Addressing the Largest Infection Prevention Gaps in Endoscope Reprocessing
It’s time to embrace new technology and promote standardization to raise best practice protocols.
Tag Archives: sterilization
CDRH Warns of Potential Device Shortage with Shutdown of Sterigenics Facility in Illinois
According to the FDA, more than 90% of products sterilized at the facility are medical devices.
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.
Understanding and Overcoming Challenges of Medical Adhesives
10 factors design engineers must consider when creating stick-to-skin medical devices.
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.
This Week’s Big Acquisition: Sterigenics Picks Up Nelson Laboratories
The deal creates the largest global sterilization and lab services operation.
Why Duodenoscopes Are So Tough to Clean
Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.
Design Verification: The Testing Phase
Part three of the design verification series discusses in detail the steps that should be taken during testing.
Design Verification: Process Considerations Before Testing
Prior to design verification of packaged products, consider the following process-related elements.
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 …
