What do compression sleeves, orthopedic drill bits and electrophysiology catheters have in common? All are eligible for single-use medical device (SUD) reprocessing—a practice more and more hospitals are adopting to save money and reduce their carbon footprint.
About 3,000 hospitals nationwide reprocess SUDs which, by law, must either be discarded after use on a single patient, or sent to a reprocessor registered with the FDA, said Dan Vukelich, president of the Association of Medical Device Reprocessors (AMDR), a trade group.
“The volume of [reprocessing] business from hospitals has definitely increased since 2000,” Mr. Vukelich said. “If hospitals reprocessed all of the 2%-5% of the SUDs cleared by FDA for that purpose, they would realize $1 billion a year in savings.”
Catholic Healthcare West (CHW), a 41-hospital chain based in San Francisco, credits the practice with reducing more than 126,000 pounds of environmental waste and saving the company $4.2 million in its fiscal year 2008. Ultrasonic scalpels, compression sleeves and cardiovascular items are just some of the devices that CHW reprocesses, said Denise Robson, CHW's administrator of surgical services and supply management. (See Table.)
The environmental and financial advantages of reprocessing SUDs make it an attractive option for hospitals—but the practice also requires commitment, planning and staff buy-in to make it work, experts said.
Addressing patient safety
One of the biggest sources of resistance to the idea of reprocessing SUDs is patient safety concerns, experts agreed. It's also one of the reasons that the Advanced Medical Technology Association (AdvaMed), a trade group that represents device makers, pushed for legislation to set standards for reusing SUDs—and got it, in the 2002 Medical Device User Fee and Modernization Act.
The Act states that reprocessors must prove to FDA that the devices they reprocess are clean, sterile and functional for a designated number of reuses. They must also obtain FDA clearance to reprocess devices on a case-by-case basis, Mr. Vukelich said.
The CDC has not been asked to investigate any disease outbreaks associated with reuse of single-use items recently, said CDC medical epidemiologist Arjuan Srinivasan, MD. While it has investigated several infectious disease outbreaks associated with syringes, needles and misuse of single-use vials, these didn't involve legitimately reprocessed SUDs, he said.
Still, some hospitals refuse to use reprocessed SUDs. The Department of Veterans Affairs prohibits their use in all its healthcare facilities, as does Sibley Memorial Hospital in Washington D.C.
“The safest approach for patients and the hospital is to use SUDS once and discard them,” said Sibley spokeswoman Sheihla Roy. A 2008 Government Accountability Office report on reprocessed SUDs said the devices don't appear to pose an increased health risk, and that FDA has increased its oversight of the devices since 2000. But the report also said there was a lack of existing FDA data and other studies to “draw a definitive conclusion” about how reprocessed SUDs stack up safety-wise against similar new devices.
In talking about safety, reprocessors stress the rigor of the cleaning and sterilization methods for reprocessed devices. Reprocessing company Ascent Healthcare Solutions of Phoenix said its cleaning and sterilization methods are based on FDA-mandated validation studies. During validations, Ascent inoculates devices with a known soil and quantity of microorganisms, then tests and develops cleaning processes to see if they can be removed, said Arthur Goodrich, a spokesman for the organization.
“Using accelerated aging techniques, the lab basically ‘bakes' the inoculants on the device,” he said, and then uses these “worst case” devices to develop and test different cleaning processes which are far more challenging than any found in an actual clinical setting. “Knowing the worst-case contamination and soil level ahead of time allows us to accurately determine if the device can be cleaned.”
Before the FDA oversight of device reprocessing, the healthcare industry didn't really have a standard for “clean instruments”—whether new or used—beyond saying that the device didn't appear visibly dirty, he added.
“With the FDA now requiring a reprocessor to obtain 510k clearance for any device it's going to reprocess, the industry has worked with the FDA to develop a superior definition of ‘clean’ for any medical device,” Mr. Goodrich said.
Federal law also requires that reprocessed devices be labeled with the name of the reprocessor, either on the device itself or on the packaging. Tara Federici, vice president of technology and regulatory affairs for AdvaMed, said physicians and nurses should look for these labels, and carefully inspect devices before use. Others note that this is a good thing to do with any device, including reusable ones that have been cleaned and sterilized by the hospital.
Richard P. Wenzel, MACP, chair of internal medicine at Virginia Commonwealth University, suggested hospitals track infection rates related to medical devices, including rates associated with first time and subsequent use of a device.
“It may turn out that the third time, for example, has a higher rate of infection than the first two,” Dr. Wenzel said.
Whether or not to obtain patient consent is another issue surrounding reuse of SUDs. Current regulations don't require hospitals to tell patients they will come in contact with a reprocessed device, said Ms. Robson of CHW, which opts not to inform patients.
Kaiser said it is open about letting customers know it reprocesses devices, though it doesn't have a system-wide protocol in place to inform patients. “We are confident there is no difference between the original and the reused device in terms of functionality or being sterile and safe,” said Dean Edwards, Kaiser's chief procurement officer and vice president of procurement and supplies.
The keys to a successful program
It's important to get staff buy-in about device reprocessing right from the start, experts said. To do that, administrators—or whomever is leading the effort—need to emphasize the advantages of the practice.
“[Communicate] the bigger picture and touch into the mission of healing and how that relates to the environment,” said Sister Susan Vickers, CHW's vice president of community health. “Taking care of our patients, employees and environment are all vital to improving the health of the people and communities we serve.”
Education is an important way to secure and maintain staff buy-in, Ms. Robson said. To that end, CHW provides educational packets on reprocessing to its facilities that explain the program's safety and environmental benefits, and encourages staff to visit the reprocessing company to see the sterilization process for themselves.
In the past, some CHW physicians were hesitant about reprocessing arthroscope trocars. But when the doctors learned more about how reprocessing worked, they changed their minds, she said.
At Kaiser Permanente, members of the oversight committee for sterile reprocessing can also visit the reprocessing company to see how it works. Mr. Goodrich said that every time he has seen reticent surgeons walk into Ascent's reprocessing facility opposed to the idea, they have left 100% converted. “They come in with arms folded and furrowed brows … and time after time, their final response is, ‘This is incredible. I absolutely had no idea’,” he said.
Hospitals that are considering how to begin a reprocessing program should start small, experts said. Focus first on devices on the patient floors, such as compression sleeves, pulse oximetry sensors, tourniquet cuffs, and pressure infusers for IV bags. Next, start thinking and discussing surgical and cardiovascular items, Ms. Robson said. For Kaiser, the key has been to roll out its program “device by device,” said Robert Gotto, senior sourcing director with procurement and supplies at Kaiser Permanente.
Hospitals also typically establish oversight committees for their reprocessing efforts, experts said. At Kaiser hospitals, the committee includes surgical, medical and sterilization staff members who are tasked with ensuring devices are suitable before they are reprocessed.
Mr. Goodrich thinks hospitals are reaching an equilibrium in using a mix of disposable and reusable devices, noting that back in the day surgical instruments were always reusable.
“Using reprocessed devices is about sustainability for our healthcare system—financial and environmental sustainability,” Mr. Goodrich said. “This is good for the system and good for the patient.”