“Advances in material sciences and biomedical engineering have enabled development of reliable and affordable single-use medical devices that are clinically equivalent to their reusable counterparts,” insisted Jason Cronwall, Senior Market Manager, Ambu Inc., Columbia, MD. “When deciding between reusable versus single-use devices, healthcare organizations must Consider the total cost of ownership and use. That assessment should include initial acquisition, ongoing repairs/servicing, reprocessing/environmental impact, hospital/provider efficiency and patient safety/outcomes.
Pros: Single-use devices allow healthcare organizations to better manage direct and indirect costs. Single-use devices eliminate costs associated with repairs/preventative maintenance as well as facility and staffing requirements associated with device reprocessing. Single-use devices can improve clinician workflow by always being available and ready for use. They also can reduce the environmental footprint by eliminating chemicals and Consumables waste produced during reprocessing. Finally, single-use and sterile devices eliminate the risk of cross-contamination and infection related to inadequate reprocessing, leading to improved patient outcomes.
Cons: Implementing single-use devices often requires reallocation of the healthcare organization’s capital and operational budgets, involving a team approach to realize savings associated with transitioning from reusable devices. That transition also involves clinicians and support staff who must also be trained and in-serviced to effectively use single-use versions of existing device technology.
“There can be many reasons to choose a single use device,” noted Seth Hendee, CRCST, CIS, CHL, CER, CFER, Clinical Education Coordinator, SPD, Heathmark Industries, Fraser, MI. “Two that stand out are when reprocessing or repair costs are high or if improper reprocessing could lead to regulatory issues as in the case of endoscopes.”
Pro: A new device is used each time. By going single-use, the chances of receiving a damaged and/or incorrectly reprocessed piece of equipment are all but eliminated.
Pro: Easier compliance. Utilizing a single use device eliminates the need for documented processing competencies on that device. Competencies on how to properly use them and dispose of the device would still be required but not processing.
Con: Still a new concept. Single-use items have been utilized in healthcare for years but now some traditionally reusable instruments, like endoscopes, are being designed and manufactured to be single-use. These instruments are still new to the market and their impact is not fully understood yet.
Healthcare organizations may have a choice of who maintains and repairs its instruments and equipment, according to Hendee, but the choice to perform preventive maintenance and repairs is not optional. Consequently, facilities may find having a service agreement with the OEM for some pieces and an independent organization for others to be the optimal strategy, he added.
“We think single-use devices have a very useful role when they help improve patient care and outcomes or when they help lower the total cost of care,” said Melissa Kubach, Educator, Mobile Instrument Service & Repair Inc., Bellefontaine, OH.
Cost is but one element.
“The key to assessing single-use devices is to look at the underlying clinical activity and to forecast Consumption for both single-use and reusable devices,” Kubach continued. “Once you know the demand side, costing out the single-use devices is easy. But pricing out reusable devices requires deeper thought. Most of the costs for reusable devices are soft dollars in that they cannot be eliminated if the device itself is eliminated. For example, if scissors are no longer reprocessed, how many fewer SPD people will you need? If you answered none, you are right. So you have to look at groups of single-use devices and how that can reduce workloads to allow for real staff efficiency.”
Reprocessing is another.
“A better approach is to ask, ‘How can we reduce the number of trays we handle?’ and then focus on how single-use devices can contribute to the reduction,” she said. “As for patient care, there’s a clear role for single-use devices when the logistics of reprocessing add costs to the reusable device. For example, the infection control risk to pre-clean, transport, reprocess and return reusable devices to remote clinics and offices is often much higher than those for the same device if it is used in a hospital setting. This represents a real chance to reduce potential for contamination and simplify and streamline internal operations.”
Pros:
Single-use devices, in the correct situations, can provide a great benefit. If the device is rarely used, but necessary to have available, it may be prudent to purchase a minimum quantity of disposables versus budgeting equipment purchase capital, repairing and training reprocessing staff.
There is less associated cross-patient infection risk for single-use items. Choosing a disposable device for a high-risk item may be justified.
When overall cost for a high-use item can result in a true verifiable cost savings for the facility.
Cons:
Loss or lack of technological equivalence is always a concern when Considering a disposable version. Disposable by its very nature is meant to be a “low-cost” replacement that does not usually translate to highly technical equipment with advanced technical applications.
Overall potential cost increases may be associated with disposable devices depending on usage and price point. While many soft costs can be eliminated, each facility would have to look closely at the math.
Reduction of product quality and performance, such as image or material quality could greatly impact physician performance and patient outcomes.
There should be some attention paid to the increased load added to the waste system whether the item is incinerated or disposed as standard trash.
A facility will have to weigh convenience versus costs, including environmental and reliability, according to Christian Berling, Vice President of Sales and Marketing, Heine USA, Dover, NH.
Pros:
Having disposable equipment for cases involving highly infectious disease patients can oftentimes alleviate stress for a facility.
It also depends on the volume usage of the product. If a product will be seldom used, disposable products might make the most sense from a financial standpoint, and time involved in caring for and maintaining the equipment.
Cons:
Disposable products are never going to be an environmentally friendly or cost-Conscious solution for a hospital.
Additionally, they often are accompanied by unreliable performance. If a product is designed to be just used once, it will not be made with the highest quality materials available.
Philip Doyle, Executive Director of Marketing, Core GI & Service, MSG Endoscopy, Olympus Corporation of the Americas, questions whether single-use device options, particularly for high-end and more complicated procedures live up to the performance expectations of traditional reusable devices when quality outcomes are affected.
Pros:
“Certain single-use devices, such as biopsy forceps, have become widely accepted because their convenience and functionality are appropriate for a relatively simple task. On the other end of the spectrum are devices like endoscopes, where the disposable equipment’s high cost and potential sacrifices in functionality may pose a significant negative performance tradeoff, compared to affordable, high-performance reusable devices.
Cons:
For procedures such as ERCP and colonoscopy, highly sophisticated endoscopes are required, according to Doyle. “A design prioritizing disposability may sacrifice performance, cost and reliability,” he noted. “Olympus endoscopes offer precise, robust handling and clinically proven visualization, including proprietary technologies like Responsive Insertion Technology and Narrow Band Imaging (NBI). In these areas, there are significant gaps in single-use endoscopes at the current technical level.
“There is a lot riding on a successful endoscopy procedure,” Doyle added. “Having the best tools could mean saving a patient’s life, from helping patients detect signs of cancer to finding and treating it successfully when avoidance is not possible. Reusable scopes are intended to provide the appropriate tool for a wide breadth of patient populations, sizes, anatomies and other unforeseen variables that require tried and true performance.”
