Patients expect safe , reliable , and evidence-based care . They don ’ t expect to contract an infection from a device that is being used to provide clinical care to them . Healthcare systems must carefully evaluate medical-device related risks and take all available steps to mitigate and preferably eliminate these risks in the interests of protecting both patients and the healthcare team alike .
three P ’ s : People , Process , and Product . This comprehensive approach provides the best possible outcomes when it is rigorously followed . This three tiered approach can assist healthcare leaders with identifying risks associated with reprocessing and in decreasing potential patient and healthcare team safety issues .
➊ People :
• Do I have the right team members performing the role for which they are most qualified ?
• How do I ensure the competency of my perioperative personnel ?
• Are my personnel able to meet the demands of our clinical practice with instrument / device reprocessing ?
• Do I have a highly functional team culture within my OR and facility ?
➋ Process :
• How is my reprocessing process validated and how often ?
• How often does the device vendor validate our reprocessing capability ?
• What other devices does our facility use that may contribute to reprocessing failures ?
• How would I know if I have a reprocessing failure and how many patients would be impacted ?
➌ Product :
• Do I want to continue to take the known risks associated with reprocessing and the risks for SSIs ?
• How old is my fleet of reusable devices and how often are they inspected , serviced , and assessed by the actual OEM device manufacturer ?
• What other third-party devices might be used through the surgical device that could result in damage to the device and create a pathway for potential device contamination ?
Patients WHO are readmitted following endoscopies are typically experiencing chief complaints of pain , bleeding , or infection . These are widely preventable complications that increase length of stay and the cost of care delivery . In addition , the patient ’ s overall experience will be negatively impacted when they contract a device-related infection . There are now FDA-cleared sterile , disposable flexible endoscopes that are readily available in the U . S . market and can assist healthcare professionals and systems with eliminating device-related infections by removing the reprocessing process from the equation completely . At right is a table that compares the use of traditional reusable flexible endoscopes and sterile , disposable flexible endoscopes . These differences are important to note when evaluating a facility ’ s infection prevention and control program as well as overall reprocessing processes .
The FDA has strongly advised healthcare facilities to begin using
Reusable Flexible Endoscope
Maintenance required Constant wear and tear Damage frequently occurs
Non-sterile , multi-patient use and risk for cross-contamination when not properly reprocessed
Reprocessing failure potential
Variable performance during procedure depending upon maintenance condition of device
Reprocessing personnel staff and equipment required
Sterile , Disposable Flexible Endoscope
No maintenance required No wear and tear
Sterile , single-patient use eliminates potential for cross-contamination when properly used
No reprocessing failure potential
Consistent performance during procedure for each patient
No reprocessing personnel Ssaff and equipment required
sterile , disposable flexible endoscopes where available to reduce the risk for device-related infections to patients . As more flexible -endoscopes become 510 ( k ) -cleared through the FDA , the use of sterile , single-use devices should become the absolute standard of care to eliminate device-related infections . By eliminating the risky part of the flexible endoscopy procedure , reprocessing the device , the overall infection risk for the patient can be virtually eliminated . Patients expect safe , reliable , and evidence-based care . They don ’ t expect to contract an infection from a device that is being used to provide clinical care to them . Healthcare systems must carefully evaluate medical-device related risks and take all available steps to mitigate and preferably eliminate these risks in the interests of protecting both patients and the healthcare team alike . To learn more about the FDA ’ s work in advancing the safety of medical devices , visit : https :// www . fda . gov / medical-devices / medical-device-safety .
J . Hudson Garrett Jr . is president and CEO of Community Health Associates , LLC . He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine ; is a fellow with the Institute for Healthcare Improvement ; and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America . Garrett is a frequent lecturer globally on patient safety , infectious diseases , and medical device reprocessing and safety . He may be reached at : Hudson . garrett @ chaassociates . com