search.noResults

search.searching

dataCollection.invalidEmail
note.createNoteMessage

search.noResults

search.searching

orderForm.title

orderForm.productCode
orderForm.description
orderForm.quantity
orderForm.itemPrice
orderForm.price
orderForm.totalPrice
orderForm.deliveryDetails.billingAddress
orderForm.deliveryDetails.deliveryAddress
orderForm.noItems
SPECIAL FOCUS


Bobbing and weaving Melinda “Mindy” Benedict, CIC, CFER, Global Senior Manager, Infection Preven- tion, Olympus Corporation of the Americas, acknowledges the appar- ent mixed messaging but urges caution before changing behaviors. “COVID-19 has created an unprecedented need for reprocessing SUDs, such as N95 respirators,” Benedict noted. “The sup-


Melinda Benedict


ply of these protective facemasks has not met the ongoing demand for these essen- tial safety tools for healthcare workers, and emergency use authorization (EUA) was provided by the FDA to reprocess these masks, provided that the reproces- sor conducts cleaning and sterilization/ disinfection of the SUDs in an appropriate manner – per FDA guidelines for decon- taminating respirators.


“Temporary allowances that may have been made to enable the continuation of patient care and meet care demands could be misinterpreted as permanent solutions,” Benedict warned. “The cur- rent EUA is a temporary solution to the pandemic-related problem of personal protective equipment shortages. Single- use devices are engineered and manu- factured to be used one time only. While some single-use devices, like the N95 facemask, are considered low-risk devices, other single-use devices are classifi ed as high-risk as reprocessing these high-risk devices could present a signifi cant ris for infection unless the original equipment manufacturer (OEM) has data supporting that the device can be reprocessed and used multiple times.”


Still, she emphasizes the increased legal liability on part of providers and service companies that carry out reuse practices. “Firms and hospitals that are reprocess-


ing SUDs are considered by the FDA to be manufacturers and as such must comply with all of the following statutory and regulatory requirements: Reprocessors of SUDs should be able to demonstrate: 1. That the device can be adequately cleaned and disinfected or sterilized


2. That the physical characteristics or qual- ity of the device will not be adversely affected by these processes


3. That the device continues to comply with applicable FDA requirements.” But navigating through the winding


and seemingly circuitous justifi cation for reusing certain SUDs during a crisis when


few other options exist leads to frustration and peril. “As a nurse and as an Environment of Care/Infection Prevention Director for many years, there was a strong focus on reusable vs. disposable supplies,” acknowl- edged Janet Pate, JD, MHA, RN, Nurse Consultant and Educator, Ruhof Corp. “For many products, it was obvious that they shouldn’t be reused. From a user’s per- spective, for the products that were permissible to be reused, it was often a


Janet Pate


struggle to educate them that if an item was labeled single-use, under no circumstances should it be reused. This was ongoing education for an extended period of time. “With the development of reprocessing facilities for some of these items it became even more confusing,” Pate admitted. “It was diffi cult to educate everyone on which items could be reprocessed by these facili- ties and why it was acceptable. After all, everyone had been educated that dispos- able/single-use items meant just that, the item should be disposed of after use. With the onset of the pandemic, suddenly it is acceptable to reuse many of these items. Although most people understand the impact of the pandemic regarding the reuse of supplies, in the future the Infec- tion Preventionists and other regulatory experts will now be faced with changing back to the practices before the pandemic. This defi nitely will be challenging, and perhaps research should be performed to evaluate if the change in practices related to certain products should remain even after the pandemic.”


As a veteran healthcare supply chain and sterile processing executive, consultant Jean Sargent knows plenty about the intri- cacies of reuse as she worked with the FDA in 2000 on educating Sterile Processing, Supply Chain and Infec- tion Preventionists about the federal agency’s new policy on reusing SUDs. “It was quite a process


to get people to under- stand the signifi cance of the policy,” said Sargent,


Jean Sargent


Principal, Sargent Healthcare Strategies. “There are many today who do not know it exists. This will create much more con- fusion. We need direction from the FDA, and then manufacturers need to update their instructions-for-use (IFUs) to include reuse of single-use devices. Otherwise,


leaving the choice to each facility may affect the safety of [the patients] on whom the reprocessed product was used. I also now fi rsthand how diffi cult it has been to find PPE that meets the approval of Infection Preventionists, clinicians, human resources, fi nance and supply chain. Still, the pandemic reaction remains an effective reminder of the fundamental tenets behind reuse, product integrity and sterility, according to Stephen Kovach, CFER, Educator Emeritus, Healthmark Industries. “For me, it brings to light what I refer to as ‘The Science of Reprocess- ing,’” he noted. “Staff who work in the medical device reprocessing department


Stephen Kovach


[know] how important of a department we are. We are no longer just the department that ‘cleans utensils.’ We know thousands of medical devices, and we have more than only steam sterilization technology at our fi ngertips.


The pandemic illuminates this context. “[Sterile Processing] staff today under- stand the importance of what they do and the impact they have on patient outcomes,” Kovach said. “This pandemic has shown how vital we are to any facility, not just to prepare something for surgery. When you read the peer-reviewed literature, you will notice that members of the department are part of those papers, so in my view, it has helped change in the C-suite the perception of the people in the basement. They have and will be vital to the facility’s survival. “The shortage has caused all depart-


ments to work together and see how they each dovetail into each other, and with science, they can make changes,” he continued. “It raised each department’s awareness within its facility, making every- body stronger, and then the patient is the winner. So from something sour, we made something sweet.”


Hits and misses Few deny that Supply Chain took a hit when the pandemic caused demand to outpace availability of products and under pressure may have missed opportunities to change processes on the fl y. “The pandemic has brought laser focus on the supply chains,” observed Gregg Agoston, Vice Pres- ident, Business Devel-


Gregg Agoston


opment, SPD Transformation Services, Page 12


hpnonline.com • HEALTHCARE PURCHASING NEWS • February 2021 11


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70