Opinion: will the real patient advocate please stand up?

Marion Sachs

Recently, I attended another manufacturer sponsored presentation by on reprocessing of "single use" Class I & II medical devices. The topic was not third-party reprocessing vs. hospital reprocessing, or a debate on effective cleaning, sterilization and decontamination of reprocessed devices (perhaps because FDA regulation and federal legislation has recently been strengthened). This presentation took a different and arguably, emotional turn. It was aimed at the heart of my profession: nursing, and my customer, the patient.

Members of the "Striking a Balance: Safeguarding Patient Care in Reprocessing" panel included a representative from ECRI; a general surgeon and laparoscopist from the Washington DC, area; a public affairs director representing the Center for Patient Advocacy; and a clinical nurse consultant for Johnson & Johnson. I'd love to tell you that it was a discussion, but there were no comments allowed from the audience and the one question per panel member reflected only the manufacturers point of view.

I've been a nurse for 28 years. I will openly tell you, my commitment to become a nurse in 1975 really didn't strike me as a profession or career at the time. I thought about it as a meaningful job: providing care to others and helping them heal. It was a job I could always fall back on, between marriage and raising a family.

As it would happen, I was seduced by the challenges and inherent worth of the profession. As I matured, I thought carefully about what I wanted out of the work environment and left institutions in which there was not a high level of collaboration and respect for the nursing staff. To this day, I find most of my nursing colleagues to be well-respected, energetic, savvy, intelligent and the staunchest advocates anywhere of quality patient care delivery.

After more than 20 years in the operating room, I took up the banner of reprocessing select single-use devices in 1997 because it made sense at my hospital. No doctor was asked to make a product change; nurses weren't asked to do more work; and when outsourced, it was an FDA-regulated practice. Medical waste was reduced. And the savings were enormous: enough to keep three full-time employees on the roster for the operating room.

This presentation insulted my intelligence as a professional and a patient care advocate. I heard a lot about "being informed" and "questioning the administrative actions" of my hospital. That's something I did on a daily basis in my nursing practice, whether in the operating room, dialysis lab or in general patient care areas. I read evidence-based data, think it through, and deliver my patient care accordingly. And if I really believe the hospital administration is compromising the standards of quality nursing practice, why would I work there?

Decisions to reprocess single-use devices within a hospital system are not made by one person, but by a multidisciplinary team of educated professionals specializing in infection control, the operating room, interventional radiology, risk management and central sterile. And yes, 90 percent of such teams are comprised of nurses like me and my, savvy colleagues.

Although federal authorities and hospitals have long regarded reprocessing as a safe alternative to the wasteful single use of durable medical devices, the guidance announced by the FDA in August 2000, and the Medical Device User Fee and Modernization Act passed last fall provide assurances that a reprocessed device is just as safe and works exactly the same as a new one. For that reason, patients and healthcare personnel can expect the same margin of safety from a reprocessed device that they expect from a new one. In fact, it could be argued that reprocessed devices are even safer because each and every one is inspected or tested.

"But wait!" I sometimes hear from a member of the operating room team, "I opened a reprocessed device last week and it didn't work properly." In the years I taught about the safety of FDA-regulated reprocessing at hospitals across the country, I routinely asked for a show of hands of those practioners who have never seen a new device, fresh out of the package, fail. Five years later, I'm still waiting for even one hand to rise.

I could provide reams, volumes and CD programs explaining why reprocessing of Class I and Class II single-use devices is safe and effective, but that's not the purpose of this commentary.

I was insulted by the insinuation that nurses who use reprocessed devices don't "care" about our patients. I am held accountable for the care I provide, and I am comfortable with the FDA-regulated reprocessing of medical devices. But when are the manufacturers of new devices going to be held accountable for their non-competitive actions? Here are some questions that I wish I had been allowed to ask:

(1) Why hasn't it been disclosed that the Center for Patient Advocacy's "scientific" survey that they've been publishing and presenting on local television stations was funded by an original equipment manufacturer?

(2) Why are new single-use medical devices changing to a lesser quality or grade of material as reprocessing gains momentum as a standard of care? For example, one manufactuerer has changed its sequential compression sleeve from a heavy blue vinyl to a green softer-vinyl to a white cloth material. I read in their marketing material that it was for "patient comfort." If so, then why do hospitals that reprocess receive the white garment while the non-reprocessing hospitals receive green?

(3) Why is Smith & Nephew letting Dr. Neil Kahonovitz speak publicly for their survey when he continues to incorrectly state that reprocessing isn't regulated?

(4) Why do manufacturers suddenly bottom out on pricing, if a hospital does not reprocess? Why wasn't I, the clinical value analysis team leader, offered that same bottom dollar pricing before you found out our hospital wanted to reprocess?

(5) Why is any orthopaedic company withholding intra-operative assistance for external fixators from hospitals that have chosen to reprocess?

(6) Instead of spending the next million dollars on fighting the reprocessing industry, why don't the original equipment manufacturers retain the durability of current "single-use' devices and partner with a reprocessor to safely reprocess them? That would be a win-win for all us.

(7) Why are physicians who are not open to reprocessing in hospitals suddenly open to the idea for their surgery centers?

Yes, these are some of the tough questions that need to be answered so that we nurses can adequately assess just who truly is a patient advocate and who is not. I, for one, want an RN running my hospital care plan. And without safe, effective cost savings initiatives that make sense, we're out the door.

I do understand business, and I realize that all of us need to make a living. But please, just give us the scientific facts. As a nurse, I already know how to be a patient advocate.

Marion Sachs, RN, MSN, CNOR, has been an educator for third party reprocessors since 1998, most recently for Minneapolis-based SterilMed Inc., where she served as director of clinical services. She is now an independent consultant to hospitals who are investigating the reprocessing of single-use devices. Ms. Sachs can be reached by e-mail at MSachs4196@aol.com.

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