Medical Device Contamination

Safety of Metals and Other Materials Used in Medical …

https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices

Building on prior work and steps outlined in the Medical Device Safety Action Plan announced in 2018, the FDA conducted a comprehensive review of metals used in implanted medical devices, due...

Sterility and Infection Control Program: Research on …

https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/sterility-and-infection-control-program-research-medical-devices

Device Related Infections: Advancing Antimicrobial Technologies - To assist stakeholders in evaluating safety and effectiveness of technologies to reduce health care …

Disposal of Contaminated Devices | FDA

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/disposal-contaminated-devices

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. Please …

ISO 13485:2016 product cleanliness and contamination …

https://advisera.com/13485academy/blog/2017/07/04/managing-cleanliness-of-a-product-and-contamination-control-according-to-iso-134852016/

The process of sterilization focuses on decontamination or removal of biological agents, whereas the cleanliness of a medical …

Reducing levels of medical device contamination through …

https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0206892

When medical devices serve as a vehicle for indirect transmission, the initial contamination tends to occur from a small number of micro-organisms that are transferred to the device, either …

Seven serious medical device malfunctions that have led …

https://www.nsmedicaldevices.com/analysis/medical-device-failures-fda-recalls/

We take a look at seven medical devices that have been hit with Class I FDA recalls in the past few years. Seven serious medical device failures 1. Allergan breast implants In July 2019, US pharma and medical …

Defective Drugs & Medical Devices | Injuries, Risks and …

https://www.consumernotice.org/drugs-and-devices/

Medical Devices Medical devices include a wide array of products, from tongue depressors and surgical robots to hip implants and surgical mesh. But medical devices don’t go through the same rigorous …

Disinfection of medical devices – all you need to know – …

https://epiguard.com/disinfection-medical-devices-all-you-need-to-know/

HAIs that most commonly appear due to inadequate decontamination procedures or harmful device reuse practices are surgical site infections (SSI), HIV infections, hepatitis B and C, …

Contamination Control in Medical Devices, …

https://www.exponent.com/services/practices/engineering/biomedical-engineering-sciences/capabilities/contamination-control-in-medical-devices-pharmac__

Chemical, particulate, and biological (bioburden) contamination events are frequently associated with plant shutdowns and product recalls. Problems can result from …