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Describing the longstanding practice of reusing single-use devices on patients as essentially "experimentation without informed consent," a top Food and Drug Administration (FDA) official made it clear recently that hospitals will have to abide by stringent new oversight or get out of the reprocessing business.
While critics have charged that the FDA is acting with little real evidence of harm to patients, the agency has ample data to justify cracking down on the process, said Larry Kessler, ScD, director of the office of surveillance and biometrics in the FDA center for devices and radiological health.
Potential dangers lurk
"Our evidence comes from the hundreds of reports we have gotten in the medical device reporting system that show potential serious problems with reprocessed devices," Kessler said. "More importantly, in our laboratory studies . . . we tried to clean and sterilize devices and had considerable difficulty. What is left is gunk, blood, [and] tissue."
The FDA is not willing to "wait around and find a series of deaths, serious injuries or infections and then do something about it," he added. "Frankly, if I go to a hospital . . . and a catheter is put in me that came out of someone yesterday — who was, [for example], infected with hepatitis C — and I am not told about it, I am not only going to be upset, I am going to be danger."
Kessler made the comments during a Dec. 13, 2000, FDA satellite teleconference designed to explain its new regulations on reuse of devices labeled for single use. The FDA is aware of a "couple of hundred" problems with reprocessed devices among the 80,000 medical device adverse events reported per year.
"I am not saying that the reprocessing necessarily caused those adverse events, but it looks like it might have been related to adverse events such as cracking, brittleness," he said.
There is also evidence coming in from Europe that shows "potential public health problems" with the practice, he added.
The agency used to leave hospitals relatively unregulated, letting them assume their own liability should reprocessing result in infection or injury to a patient.
Under its new policy, the FDA will begin enforcing premarket submission requirements [i.e., premarket notification 510(k) and premarket approval applications] on Feb. 14, 2001, for all class III devices. Those are generally considered at higher risk of causing possible infections or adverse outcomes due to reprocessing. (See additional deadlines, commonly asked questions, p. 27.)
Hospitals have three options
Hospitals basically have three options: work with the FDA and comply with all regulations; contract with a third-party reprocessor that is regulated by the FDA; or "get out of the business," Kessler said. "They can talk to their medical device suppliers, and if they are using single-use devices, they should buy enough to use for single use."
Though he broached the informed consent issue in response to a question during the conference, Kessler left the issue of informing patients that a device was reprocessed to medical ethicists.
"The FDA’s rules and regulations about informed consent really are only covered in investigational devices — a device that is new and [in] trials," he said. "This is an ethical question for hospitals and patient care providers."
Striking a more conciliatory tone, Kessler said the FDA recognizes that the regulations under the Food, Drug, and Cosmetic Act, which is designed for device manufacturers, are not "a perfect fit" for hospitals.
"We are trying to make it work, and we are going to educate hospitals and work with them," he said. "Right now, the process that is ongoing out there is something like experimentation without informed consent. We are trying to get to an educated way for hospitals and the FDA to work together to make sure patient care and devices are safe."
So-called "open but unused" devices, (i.e. orthopedic screws that are unpacked but not used in a procedure) are not subject to the regulations, Kessler said. "In that case, we are encouraging hospitals to look at their procedures in-house," he said.
"Once in a while, the FDA will become aware of a situation where hospitals will have a device that is opened and unused. They will sterilize it with procedures they feel are safe, but may be in conflict with the original equipment manufacturer (OEM) instructions about sterilization," he said. "The resulting sterilization may harm the product. Look at the instructions in the original manufacturers’ labeling. If it does not tell them how to do resterilization and reprocessing, we encourage them to go back through the OEM to see if they can provide instructions."
In addition to rigorous quality controls for cleaning and disinfecting a reused single-use device, hospitals that conduct the practice must ensure that "functionality testing" is part of the process, explained Larry Spears, acting director of compliance in the FDA center for devices and radiological health.
"As they go through and validate the various processes — whether it is cleaning, disinfection, or sterilization — they want to find out whether . . . those processes are affecting functionality," he said. "Are they affecting materials? Is there degradation of materials and at what rate are they degrading?"
If a hospital elects to continue reprocessing without FDA clearance beyond the respective deadlines, it will be in violation of the law, Spears reminded.
"We want to make sure that hospitals do understand what their requirements are, and we are trying to do all that we can to make sure that the information is out there," Spears said. "Once we begin the enforcement period, typically we do go through a process of providing warnings when there is a problem. We don’t typically — unless there is a real public health risk involved — shut down facilities immediately."
[Editors note: To purchase a video of the FDA teleconference, "Reprocessing Single-Use Devices in Hospitals: A Primer on FDA Requirements," ICPs can contact the National Audiovisual Center, 5285 Port Royal Road, Room 1008, Springfield, VA 22161. Fax: (703) 605-6889. Telephone: (703) 605-6186. Program order #AVA20859-VNB1INA. Additional reprocessing information can be found at the FDA’s reuse homepage: www.fda.gov/cdrh/reuse/index. shtml.]