FDA Holds a Public Workshop on Reprocessing of Reusable Medical Devices
on June 8th and 9th, 2011
The Food and Drug Administration (FDA) held a public workshop to discuss factors affecting the quality of reprocessing of reusable medical devices on Wednesday and Thursday. The FDA, as well as healthcare practitioners, industry representatives and the scientific community, worked to identify issues involving inadequately reprocessed reusable medical devices. This forum allowed all stakeholders in the healthcare community to hear from hospital staff, manufacturers, healthcare engineers, and government officials. While the topics covered various reusable medical devices, surgical components and flexible endoscopes appeared to attract the greatest interest.
As a pioneer in healthcare practice and device efficiency with a focus on infection control solutions for flexible endoscopy, Vision-Sciences was in attendance to develop a greater understanding of the issues involved for all stakeholders, and with a desire to contribute to the development of the best in guidance documentation, leading to innovative change in design where possible, all leading to an end point of enhancing patient safety. The workshop provided a great place to hear the needs and interests of all healthcare parties.
A great deal of emphasis was placed on flaws in device design, specifically those that make cleaning and disinfection/sterilization difficult. Issues such as the difficulty in cleaning, brushing, and flushing the lumen/working channels of conventional flexible endoscopes and instruments appeared paramount.
Some additional topics that were discussed included: adequate validation of manufacturer IFU’s, clear/easy to follow IFU’s, Central Services challenges, challenges manufacturers face, Non OEM repairs to reusable medical devices, and an overview of the FDA’s draft guidance on Reusable Medical Devices.
For more information on the Workshop, please visit: Public Workshop - Reprocessing of Reusable Medical Devices
Vision-Sciences is the developer of EndoSheath® Endoscopy, which combines state-of-the-art endoscopic technology with a sterile, disposable microbial barrier (including a disposable working channel). For more information on our technology, please visit www.visionsciences.com to learn more!