Your mission, should you choose to accept it, is to figure out a strategy in which we can ensure that our hospital is functioning at optimal levels with shelves that are full of clean and ready-to-use medical devices.
To reuse or to dispose is the question. Do you have the best solution?
Fueled 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 surgical 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 reusable – 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 disinfection/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 important,” 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 cannot determine that reuse is safe or effective. The categorization is very sound.”
However, according to Thording, there are three practical problems with this categorization that providers routinely experience:
1. Single-use devices are often very expensive 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 cardiology 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 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 operational flags.
3. The single-use label is a luring concept to the manufacturer that shifts the economic burden downstream. In the 1990s and 2000s, U.S. medical device manufacturers routinely shifted labeling from reusable to single-use, as they saw profits drop due to hospital device re-use. This often happened to the label without 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 political climate focuses on the environmental footprint of healthcare as well as the economic consequences of the “single-use” label and the supply chain vulnerability associated with the reliance of a single 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.”
According to Thording, “the single-use device reprocessing industry is comprised of highly sophisticated medical device re-use companies that have FDA clearance to reprocess single-use devices for hospitals. With this, a third category has emerged alongside reusables and disposables; the single-use reprocessed device. Hundreds of medical devices, from OR devices to patient care devices and cardiology devices have received clearance to be reprocessed (these are “single-use” labeled devices that can cost thousands of dollars). They have been cleared by FDA to be reprocessed and sold to hospitals because their functionality and patient safety characteristics are similar to a new device.”
Pandemic to Post-pandemic
The impact of COVID-19 on the healthcare supply chain caused an increased focus on the reusable versus disposable debate, as hospitals and facilities were soon scrambling with the ways and means to have all the necessary supplies available.
“In many ways, the pandemic changed the single-use mindset in US healthcare,” states Thording. “Product shortages emerged (and some of these continue today), that have made supply chain and other hospital staff question the extensive use of disposable devices. The lesson learned from the pandemic is that providers need to ask manufacturers to stop focusing on designing products for single use and start developing products that can be reprocessed and reused. Today, the trend is going in the opposite direction, which is not sustainable, neither from an environmental standpoint, from a patient care standpoint, or from a cost standpoint.”
In September of last year, the Agency for Healthcare Research & Quality came to the same conclusion, stating that “Reliance on single-use disposable medical supplies and devices not only leaves health systems vulnerable to supply chain disruptions, as seen with the COVID-19 pandemic, but they are frequently cited as containing higher life cycle emissions per use compared with equivalent application of reusable alternatives. Healthcare organizations should strongly encourage and facilitate resource stewardship.”
Now that we appear to be entering a post-pandemic era, strategies and tactics are continuing to evolve in favor of reprocessing devices.
According to Thording, “we still see supply shortages really challenging hospitals, to the point where at times, it is hard for them to conduct important procedures because key devices are not available. As a regulated single-use device reprocessing company, we often get calls from hospitals asking us to send a reprocessed device, because, ‘we either use a reprocessed device, or I have to go tell the doctor that we have to cancel the procedure.’ Reprocessing provides a means for hospitals to find a stop-gap solution in supply shortage situations, but more importantly, the re-use of devices simply increases supply chain resilience, which impacts not only physician satisfaction but also patient care quality. Many of our hospital partners are realizing this and signing up for more extensive reprocessing programs.
Not all devices can be reprocessed and reused. Some are simply too technically complex, fragile, or physically/mechanically impossible to clean. Some devices should be disposable. The point is this: Manufacturers have, over the past decades, focused on making more and more devices disposable (or single-use), and this trend needs to be reversed. Over-reliance on disposable devices creates great vulnerabilities, increases environmental harm, and they simply cost too much. While manufacturers change their strategies, single-use device reprocessing provides a safe, regulated solution for hospitals when it comes to certain types of devices. Reprocessing has become a very advanced practice, and even very delicate devices can often be reprocessed.”
A steady balance
Maintaining an appropriate and effective balance in the types of medical devices, whether reusable or disposable, is proving to be a difficult one to achieve and maintain.
According to Marie H. Wilson, MSN, RN, CIC, Infection Preventionist, Infection Preventionist and Chair of APIC’s Communications Committee, “the pandemic has emphasized the need for balance between single-use and reusable items in healthcare. While organizations may prefer single-use products because of the decreased risk of transmission due to reprocessing errors, this risk needs to be balanced with the risk of the product not being available. We’re having to produce tiered plans to ensure supply stocks to continue care, requiring nimble purchasing departments and training resources when a product shift occurs.”
In order to develop strategies and tactics for properly using reusables and single-use-only products, Wilson added that it is vital to have regular practices and methods that enable smooth processing across an entire facility.
“Ensure there is a routine process for product evaluation by key stakeholders in the organization, including an Infection Preventionist,” Wilson continued. “These don’t have to laborious meetings, as I’ve seen them successfully managed via a form sent through email.
“Additionally, if at all possible, limit the ability for new (and potentially unapproved) products from entering the healthcare setting. Ensure staff have at least an awareness that an approval process exists.
“Finally, one of the most valuable lessons out of the pandemic is the development of robust tiered contingency plans ready to be deployed at a moment’s notice. Consider drafting a list of products required to continue providing care and explore possible alternatives so key stakeholders may evaluate/approve prior to shortages. Theoretically, this allows for quick pivots in purchasing to secure supplies in times of shortages. We’re also seeing a shift/inclination to invest more in reusable items (for example, laundered gowns for personal protective equipment) where appropriate.”
The bottom line
Cost-effectiveness is the primary issue that hospitals and healthcare facilities focus on in determining whether or not to use disposable or reusable medical devices.
In addition to medical gowns and PPE, scalpels are one of the more frequently used items that are offered as reusable as well as single-use equipment.
Some of the pros of reusable scalpels include the ability to sterilize them after each use which provides cost-effective benefits. However, this cost-effectiveness relies upon proper autoclavability. On the other hand, disposable scalpels ensure bacteria is not transmitted due to their single use. Although, cost is more of an issue with disposable scalpels because they have to keep being purchased.
All things considered, it is clear that there is still plenty of space for both reusable and disposable devices in the healthcare industry, and it is an issue that deserves strict attention to assure that the best option is always taken.
Scott Tomko | Managing Editor
Scott Tomko was previously Managing Editor for Healthcare Purchasing News.
