A quantitative assessment of residual protein levels on dental instruments reprocessed by manual, ultrasonic and automated cleaning methods

Vassey, Matthew; Budge, Claire; Poolman, Toryn; Jones, Phil; Perrett, David; Nayuni, N.K.; Bennett, Peter; Groves, P.; Smith, A. J.; Fulford, Martin R.; Marsh, Philip; Walker, James T.; Sutton, J. Mark; Raven, Neil

doi:10.1038/sj.bdj.2011.144

Cited by 40 publications

(31 citation statements)

References 22 publications

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“…A further element of the study assessed residual protein contamination on a range of dental instruments after routine cleaning and disinfection in general dental practice in England [22]). The study showed a number of instrument types and cleaning procedures where the upper interquartile range for residual protein was in excess of 100 µg.…”

Section: Discussionmentioning

confidence: 99%

Bioassay Studies Support the Potential for Iatrogenic Transmission of Variant Creutzfeldt Jakob Disease through Dental Procedures

Kirby¹,

Dickinson²,

Vassey³

et al. 2012

PLoS ONE

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BackgroundEvidence is required to quantify the potential risks of transmission of variant Creutzfeldt Jakob (vCJD) through dental procedures. Studies, using animal models relevant to vCJD, were performed to address two questions. Firstly, whether oral tissues could become infectious following dietary exposure to BSE? Secondly, would a vCJD-contaminated dental instrument be able to transmit disease to another patient?MethodsBSE-301V was used as a clinically relevant model for vCJD. VM-mice were challenged by injection of infected brain homogenate into the small intestine (Q1) or by five minute contact between a deliberately-contaminated dental file and the gingival margin (Q2). Ten tissues were collected from groups of challenged mice at three or four weekly intervals, respectively. Each tissue was pooled, homogenised and bioassayed in indicator mice.FindingsChallenge via the small intestine gave a transmission rate of 100% (mean incubation 157±17 days). Infectivity was found in both dental pulp and the gingival margin within 3 weeks of challenge and was observed in all tissues tested within the oral cavity before the appearance of clinical symptoms. Following exposure to deliberately contaminated dental files, 97% of mice developed clinical disease (mean incubation 234±33 days).InterpretationInfectivity was higher than expected, in a wider range of oral tissues, than was allowed for in previous risk assessments. Disease was transmitted following transient exposure of the gingiva to a contaminated dental file. These observations provide evidence that dental procedures could be a route of cross-infection for vCJD and support the enforcement of single-use for certain dental instruments.

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Section: Discussionmentioning

confidence: 99%

Bioassay Studies Support the Potential for Iatrogenic Transmission of Variant Creutzfeldt Jakob Disease through Dental Procedures

Kirby¹,

Dickinson²,

Vassey³

et al. 2012

PLoS ONE

View full text Add to dashboard Cite

show abstract

“…endodontic fi les and reamers were, due to their complex structure, inherently diffi cult to clean. This research supported the enforcement of single use policy for dental fi les and reamers which may otherwise have been reprocessed, sterilised and reused (76) . There was much debate amongst the dental community when this was decided by the Department of Health in a letter from the Chief Dental Offi cer and was reinforced by the release of 'Potential vCJD transmission risks via dentistry -An interim review' (77,78) .…”

Section: Example Of New Endoscopy Washersmentioning

confidence: 96%

The importance of decontamination in hospitals and healthcare

Walker

2014

Decontamination in Hospitals and Healthcare

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“…Ultrasonic Cleaning Methods -This provides the most efficient way of removing soil from some medical devices. Ultrasonic technology uses sound waves in a liquid as a cleaning method, in a process known as "cavitation" [273]. The sound waves in the liquid produce bubbles that burst on contact with surfaces, which then removes soil from the device's surface.…”

Section: Mechanical (Automated)mentioning

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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A quantitative assessment of residual protein levels on dental instruments reprocessed by manual, ultrasonic and automated cleaning methods

Cited by 40 publications

References 22 publications

Bioassay Studies Support the Potential for Iatrogenic Transmission of Variant Creutzfeldt Jakob Disease through Dental Procedures

Bioassay Studies Support the Potential for Iatrogenic Transmission of Variant Creutzfeldt Jakob Disease through Dental Procedures

The importance of decontamination in hospitals and healthcare

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

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