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SAN DIEGO -- There are myriad risk management issues to be considered before a health care institution begins reusing medical devices designed to be disposable to lower its costs.
The trend toward reusing single-use medical devices is not a new one, according to Malcolm S. Parsons, vp of risk management at Doctors Hospital in Columbus, Ohio.
"The idea of reusing devices that are produced as single-use devices goes back to the early '80s," Mr. Parsons said earlier this month in a presentation at the annual conference of the American Society for Healthcare Risk Management in San Diego.
"In the mid-'90s we saw a host of barriers fall that produced a surge in the reuse of single-use devices," Mr. Parsons said. "All with one thing in mind: cost."
But, while the trend of using disposable products more than one time is growing as a cost-cutting measure, decisions about what single-use items will be reused frequently aren't given the attention from risk managers they demand, Mr. Parsons said.
"One of the things I have encountered in numerous hospitals is the decision-making process is being made where it shouldn't be made," he said. "It's being made in the cath lab. It's being made by the materials manager."
"One of these days somebody's going to get a wake-up call with regard to 'How long have you been reprocessing and did you know there was a potential for an adverse patient event?' " the risk manager said.
Mr. Parsons noted that in the 1990s more and more medical products have come on the scene in disposable fashion.
At the same time, there are no laws against reusing such devices, and organizations like the Centers for Disease Control have lifted recommendations against re-using some single-use devices within certain parameters, while the American Hospital Assn., which has recommended against reuse, is in the process of revisiting the issue.
In other countries, reuse of disposable medical devices is fairly commonplace, Mr. Parsons noted. "In Canada, reuse is not a major issue," he said. "In Australia, reuse is very prominent."
But there are many serious reasons that the issue needs to be given considerable attention from a risk management perspective, Mr. Parsons said.
"Liability areas that we're concerned with are vicarious liability, corporate liability and a breach of our duty to our patients," he said.
Before authorizing the reuse of a device, a health care institution must consider whether cleansing the device for reuse might weaken its components or alter its composition, resulting in a loss of efficacy.
There are also risks associated with the potential for mechanical failure of the reused device, as well as failure to adequately test and inspect the device, failure to build in safeguards to minimize product deteriorations and the failure to warn users of associated risks.
Then there are the risks of adverse patient reactions to the sterilizing agent or other chemical residue on the reused device, biological toxins or other fever-inducing agents on the device or the possibility of embolisms resulting from particulate matter remaining on the reused device.
Patients' informed consent is another concern. "I've been in this business a long time and I've done a lot of things without a conscience. This thing I'm not going to do without a conscience," Mr. Parsons said. "I think you need to tell your patients. If I was your patient. . .I'd want to know."
The facility also must determine whether it will reprocess devices in-house or deal with an outside reprocessing firm.
Outsourcing the reprocessing function allows for some risk transfer to the reprocessor, Mr. Parson noted, while in-house reprocessing keeps all the liability in-house.
But, it's critical that the risk manager of a health care institution that is outsourcing reprocessing examine the reprocessing company's insurance policies -- simply seeing a certificate of insurance is not enough.
"And let's not forget about our staff," Mr. Parsons said. Staff may be exposed to biohazards as a result of reusing disposable devices, he said.
"It's not just a matter of using a device, throwing it in a box and waiting for John Doe to come over from a reprocessing company," he said.
Before engaging in a policy of reusing certain disposable devices, a health care institution must take a long look at what's going to be re-used and set strict policies and procedural guidelines, Mr. Parsons said.
"Make a determination what devices are going to be reprocessed. Look at the design of the product," he said. "And in that regard, you'll find that manufacturers are starting to come to the table."
The hospital should create a reuse committee and "invite most of the Free World" to participate, Mr. Parsons said. Hospital attorneys, managers, directors all should be involved, as well as the facility's medical staff.
"You start making decisions that involve your medical staff and the instrumentation that they will use (without their participation), rest assured, you're going to have a mutiny," he said.
Finally, Mr. Parsons said, whether it's pro or con, the risk manager must take a position on the issue.