SPECIAL FOCUS from the COVID-19 pandemic subsides,”
he insisted. “Some will make the argument that if it was acceptable during the pan- demic, it proves these items are capable of multiple uses. However, just like approval of novel drug therapies under FDA’s Emergency Use Authorization, this short- term approval does not involve the same level of scrutiny as an official approval or registration.
“Formal approval for reusing items designed to be disposable would require new standard methods and specifications to first be developed and validated,” he continued. “Products would have to be tested to these new standards and demonstrate sufficient performance after reprocessing. Novel reprocessing methods might have to be developed that can effec- tively decontaminate these items without causing damage to the filtration, barrier or cleaning properties for items such as respi- rators, gowns and wipes, respectively. All this could create a slippery slope where many products are considered reusable after processing. Some can withstand a few cycles whereas others can be reused for more cycles. How will the number of use/ processing cycles effectively be tracked and documented for each type of item?”
Jumping through hoops Melinda “Mindy” Benedict, MS, CIC, CFER, Global Senior Manager, Infection Prevention, Olympus Corporation of the Americas, traces the reprocessing of SUDs back to the 1970s, and even though the FD regulated these activities by official policy nearly three decades later, compli- ance among healthcare facilities varies. Further, the FDA allows the reprocessing and reuse of certain SUDs, but only when that task is performed by an authorized company or service provider, she added. This means that hospital sterile process- ing departments would be classified as remanufacturers of the devices. The FDA wisely remains concerned about the public health risk presented by a reprocessed SUD, according to Benedict, who refers to and cites from the FDA policy. “Some devices, which are low-risk when used only one time, may present an increased risk to the patient upon repro- cessing,” Benedict noted. “Other SUDs are low ris when used for the first time and remain low risk after reprocessing, provided that the reprocessor conducts cleaning and sterilization/disinfection of the SUD in an appropriate manner. Other SUDs, however, cannot be reprocessed safely and should not be reprocessed and reused under any circumstances.”
Establishing a course of action “The long-term public health consequences of reprocessing single-use devices will be determined through process audits, identification of hospital-acuired infec- tions and monitoring the efficacy of SDs that have undergone multiple episodes of reprocessing,” she said. “At present low-risk devices such as N95 respirators are being successfully reprocessed during this pandemic. However, it is important for anyone considering reprocessing a single- use device to know which devices can and cannot be safely reprocessed and who should be doing the reprocessing. Certain SUDs cannot withstand the same material stress during cleaning, disinfection and sterilization.”
Just because a policy door may be
ajar doesn’t necessarily mean it should be kicked open in desperation in the future, according to Janet Pate, JD, MHA, RN, Nurse Consultant and Educator, Ruhof Corp. “Although exceptions are made during a pandemic to assist with supply shortages and for Emergency Use Authorization, it should not be forgotten why these stringent processes are in place,” Pate indicated. “The approval process is to ensure that adequate research has been conducted to allow the use or reuse of the product in a safe man- ner. It gives adequate time for the discovery of unforeseen problems/concerns with the new product or process to be revealed that otherwise might not be immediately obvi- ous. There needs to be a balance of critical need and safety for products and medica- tions that are released for use.
“In the future, it may be difficult to convince the public that it is in every- one’s best interest that the long process of research and development is necessary,” she continued. “This may be debated especially if there were no adverse reac- tions or problems during the pandemic. The FDA and manufacturers may be encouraged to shorten the time currently required for manufacturing medications and products, and the actual time they are released. Perhaps the pandemic will enhance the production and approval of medications and supplies if it can be done in a safe, reasonable manner and delete the significant wait time between development and implementation. If this is done in a safe, reasonable method, it could benefit everyone in the future.”
Jean Sargent, Principal, Sargent Health-
care Strategies, and a former hospital sup- ply chain and sterile processing executive, dismisses the idea that Sterile Processing and Distribution (SPD) departments are as ualified to be manufacturers as the device
16 February 2021 • HEALTHCARE PURCHASING NEWS •
hpnonline.com
manufacturers themselves, which is how they would be classified and considered under FDA policy.
“In the end, sterile processing is not a
manufacturer and must have IFUs that state specifically how to complete the pro- cess,” Sargent said. “This must come from the manufacturers that have to complete testing to ensure their IFUs are providing appropriate direction for safe use of the devices. This is not something they have at hand and must develop.”
Like Sargent, Stephen Kovach, CFER, Educator Emeritus, Healthmark Industries, remembers the battle over reuse of SUDs and working with the FDA to address the issue some 20 years ago. “Unfortunately, the shortage of many products has shown how dependent we have become on certain supplies from outside our border for medical facilities to give the care they need regardless of a pandemic,” Kovach noted. “This has forced us to be creative, to work together and to use science to find solutions. If one reads the various studies done on this subject, they are based on science, which is the dif- ference. Before, facilities were reprocessing single-use items with not much data or information behind them.
“Short term, it helps us out while we get
the supply chain for various products,” he continued. “Where it goes from there is anybody’s guess. But the future we can see is unlimited because this pandemic has shown we can solve any issue, even ones that we were told we should not do – such as reprocessing single-use devices – but with teamwork and science behind us.”
Turning point If anything, the pandemic has brought healthcare providers and suppliers to an inflection point regarding supplies and supply chains, insists Gregg Agoston, Vice President, Business Development, SPD Transformation Services, SpecialtyCare. “For supplies, we know that reusable
items that can be safely reprocessed are more economical and environmentally friendly in most cases,” he indicated. “Disposable items offer the convenience of use and provide a ‘feeling’ of greater safety because the item is new. Evidence of our society’s reliance on disposable items is [shown] by the number and size of our landfills. “Sterile Processing departments across
the country process millions of reusable instruments and clean thousands of pieces of durable medical equipment daily,” Agoston continued. “When reprocessed correctly following the manufacturer’s guidelines, reprocessing is safe and effec-
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