Single or Multiple-Use Medical Instruments?

Today's Wall Streeet Journal rejuvenates a long-standing debate in hospitals: that of re-cycling equipment that is labeled "single use" to save on costs. Re-sterilization of instruments has become a multi-million dollar industry. Why? Because what hospitals care about most these days is saving money on consumables, and what better way to save than to recycle an instrument for a small fee and charge the patient for a new single-use instrument.

In effect, this is done every day in hospitals that reprocess instruments.

Now to be fair, what really happens from the hospitals' perspective is they get a lump sum reimbursement payment for a procedure and must use that amount to pay for all of the procedural consumables, including instruments. That lump sum payment amount is negotiated with the insurer well before any talk of re-using instruments occurs. It is usually negotiated assuming new "single-use" instruments are used. Further, because reprocessing has been "approved" by the FDA for some instruments under careful regulation, it's legit and hospitals can save a bundle.

Although rare, legal precedent has been established where re-used catheters were found dangerous. Was this a frivolous case or were there circumstances that were less than ideal? At least one jury thought their might have been a problem.

Cases like this sent shock waves around local hospitals - at least for a time.

But money is a strong motivator. Equipment and staff aren't getting cheaper. So to reassure hospitals, the re-sterilization industry began offering liability coverage as a form of indemnity against potential legal challenges regarding the safety of their service. Also, they point to the FDA which has sanctioned their process as "safe."

So naturally, many hospitals have entered back into the fold of re-use.

The instrument manufacturing industry is now understandably incensed and outraged at these reprocessors because the practice of instrument re-use substantially cuts into their bottom line profits. In my estimation, manufacturers sell about one tenth of their usual instruments to hospitals, since it is not uncommon for a "single-use" non-metallic instruments to be reprocessed 8 to 10 times before being discarded. Some metallic instruments may be used far longer.

Meanwhile, patients do not see the savings - the hospitals pass this on to cover other expenses. C'est la vie.

But the manufacturers have one thing on their side: the patient safety argument. You can never be too safe these days.

The manufacturers can point to ethylene oxide (used to sterilize instruments that cannot withstand heat) that can be harmful to humans, and there have been instances where excessive levels were detected on re-processed electrophysiology catheters when screened. For the clinician, there's no readily-apparent way to detect for residual ethylene oxide contaminants before procedures at the patient's bedside, so we take it in trust that levels are satisfactorily low. Were the instruments allowed to "air" for 14 days? Impossible to tell - we have to rely on those handy-dandy FDA inspections to assure compliance. Or alternatively, there have been small studies that found proteinacious material on catheters after re-sterilization. Eeeewwww.

So to combat the large preprocessing industry, device manufacturers wanted patient's to consent to the use of re-sterilized and re-used equipment during their surgeries. Seems reasonable, right?

But this hasn't happened.

Imagine.

Now to be fair, I have been on both sides of this debate - I have worked at institutions that have re-sterilized instruments and I have worked at institutions that are single-use. I found that doctors are shoved into this debate unwittingly: we need the hospital to do our procedures and provide the instruments, but may not like having to use re-processed instruments on our patients. In the case of electrophysiology catheters - they just don't handle the same. Further, the thought that a patient is unaware of this practice is unsettling. Because of the nature of medicine these days, we assume the responsibility for the patient's well-being in tandem with the hospital. Yet often, we are not part of the discussion regarding the use of preprocessed instruments. If we are, then the whole murky area of what it took for doctors to agree to using these re-used catheters begins to raise its ugly head.

So while economic arguments exist on both sides of the device re-reprocessing fence, we must not lose sight that it's the patient that matters here. Certainly, if re-used instruments are being used in a laboratory, I believe that patients should be made aware and have this included in their informed consent, with any potential risks spelled out. Further, if a patient knew they could apply some of the cost savings of re-processing toward their procedure costs, then perhaps they'd be more willing to agree to the practice.

But the subterranean way things happen now is not acceptable.

Given the current satate of affairs, here's the ultimate litmus test on this issue in my book:

If you were having a procedure, which instrument(s) would you want used on yourself: re-processed or single-use?

-Wes