By Lars Thording

The reprocessing industry is growing and becoming more successful, both in the U.S. and internationally, as more healthcare providers look to reduce costs and environmental harm without compromising patient care. As this industry’s success attracts more companies eager to enter the market, hospitals and surgery centers face an influx of reprocessors promising savings and sustainability. However, as more reprocessing companies flood the market, it becomes critically important that healthcare organizations hold their reprocessing partners to the highest standards to ensure patient safety, quality outcomes, and maximum program value.

Single-use medical device reprocessing is a highly regulated activity with arguably stricter rules than those that have to be observed by the original manufacturers that design and market the original medical devices. This means that any reprocessing company that follows the law can be assumed to maintain high standards. However, regulations can be interpreted differently, oversight isn’t constant (and partially the responsibility of the reprocessing company itself), and even the strict rules of the regulatory system may not be enough to guard the healthcare facility against utilizing faulty devices or achieving sub-par results from their reprocessing partner.
Healthcare organizations should demand higher standards from their reprocessing partners than those formally imposed on the industry by regulation, ensuring the highest quality devices, highest patient safety, and optimal reprocessing program results. Only with standards that exceed those demanded from a regulatory perspective can the reprocessing industry retain its role in the market and its position in the medical device industry. This is because medical device re-use, however safe it may be, will always be subject to questions about safety, quality, and functionality. In addition, the involvement of original manufacturers in the reprocessing industry has introduced a risk that reprocessing programs are not designed to produce maximum savings and environmental impact for the hospital—but to drive maximum profitability for the manufacturer.

Here's what holding reprocessors to high standards looks like.

Quality Systems. Healthcare organizations should hold their reprocessors accountable for uncompromised product quality and safety, with stringent demands on their quality systems. No shortcuts should be taken in terms of cleaning, inspection, and testing, and the quality control system should have redundancies to ensure every single device is safe and functional. Reprocessors should test and inspect each device, as opposed to a sample of devices from each lot. Without these expectations, healthcare providers risk lower quality and safety in the reprocessed devices they use.

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