Panel delivers mostly ones-sided snub of reprocessed SUDs - Operating Room

With the matter seemingly settled by a 2001 ruling by the Food and Drug Administration that granted legitimacy to the practice, the long-simmering question of reprocessing single-use medical devices appears to be morphing into a battle for the hearts and minds of clinicians who make daily decisions regarding the use of reprocessed medical products. What could signal the first salvo in an emerging marketing war between the sides for and against SUD reuse was fired this spring during an educational session at the Association of periOperative Registered Nurses annual congress in Chicago.

A panel discussion at a local hotel, sponsored by Ethicon Endo-Surgery, the unit of Johnson & Johnson that manufactures and markets a range of single-use devices, drew some 200 perioperative nurses for a panel discussion titled "Striking a Balance: Safeguarding Patient Care in Reprocessing," despite a 6:00 a.m. start time on a chilly downtown Chicago morning. Appearing on the panel were James P. Keller, MS, director of the Health Devices Group for ECRI, the Plymouth Meeting, PA-based technology assessment concern; Terrence M. Fullum, MD, FACS, director of advanced laparoscopic surgery at Providence Hospital in Washington DC; Vangie Dennis, RN, CNOR, of Promina Gwinnett Health Systems, Duluth, GA; and Laura Trevino, director of public affairs for the Center for Patient Advocacy, a watchdog agency based in McLean, VA. Of the four panelists selected for the discussion, all but Keller, who delivered a look at the hard regulatory issues surrounding the matter, mostly spoke out against the practice of reprocessing single-use devices.

No representative of the reprocessing community was invited to the event, which carried a distinct tone that cautioned nurses to renounce the choice of most reprocessed medical devices. By far the strongest warnings were voiced by Laura Trevino, whose Center for Patient Advocacy has clashed publicly with the Association of Medical Device Reprocessors (AMDR), the trade association representing the reprocessing industry. In a recent letter to the AMDR, the Center shot back against charges leveled by the AMDR of making inaccurate statements concerning the safety of reused single-use medical devices and the potential risk they pose to patients. In that letter, Center executive director Terre McFillen-Hall wrote, "Questions surrounding the safety and quality of reused single use medical devices have been the driving force behind our efforts on this issue. We strongly believe that these questions remain unanswered. Those risks can include infection, transmission of communicable diseases, diminished device performan ce and even malfunction. Our goal has been, and continues to be, to educate patients about this practice, let them know they have a right to refuse the use of reused devices during surgery and empower them with the tools they need to exercise those rights."

A statement about reprocessing posted on the Center's website said, "In an effort to save money, many healthcare facilities are reusing medical devices that are designed, manufactured, and approved by the FDA to be used one time only. According to recent FDA figures, about 25 percent of hospitals currently engage in the practice of reusing single use medical devices. However, a survey by the Center shows that the vast majority of surgeons and nurses oppose the reuse of single use devices. Perhaps more alarmingly, most patients aren't even aware of this practice. The Center for Patient Advocacy is working to educate patients about this potentially dangerous practice and let them know that they have a right to refuse the use of these devices in their surgery."

Trevino, meanwhile, pressed the issue during her remarks. She cited the Center's survey which reported that "74 percent doctors believe that the practice of reprocessing single-use only devices poses a health and safety risk to patients," that "79 percent of surgical nurses believe that the use of reprocessed single-use devices should be discontinued," and that "77 percent of consumers are uncomfortable with the idea of reprocessed single-use devices being used in their surgery." Offering the Center's "consent form" that appears on the Center's website, Trevino said to the group, "Imagine for a moment what this might mean for you, the recipient of a reprocessed single-use device. What if the patient you inherited the device from suffered from hepatitis or HIV infection? Wouldn't you want to know? Wouldn't you want to be asked for your consent?" Reprocessing used single-use devices, she argued, "could" present a risk to patient safety, and lleave open the "potential" for infection and/ or malfunction if the ri sk is not adequately addressed by reprocessing. Materials and parts on a single-use device are not designed to withstand multiple sterilizations, she added.

Device reprocessors have steadfastly denied those allegations, pointing to acceptance and sanctioning of the science enveloping their process by the FDA and the successful use of reprocessed medical devices on thousands of patients, a strategy that they insist has also saved financially strapped hospitals millions of dollars in supply costs.

Trevino, who conceded in a brief interview immediately after the Chicago event that she was neither a scientist nor a clinician and admitted that she has never visited a medical device reprocessing company, failed to return phone calls from HPN seeking further comment. Similarly, officials representing AMDR companies declined to address the issue on the record. Privately, however, they expressed frustration with being unable to defend the reprocessing process during the panel discussion. One official hinted that the Center for Patient Advocacy and its drive against reprocessing were being financed by original equipment manufacturers, although that assertion could not be confirmed.

Panelist Vangie Dennis joined Trevino in urging against SUD use, framing her comments around patient safety. "I will not tolerate lax standards," she said, "not even to the degree where there is a chance of harm. And if I think patient care is being compromised, by a used single-use device or anything else, I am going to speak up. Ask yourself, 'would I be comfortable with the instruments on this tray if I were the patient?' Make sure the people making purchasing decisions in your hospital think about these issues the same way."

Surgeon Fullum was more tempered in his remarks, stopping short of outright rejecting the use of reprocessed medical devices. "I count on the OR nurse to keep me informed on issues related to patient safety," he told the group. "I want to know more about the status of my instruments. I want to know that the instruments I am using are going to work correctly. I want the nurse to know if the tools he or she is placing in my hand have a track record. If they're reprocessed, I believe I have the right to know that."

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