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

Rogez-Kreuz, Christine; Yousfi, Rahima; Soufflet, C.; Quadrio, Isabelle; Yan, Zheng-Xin; Huyot, V.; Aubenque, Céline; Destrez, P.; Roth, Klaus Edgar; Roberts, Charles G.; Favero, Maktin S.; Clayette, Pascal

doi:10.1086/598342

Cited by 63 publications

(53 citation statements)

References 27 publications

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“…Studies that have used these methods have reported survival of prion infectivity after autoclaving at 134°C for 18 minutes or more (Table 2). 13-16,19,20,22 Two studies in particular reported survival of infectivity despite subjecting the wires to detergent washing before autoclaving at 134°C for 18 minutes. 15,19 In these same studies, a decontamination protocol with sodium hydroxide (NaOH) treatment followed by autoclaving at 134°C for 18 minutes was not completely effective, which indicates that prion sterilization protocols that combine chemical treatment with autoclaving should be carefully selected.…”

Section: Resultsmentioning

confidence: 99%

Management of Neurosurgical Instruments and Patients Exposed to Creutzfeldt-Jakob Disease

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Sehulster

et al. 2013

Infect. Control Hosp. Epidemiol.

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OBJECTIVE To summarize the approaches used to manage exposure of patients to inadequately sterilized neurosurgical instruments contaminated as a result of Creutzfeldt-Jakob disease (CJD). METHODS Information on past CJD exposure incidents reported to the Centers for Disease Control and Prevention (CDC) was aggregated and summarized. In addition, inactivation studies were reviewed, and data from selected publications were provided for reference. RESULTS Nineteen incidents of patient exposure to potentially CJD-contaminated instruments were reported to the CDC, including 17 that involved intracranial procedures and 2 that involved ophthalmologic procedures. In more than 50% of incidents, the neurosurgical procedures were performed for diagnostic work up of the index patients. At least 12 of the hospitals had multiple neurosurgical sets, and the CJD-contaminated instruments could not be identified in 11 of 19 hospitals. In 12 of 15 hospitals with neurosurgical incidents, a decision was made to notify patients of their potential exposure. CONCLUSIONS Neurosurgical instruments used for treatment of patients with suspected or diagnosed CJD or patients whose diagnosis is unclear should be promptiy identified and sterilized using recommended CJD decontamination protocols. Inability to trace instruments complicates appropriate management of exposure incidents. The feasibility of instituting instrument tracking procedures should be considered.

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Section: Resultsmentioning

confidence: 99%

Management of Neurosurgical Instruments and Patients Exposed to Creutzfeldt-Jakob Disease

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Sehulster

et al. 2013

Infect. Control Hosp. Epidemiol.

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“…Two additional sterilization modalities are currently being developed: hydrogen peroxide gas vapor sterilization (e.g., STERRAD Ò , Ethicon Inc., Somerville, NJ), and ozone sterilization (TSO3 Inc., Dalton, Quebec, Canada) [13,14]. At this time, both are unavailable for clinical use with flexible endoscopes in the United States.…”

Section: Resultsmentioning

confidence: 99%

“…The current recommendation is to quarantine or incinerate surgical instrumentation after contact with contaminated patients, which is expensive and cumbersome [7,38]. Prions are unusually resistant to disinfection by conventional chemical high-level disinfectants/sterilants [13,39]. Variant Creutzfeldt-Jakob disease (vCJD) seems to be mainly transferred by consumption of beef products containing the bovine spongiform encephalopathy agent [38].…”

Section: Discussionmentioning

confidence: 99%

Use of flexible endoscopes for NOTES: sterilization or high-level disinfection?

et al. 2009

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“…Therefore, any potential risk of recontamination is greatly reduced. Also, because the devices can be stored in a sterile manner until they are needed, the hospital saves valuable time [ 309]. Lastly, the STERRAD system takes up minimal room and necessitates no extra venting or separate water connections.…”

Section: Gas Plasma (Sterrad) Sterilizationmentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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

Cited by 63 publications

References 27 publications

Management of Neurosurgical Instruments and Patients Exposed to Creutzfeldt-Jakob Disease

Management of Neurosurgical Instruments and Patients Exposed to Creutzfeldt-Jakob Disease

Use of flexible endoscopes for NOTES: sterilization or high-level disinfection?

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

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