(2) not the healthcare facility, but a third-party outsourcing company will reprocess the single-use devices for the healthcare facility’s reuse, in part to shift to the contracted company all regulatory responsibilities and the legal liability associated with reprocessing single-use devices.
- The medical facility should obtain both a risk and a cost analysis from its own staff and resources or from a third-party company demonstrating that outsourcing the reprocessing of one or more single-use devices reduces the facility’s costs, compared to the facility using the disposable device once and then discarding it (again, without compromising patient safety).
It is my assessment that the healthcare facility itself not reprocess single-use devices, but rather shift the responsibility and expertise to a fully-insured and FDA-regulated third-party company;
(3) the healthcare facility has confirmed that the practice of reusing single-use devices will not adversely impact the medical facility’s accreditation (and/or would not cause the facility to be cited during a state health inspection);
(4) the medical facility has diligently contacted surrounding medical facilities and has determined that this practice is considered an acceptable standard of care.
- The results of this informal survey would likely provide the medical facility with important insight, no matter its decision. During this informal survey the facility might want to learn the name of third-party outsourcing companies that a surrounding medical facility has used and would recommend;
(5) before contracting a third-party company for outsourcing the reprocessing of single-use devices, I would recommend that the healthcare facility have some of its staff visit one or more such companies that might be under consideration, to inspect the companies’ practices and documentation first-hand and to become more comfortable with making the right decision; and
(6) I would recommend that the healthcare facility ensure (and have valid documentation verifying or declaring) that any third-party outsourcing company under consideration:
- be registered with and be regulated by the FDA (and, ideally, has recently been inspected/audited at least once by the FDA without the Agency having documented any significant lapses, breaches or quality deviations, and that the company be “ISO certified”), with the company declaring in writing its full compliance with current FDA regulations and with all other applicable requirements of federal law (i.e., the Food, Drug, and Cosmetic Act);
- has received from the FDA a written 510(k) clearance letter for reprocessing the specific type(s) of single-use devices that the healthcare facility intends to reuse. I would recommend that the medical facility:
- receive and review a copy of this clearance letter (click here for an example of such a 510(k) letter) for, among other purposes, to verify its consistency with the type of single-use device that it is seeking to have the company reprocess; and
- ensure that this 510(k) clearance is currently intact and has not been voided or is otherwise under current FDA scrutiny; and
- has on file validation data demonstrating from quality and infection-control perspectives that the reprocessed device is “as safe and effective as its predicate device,” namely, as a new, single-use (and not reprocessed) device.
Summary and conclusions
In summary, the decision to reprocess a single-use device cannot be arbitrary, but requires some thought, analyses, and organization, and that some criteria be satisfied. Healthcare facilities are advised either not to reuse single-use devices or, if considering doing so, to first satisfy the aforementioned criteria.
This would include the healthcare facility’s staff visiting a few third-party companies and contracting the one that is: (i) convenient, reliable, and cost-effective; (ii) understands all of the responsibilities of reprocessing single-use devices for reuse; (iii) is fully insured and will provide full indemnification to the medical facilities and (as appropriate) will warranty its reprocessed devices; (iv) has on file all of the necessary documentation to support this practice’s safety, quality, and regulatory soundness, including a 510(k) clearance letter for each type of disposable device it intends to reprocess for the medical facility’s reuse (and will provide to the medical facility copies of this documentation as well as declaration statements as the facility deems necessary).
The follow references are provided for the reader’s interest and education:
- A report by the GAO entitled “Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted
- The Reuse of Single-Use Devices (by Premier Inc).
- A summary of several organizational statement about this practice.
- “Business booms for third party reprocessors.”
- “Single-Use Device Reprocessing.”
Article by: Lawrence F Muscarella, PhD posted on 12-21-2012; updated 7/24/2014, Rev A.