SPECIAL FOCUS
2. “Disposable items have a place, but if there is a safe and effective reusable device, this should be preferred or at least held in reserve to hedge against shortages,” he noted. “Envi- ronmentally, reusable devices tend to have a much lower impact vs. disposable supplies. Think of all the single-use water bottles that now litter the earth.
3. “The biggest challenge that the pandemic created for supply chains is how they balance carrying inventory to avoid shortages versus ‘just-in-time inventory management systems’ that rely on matching inventory to demand,” he indicated. Significant spies in demand caused by a pandemic or other catastrophe are not fully accounted for. Without dependable manufacturing capabilities and logistics, there is great risk of future shortages.
4. “The opportunity for industry is in the creation of local manufacturing capability for medical devices, supplies and pharmaceuticals and in the development of reusable supplies that could be used in place of disposable items,” he concluded. HPN
For more information visit the following links:
• Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Autho- rizations Revising Which Types of Respirators Can Be Decontaminated for Reuse | FDA
https://www.fda.gov/news-events/press-announcements/ coronavirus-covid-19-update-fda-reissues-emergency-use-authorizations-revising- which-types
• Investigating Decontamination and Reuse of Respirators in Public Health Emergencies | FDA
https://www.fda.gov/emergency-preparedness-and- response/mcm-regulatory-science/investigating-decontamination-and-reuse- respirators-public-health-emergencies
• FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic | FDA
https://www.fda.gov/medical-devices/personal-protective- equipment-infection-control/faqs-shortages-surgical-masks-and-gowns-during- covid-19-pandemic
• Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers | FDA
https://www.fda.gov/medical-devices/letters-health-care-pro- viders/surgical-mask-and-gown-conservation-strategies-letter-health-care-providers
• Questions About Personal Protective Equipment (PPE) | FDA https://
www.fda.gov/medical-devices/personal-protective-equipment-infection-control/ questions-about-personal-protective-equipment-ppe
Experts urge healthcare to plan now
for next pandemic, crisis Reusing single-use devices draws concerns amid creativity by Rick Dana Barlow
A
s the COVID-19 pandemic depleted storeroom shelves to the point that manufacturing scrambled to catch up to demand, the Food and Drug Administration (FDA)
granted “Emergency Use Authorization” for certain products to solve short-term supply problems and the federal agency granted a limited green light to reusing certain single-use products, such as N95 respirators.
When it comes to the oft controversial issue of reusing single- use devices (SUDs), at best the FDA can point to its policy on the practice put in place in 2000 – two decades ago. At worst, however, the agency’s leaving the door cracked open may demonstrate the need for some fleibility during a crisis nearly spinning out of control, but it also leaves any hard line open to interpretation long-term once the crisis abates. perts argue the providers and suppliers perhaps should be equally confused and concerned.
K. Mark Wiencek, Ph.D., Lead Microbiologist, Contec Inc., acknowledges that the ongoing tizzy primarily focuses on the reuse of certain personal protective equipment (PPE) designed to be disposable, but does that lead to more harm than not? “While any measure that can help reduce the risks to short-
term issues of protecting healthcare workers and patients should be eplored, there are several concerns if these measures were adopted longer term,” Wiencek told Healthcare Purchasing News.
Disposable items that include tetilefabric components are designed to meet the requirements of protection through single- or short-term use while minimizing durability to reduce cost. They are not designed or constructed to withstand reprocessing. “Some studies may have been able to demonstrate that certain items can be cleaned and decontaminated without destroying the minimum filtration, barrier or cleaning properties, but if all disposables were forced to meet the stringent requirements for products that are designed to be reusable, the disposables would no longer be affordable, he continued. Cleaning tetiles presents its own set of challenges as the products that provide superior performance contain microfiber. The delicate microfibers are ecellent at grabbing and holding onto particles but mae it difficult to effectively remove the particles during reprocessing without damaging the fibers. This becomes an acute issue in the cases where the products are contaminated with pathogens and must be re-laundered at high temperatures or with bleach to effectively decontaminate the products before returning to use.” Even in the face of future crises and pandemics in 2022 and beyond, Wiencek questions whether the FDA should update its policies to enable limited reuse of SUDs to relieve the pressure from pent-up demand and lackluster supply. Caution is advised if facilities or regulatory agencies rela their guidance on re-using single-use items after the emergency
14 February 2021 • HEALTHCARE PURCHASING NEWS •
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