INFECTION PREVENTION Mission Improcessable
Economy, ecology and efficacy demand a combination of resources and contingencies for all by Scott Tomko
F
ueled by a pandemic that wreaked havoc throughout the healthcare supply chain, the debate continues
over using reusable versus disposable medical devices and equipment. Each and every day, countless surgi- cal instruments and medical devices are reprocessed and reused. A Quick Safety Report from the Joint Commission states that because of the costs of physical space, supplies, equipment, and personnel to perform reprocessing and sterilization of reusable devices, some organizations choose to use disposable instruments and devices for critical procedures in some or all areas of their facility. For organizations performing reprocessing, ensuring that those instruments and devices are reus- able – that they are in good condition, and can be cleaned and sterilized following validated manufacturer’s instructions – is critical to patient safety. The FDA requires that reprocessing
instructions are part of labeling, and in 2015 published guidance to ensure that the appropriate level of reprocessing is addressed based on the intended use of the device. Although reprocessing has become an
essential part of hospital operations, its maintenance and effective operations hinge on staff and resources that must be adequately trained and provided for. Human error is undoubtedly one of the main hurdles in assuring that proper dis- infection/sterilization has been achieved.
The category is clean Reusable devices are equipped with a set of instructions that directs the facility how to clean and sterilize them for another use; disposable devices do not come with such instructions and are supposed to be discarded after a single use.
“The distinction is useful and import- ant,” states Lars Thording, VP, Marketing & Public Affairs for Innovative Health
LLC. “Devices that are labeled “single-use” are devices that cannot safely be re-used, because the devices cannot be safely cleaned or because their functionality is compromised after a single use. Devices that are labeled “re-usable” are devices that can be cleaned easily and do not lose functionality after one use. It is important to note that re-usable devices also come with Instructions For Use (IFUs) that limit reusability to a certain number of uses, after which the manufacturer
Lars Thording
cannot determine that reuse is safe or effec- tive. The categorization is very sound.” However, according to Thording, there are three practical problems with this categorization that providers rou- tinely experience: 1. Single-use devices are often very expen- sive and very well designed, leaving the provider wondering why they have to be thrown away after a single use. During the pandemic, this problem came up close when nurses had to wear yesterday’s mask or gloves in order to serve their patient population. In cardi- ology labs, single-use devices that cost $2,000-4,000 are routinely thrown away after a single use. This creates massive financial problems for the service line and the hospital, limits their ability to provide for patients, and threatens service line financial viability at the hospital. Single-use is not financially viable for the hospital, and at critical times, the over-reliance on single-use devices limits the ability of the provider to provide proper care.
2. Hospital operations are typically not designed to have their Sterile Processing Department (SPD) treat each device per its IFU. SPD departments typically treat all re-usable devices the same way: They get wiped down, and they get cooked in
20 February 2023 • HEALTHCARE PURCHASING NEWS •
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the sterilization unit. Consequently, how many times the device has been reused is neither recorded nor responded to: Devices are used until they fail. And devices are not tested prior to reuse to determine if they will fail with the patient on the table, raising patient safety concerns as well as opera- tional flags.
3. The single-use label is a luring concept to the manufacturer that shifts the eco- nomic burden downstream. In the 1990s and 2000s, U.S. medical device manufac- turers routinely shifted labeling from reusable to single-use, as they saw prof- its drop due to hospital device re-use. This often happened to the label with- out substantial changes to the IFU. This continues today. A single-use device is valuable to the manufacturer, because the more the hospital throws away, the more they have to buy more devices. Meanwhile, the more the hospital throws away, the bigger the environmental impact, the higher the spending, and the more vulnerable the provider is to supply chain shortages. These are three consequences US hospitals cannot ignore today, and therefore, the single-use label, as important as it is to patient safety, has also become a contentious issue. However, the prevalence of single-use device usage in healthcare has come under much criticism of late, as the current polit- ical climate focuses on the environmental footprint of healthcare as well as the eco- nomic consequences of the “single-use” label and the supply chain vulnerabil- ity associated with the reliance of a sin- gle supplier. This has resulted in the emergence of “third parties which have been approved by the FDA to reprocess specific medical devices labeled for single use and must abide by strict rules that may be even more strict than those applicable to the original manufacturers of the SUD.”
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