Tim Merchant, the vice president of sales and reprocessing at MEDISISS, and Jason Wanderse, chief executive officer of MEDISISS, gave a presentation titled "Reprocessing: the Winning Combination." MEDISISS is a device reprocessing company owned by Medline.
The reprocessing industry really took off in the late 1990’s and has grown to become a $400 billon industry. In 2002, the FDA stepped in and shaped the industry into what it is today. "Reprocessing is one the most scrutinized industries in the county," said Mr. Merchant. The three big players in reprocessing are Medline, Stryker and Johnson & Johnson. Each of these companies has had to go through the arduous process of receiving FDA 510(k) clearance to earn approval for reprocessing.
The key to medical device reprocessing is the improvement of profitability without compromising the quality of care. The current healthcare climate has made this goal a high priority for ambulatory surgery centers, as well as all providers. "Reprocessing is one of the top three opportunities to drive cost savings in healthcare today," said Mr. Merchant.
"Reprocessed devices have been found to have fewer defects than that of new devices," said Mr. Merchant.
Device reprocessing represents a significant opportunity for savings in healthcare. "If every surgery center and hospital in the country reprocessed their devices, they could save the healthcare industry $2 billion annually," said Mr. Merchant. Reprocessing currently accounts for the national reduction of 10 million pounds of waste and of the 70 million devices used nationally there has been no reported loss of quality or increase in infection. Ambulatory surgery centers could potentially save $20,000 a year per operating room without compromising any aspect of the standards of care.
"Through reprocessing, surgery centers have the opportunity to save 50 percent of what would normally be spent on original equipment manufacturer devices," said Mr. Merchant.
Surgeons may balk at the idea of performing procedures with reprocessed devices. However, often they are unable to even tell the difference between new and reprocessed devices.
"In form, fit and function reprocessed devices are the same as a new device," said Mr. Merchant.
Surgery centers send devices to a reprocessing company, such as MEDISISS, after a suggested quick 30-second pre-clean. This small step can increase the number of devices that can be returned by 40 percent. The removal of blood and bioburden eliminates a lot of pitting and corrosion caused by these materials.
Then the device is sent to a medical grade facility with stringent quality standards. At MEDISISS, devices enter the facility in bins that are separated by surgery center. Standard procedure calls for no comingling of devices. Surgery centers are notified of the arrival of devices and given an estimated return date. In the decontamination room, each device goes through a number of cleaning processes; each device has discrete cleaning protocols. Each step must be signed off on and validated.
"It is a very tightly controlled process. We document what we have done with each of these devices, who worked on the device, what chemical was used and what machine was used," said Mr. Wandersee.
After each device has gone through the decontamination process, it is dried and sent to the refurbishment area. "In refurbishment we focus on restoring the original functionality of the device and managing surgeon’s perceptions by doing things like resurfacing devices.," said Mr. Wandersee.
After refurbishment, each device is placed under a microscope and screened for any potential risks of reuse. Any device with a potential risk is rejected. Devices then go through the final wash area. Here, anything that may have been introduced to the device in reprocessing facility, such as residuals from cleaning agents or materials we introduced in the refurbishing process, is removed. Prior to packaging, each device is carefully inspected beneath a microscope for a second time.
The final step before shipping is sterilization. "At the end of this process, we are fully liable for these devices," said Mr. Merchant. Though MEDISISS is fully insured, the policy has never been tested due to the scrutiny of the process each device undergoes.
While the majority of reprocessing occurs outside of the surgery center, it is important to remember the process begins at the ASC. "Everyone needs to be committed to the program in order for it to work. Makes sure you properly education people so they are comfortable with the decision the surgery center has made," said Mr. Wandersee.
Click here to learn more about Medline and MEDISISS.
Click here to access a PDF of the webinar.