A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli

Ross, Andrew; Baliga, Christopher; Verma, Punam; Duchin, Jeffrey S.; Glück, Michael

doi:10.1016/j.gie.2015.04.036

Cited by 159 publications

(133 citation statements)

References 22 publications

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“…Nevertheless, Olympus never brought this information to the FDA and did not alert any American hospitals, physicians, or patients about the risk of infection until February 2015. Additionally, although at least a dozen separate American hospitals traced antibioticresistant infections directly to duodenoscopes, these hospitals did not notify the FDA about these infections even though they are legally obligated to do so [223]. In fact, not a single American hospital, which experienced the duodenoscope infection outbreaks, sent the required adverse event forms to either the FDA or the duodenoscope manufacturers [224].…”

Section: Consequencesmentioning

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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Section: Consequencesmentioning

confidence: 99%

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

Reifschneider

2018

Preprint

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Section: Downloaded Frommentioning

confidence: 99%

“…It should be noted that although the authors refer to the baseline transmission rates as "low," there are no benchmarks for what rate would be considered acceptably low. Transmission from a single index patient can lead to an outbreak with associated deaths for some resistant organisms of high virulence, so the tolerance for any transmission would be quite small in those cases (6,23,24).During interval II, 550 isolates were sequenced, and genotyping data suggesting transmission events were relayed immediately to infection control personnel. Analysis of these isolates by cgMLST did not reveal a statistically significant change in inferred transmission rates between the two intervals.…”

mentioning

confidence: 99%

Commentary: Next-Generation Epidemiology: Using Real-Time Core Genome Multilocus Sequence Typing To Support Infection Control Policy

Dekker

Frank

2016

J Clin Microbiol

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M ultilocus sequencing typing (MLST), introduced by Maiden and colleagues in 1998, has come to represent one of the most widely used and successful molecular methods for strainlevel classification of bacterial isolates (1). MLST schemes work by indexing sequence variation in a small set of housekeeping genes to a numerical classification system. Each novel sequence occurring at any of the selected loci is named as a unique numbered allele, and the profile of a given isolate is specified by the numbers representing the allelic composition. Each combination of alleles is assigned a unique sequence type (ST), and STs, in turn, can be grouped into higher levels of classification (2, 3). The ability of MLST to resolve closely related strains is limited in principle by the absolute sequence diversity present in the loci covered by the scheme and by the manner in which this sequence diversity distributes across the population to be classified. As MLST schemes require conserved PCR primer binding sites, the targets must also be sufficiently conserved so that the method works robustly, and this puts limits on the resolution of classical MLST (3). MLST schemes have now been developed for Ͼ100 genera and species, and continuously updated databases are maintained by the University of Oxford, United Kingdom (pubmlst.org), Imperial College London, London, United Kingdom (http://www.mlst.net/), and others.Classical MLST analysis, developed to be compatible with Sanger sequencing methods, is based on 400-to-500-nucleotide segments of (usually) seven genes, encompassing Ͻ0.2% of the bacterial genome in many cases (3). Advances in whole-genome sequencing (WGS) and the availability of a large number of assembled bacterial genomes have made possible new approaches to strain-and clone-level epidemiologic tracking of isolates, including the ability to apply MLST schemes on a genome-wide scale. Inference of clonal relationships from the comparison of wholegenome sequences for the purpose of epidemiologic investigations can involve a bit more subtlety than classical MLST analysis, however, and there are abundant opportunities for drawing incorrect conclusions. Perhaps the simplest of the many available approaches is that of direct-alignment-based (single nucleotide polymorphism [SNP]-based) phylogenetic analysis, often built on the underlying statistical assumptions of independent individual substitution events. Direct-alignment-based phylogenetic analyses have been used to study the population structures of bacterial outbreaks and to construct transmission maps in a variety of epidemiologic investigations (4-6). However, single recombination events, mobile genetic element insertions, or other horizontal genetic transfer events can result in multiple SNPs or more-complex rearrangements over a contiguously exchanged or interrupted region. Consequently, genome-wide direct-alignment methods, in addition to being computationally expensive, may result in the generation of incorrect tree topologies due to such rearrangements (7). Alternative...

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“…Poor hand hygiene by clinic staff plays a crucial role in further spreading the bacteria [23,27]. The duodenoscope, due to its complex design that makes reprocessing difficult, becomes a transmitter of bacteria unless reprocessing achieves total bacterial elimination [18,19,20,21,22,23,24,34]. Since infections with these bacteria do not necessarily occur immediately after an endoscopic intervention, and transmitter patients from other wards are not necessarily endoscoped, the underlying route of these bacterial outbreaks is difficult to ascertain.…”

Section: What Changes Have There Been To Duodenoscopes and The Bactermentioning

confidence: 99%

Hygiene: The Looming Achilles Heel in Endoscopy

Jung¹,

Beilenhoff²

2016

Visc Med

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Background: Since the late 1970s there have been sporadic reports of nosocomial infections linked to endoscopic procedures. Infections by multidrug-resistant organisms (MDRO) have an increasing impact on healthcare systems worldwide. Since 2010 outbreaks involving MDRO have been reported as a result of endoscopic retrograde cholangiopancreatography (ERCP) from the USA, France, Germany and the Netherlands. Methods: This article evaluates the recent outbreaks and developments and demonstrates a structural approach to how to prevent future infections. Current national and international guidelines were used as a basis for discussions. Results: In some cases insufficient cleaning or drying supported the outbreak. In the majority of cases, outbreaks occurred despite the apparently appropriate reprocessing protocols being in use. Microlesions were identified on a number of endoscopes, which supported the growth of bacteria and represented a vehicle for the transmission of infectious material. National official bodies responded with warnings. Manufacturers informed their customers accordingly. Separate, purpose-designed reprocessing rooms and a sufficient number of competent staff provide the structural quality for a safe reprocessing. The process quality includes a thorough cleaning of all endoscope channels and crucial instrument components, followed by an automated and validated reprocessing procedure. Strict adherence to manufacturers' recommendations is essential. The outcome quality should be evaluated by regular audits, validation of reprocessing procedures and microbiological surveillance. If outbreaks occur, a close co-operation with official bodies and manufacturers is essential. Conclusion: Health care professionals and manufacturers should be aware of their responsibility to ensure patient safety. A structural approach is key in prevention of endoscopy-associated infections.

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A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli

Cited by 159 publications

References 22 publications

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

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

Commentary: Next-Generation Epidemiology: Using Real-Time Core Genome Multilocus Sequence Typing To Support Infection Control Policy

Hygiene: The Looming Achilles Heel in Endoscopy

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