Risk Factors To Consider When Selecting Medical Devices For Pharmaceutical Applications

 

 

Using any medical device brings with it an element of risk at the clinical level, where risk represents the probability of occurrence of harm and the consequences of that harm (severity). While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. 

 

Such risks are foremost about injury to the patient and to the user and other persons, with the need to consider risk across the medical device life cycle. Other associated risks may be to the environment or with any data collected. The various risks are set out in ISO 14971.

It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk to patients and users posed by these devices. This article assesses the common risk areas that require assessment.

Tim Sandle has published a new article, see:  https://www.outsourcedpharma.com/doc/risk-factors-to-consider-when-selecting-medical-devices-for-pharmaceutical-applications-0001 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Probing the nature of Candida auris

 

Candida auris was first identified in 2009. The fungus, which led to serious outbreaks in hospitals and other care settings, alarmed scientists as it evaded traditional medications to treat fungal infections. Since then, the race has been on to better understand the fungus and hopefully better control it.

 

New research from University of Michigan marks a major step forward in understanding C. auris biology, homing in on the genetics behind its ability to shape-shift from a round yeast form to a more hair-like, filamentous form.

 

Notably, the fungus has now been found on all inhabited continents and different variants and morphologies have emerged in different parts of the world. Determining the genetics behind these variants is key to determining how form and disease are related. But until now, studying C. auris' genes has been difficult.

 

 

This has bene overcome using genetic tools based on a DNA-based CRISPR-Cas9 technique and a bacterium that commonly infects plants. Exploiting the bacteria's ability to infect fungi as well, the team used it to insert DNA into the genome of C. auris. Screening the genetically modified cells for ones that had different morphologies, or structures, lent clues to which genes were controlling it. The team is the first to use these methods successfully in C. auris.

 

The researchers are now seeking to uncover the genetic factors behind C. auris' ability to spread so well on hospital and other surfaces.

 

Journal Reference:

 

Darian J. Santana, Teresa R. O’Meara. Forward and reverse genetic dissection of morphogenesis identifies filament-competent Candida auris strains. Nature Communications, 2021; 12 (1) DOI: 10.1038/s41467-021-27545-5

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Exploring the link between compost and pathogen Aspergilli

 

Fourteen percent of Aspergillus fumigatus isolates cultured from garden soils were found to be resistant to an agricultural triazole antifungal drug, tebuconazole. Tebuconazole resistance confers resistance to medical triazoles that are used to treat aspergillosis, a lung infection that can be serious, which results from inhalation of A. fumigatus spores.

 

In the study, researchers found that compost and compost-enriched soils contain high concentrations of A. fumigatus spores.

 

 

A novel aspect of this study is that the soil samples -- 509 -- were collected from gardens by 249 citizen scientists. The samples were all collected on the same day, June 21, 2019. From these, the investigators cultured 5,174 isolates of A. fumigatus. Many of these A. fumigatus isolates contained polymorphisms in the cyp51A gene, which is frequently associated with triazole-resistance. Soil samples containing compost were significantly more likely to grow tebuconazole-resistant A. fumigatus strains than those that did not, and compost samples grew significantly higher numbers of A. fumigatus than other soil samples.

 

The study was motivated by a growing number of cases caused by triazole resistant A. fumigatus spores. While many people normally inhale spores from the environment, including those of A. fumigatus, those with weak immunity, due to immune-suppressing drugs, conditions such as diabetes or rheumatoid arthritis, or lung damage from infection by tuberculosis, COVID-19, severe influenza or smoking, are especially vulnerable,.

 

The data suggests that handling compost and compost-enriched soils exposes individuals to large numbers of spores and that behavioral changes on their part, and action taken by the composting industry could reduce these exposures.

 

Journal Reference:

 

Jennifer M. G. Shelton, Roseanna Collins, Christopher B. Uzzell, Asmaa Alghamdi, Paul S. Dyer, Andrew C. Singer, Matthew C. Fisher. Citizen-science surveillance of triazole-resistant Aspergillus fumigatus in UK residential garden soils. Applied and Environmental Microbiology, 2022; DOI: 10.1128/AEM.02061-21

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Escherichia coli resistance gene identified

 

Scientists have pinpointed a gene that helps E. coli bacteria evade antibiotics.

 

The University of Queensland-led study found a particular form of the bacteria -- E. coli ST131 -- had a previously unnoticed gene that made it highly resistant to commonly prescribed antibiotics.

Escherichia coli sequence type 131 (ST131) is a major cause of urinary and bloodstream infections. Its association with extended-spectrum β-lactamases (ESBLs) significantly complicates treatment. Isolates belonging to ST131 are identified by PCR and multilocus sequence typing (MLST), and then characterized for antibiotic resistance, CTX-M-type extended-spectrum β-lactamase genes, fluoroquinolone resistance genes, O types, phylogenetic groups, virulence factors and PFGE patterns.

 

 

Bacteria have genetic structures in their cells -- called plasmids -- that are traded quickly and easily between each other.  This resistance gene is in one such plasmid and is swiftly making E. coli ST131 extremely resistant to widely prescribed fluoroquinolone antibiotics. 

The findings have given the team the first clues to explain how antibiotic-resistant E. coli ST131 has emerged and spread so quickly around the world.

 

See:

 

Minh-Duy Phan, Kate M. Peters, Laura Alvarez Fraga, Steven C. Wallis, Steven Hancock, Nguyen Thi Khanh Nhu, Brian Forde, Michelle J. Bauer, David L. Paterson, Scott A Beatson, Jeffrey Lipman, Mark A. Schembri. Plasmid-mediated ciprofloxacin resistance imparts a selective advantage on Escherichia coli ST131. Antimicrobial Agents and Chemotherapy, 2021; DOI: 10.1128/aac.02146-21

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)