Cleaning, disinfection and sterilization of surface prion contamination

McDonnell, Gerald; Dehen, Capucine; Perrin, Audrey; Thomas, Vincent; Igel-Egalon, Angélique; Burke, Peter; Deslys, Jean‐Philippe; Comoy, Emmanuel

doi:10.1016/j.jhin.2013.08.003

Cited by 30 publications

(19 citation statements)

References 18 publications

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“…The successful inactivation of a Creutzfeldt-Jajob disease (CDJ) agent (Taguchi et al, 1991), the inactivation of 22A strain of scrapie agent (Taylor et al, 1997), the prion decontamination (McDonnell et al, 2013;Murphy et al, 2009) and inactivation of potentially infectious agents including virus, bacteria, fungi and protozoa (Kaye et al, 1998;Murphy et al, 2007;Neyens et al, 2003;Dixon et al, 2012) have been proved.…”

Section: Introductionmentioning

confidence: 99%

Inactivation of Geobacillus stearothermophilus spores by alkaline hydrolysis applied to medical waste treatment

Pinho

Nunes

Lobo-da-Cunha

et al. 2015

Journal of Environmental Management

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Although alkaline hydrolysis treatment emerges as an alternative disinfection/sterilization method for medical waste, information on its effects on the inactivation of biological indicators is scarce. The effects of alkaline treatment on the resistance of Geobacillus stearothermophilus spores were investigated and the influence of temperature (80 o C, 100 o C and 110 o C) and NaOH concentration was evaluated. In addition, spore inactivation in the presence of animal tissues and discarded medical components, used as surrogate of medical waste, was also assessed. were approximately 3 times lower than those at 100 o C (8.8e1.6 min). Independent of the presence of animal tissues and discarded medical components, 6 log10 reduction times varied between 66 and 5 min at 100 o C-0.1 M NaOH and 110 o C-1 M NaOH, respectively. The alkaline treatment may be used in future as a disinfection or sterilization alternative method for contaminated waste.

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Section: Introductionmentioning

confidence: 99%

Inactivation of Geobacillus stearothermophilus spores by alkaline hydrolysis applied to medical waste treatment

Pinho

Nunes

Lobo-da-Cunha

et al. 2015

Journal of Environmental Management

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“…Alternatively, biological indicators spread many spores within the autoclave, and the spores are then allowed to incubate for 24-hours. If all the spores have been terminated, then the sterilization process can be deemed to be successful [302].…”

Section: Steam 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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“…[18][19][20] A variety of other proteases also has shown little detrimental effect on 263K or RML scrapie agent brain titers in different material contexts. 21,22 Indeed, PK C Pronase yielded negligible destruction of RML infectivity without first pre-heating samples at 100 C for 15 min in 4% SDS. 22 In a physiological context, TSE agents, like many viruses, can survive proteolytic digestive juices whereas PrP does not.…”

Section: Introductionmentioning

confidence: 99%

Rapid chemical decontamination of infectious CJD and scrapie particles parallels treatments known to disrupt microbes and biofilms

Botsios

Tittman²,

Manuelidis

2015

Virulence

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Neurodegenerative human CJD and sheep scrapie are diseases caused by several different transmissible encephalopathy (TSE) agents. These infectious agents provoke innate immune responses in the brain, including lateonset abnormal prion protein (PrP-res) amyloid. Agent particles that lack detectable PrP sequences by deep proteomic analysis are highly infectious. Yet these agents, and their unusual resistance to denaturation, are often evaluated by PrP amyloid disruption. To reexamine the intrinsic resistance of TSE agents to denaturation, a paradigm for less resistant viruses and microbes, we developed a rapid and reproducible high yield agent isolation procedure from cultured cells that minimized PrP amyloid and other cellular proteins. Monotypic neuronal GT1 cells infected with the FU-CJD or 22L scrapie agents do not have complex brain changes that can camouflage infectious particles and prevent their disruption, and there are only 2 reports on infectious titers of any human CJD strain treated with chemical denaturants. Infectious titers of both CJD and scrapie were reduced by >4 logs with Thiourea-urea, a treatment not previously tested. A mere 5 min exposure to 4M GdnHCl at 22 C reduced infectivity by >5 logs. Infectious 22L particles were significantly more sensitive to denaturation than FU-CJD particles. A protocol using sonication with these chemical treatments may effectively decontaminate complicated instruments, such as duodenoscopes that harbor additional virulent microbes and biofilms associated with recent iatrogenic infections.

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Cleaning, disinfection and sterilization of surface prion contamination

Cited by 30 publications

References 18 publications

Inactivation of Geobacillus stearothermophilus spores by alkaline hydrolysis applied to medical waste treatment

Inactivation of Geobacillus stearothermophilus spores by alkaline hydrolysis applied to medical waste treatment

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

Rapid chemical decontamination of infectious CJD and scrapie particles parallels treatments known to disrupt microbes and biofilms

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