By Ruth Van Gerpen, MS, RN-BC, APRN-CNS, AOCNS®, and Seth Eisenberg, RN, ASN, OCN®, BMTCN

Malfunctioning medical products can pose safety risks to both patients and nurses and waste valuable time and resources. All medical devices and equipment used in the United States must pass specific manufacturing requirements before they can be approved for sale. But every product, regardless of performance, is subject to malfunction. A challenge for nurses is determining whether an issue is a rare failure or if the product is legitimately problematic.

The first step is to follow your organization’s policies and report the malfunction so an internal investigation can occur. Then, using an evidence-based, problem-solving approach that integrates the evidence from studies, patient preference, and clinical expertise in making decisions about patient care can assist with resolution. It leads to higher-quality care, improved patient outcomes, reduced costs, and increased nurse satisfaction.

ONS Focus Group Recommendations

The ONS Supply Safety Focus Group, which met on March 19, 2020, determined the following steps to assess equipment malfunction issues.

Ask questions: How often is it occurring? Did it just happen to you, or have several of your colleagues or other nurses in your organization also reported the issue? Or maybe it’s a problem across the country. Consider reaching out to colleagues or posting an inquiry on an ONS community to find others who have experienced similar issues and what solution was implemented.

Why isn’t the product working? Are staff using it correctly? Evaluate how education was provided and whether additional review is needed. Gather specific examples of how and when the product malfunctioned, any precipitating events, and unexpected outcomes. If possible and safe, collect the products and package lot numbers to determine whether the issue is limited to one batch or the entire design.

Attain information or evidence: Identify one person (or department) to lead the investigation. This avoids duplication of work, inconsistent communication, and potentially contradictory information being provided downstream and to frontline staff.

Reach out to the manufacturer. Most companies have representatives and clinical educators to assist with identifying possible causes and offer suggestions, education, or alternate products that could better meet the intended need.

Collecting as much data as possible (especially from other organizations) prior to contacting the manufacturer is crucial. A manufacturer may approach a malfunction that has occurred at several organizations across the country differently than more isolated reports from a single institution or unit. Widespread research as to the extent of the malfunction can helpful. And make sure the manufacturer knows what other products are being used with the problematic one because the issue could be related to an unforeseen incompatibility between two products.

Assess the findings: If the company identifies a product or design issue, inquire about next steps. It may recall the lot and issue a different lot or provide a revised version. Or the company may already working on new version that corrects the issue and can provide a timeline for its availability.

Appraise alternatives: If the product itself is the problem, conduct a short trial with an alternate product or products. Be meticulous in your evaluation to avoid jumping from one issue to a new issue. The pilot should include all of the situations that were problematic for the initial product.

Apply or integrate the information: Evaluate the information gathered and discuss it with clinical experts at your facility. Present a summary with recommendations to the oversight committee. You may need to justify a higher-cost item by detailing why the less expensive product failed. If a new product is selected, provide training and revise procedures and resource materials to reflect the practice change. For re-education, develop a plan that includes re-evaluation of the device.

Assess the outcome: Ask staff if the previous concerns are still present or if they’ve found additional problems. Evaluate the process or product changes through planned, regular observation. Maintain communication with the company representatives or clinical educator for product updates or new information that becomes available.

Clinical nurses are typically the main users for most products yet are often left out of the product selection loop. Using an evidence-based practice model offers a roadmap to effectively navigate product concerns to improve the quality and safety of patient care.