Opinion 1: Reprocessed medical devices are safe and cost-effective
Massachusetts is in the midst of a public policy debate that pits the medical device reprocessing industry against the much larger original equipment manufacturers lobby. At stake is the right of hospitals to save desperately needed health care dollars and keep unnecessary waste out of landfills - without risking patient safety.
The issue revolves around the reprocessing of medical devices, a decades old practice that has been used safely and effectively under FDA's regulation, by hundreds of hospitals nationwide.
Next week, Massachusetts legislators will be asked to consider two bills that would result in the elimination of a safe and cost effective competitor to the original equipment manufacturers (OEM) of certain medical devices. If it's eliminated, the implications for an already stressed health care industry, not to mention the environment, will be significant.
These two bills (HB2233 and SB1338) purport to be about patient safety. They are not. They are about corporate profits. Some of the country's largest OEMs are located in Massachusetts. They stand to realize millions of dollars of additional profits if this reprocessing were to be suddenly unavailable to the hundreds of Massachusetts surgeons and medical professionals.
The practice of reprocessing original "single use devices" (SUDs) involves the extensive cleaning, sterilization and repackaging of a small group of devices pursuant to FDA requirements. Data collected by the FDA shows that the reprocessing of devices may even create a safer product.
But then what does "single use" mean? The "single use" label is not an FDA requirement but is chosen at the manufacturer's discretion. So let's be honest, OEMs want to sell more by simply labeling the package or device "for single use."
Since this industry began, medical device reprocessing has taken a serious financial bite out of the manufacturer's profits. Our companies have safely reprocessed more than 50 million medical devices. It has also had a substantial impact on the price of original equipment. For example, biopsy forceps used to cost a hospital about $49; after hospitals started reprocessing them, the manufacturers dropped the price to about $15.
Reprocessing not only makes economic sense for hospitals, it is good for the environment as well, helping divert more than 10,000 tons of medical waste from the waste stream in the last decade.
Reprocessing is safe. America's finest medical facilities use reprocessed medical devices, including 17 of the 18 ranked by US News & World Report in 2007 as the nation's "Honor Roll" hospitals.
In short, reprocessing plays a vital role in our health care system. Don't let the OEMs' concern for their bottom lines take away one of the few ways that hospitals can realize substantial cost savings while maintaining the highest level of patient safety.
Daniel J. Vukelich is executive director of the Association of Medical Device Reprocessors, a Washington, D.C.-based trade association representing third-party reprocessors of medical devices labeled
for single use.
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