Debris In Medical Devices

Reprocessing of Reusable Medical Devices | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices

Inadequate cleaning between patient uses can result in the retention of blood, tissue and other biological debris (soil) in certain types of reusable medical devices. This debris can allow...

Working Together to Improve Reusable Medical Device …

https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/working-together-improve-reusable-medical-device-reprocessing

Regulatory Science Tools to Help Assess …

https://www.fda.gov/medical-devices/science-and-research-medical-devices/catalog-regulatory-science-tools-help-assess-new-medical-devices

An essential role of the Office of Science and …

Factors Affecting Quality of Reprocessing | FDA

https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/factors-affecting-quality-reprocessing

Hinges; Sleeves surrounding rods, blades, activators, inserters, etc.; Adjacent device surfaces between which debris can be forced or caught during use; O-rings; Valves that …

Analyzing Particulate Matter on Medical Devices

https://www.mddionline.com/news/analyzing-particulate-matter-medical-devices

USP 788 describes two methods for analyzing particulates in injections and parenteral infusions: light obscuration (method 1) and microscopic (method 2). 2 These …

Medical litter: Device debris poses serious risk

https://www.nbcnews.com/health/health-news/medical-litter-device-debris-poses-serious-risk-flna1C9452966

“Patients who harbor such material may subsequently experience complications such as local tissue rejection, inflammation, perforation, blood vessel …

Cleaning | Disinfection & Sterilization Guidelines

https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html

For instrument cleaning, a neutral or near-neutral pH detergent solution commonly is used because such solutions generally provide the best material compatibility profile and good …

U.S. FDA classifies recall of Philips' respiratory devices as most ...

https://health.economictimes.indiatimes.com/news/medical-devices/u-s-fda-classifies-recall-of-philips-respiratory-devices-as-most-serious/98014435

1 day ago · Medical Devices U.S. FDA classifies recall of Philips' respiratory devices as most serious The U.S. health regulator said the silicon foam used in some reworked …

Toxicity of Metals Released from Implanted Medical …

https://www.sciencedirect.com/science/article/pii/B9780444594532000056

Medical devices made from metallic components can release metal ions or wear debris and can therefore expose patients to many of the same metals that they are …

Philips Respironics Recalls Certain Reworked Philips …

https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-reworked-philips-respironics-trilogy-100200-and-garbin

As of January 4, 2023, there have been 82 MDRs (63 MDRs for foam delamination and 19 MDRs for particulate debris contamination) and no deaths. Who …