October 17, 2016

Action steps for safe use of reprocessed single-use medical devices

By: OR Manager

In the United States and globally, the use of reprocessed medical devices labeled and marketed by their original equipment manufacturers as “for single use only” has become commonplace. Large health systems have saved many millions of dollars annually and diverted many hundreds of tons of medical waste by using reprocessed single-use devices (SUDs).

Reprocessing SUDs is a manufacturing process regulated by the US Food and Drug Administration (FDA). Based on the FDA’s data analysis of reprocessed SUDs, the agency has stated that no data indicate the practice creates a higher risk to patients.


Developing a policy for reprocessed SUDs

A well-considered facility policy concerning the use of reprocessed SUDs avoids ad hoc decision making by individuals or departments. OR managers should support their organizations in making a formal decision about use of reprocessed SUDs and document the rationale for the decision, even if the decision is not to use them.

Facility policy should provide criteria to guide the selection of FDA-cleared reprocessed SUDs and an FDA-registered reprocessor that best fits the facility’s needs. Policy should also include requirement of documentation from the third-party reprocessors that they are cleared by the FDA to reprocess the specific SUD(s) identified by the healthcare facility and other documentation as may be required by applicable Medicare Conditions of Participation.

Here are seven action steps to consider taking toward safe use of reprocessed SUDs.


Review laws, regulations, and litigation trends

Theoretically, facilities may be exposed to potential liability for negligence in deciding to use reprocessed SUDs (or selecting an unqualified reprocessor) or, under other theories of liability, for improperly reprocessing SUDs themselves. A facility’s decision to provide reprocessed SUDs would most likely not subject the facility to strict liability—a theory of liability that does not require the plaintiff to prove negligence.

A search of databases of federal and state court product liability and medical negligence cases revealed no cases in which a healthcare organization has been sued for negligence regarding its decision to provide FDA-cleared reprocessed SUDs or cases in which a clinician was sued for using an SUD reprocessed by an FDA-registered third-party reprocessor.

Original equipment manufacturers and medical device reprocessors may be held liable under several theories of liability, including strict liability and breach of warranty. In 2011, a federal district court in Minnesota analyzed several theories of potential liability in a suit brought by an injured patient against an original equipment manufacturer and a reprocessing company regarding a reprocessed SUD used in a cardiac procedure. The case is discussed in US Court Analyzes Liability Regarding Reprocessed SUD.

Hospitals that outsource reprocessing to FDA-registered third-party reprocessors instead of reprocessing in house reduce potential liability for patient harm that could arise in connection with improper reprocessing. That is because third-party reprocessors are treated as manufacturers for purposes of strict liability.


Support a reuse committee

The committee should involve staff from various departments including administration, central supply, clinical staff from departments that would be using reprocessed SUDs, clinical/biomedical engineering, ethics committee, facilities management, finance, infection control, legal counsel, materials management, risk management, patient safety, public relations/marketing, and quality improvement.

Representatives from the reuse committee can garner information about concerns of the clinical staff, such as patient safety, liability risk, and ethics, by attending departmental meetings to discuss reuse of reprocessed SUDs. Committees should be familiar with SUDs that are commonly reprocessed because not all SUDs are eligible for reprocessing.

Clear policies and procedures developed by the reuse committee can avoid ad hoc decision making by individuals in a single department. No decision should be made without hospital administration or board involvement. The facility ultimately bears potential liability for the committee’s decisions.


Consider informing patients

FDA considers SUDs reprocessed in accordance with FDA regulations to be substantially equivalent to new devices and has not identified an increased risk to patient safety from their use. Thus, obtaining a patient’s informed consent that a reprocessed SUD may be used in a planned procedure is not a legal requirement—absent a specific state statute requiring the patient’s consent.

However, fear, mistrust, and lack of awareness of the safe use of reprocessed SUDs may cause some patients to react negatively to learning, after the fact, that a reprocessed SUD was used in their care.

Patient fear is understandable given that patients have been infected and put at risk of serious infection from reusable devices, notably complex semiflexible and flexible endoscopes that may have been inadequately cleaned, sterilized, or disinfected.

Disclosing to patients that a facility safely uses reprocessed SUDs from FDA-approved sources and informing them of the benefits gleaned from their use is a good risk management and ethical practice.

Hospitals that wish to disclose to patients or the public their use of reprocessed SUDs should state the rationale for reuse, which may include cost savings, environmental sustainability, and consideration of ethics principles of beneficence, avoidance of malfeasance, and distributive justice—for example, if the facility’s cost savings are put to use for quality improvement initiatives.

Facilities may wish to include information about the benefits of using reprocessed SUDs in patient brochures, on the facility’s website, and in materials provided at admission. General intake forms that inform patients of the hospital’s best practices might state that the hospital reuses and reprocesses its own (reusable) medical devices and outsources to an FDA-regulated vendor for commercial reprocessing and remanufacturing of SUDs.

A commitment to increasing the use of reprocessed FDA-eligible SUDs is an element of the Healthier Hospitals Initiative, a collaborative effort of several organizations and health systems that provides a framework and resources for hospitals to engage in sustainability initiatives.

Indeed, US News and World Report’s honor roll of hospitals, an annual report that ranks hospitals nationally against various measures, includes many facilities that use reprocessed SUDs. Most hospitals honored by Practice Greenhealth, a nonprofit membership organization supporting environmentally sustainable healthcare, have chosen to use reprocessed SUDs.

All surgical staff who will use reprocessed SUDs should be fully aware of the facility’s policy about use of reprocessed SUDs and be informed of the reprocessed SUDs that are used in the facility.


Overcome resistance

OR managers should anticipate that some clinical staff, notably gynecology surgeons, may be resistant to the use of reprocessed SUDs. In 2012, the American College of Obstetricians and Gynecologists (ACOG) issued a committee opinion, “Reprocessed Single-Use Devices,” that raised safety and ethics considerations for obstetricians and gynecologists.

The opinion, reaffirmed in 2014, states that the use of a reprocessed SUD provides no direct benefit to an individual patient or her physician and reminds the operating surgeon of his or her ethical responsibility to make a good-faith effort to know whether reprocessed SUDs are to be used.

Clinicians concerned about the quality or safety of reprocessed instrument(s) are cautioned not to use them. The document also calls for studies to evaluate the safety of reprocessed SUDs used in gynecologic surgery and recommends adverse event reporting that identifies SUDs.

In response to the ACOG committee opinion, Stryker Sustainability Solutions, a major FDA-approved reprocessor of SUDs, issued a position statement rebutting certain statements in ACOG’s committee opinion, agreeing with some statements, and providing additional information about reprocessed SUDs.

In brief, Stryker questions the reliability and accuracy of studies cited in the ACOG committee opinion, and states that none of the safety or quality concerns raised in the studies cited in the ACOG committee opinion were taken to the FDA for action, despite “repeated demands” by Stryker to do so.

Stryker agrees that healthcare facilities should inform and educate clinicians about the reprocessed SUDs they supply for patient care. Stryker states that obtaining a patient’s informed consent to use a reprocessed SUD remains within the realm of a physician’s decision making.

OR managers should ensure that staff are made aware of peer-reviewed studies concerning the reuse of SUDs reprocessed in conformity with FDA standards. They should encourage surgical staff to make their concerns about reuse of reprocessed SUDs known to the reuse committee so that the issues may be appropriately addressed. Instruct physicians that reprocessed SUDs are identifiable as such on their packaging and on the device itself, and encourage concerned physicians to periodically check the FDA database for any adverse events related to SUDs.


Be familiar with selection and evaluation criteria

The FDA has not cleared class III SUDs for reprocessing. Reuse committees can determine which reprocessed SUDs are cleared by the FDA. The agency’s 510(k) database provides a search function to find medical devices that the FDA has cleared under the 510(k) process, including reprocessed SUDs. As of mid-2015, the FDA has cleared more than 240 medical devices for reprocessing.

The FDA maintains a searchable list of registered entities or vendors that reprocess and market SUDs for reuse after reprocessing. The list is available on the FDA’s establishment registration and device listing web page. Information about a reprocessor’s inspection history is available at the CDRH FOIA Electronic Reading Room (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/default.htm).

When evaluating third-party reprocessors, the facility’s reuse committee should consider whether the reprocessing company’s practices comply with the healthcare organization’s relevant policies.

Typically, third-party reprocessors provide a template of policies and procedures that outline general information about reprocessing SUDs as well as staff roles and responsibilities for supporting reprocessing initiatives.

The committee should determine whether the reprocessor will tailor its SUD collection system to meet the facility’s needs, such as locating containers to collect devices for reprocessing in different locations in the facility to maximize collection.

OR managers can guide the selection process by providing the reuse committee with questions to ask about the reprocessor’s manufacturing practices, safety, and regulatory compliance. For more information about these issues, see “Questions to Ask When Evaluating Third-Party Reprocessors” in the full article from ECRI Institute.

Facilities may wish to search the FDA’s database Inspections, Compliance, Enforcement, and Criminal Investigations (available at http://www.fda.gov/ICECI) for warning letters and other regulatory actions the agency has taken against the reprocessor.

The reuse committee will monitor the program’s effectiveness for maintaining patient safety and achieving its financial and environmental goals. In addition, it will determine whether the third-party reprocessor collects data and provides reports to facilities about the ongoing impact of reprocessing.


Be aware of contract provisions

Original equipment manufacturers have acquired third-party reprocessing companies or forged exclusive business arrangements with reprocessors. In addition, some manufacturers reportedly modified certain SUDs by adding a chip that renders the devices unable to be reprocessed by a third party.

Some original equipment manufacturers have reportedly changed their purchasing contracts for SUDs to include provisions that would prohibit or inhibit healthcare facilities from using third-party reprocessors to reprocess SUDs that are subject to the contract. Manufacturers might also offer discounts to healthcare facilities for not reprocessing their SUDs, or may offer their own reprocessed SUDs to facilities for purchase.

As market changes continue, healthcare facilities should carefully review contracts for the purchase of SUDs and reprocessed SUDs and analyze costs and other factors that may present barriers to the use of reprocessed SUDs. Some original equipment manufacturers may bundle contracts for reprocessed and new SUDs, limiting the number of devices that can be reprocessed and setting medical device purchase quotas. These and similar provisions that inhibit SUD reprocessing may decrease cost savings.

To reduce the risk of potential liability regarding selection of an SUD reprocessor, facilities should consider including a provision in the contract that would require the reprocessing company to provide immediate written notification of any warning letters or regulatory action taken by the FDA against the reprocessor.

Facilities should also require reprocessors to provide proof of sufficient liability insurance and ensure that the contract includes favorable indemnity and hold-harmless provisions.


Capture and report adverse events

If healthcare facilities do not track whether a reprocessed SUD is used in a procedure, it is difficult to gather data about whether their use contributes risk to patient safety. OR managers should ensure that the department’s event reporting system captures adverse events that involve reprocessed SUDs and that staff know how to report them.

Healthcare facilities are legally required to report suspected medical device-related deaths to both the FDA and the manufacturer, if known, and serious injuries to the manufacturer or, if the manufacturer is unknown, to the FDA.

The mandatory MedWatch report has a specific field to indicate whether the involved device was a reprocessed SUD. Voluntary reports about serious adverse events associated with a medical device may also be made. ✥

This article is excerpted from ECRI Institute’s Healthcare Risk Control guidance published August 13, 2015. For the full article, including references, please contact communications@ecri.org or call (610) 825-6000, ext. 5377.


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