Sterilization
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| Disassembly instructions for loaner instruments aren't provided to hospitals and one vice president of supply chain management has brought it to the attention of the FDA, though the debate continues in the industry as to whether instructions are necessary. Central service organizations convened to write a position paper on the topic, which was released last summer. Though the process will be a slow one, the FDA is enforcing the requirement. |
The topic of loaner instruments has been preoccupying Gary Metcalfe for some months now.
Metcalfe, vice president for supply chain management at Excela Health, a partnership of three hospitals in Greensburg, Pa., has been trying to convince manufacturers to provide written instructions for taking loaners apart so they can be cleaned properly.
He hadn't had much luck until late May, when officials at the FDA, after talking to Metcalfe, took the first steps in drafting proposed regulations that would require such instructions. FDA officials say rule-making would likely be a slow process involving the formation of an internal panel to write the rules, followed by a request for feedback from manufacturers. But Metcalfe says he is heartened by the news.
How it began
Metcalfe's quest for disassembly instructions began last year when surgeons in one of Excela's operating rooms found debris from a previous operation in not just one, but several sets of loaner instrumentation. He was concerned. The makers of artificial hips, knees and spines loan instruments to a hospital, sometimes for a fee, to implant the manufacturer's products. While the contaminated instruments at Excela had been sterilized, debris may not have been fully sterilized and possibly could enter a patient and cause lesions.
Investigating the incidents, Metcalfe learned that the debris was lodged in instruments that had not been fully disassembled. But the people in central sterilization who had cleaned them told him they did not know they could be broken down further.
"There is a screw-on cap that appears to be welded, but it actually comes off," he says. Metcalfe did not blame his staff. They have to deal with perhaps dozens of different types of loaners and cannot be expected to be intimately aware of each one. "Unless you had instructions, you wouldn't be familiar enough to know that the cap screws off," he says.
Metcalfe learned that manufacturers were expected to supply disassembly instructions from a position paper on managing loaner instruments and implants, released last summer by a joint committee of the American Society of Healthcare Central Service Professionals (ASHCSP) and the International Association of Healthcare Central Service and Materials Management (IAHCSMM), both of which represent central service (CS) departments in hospitals.
The paper stated that the vendor should "provide manufacturer's written instructions for disassembling, cleaning, packaging and sterilizing the instruments," and advised that "if written instructions have not been provided, contact the manufacturer and have the pertinent information faxed." But finding the instructions proved impossible.
Although manufacturers provide pages of instructions on use, sterilization and other aspects of loaners, he found nothing on disassembly. Sales reps who deliver the loaners and officials at the main offices told Metcalfe they didn't have such instructions because disassembly was simple and self-evident. Metcalfe wrote to IAHCSMM, "I'm interested in learning how organizations obtain the manufacturer's written instructions for instrumentation disassembly."
Calling in the FDA
Metcalfe decided to report the problem to the FDA. Naming manufacturers who do not provide disassembly instructions, he filled out several MedWatch Form 3500 reports, which are available on the FDA Web site, and discussed the matter directly with two FDA officials.
The FDA monitors labeling of medical devices in two kinds of approval processes, according to Daniel S. McGunagle, a medical device report analyst in the agency's office of surveillance and biometrics. In premarket approval, the FDA pronounces a device safe and effective, and in premarket notification, the more common type, a device is shown to be "substantially equivalent" to devices that are on the market, he says.
But McGunagle says labeling requirements do not mandate that orthopedic loaner manufacturers provide disassembly instructions. "Our current practices were not developed with this in mind," he says. "They were developed 20 or 25 years ago when this was a nonissue." Back then, "most instruments did not disassemble, and if they did it was self-evident." But times have changed, and "the current labeling requirements have not kept up with the changes," he says. "Instruments have become more sophisticated and complex."
In the last full week of May, McGunagle says, he and Janie Fuller, a regulatory review officer in the FDA's Office of Surveillance & Biometrics, sent a memo to FDA decision-makers recommending that the agency assemble a multidepartmental group to compose guidelines for disassembly instructions. McGunagle says this action team, as it is known in the FDA, would be composed of representatives from four different FDA departments, including his own, and would propose revisions to existing FDA guidance documents. He says the action team could be set up in a matter of weeks, but more pressing issues would slow down the timetable. The team's recommendations would then probably be published in The Federal Register. Manufacturers and others would have a few months to respond. FDA officials say agency actions have a lot to do with feedback they get from users like Metcalfe. Last year, at IAHCSMM's fall conference, Larry Spears, deputy director of the FDA's office of compliance, told members that the agency needs to receive MedWatch reports before it can take action on a variety of issues.
McGunagle reports that his office has received MedWatch reports from several users complaining about lack of instructions on disassembling orthopedic loaner instrumentation.
McGunagle says he was not sure about the full extent of the problem. "The difficulty in assuring that the surgical instruments are clean prior to sterilization appears to pose a risk," he says. "The magnitude of this risk is unknown because the concern for the inability to disassemble the instruments is based on a reasonable conclusion about the possible effects of not disassembling the instruments. [But] there is no evidence that anyone has been injured."
Loaner problems
While everyone in the CS community seems to agree that loaners are particularly difficult to keep track of, they disagree on whether they need written disassembly instructions.
A CS department can deal with a wide variety of loaner sets. Michele McKinley, manager of sterile processing at 408-bed Good Samaritan Hospital in Los Angeles, has a list of 48 vendors that provide loaners for orthopedic and spinal implants and each of them may have two to three different kinds of sets.
But Dorothea Conroy, R.N., president of ASHCSP and central services manager at Methodist Hospital in Henderson, Ky., says she sees no need for written instructions because her supervisor for central sterilization is usually familiar with the instrumentation and, if not, the sales rep would explain.
Conroy says the peculiar circumstances of loaners--unfamiliar instruments that are used for a short time--make it essential that hospital officials have a very clear idea of how to deal with them. "We demand the specific requirements," she says. "When you ask what needs to be done, the reps sometimes say, 'Whatever you normally do.' We say no, we want to know the specific time, temperature and what process. Does it need to be hand-washed or can it have a water bath?"
Anne Cofiell, a sterilization consultant based in Mt. Laurel, N.J., says hospitals need to have clear policies and procedures for handling loaners.
"There is a great deal of diversity about how they are handled," she says. For example, the sets may be delivered to the OR or to the CS department. She asks, "Can you get the OR person to listen to the CS person?"
But Cofiell, who helped write the ASHCSP-IAHCSMM position paper, says she still endorses the paper's recommendation to get written directions, even though it's impossible to do so right now. "This is a real problem," she says.
Richard W. Schule, another co-author of the position paper, agrees that manufacturers should supply the instructions. Even as manager of the surgical processing department at the Cleveland Clinic Foundation, which operates four hospitals in the Cleveland area, with about 1,000 beds, Schule says it is difficult to get companies' attention. "The manufacturers' main concern is to satisfy the doctor," he says. "They don't take cleaning and sterilization into account."
Manufacturers' reply
Of the manufacturers asked to comment by MMHC, only two replied, concluding that hospitals should not be having problems figuring out disassembly.
Officials at DePuySpine, a Raynham, Mass.-based maker of spinal implants and a subsidiary of Johnson & Johnson in New Brunswick, N.J., do not think disassembly of instruments is a problem, according to Nicole Dalomba, a company spokesperson. While some instrumentation has to be taken apart, this is not a complicated procedure, she says.
Brad Bishop, spokesman for Warsaw, Ind.-based Zimmer, says the company provides disassembly instructions for such individual instruments as reamers on its Web site, but he added that most instruments in Zimmer's loaner trays come in just one piece. He added that sales representatives hand out disassembly instructions when they deliver loaners, but he was not sure whether they do so every time. He says sales reps also provide inservice training on cleaning the instruments, which includes disassembly.
"Most of their activities are with the OR, but they're pretty familiar with most parts of the hospital," Bishop says. However, he says some hospitals restrict sales representatives' movements, which may make it difficult for them to get to sterile processing.
In addition to Zimmer, Don Gordon, the new president for IAHCSMM, says he has found Tuttlingen, Germany-based Karl Storz, with U.S. offices in Culver City, Calif., also to be helpful with providing directions. Gordon says that not all manufacturers appear to be cooperative. He says one of the major companies was invited to a panel discussion on loaners at IAHCSMM's annual meeting in Cleveland, but it chose not to participate.
What to do?
While the wheels turn at the FDA, Metcalfe is hoping that group purchasing organizations can put pressure on manufacturers to provide disassembly instructions.
But Dave Baker, vice president for medical-surgical contracts at Amerinet, a St. Louis-based GPO for more than 1,800 hospitals, says GPOs have little influence over loaners. He says orthopedic implants represent the epitome of the surgical preference item, with doctors adamantly refusing to switch brands to fulfill a GPO contract. Baker says Amerinet, like other GPOs, has not been able to negotiate any national contracts for orthopedic implants, but it is launching a new program that helps hospitals negotiate a local price with such companies as Smith & Nephew and Zimmer.
Gordon, the new IAHCSMM president, says he will try to arrange a meeting with manufacturers on disassembly and other problems with loaners. "There is a great need for CS leaders and orthopedic tray manufacturers," Gordon says, "to meet and discuss the problems associated with their trays."
Leigh Page is a freelance writer based in Oak Park, Ill.
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