FDA’s Warning on Infections Linked to Urology Scopes Underscores Training, Competency Needs
April 14, 2021
IAHCSMM previously shared with membership the April 1, 2021, warning letter from the U.S. Food and Drug Administration (FDA) to healthcare providers (including those working in reprocessing units of healthcare facilities) about the risk of infections associated with reprocessed urological scopes. The FDA’s letter, coupled with previous studies that identified infection risks in these and other types of endoscopes, underscores the critical importance of proper training, competency and due diligence.
“We always need to check and ensure that our processes are correct and that all staff have proper training in all steps in flexible endoscope reprocessing,” stressed IAHCSMM Education Director Natalie Lind, CRCST, CHL, FCS. “All steps in reprocessing have the potential to impact patient safety.”
Raising awareness and remaining vigilant to reduce the risk for reprocessing errors and infections is always necessary and prudent. “All the recommendations given by the FDA are not only reasonable but are also outlined in the instructions for use and should be part of any department’s training and competency program,” said Damien Berg, BS, BA, CRCST, an IAHCSMM Past-President and AAMI Fellow who serves as Regional Manager of Sterile Processing at UCHealth in Northern Colorado.
Berg also stresses the important role certification and continued education can play in positive outcomes.
“As with any profession, becoming certified and staying on top of the changes and latest trends in the industry through education are great ways of raising that awareness, and it will help stop the line of potential problems with inappropriate processing,” he said. “While reprocessing is just one link in the infection chain, we as certified professionals owe it to our patients to continue to raise the bar with thorough and accurate processing.”
Numerous continuing education resources are available for SP professionals to help broaden knowledge and sharpen skill sets across all instrument types, including more challenging devices such as flexible endoscopes. IAHCSMM offers a wide range of offerings including textbooks and workbooks, lesson plans (available online through your IAHCSMM account and also in each issue of PROCESS magazine—these are valuable learning tools for any SP professional, regardless of certifications held), webinars, podcasts, staff education DVDs, and more. Ofstead & Associates also offers outstanding educational webinars (many of which directly address cleaning efficacy, drying and inspection of flexible endoscopes—and other ways to reduce risk of exposure, injury and infection associated with the devices), and all are offered free throughout 2021 with the code FREE.
Click Here to read the full FDA warning letter.