septicemic shock.Results:Out of 198 patients, incidence of post-operative fever was 3.5%, SIRS was 1.7%, pyelonephritis was 0.7% and septicemic shock was 0%. This is statistically significantly low septicemia rate among patients undergoing URS and /or RIRS as compared to the available literature. No health hazards of plasma sterilization were noted. No damage to the endoscopes or instruments was noted.Conclusion:Sterrad NX based on hydrogen peroxide gas plasma (HPGP) technology is highly efficacious, safe and the modality for sterilization of instruments, including heat labile instruments such as semi rigid, flexible and chip on the tip endoscopes and other EndoUrology armamentarium.

How to Sterilize 3D Printed Objects for Surgical Use? An Evaluation of the Volumetric Deformation of 3D-Printed Genioplasty Guide in PLA and PETG after Sterilization by Low-Temperature Hydrogen Peroxide Gas Plasma

Introduction: In the present time, there is rapid development in the application of 3D printing technology in surgery. One of the challenges encountered by the surgeon is the sterilization of these 3D-printed objects for use in the operating room. Materials and Methods: Forty-two identical cutting guides used for genioplasty were 3D-printed: twenty-one in Polylactic acid (PLA) and twenty-one in Polyethylene terephthalate glycol (PETG). The guides were CT scanned after printing. They were then sterilized with the low-temperature hydrogen peroxide gas plasma technique (Sterrad®). A CT scan of the guides was also performed at T1 (after printing) and T2 (after sterilization). A software (Cloudcompare ®) was then used to accurately compare the volume of each guide at T0 (the initial computer-aided designed guide) vs T1 and T1 vs T2. Statistical analysis was then performed. Results: Although there are differences that are statistically significant for each series between T0 and T2 and T1 and T2 for both PLA and PETG, this had no impact on the clinical use of sterilized objects using hydrogen peroxide sterilization technique because these morphological differences were minimal at less than 0.2mm. Conclusion: Morphological deformations induced by the hydrogen peroxide sterilization are sub-millimeter and acceptable for surgical use. The hydrogen peroxide sterilization is, therefore, an alternative to avoid the deformation of 3D-printed objects made from PLA and PETG during conventional steam sterilization (autoclave). To the best of our knowledge, this is the first study regarding the morphologic deformation of 3D-printed objects in PLA and PETG after sterilization for medical use.

Optimization of sterilization methods for electrospun poly(ε-caprolactone) to enhance pre-osteoblast cell behaviors for guided bone regeneration

The aim of this study was to determine the optimal sterilization procedure for biodegradable polyester-based guided bone regeneration membranes. The effects of sterilization using low-temperature hydrogen peroxide gas plasma, 75% ethanol (EtOH; two soaking times), and ultraviolet radiation on the structure and biological properties of electrospun poly(ε-caprolactone) membranes were investigated. The results demonstrated that all were effective sterilization methods. The membranes were then assessed for surface structure, wettability, and in vitro cellular responses including osteogenic differentiation by seeding with pre-osteoblasts (MC3T3-E1 cells). The cells grew well on all the sterilized membranes. The low-temperature hydrogen peroxide gas plasma–sterilized membranes, which exhibited significantly improved hydrophilicity ( p < 0.05), were better for cell osteogenic differentiation compared to the membranes sterilized by other methods. In addition, the cell behavior on the membranes sterilized by EtOH was superior to those sterilized by ultraviolet radiation. Finally, EtOH soaking time appeared to influence cell behavior. The results suggested that low-temperature hydrogen peroxide gas plasma treatment is the most promising method to sterilize electrospun poly(ε-caprolactone) membranes for guided bone regeneration.

Hydrogen Peroxide Vapour in the Proximity of Hydrogen Peroxide Sterilisers

Background: Some employees engaged in central services in a hospital have experienced irritation to the eyes and throat near the hydrogen peroxide (HP) steriliser. Method: The concentrations of hydrogen peroxide vapour (HPV) in the proximity of HP sterilisers (low-temperature hydrogen peroxide gas plasma steriliser: Sterrad NX®, Sterrad 100S®, and Sterrad 200®, Johnson & Johnson, and Low-temperature vaporized hydrogen peroxide steriliser: Amsco V-PRO1®, Sakura Seiki) were measured with an electrochemical detector. Results: HPV was present at higher concentrations than anticipated. Conclusion: Adequate air conditioning, donning gloves for bag handling, supplied-air respirator use for door opening, and other measures for the security of healthcare personnel should be seriously reevaluated.

Inactivation of Animal and Human Prions by Hydrogen Peroxide Gas Plasma Sterilization

Prions cause various transmissible spongiform encephalopathies. They are highly resistant to the chemical and physical decontamination and sterilization procedures routinely used in healthcare facilities. The decontamination procedures recommended for the inactivation of prions are often incompatible with the materials used in medical devices. In this study, we evaluated the use of low-temperature hydrogen peroxide gas plasma sterilization systems and other instrument-processing procedures for inactivating human and animal prions. We provide new data concerning the efficacy of hydrogen peroxide against prions from in vitro or in vivo tests, focusing on the following: the efficiency of hydrogen peroxide sterilization and possible interactions with enzymatic or alkaline detergents, differences in the efficiency of this treatment against different prion strains, and the influence of contaminating lipids. We found that gaseous hydrogen peroxide decreased the infectivity of prions and/or the level of the protease-resistant form of the prion protein on different surface materials. However, the efficiency of this treatment depended strongly on the concentration of hydrogen peroxide and the delivery system used in medical devices, because these effects were more pronounced for the new generation of Sterrad technology. The Sterrad NX sterilizer is 100% efficient (0% transmission and no protease-resistant form of the prion protein signal detected on the surface of the material for the mouse-adapted bovine spongiform encephalopathy 6PB1 strain and a variant Creutzfeldt-Jakob disease strain). Thus, gaseous or vaporized hydrogen peroxide efficiently inactivates prions on the surfaces of medical devices.

欧州における滅菌の最新事情と新型過酸化水素低温プラズマ滅菌装置の位置付け(第82回日本医科器械学会大会ランチョンセミナー5記録)

欧州における滅菌の最新事情と新型過酸化水素低温プラズマ滅菌装置の位置付け(第82回日本医科器械学会大会ランチョンセミナー5記録)

Comparison of low-temperature hydrogen peroxide gas plasma sterilization for endoscopes using various Sterrad™ models

This study compared the effectiveness of sterilizing four types of endoscope using different models of the Sterrad system (Sterrad 50, 100, 100S and 200). Sterilization levels meeting international requirements were attained in all cases with carriers inoculated with Geobacillus stearothermophilus spores. The endoscopes were tested in half cycles ('overkill'). This is the first study to compare the Sterrad models marketed to date in terms of effective sterilization of endoscopes with narrow lumens.

Measures taken to reduce damage and repair costs of rigid endoscopes during their handling and processing in surgical practice

An increased number of surgical procedures using endoscopic techniques has resulted in a more frequent use of rigid endoscopes. A side effect of this is that more instrument damage has been noticed. Measures must be taken in instrument handling procedures to reduce the incidence of instrument damage and the cost of instrument repairs. Impacts of such changes have been studied. The incidence and types of damage to rigid endoscopes was followed during a six-year period. During the time period of the study certain changes in instrument handling and processing were introduced. Improved education and training of personnel was instituted as well as a change in sterilization practice. Measures taken in instrument processing have resulted in a total reduction of instrument damage of 35%. High temperature damage to lenses was reduced in the order of 80% when low-temperature hydrogen peroxide gas plasma was applied for sterilization instead of steam autoclaving. The introduction of educational and training programs to raise the awareness of the staff in instrument handling and the use of low-temperature gas plasma for sterilization can considerably reduce the incidence of instrument damage and reduce the cost for instrument repair. It can be assumed that the reduction of damage to instruments also has a beneficial influence on the quality of the endoscopic surgical procedures because less time is lost, and possibly the image quality can be improved.

Contamination of bronchoscopes with Mycobacterium tuberculosis and successful sterilization by low-temperature hydrogen peroxide plasma sterilization

Background: The transmission of mycobacteria by bronchoscopes has been reported several times in the last years. To explore methods to prevent transmission of tuberculosis in this way, we sterilized contaminated bronchoscopes with low-temperature hydrogen peroxide gas plasma sterilization. Methods: Bronchoscopes were contaminated with Mycobacterium tuberculosis and decontaminated with a washer/disinfecter (“normal washing”). Some were additionally disinfected with glutaraldehyde (“intensive washing”). Afterward the bronchoscopes were sterilized by low-temperature hydrogen peroxide plasma sterilization. Results: After normal washing, 8/17 samples had positive results by culture, and 7/17 had positive results by nucleic acid amplification technique. After intensive washing, all samples had negative results by culture, and 10/25 had positive results by nucleic acid amplification technique; after sterilization with low-temperature hydrogen peroxide plasma sterilization, all samples had negative results by culture and nucleic acid amplification technique. Conclusion: Washing of bronchoscopes, as performed normally, is not sufficient for decontamination of bronchoscopes. Additional disinfection is recommended. If the nucleic acid amplification technique is used for diagnostic procedures, sterilization by low-temperature hydrogen peroxide plasma sterilization is recommended to avoid false-positive results.

Effect of gas-plasma sterilization on the osteoinductive capacity of demineralized bone matrix.

The current study evaluated the effect of low-temperature hydrogen peroxide gas plasma sterilization on the osteoinductive capability of human demineralized bone matrix using a rat model. Twelve athymic rats received three separate implants consisting of steam-sterilized demineralized bone matrix (negative control), sterile-harvest demineralized bone matrix (positive control), and gas-plasma-sterilized demineralized bone matrix. A demineralized bone matrix pellet from each sterilization group was placed individually into one of three separate soft tissue pockets created in the epaxial musculature of each rat. All 12 rats were euthanized 9 weeks after implantation. Each implantation site was removed along with 0.5-cm normal tissue around the implant. Histologic examination was done on each implant site to determine the presence or absence of new bone, cartilage, or bone marrow elements. All 12 sterile harvest demineralized bone matrix sites histologically contained new bone elements, whereas none of the negative control or gas plasma sterilized demineralized bone matrix sites contained any of these same elements. The results of this study indicate that demineralized bone matrix sterilized with low-temperature, gas-plasma sterilization loses its osteoinductive capacity in a manner similar to that of steam-sterilized demineralized bone matrix, making low-temperature, gas- plasma sterilization unsuitable as a method of secondary sterilization of demineralized bone matrix.

Hydrogen peroxide gas plasma sterilization is effective against Cryptosporidium parvum oocysts

The aim of this work was to evaluate in an immunosuppressed rat cryptosporidiosis model a new method that combines vacuum and low-temperature hydrogen peroxide gas plasma for sterilization of endoscopic material contaminated by Cryptosporidium parvum. Rats were challenged with oocysts either air-dried or air-dried and treated with vacuum alone or associated with gas plasma. No rat was found infected after gas plasma exposure of oocysts, whereas vacuum or air-drying alone resulted only in a decreased infectivity.