The Society of Gastroenterology Nurses and Associates (SGNA) in May, 2013, updated its position statement “Reuse of Single-Use Critical Medical Devices.” Dr. Muscarella’s article and position on this topic provided herein shares some similarities with SGNA’s position statement (updated; May, 2013), but with some differences that the reader may appreciate.

Introduction 

Some healthcare practitioners have asked me about the safety, quality and prudence of reprocessing and reusing disposable devices, including sequential compression devices (SCDs) and certain other types of disposable devices, such as single-use biopsy forceps used during gastrointestinal (GI) endoscopy. Conclusions about the merit and validity of this healthcare practice are not straightforward or self-evident.

Initially, I unequivocally and unconditionally opposed the reuse of single-use devices, in part because this practice seems, at least on its face, to violate the principles of propriety, quality, and transparency in health care.

After all, it is reasonable to conclude that a patient on whom a disposable device were first reprocessed and then reused would not be informed of this practice, despite the patient’s implicit expectation and, depending on reimbursement, that the patient may be charged for a new, single-use item.

Click here to learn about Dr. Muscarella’s program designed to help medical facilities manage and reduce risk and improve both quality and patient safety.

Further, that a primary aim for a medical facility’s reuse of a device labeled by its manufacturer (known as the “original equipment manufacturer,” or OEM) as single-use, respectfully, is typically not to improve patient safety as much as to address and contain rising healthcare costs is a consideration that cannot be readily dismissed.

Due diligence

An unwelcome scenario to consider and that might arise would be if a patient were to be injured during a medical procedure and the investigation linked the harm to the medical facility’s reuse of a single-use device, in violation of the facility’s quality system and written policies and procedures.

This becomes all the more potentially problematic if the patient had not been informed of or conspicuously consented to this practice being employed as part of treatment.

It is my opinion that due diligence be exercised and this possibility of patient harm be fully considered, addressed, and resolved (by the relevant departments, including infection control, quality assurance, and risk management) before a medical facility decides that the practice of reusing reprocessed, single-use devices may be appropriate.

On the other hand, however, there are some disposable devices that, for all intents and purposes, are seemingly reusable but that are labeled and marketed by their OEMs as single-use for a number of reasons, including to reduce liability and to avoid expensive pre-market testing that requires demonstration that the device can be safely reprocessed without transmitting disease.

Other reasons may also include design considerations, the competition, and, possibly, such incentives as to enhance its revenues.

Indeed, the labeling of an otherwise reusable device as disposable is (of course) entirely legal and the manufacturer’s prerogative.

FDA regulation

As the U.S. Centers for Disease Control and Prevention (CDC) has published (click here), the FDA considers healthcare facilities or contracted third-party outsourcing companies that reprocess and reuse single-use devices to have become themselves the “manufacturer” of these devices.

As a consequence, these facilities and companies are required by federal law to comply with the same regulatory and quality requirements that the FDA expects of the original equipment manufacturer (or, “OEM”) who labeled and sold the device as single-use.

Remember to click here to learn about Dr. Muscarella’s program designed to help medical facilities manage and reduce risk and improve both quality and patient safety.

Published guidelines

Most professional organizations oppose the practice of reusing single-use devices, which is most understandable.

  • One organization states without equivocation that:

“In the absence of substantial scientific evidence to prove the safety and effectiveness of reprocessed critical medical devices in the endoscopy setting,” this organization “maintains the position that critical medical devices originally manufactured and labeled for single use should not be reused” (click here to read more).

  • Another organization similarly writes:

“The primary problems associated with reuse of disposable accessories are concerns about their sterility and proper performance subsequent to reprocessing. Third-party companies that specialize in reprocessing of single-use devices are responsible for providing essential quality control pertaining to sterility and integrity of the equipment after processing. Liability issues that result from reuse of single-use devices are complex and may vary by state.” (Click here for a detailed discussion of this stance.)

Criteria to consider

For some types of single-use devices, data do suggest that it might be scientifically acceptable to reprocess and reuse them safely.

I might, therefore, become more comfortable with a medical facility reusing single-use devices — these two organizations’ aforementioned position statements notwithstanding — but only if a number of criteria were satisfied.

Click here to read Dr. Muscarella’s published peer-reviewed article that features a root cause analysis (RCA) of a bacterial outbreak in 2009 (Texas) that was linked by the investigators to the faulty cleaning of complex arthroscopic instruments that reportedly did not facilitate reprocessing.

These criteria include the medical facility:

(1) being transparent about this practice, documenting its reuse of certain single-use devices in its appropriate policies and procedures;

(2) listing on file those single-use devices that it reuses;

(3) perform trending analyses for each of these listed devices to confirm their being safely reused; and

(3) documenting and having on file both justification for performing this practice and verification of its safety, effectiveness, and quality for each listed type of single-use device that the medical facility will reuse on patients.

  • Such documentation can be garnered from a number of sources, including from the FDA’s databases, the medical literature, the medical facility’s own experiences, and third-party reprocessing companies whose models are based on the safe reprocessing of single-use devices.
  • Moreover, this documentation would confirm that the medical facility’s practice of reusing single-use devices does not compromise any of its internal quality standards and, to be sure, patient safety (e.g., this documentation would confirm that no patient injuries have been associated in the medical literature or the FDA’s databases with the specific single-use device’s reprocessing and reuse);

(Continued on Page 2 …)

Leave a Reply

Your email address will not be published.