Two experts recently shared information about reprocessing surgery center equipment: Scott Jackson, executive director of surgical solutions for Henry Schein in Greenville, SC, and Ken Diebner, vice president of sales, Provision Device Reprocessing Solutions, Inc. in Bend, OR. (Editor’s Note: This transcript has been lightly edited for length and clarity.)
Same-Day Surgery: How has the COVID-19 pandemic affected the way surgery centers reprocess equipment?
Jackson: Surgery centers are continuing to adopt reprocessing initiatives for a variety of reasons. The increase in device-intensive procedures in surgery centers, such as orthopedics, spine, and cardiac, has elevated the demand for single-use device reprocessing (SUD) because of its cost-effectiveness for these devices. Orthopedic growth is concentrated in an outpatient setting, and cardiac procedures are continuing to shift from office-based laboratories to ambulatory surgery center (ASC) settings.
Also, patient care delivery methods continue to shift to convenient settings. As centers are navigating the post-COVID-19 landscape, SUD reprocessing can help effectively manage the evolving caseload.
Diebner: The most significant trend within these surgery centers is the desire to reprocess orthopedic devices. There are three main reasons why orthopedic devices are reprocessed.
First, orthopedic procedures usually are the largest volume procedure within an ASC. Second, there are more SUDs used in orthopedic procedures than in any other procedure. Third, the SUDs used in orthopedic cases are typically among the most expensive of SUDs used.
COVID-19 also has had a tremendous impact on surgery centers, amplifying the desire to adopt a reprocessing initiative. The drop in Medicare reimbursement, along with additional safety measures needed for patients and staff, has shined a light on the benefits of engaging in a reprocessing initiative.
During the height of the pandemic, many hospitals and surgery centers across the country canceled or delayed surgical procedures, resulting in a significant loss of revenue and profit for surgery centers.
As the market began to reopen in May and June 2020, surgery centers began investing in additional personal protective equipment (PPE) measures and practices to protect their staff and patients, in turn increasing operating costs.
Then, at the start of 2021, the provider community was hit with reductions in Medicare reimbursement for surgeon fees and procedural reimbursement. Each of these aspects weakened the financial viability of surgery centers, causing these centers to find ways to offset the loss in profitability.
SUD reprocessing often is recognized as the single most significant source of ongoing savings within a surgery center.
Today, facilities that engage in a reprocessing initiative are expanding the scope of devices they collect, and facilities that never implemented a reprocessing program are now exploring how.
SDS: On reprocessing, how do surgery centers excel, and where is there a need for improvement?
Jackson: The surgery centers that tend to gain the most from SUD reprocessing are those that have surgeon and staff buy-in. Implementing SUD reprocessing requires a degree of change management, which needs to be driven by the staff and surgeons. Once this buy-in occurs, then the savings can begin to accelerate.
Diebner: Surgery centers are getting it right by simply engaging in a reprocessing program. But to reap the maximum benefits, surgery centers need to engage across the full spectrum of devices that can be reprocessed. Many surgery centers simply check the box that they are reprocessing, but sometimes fail to manage the program for maximum savings.
For example, a facility may reprocess their arthroscopic shavers and abraders, as well as their arthroscopic trocars and cannulas, but overlook the significant savings available from collecting and reprocessing devices such as the bipolar sealers, ablation wands, carpal tunnel release blades, saw blades, drill bits, burs, rasps, reamers, suture lassos, guide wires, and guide pins.
SDS: Are there problems with manufacturer’s reprocessing instructions that surgery center leaders should address?
Diebner: All surgical facilities reprocess reusable devices within their centers and must follow manufacturer guidelines for reprocessing these types of devices. However, SUD reprocessing is performed by third-party FDA-licensed, FDA-cleared companies.
Surgery centers collect SUDs, cleanse the devices to remove any blood or bioburden, and send the devices to the reprocessing company. The reprocessing company refurbishes the devices and brings them back to a condition that is substantially equivalent to that of new devices.
Misunderstandings surrounding the use of reprocessed SUDs usually surround the misconception that reprocessed devices are not as good as the original device. In fact, the exact opposite is true. In a study by Banner Health in Arizona, it was found that new devices fail as much as five times more frequently than reprocessed devices.1
SUD reprocessing companies go to great lengths to overcome this misconception. First, the FDA requires proof that the reprocessing company can provide a product that is substantially equivalent to that of a new device in the areas of form, fit, and function. Second, the reprocessing company must be licensed by the FDA. Third, the reprocessing company must secure premarket clearance from the FDA to market their devices in a process known as a 510(k) submission, just as the original manufacturer does.
SUD reprocessing involves processes that go far beyond just decontaminating and cleaning used devices. Each device is completely refurbished to ensure that it will function like that of a new device. Each device also is inspected under a microscope from the distal tip at one end to the proximal tip at the other end to ensure that there are no microscopic flaws in the device that may cause the device to malfunction. Each device is tested to ensure that it performs as expected. In comparison, when an original equipment manufacturer produces devices, they may have production runs of 10,000 units or more. Since it is impossible to check every device, their quality team selects random samples from the production run. If those samples pass their quality parameters, then the entire production run is cleared. Unfortunately, this process misses certain devices that should not have been cleared and, thus, accounts for the reason why new devices fail as much as five times more frequently than that of reprocessed devices.
The second misconception is that the use of reprocessed devices may cause a higher rate of postoperative infection than that of new devices. This is usually driven by fear, that if something were to go wrong or a patient were to contract a postoperative infection, the surgery center would be at risk.
The reality is that reprocessed devices are sterilized in the same way that new devices are sterilized. Devices from original equipment manufacturers and reprocessing companies [are sterilized with] ethylene oxide gas. We each use what is referred to as the standard overkill method, meaning that we expose devices to ethylene oxide gas for twice the amount of time that it takes to achieve a sterility assurance level (SAL) of 10-6. This means that there is only one in 1 million chance of a spore surviving ethylene oxide sterilization. It is the highest level of sterilization that can be achieved on Earth. One can only get beyond 10-6 SAL if they sterilized products in a vacuum.2
SDS: If you could give surgery center leaders one important piece of reprocessing advice, what would it be?
Jackson: As device-intensive procedures become more prevalent in ASCs, it is important that ASC leaders determine how they will manage the escalating cost of devices. SUD reprocessing should play a role in an ASC’s strategy in helping control these device costs. There are many benefits, including cost containment and environmental sustainability.
Diebner: It is important that surgery center leaders and reprocessing staff obtain support from the surgeon owners and administrators in their centers. Surgeon owners and administrators can, and should, help drive this initiative. Surgery center leaders must explain the reprocessing initiative to their staff, detailing the benefits that it will produce for the center.
For example, they should explain to their staff that the center will save a significant amount of money. These cost savings will allow the facility to enhance patient care, purchase unbudgeted capital equipment, or pay for staff salaries. Surgery center leaders also should educate their staff on the full scope of devices that can be reprocessed, monitor the progress of the program, and coach their teams on what needs to change to maximize savings. If this comes from the top down to the OR techs, a reprocessing initiative will be extremely successful.
- Loftus TJ. A comparison of the defect rate between original equipment manufacturer and reprocessed single-use bipolar and ultrasound diathermy devices. J Med Devices 2015;9:044501.
- von Woedtke T, Kramer A. The limits of sterility assurance. GMS Krankenhhyg Interdiszip 2008;3:Doc19.