A Clean Start: Priority Issues From the AAMI/FDA Medical Device Reprocessing Summit
http://www.aami.org/reprocessing/Materials/PDF/2011_Reprocessing_Summit_publication.pdf
Determining the appropriate soils that represent the soils from actual use is a continuing question for validation studies, just as determining the appropriate verification assays is a struggle for end-user verification, according to Bryans and two other summit presenters, Emily F. Mitzel, laboratory manager at Nelson Laboratories, Inc., and Ralph J. Basile, vice president, Healthmark Industries Company, Inc.
Super heated steam; shoes for SPD; proper use of containers for IUSS
http://www.hpnonline.com/inside/2012-02/1202-CSsolutions.html
Quality assured: SPDs improve processes, outcomes
"The healthcare field is dynamic. Scientific advances have brought about some incredible advances in surgical and medical technology and instrumentation, which has advanced the quality of care. This new technology is more complex than ever before and thus presents a great challenge to SPDs, relative to care, reprocessing and sterilization," said Ray Taurasi, MBA, CRCST, CHL, FCS, ACE, director of clinical sales and service, eastern region, Healthmark Industries. "SPD requires the tools, resources and knowledge to address these new challenges and ensure quality outcomes."
Probing the Challenges of Endoscopes: BI&T
...“The issue with flexible endoscopes, like any lumened device, is that the internal channels are not visible for inspection after cleaning,” says Ralph Basile, vice president with Healthmark Industries Company, Inc., an infection control products manufacturer in the Detroit, MI, area. “Thus, if improperly reprocessed, gross organic debris can remain and provide a source of contamination. Further, while automated devices are more widely used, manual procedures remain key to cleaning, including bedside cleaning. Failure to adequately flush the device immediately after use, and extended time between use and reprocessing, greatly increases the chance the device will not be effectively reprocessed. Even use of automated devices has not been a guarantee of success, as recent news headlines have demonstrated. Improper use of these devices has resulted in compromised instruments.
In addition, original equipment manufacturers (OEMs) often guarantee endoscope performance only if the devices are repaired by the OEM. Storage is a related issue that remains a potential problem. For devices that are used frequently—daily or more often—storing properly reprocessed scopes is not an issue, Basile says. However, “extended storage of scopes can lead to problems, particularly if the channels are not effectively dried after reprocessing with an alcohol flush and forced-air drying,” he says. “The good news is that there are now tools available to test flexible endoscopes for cleanliness,” he adds. Healthmark, for example, offers tests for organic soils and also for microbial contamination after extended storage. “These tests are easy to use, with easy-to-interpret results. They also provide rapid results—all key features in busy endoscopy centers.”


