Safety concerns mount as more hospitals recycle single-use devices
About one-fourth of U.S. hospitals now clean and reuse single-use devices such as surgical scissors, pulse oximeter sensors, ultrasound catheters, and compression sleeves, raising concerns about patient safety.
Although this "reprocessing" movement is supported by hospital administrators and green-conscious employees and is transforming the healthcare sector's reputation as one of the biggest contributors to waste, it's controversial, with opponents ranging from patient advocates to manufacturers who are concerned about safety.
"It is unconscionable for a healthcare worker or an institution to subject an unsuspecting and uninformed patient to unnecessary risk just to save a few dollars," said Michael Bennett, president of the Coalition for Patients' Rights in Maryland. "There are plenty of other areas in healthcare where money can be saved without jeopardizing patient safety, such as better infection control and fewer errors."
He contends hospitals should find vendors that provide durable items that are not marked for single use.
But a recent Government Accountability Office study found that reprocessing is safe, despite little research to date on the emerging trend.
In addition, among the 434 adverse events reported to the FDA between 2003 and 2006 in which reprocessed SUDs were identified, "only 65 actually did involve a reprocessed device, and all adverse events were similar to those reported for new devices," said Dr. Martin A. Makary, a surgeon and associate professor of public health at John Hopkins University School of Medicine who has studied the trend.
Makary has traveled to FDA-approved reprocessing plants to evaluate how the equipment is cleaned and refitted. About 100 medical items have FDA approval for reprocessing to be reused at hospitals.wrote Makary, who is co-author of an analysis of reprocessing with renowned John Hopkins safety expert Dr. Peter J. Pronovost to be published in the March issue of the journal Academic Medicine.
To learn more about reprocessing equipment at hospitals:
- check out this commentary in Academic Medicine
- read this Baltimore Sun article
Comments
I personally initiated formal "single-use" recycling as early as 1996 in three health systems where I served, after including and educating every level of nurse and physician involved. Most of these items were catheters used in the cardiac cath lab for electrophysiology studies or ablations, costing over $1,000 each with 5-7 used per EP cath patient.
The fact is that most hospitals were already recycling these items by sending them through the same in-house cleaning and sterilization as the “reusable†items/surgical instruments. The hospital usually calls this “re-useâ€, not “recyclingâ€.
My concern was that some of these “single use†items contained electrodes and/or moving parts and were neither individual inspected against manufactures’ functioning standards, nor tracked for total number of times used when cleaned and sterilized in-house.
The “recycling†program bar-coded and tracked each item by patient use, and limited total recycle use to either 5 or 7 uses at the most. Once used, the item was placed in a secure container with disinfecting solution, shipped to the external recycle center where it was cleaned, inspected under microscopes for any remaining contamination or wear, tested according to original manufacturers standards, then shipped for sterilization and packaging at probably the same plant and process originally used by the manufacturer, then returned to us.
Thus, my costs actually increased as we were no longer using items until they were visibly worn or did not function (at which time a new one would used), and I had to incur the external recycling costs. But, I had a documented, inspected and tightly controlled process.
Sophisticated devices such as $1,200 surgical staplers are marked “single-use†by the manufacturers without any scientific evidence simply to sell more of them. And, opposition to formal “recycling†is thus a scare tactic by the manufacturer unsupported by evidence.
Patient advocacy groups should be requiring formal recycling programs, not opposing them and thus forcing “single-use†sophisticated items back into hospital in-house sterilization along with rib-spreaders surgical pliers.
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