Failing to Properly Clean, Disinfect and Sterilize Devices Among Top Patient Hazards
Healthcare facilities need to make sure they have enough personnel and equipment that can manage device reprocessing.
Tag Archives: contamination
Olympus, Fujifilm and Pentax Warned by FDA for Compliance Failures
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
Pentax Medical Recalls Certain Duodenoscopes
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
Dirty Endoscopes: FDA Outlines Risks of Cross Contamination for Device Components
The agency released a guidance document with product design recommendations to help prevent contamination from device components.
Reprocessing Warning
As FDA recommended in its comments to healthcare, it is imperative that providers inform their patients of all risks. However, it is incumbent upon patients to become knowledgeable consumers and ask questions about any procedure they are being exposed to, including the use of instruments that may have been reprocessed.
Ask the Expert: Home Use Devices and Sterilization
The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for …
The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for …
