At a two-day summit jointly convened by AAMI and the Food and Drug Administration (FDA), nearly 250 experts debated an issue of critical importance for patient safety—how to improve the reprocessing of reusable medical devices, with solutions such as better device design, clearer instructions, more training, and better pay for sterile processing technicians.
"We are asking people who could make more at Burger King to do high-risk, highly technical and challenging processes under adverse conditions with little training, and little support," says Ramona Conner, manager of standards and recommended practices with the Association of periOperative Registered Nurses (AORN).
Conner was one of many speakers at the Oct. 11-12 AAMI / FDA Medical Device Reprocessing Summit, held at the agency’s White Oak Campus in Silver Spring, Md. Reusable medical devices, such as endoscopes and forceps, that are improperly cleaned and sterilized, can be contaminated with blood, tissue, and other biological material, allowing potentially dangerous microbes to survive. The FDA has focused attention on the issue in the wake of reports about patients getting sick after being exposed to contaminated devices.
At the summit, sterile processing managers, technicians, regulatory affairs professionals, clinicians, nurses, clinical engineers, industry representatives, and regulators prioritized the challenges to safe reprocessing. The challenges included high technician turnover, poorly designed devices, and what many described as complicated instructions for use (IFU) from manufacturers regarding cleaning.
Sterile processing departments are required by the Joint Commission and other accreditation organizations to clean and disinfect a reusable device per the manufacturer’s IFU. But that is a lot harder than it looks, some speakers said.
"Some of these instructions are quite cumbersome," said Sue Klacik, corporate director of the International Association of Healthcare Central Service Materiel Management and manager of central services at St. Elizabeth Health Center in Youngstown, Ohio.
Speakers said that most IFUs are more than 75 pages long, and sometimes give conflicting or confusing instructions. "We should have standard definitions, standard soaking times, brushing, and rinsing directions," says Linda Condon, head of sterile processing for Johns Hopkins Hospitals in Baltimore. "Make the cleaning instruction simple and concise."
The devices themselves have also become more complex and harder to clean, says Victoria Hitchins, research microbiologist at the Office of Science and Engineering Laboratories in FDA’s Center for Devices and Radiological Health. "Today, you can’t see if the inside of the device is visibly clean due to long and/or narrow, opaque lumens and hinges."
"Good instrument design is the first step to safe and effective instrument reprocessing," says Thomas Gilmore, senior manager of product development for cleaning disinfection and sterilization at manufacturer Olympus America Inc. in Allentown, Pa.
Klacik said that manufacturers also need to engage with sterile processing on how a device should be cleaned, just like they do with clinicians on how it should be used. "A lot of times sales reps come in and talk to surgeons and nurses but forget to come down to central services," she says. "Some of the sales reps that do come to the department don’t know the care and cleaning of the instrumentation."
One industry executive urged healthcare personnel to talk to manufacturers about these issues.
"If there are challenges in the field, please bring it to the manufacturer," says Vana Poovala, manager of regulatory affairs for Philips Electronics North America. "Communication, feedback is very important to us to improve our processes. Sometimes we don’t hear from the customers about what their issues are."