Single-Use Device Reprocessor Addresses 10 Misconceptions of the Industry

Lars Thording, PhD, senior director of marketing and public affairs at Stryker Sustainability Solutions, formerly Ascent, responds to 10 misconceptions about third-party reprocessing of single-use devices.

Misconception 1: Medical devices are designated for single use based on determinations by regulators.


Dr. Thording's response: Devices are designated for single use by the original manufacturers, not by the FDA or any other regulator. The manufacturers may apply single-use designation for economic or marketing reasons, rather than for patient safety.


Misconception 2: Only low-quality providers who cut corners use reprocessed medical devices.


Response: All of the hospitals listed on U.S. News & World Report's Honor Roll employ single-use reprocessing programs. More than 1,800 hospitals and hospital systems across the country use Stryker Sustainability Solutions' reprocessing programs alone.


Misconception 3: Reprocessing SUDs is not well regulated.


Response: The FDA strictly regulates third-party SUD reprocessing, based on rules that are even more thoroughgoing than those applied to the original manufacturer. The FDA must provide 510(k) clearance for each type of item that is reprocessed to assure that it is substantially equivalent to the original device. In addition to the Code of Federal Regulations, Title 21, Part 801 Labeling, reprocessors must follow further FDA rules as listed in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and Medical Device User Fee Stabilization Act of 2005 (MDUFSA).


Misconception 4: Reprocessed single-use devices are of lower quality than the original devices and increase patient risk.


Response: SUD reprocessors must comply with extensive FDA quality requirements, and there is no evidence that use of reprocessed devices increases patient risks.


Misconception 5: The design features of SUDs make them unsuitable for reprocessing and re-use.


Response: To obtain the FDA's 510(k) clearance to reprocess a device, the reprocessing company must demonstrate that the device can be restored to its original condition in terms of cleanliness and functionality. If a design feature impedes this goal, the company would not propose to reprocess the device and the FDA would not approve it.


Misconception 6: Chemicals and detergents used in reprocessing leave behind residues that affect performance and make reprocessed SUDs dangerous for patients.


Response: Before the FDA allows companies to reprocess a certain type of device, they must prove it can be cleaned, sterilized and rendered functional at the level of the original device. If it cannot be cleaned of all detergents and residue, it cannot be reprocessed.


Misconception 7: Reprocessing SUDs is the same thing as reprocessing reusable devices.


Response: Reprocessing single-use devices is, in fact, very different from reprocessing reusable devices. While SUD reprocessing is a highly regulated field, reprocessing reusable devices takes place in-house at many hospitals and ambulatory surgery centers. These activities are not regulated by the FDA and do not have to meet the standards set down for single-use devices.


Misconception 8: Reprocessed medical devices don't benefit patients.


Response: Reprocessed SUDs cost about half as much as the original device, allowing some hospitals to save more than $600,000 a year. Hospitals and ASCs can use the savings to enhance quality of care by investing in new personnel or equipment. In addition, reprocessing helps the environment by diverting thousands of pounds of medical devices from landfills.


Misconception 9: SUD reprocessing is not applicable to my facility.

Response: More than 100 single-use devices have received FDA designation for reprocessing. They are used in a wide range of clinical areas, including orthopedics, gastroenterology, general surgery, endoscopic surgery and cardiology. Some reprocessed SUDs, such as compression sleeves and pulse oximeters, are used all over the hospital and in many kinds of ASCs. The list of reprocessed SUDs includes common OR devices, such as trocars and harmonic scalpels, and electrophysiology devices such as EP catheters. Even small hospitals and ASCs can benefit from third-party reprocessing programs, saving hundreds of thousands of dollars.


Misconception 10: Working with reprocessing companies would require a great deal of work, such as cleaning and sorting used devices and bringing them to the company for reprocessing.

Response: Collecting used devices does not require any extra effort by hospital or ASC personnel. Clinical staff only have to remember to place used devices in special bins that are regularly collected by the reprocessing company. No sorting or cleaning is necessary.


Learn more about Stryker Sustainability Solutions.


Related Articles on Reprocessed Single-Use Devices:

Legal Trends in Infection Control

ASCs Should Take Advantage of Their Surgical Supply Distributors

Unannounced Follow-Up Visit From FDA Confirms MO's University Hospital Improved Infection Control Practices


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