Hospital Buyer

Earlier this month, the Washington Post published a series of articles on the reprocessing of single-use devices (SUDs), first covering savings and safety concerns and explaining the process, then the consequences of cuts, and industry ramifications (followed up by a Q&A with readers). Inflamed by the conclusions of these articles, the Association of Medical Device Reprocessors fired back a defensive but argumentative statement while Rep. Rosa L. DeLauro (D-Conn.), the ranking Democrat on the House Appropriations subcommittee that oversees the FDA reacted by suggesting the FDA should increase the number of inspectors assigned to reprocessors. That may be necessary, but the AMDA is right to point out that brand new products are not flawless in the first place. Thomas M. Davis III (R-Va.), chairman of the House Committee on Government Reform, also wrote to the FDA a few days later.

Today in the Rockford Register Star we find several examples of hospitals in Illinois which get significant cost savings out of reprocessing with no safety issues reported so far. Some patients would like to be informed of that practice though, expecting transparency from hospitals, and maybe even sharing in the savings. It is true that Original Equipment Manufacturers (OEMs), hospitals and reprocessors have somewhat conflicting goals. While OEMs do label SUDs as such, hospitals concerned with rising costs might see this as a profit maximization choice if not rent-seeking, rather than a genuine safety warning. After all, rubber and metal devices have been sterilized and re-used for decades. However, some plastic products might be more brittle and/or not easy to clean, especially since their manufacturers intend and get approval for single use. Still, savings of 50% or more off the price of a new device and reduced medical waste are hard to shrug off. And it is likely that OEMs and reprocessors will reject responsibility on each other when problems occur.

Reprocessing started in the late eighties but grew more significantly through the last ten years, leading the Food and Drug Administration (FDA) to start regulating the practice five years ago (see Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and its revision in 2004). The FDA’s website even has a whole section dedicated to reuse. In 2002 they ran a survey which indicated close to one hospital in four practised reprocessing, but as of now the three biggest reprocessors say they serve 3,370 accounts out of about 4,800 hospitals in the US, which would indicate a leap to 70%. Maybe the self-reported FDA survey under-reported reprocessing, or maybe increasing hospital bed size, itself a factor of hospital profitability, played a role during the last few years as they tend to do it more than smaller ones.

A bit like the relationship between brand-name drugs and generics, medical reprocessing is a complex issue with health and fiscal ramifications and no clear-cut answer. The Washington Post compilated numbers from several sources and estimated reprocessor sales went from about $40M in 2001 to more than $120M in 2005 (since hospitals have tended to stop doing the reprocessing themselves in favor of outsourcing), and sized the SUD and overall medical devices markets at $3B and $80B respectively. It is unlikely that this is the last time we hear about it in contradictory terms.

December 30, 2005 Related topics: Ethics & Scandals, Quality, Safety, Errors, Cost savings