Have you wanted to start a reprocessing program for devices labeled for single use but faced a barrage of concerns from your physicians and clinical staff? Many of these objections are based on fiction, according to Amy J. Gagliardi, vice president of the supply chain at Westchester, IL-based Regent Surgical Health, which develops and manages surgery center partnerships. Gagliardi spoke on reprocessing at the most recent Ambulatory Surgery Center Association annual meeting.
The usual cost of a reprocessed device is one-half the cost of a new device, she says. You can save between $15,000 and $25,000 per OR, Gagliardi said. In 2013, Regent Surgical Health had $197,000 in device savings and $3,582 in waste savings, she said.
Gagliardi expects Regent to save half a million in 2014. “It’s a no-brainer,” she said. “You’ll save 50% off what you’re currently paying. That’s negotiable; always ask for more.” Regent reuses devices two to three times, with stringent testing.
Three thousand hospitals and 1,500 ambulatory surgery centers are reprocessing, donating, or recycling, Gagliardi said.
“Opened but not used pulse oximeters are a great place to start,” Gagliardi said. When Regent reuses a device, it is documented on the operative records. There is a sticker on the patient chart and preference card.
In its Guideline for Sterilization, the Association of periOperative Registered Nurses (AORN) recommends that devices labeled for single use shouldn’t be reprocessed unless the FDA guidelines for reprocessing them can be met. Most healthcare facilities don’t have the capabilities to meet these requirements, AORN says.
The Food and Drug Administration (FDA) has passed regulations for reprocessing and stated that reprocessed medical devices are to be viewed no differently from those of the original equipment manufacturer (OEM), Gagliardi said.
Gagliardi offered these “fact-or-fiction” statements to help sort out the misinformation about reprocessed devices:
Manufacturers label some medical devices “single use” because these devices are unsafe for more than one use.
Answer: Fiction. The FDA has no labeling requirements regarding the number of times a device can be used, Gagliardi said. The term “single use only” was developed by OEMs for products they determined to be disposable, she said.
Remanufactured medical devices fail more often than original devices, which leads to more patient harm.
Answer: Fiction. Gagliardi says the FDA’s analysis of adverse events related to single-use devices (SUDs) shows that there is no “causative link between a reprocessed SUD and reported patient injury or death.”1 In addition, the Government Accountability Office (GAO), formerly the General Accounting Office, reviewed available information and said there was no indication that SUDs present a greater risk to patients than new devices do, she said. One GAO report said, “The hospital infection control practitioners, risk management executives, and patient safety experts we interviewed told us that careful reprocessing of the types of SUDs that can be properly cleaned and sterilized does not pose an additional risk to patient health.”2 However, the same report said, “It is also clear that some SUDs cannot be safely reprocessed, procedures for safe reprocessing are not always followed, and the limitations of the information available about SUD reprocessing argue for monitoring the practice.”
Only the OEM can safely reprocess a device.
Answer: Fiction. Whoever is reprocessing the device must ensure that the device will be the substantive equivalent of a new device, Gagliardi said. The device re-processors must show documentation to the FDA that their reprocessing processes will provide a safe and effective product. OEMs don’t have to do this, Gagliardi said.
The physician is liable if a reused product fails.
Answer: Fiction. The OEM or re-processor that becomes the OEM bears full responsibility and liability for the safety and efficacy of the device, Gagliardi said. There is no distinction because the devices are equivalent, she said.
Here are some reprocessing tips from Gagliardi:
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Investigate medical device reprocessing (MDR) companies. Not all are alike, she said, so visit their facilities and include your surgical techs, Gagliardi said. If you have staff members who are resistant to reprocessing, have them visit the MDR facility early in the process, she said. Determine if the MDR reprocesses all devices or is selective.
“We had blinders on,” she said. “One company could reprocess half of the products another company could.”
Also find out if the employees are certified. Ask for a copy of their most recent Good Manufacturing Practices (GMP) inspection by the FDA.
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Establish a reprocessing committee named a “re-manufacturing committee.” Include representatives from the OR, materials management, infection control, sterile processing, risk management, and quality improvement. Have your committee in place before any decisions are made, Gagliardi suggested. “Word will get out quickly, so you need to work fast,” she said. Establish monthly meeting to discuss objectives, savings, and issues, and keep minutes, she advised.
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Develop an intensive educational program for surgeons and staff. Take advantage of the MDR’s resources to go into the OR and work with the surgeons and staff.
On the physician preference cards at Regent Surgical Health, the device is listed and the reprocessed device, with an “R” in front, is listed at the reduced cost, sometimes 50%. Physicians circle which one they want to use.
Emphasize safety, Gagliardi said. Require the MDR to provide continual education, she advised. The most important person to educate is the surgical tech, Gagliardi said.
Education, early and often, is a critical step, Gagliardi said. “We thought we educated enough, then found the OEMs undermined the entire process,” she said. The result was that the potential savings for the nine hospitals in the system was reduced from $3.5 million to $500,000 in one year.
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Don’t take an approach of “try it.” It might give a signal that the process is not safe, Gagliardi said.
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Have numerous locations for device pick-ups.
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Make sure shipped containers meet Department of Transportation regulations.
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Notify the MDR if you receive a recall notice from the OEM. If the MDR has a recall, have a system in place for immediate notification, such as an email blast.
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Document quality issues. Save product and packaging if possible. Save the MDR quality assurance report. Keep all reports in a central storage area.
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Keep an updated record of all devices your MDR has reported to the FDA as being re-processed.
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Ensure any new contracts you sign don’t have exclusions for reprocessing.
Regent has been reprocessing since 2008 and still meets resistance. “It’s difficult to undo the damage from sales reps who are unhappy that they will lose business,” Gagliardi said.
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Food and Drug Administration. Single-use devices. Statement of Daniel Schultz, MD, director, Center for Devices and Radiological Health, before the House Committee on Government Reform. Sept. 26, 2006. Accessed at www.fda.gov/newsevents/testimony/ucm110940.htm.
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General Accounting Office. Medical Devices. Reprocessing and Reuse of Devices Labeled Single-Use. June 27, 2000. Accessed at www.gao.gov/assets/110/108509.pdf.
