Thursday, March 20, 2008

Healthcare and Landfills: Inside the Complex World of Medical Reprocessing (Recyling)

--trends + business + politics--

In the world of recycling, there are winners and losers, beyond the Eco-centric talk. Industries stand to gain and lose billions on new business practices that make new use, or reuse, of discarded materials. One of the most heated areas that exemplifies this is the medical reprocessing field. From scissors and scrubs to surgical blades and catheters, medical reprocessing firms are making millions sterilizing and repackaging typically single use hospital equipment eliminating thousands of tons of medical waste in landfills. But safety is still in question, although largely by the single use manufacturers.

Device makers are going head to head with reprocessors, saying that they cannot guarantee for the safety of their single-use devices when they are “reconditioned.” Under current industry regulations and standards, the Food and Drug Administration allows many one-time-use devices to be reused, even though it acknowledges that there are shortcomings in its oversight of industry, that was nearly non existent a decade ago. The players in the reprocessing industry are also in question, many with greater claims to entrepreneurship than any scientific or medical expertise (including a few who have run afoul of federal authorities).

Horace Goodrich was an oil-man from a small town near Waco Texas who saw a business opportunity in reprocessing in the mid 1990’s and by 1998 had merged with Orris Inc. and Applied Medical Technologies Inc., to create Phoenix-based Alliance, the largest reprocessor in the United States. The company admits to having no Medical professionals on its senior executive team. It also admits that it surprisingly doesn’t even have a clinical advisory board, Alliance is in active plans for a merger with Vanguard Medical Concepts Inc., another major reprocessor. Vanguard also stated that that it has no physicians or medical professionals of any kind amongst its senior executives. The only player who professed to have a medical team collaborating was SterilMed Inc., who said that it does have an advisory board of physicians and that its vice president of research and development has a doctorate in biochemistry.

Then there is the story of Mark Aldana, an inventor from St. George, Utah, who started a company in the early 1980s that supposedly created a cheaper, more efficient fuel additive for use in gasoline. In court records, automakers at the time said his product created pollution, and in 1986, the Environmental Protection Agency put a stop to his fuel additive. He jumped into the medical reprocessing business in the early 1990s when a surgeon friend asked him whether he thought he could refurbish medical devices. From 1999-2002 his company Applied Medical Technologies was hit by dozens of manufacturing violations by the Texas Department of Health and the FDA, which cited his firm for “failing to validate its sterilization process, provide employee training or follow procedures for handling complaints.” By August 2003, Aldana was forced to sign a Justice Department consent decree of permanent injunction, and by that October, he closed shop altogether selling it to another reprocessor, ClearMedical Inc. of Bellevue, Wash. Aldana has operated as a consultant since, as the FDA can not regulate consultants in the field.

The industry association AMDR (American Association of Device Reprocessors) site provides a bit of information and a listing of members that only include two companies, Ascent Healthcare and SteriMed. Add to that the fact that the FDA in the last several years, has found several reprocessors in violation of good manufacturing practices, even barring some after repeated violations (many of whom re-entered the business) and you have a very shaky industry that can leave both the medical community and the consumer population asking some big questions. But supporters cite that we need to look at the hard numbers, and see the complete picture of the emerging industry.

The FDA-regulated, third-party reprocessors in the U.S. have amounted to 40 million devices with no evidence, from any source, of an increased risk to patient safety. Reprocessors' safety record is every bit as good as, if not better than, the safety record of the original equipment manufacturers (OEMs). In addition, the FDA has been stepping into the industry much more. Currently reprocessors are required to to register with it. Companies, in addition, must get FDA clearance for each type of device they want to reprocess. Clearance is considered by the agency as any reprocessed device that is "substantially equivalent" to the new single-use device. Tighter restrictions hopefully mean more safety for the consumer. But many small reprocessors fail to register altogether with the FDA. In interest of keeping consumer aware of medically reprocessed medical equipment applied in their care, Massachusetts has introduced a patient-consent bill which requires hospitals to obtain permission from patients before using a refurbished single-use device on them.

But the push back continues from reprocessors who claim that the single use industry (their opposition) has its own scams, labeling products single use to drive business that clearly are not single use. And hospitals that stand to gain enormous cost savings from reprocessing are driving the industry, while business leaders in the field site thousands of tons of landfill waste being spared. In short - its a complex story...whose ending is far from being written.

All this begs to question, while the industry is busy figuring out regulations, standards, and who wins the biggest piece of the pie – who stands to lose the most? Business’ that make claims to being more earth friendly or conscious, must be required to undergo as much scrutiny (if not more) than their counterparts. And in the case of the medical reprocessing field, the issue is truly a matter of life and death. How comfortable are most patients in risky surgical environments having reused scissors and blades? At what point are we willing, and not willing, to take risks for the sake of our planet ? Recycling plastic, and buying organic is one thing – but is using a recycled catheter in the same category? And most importantly, when (and where) do consumers get to weigh in ?

For more information on medical reprocessing go to AMDR SITE

Post inspired by articles in the Washington Post & the Associated Press

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