Debunking Myths: 3rd-Party Biomedical Equipment Services in Healthcare Explained
There's no question that 3rd-party replacement parts and repair services can lower medical device costs for healthcare organizations. Unfortunately, misinformation and incorrect assumptions overshadow many of the other benefits that 3rd-party servicing has to offer. Partnering with the right 3rd-party biomedical equipment company can make a critical impact by reducing equipment downtime, extending device lifespans, lowering "soft costs," and more. Believe it or not, these advantages don't have to mean compromises in care quality or patient safety.
After reviewing information and opinions regarding 3rd-party servicing entities, a 2018 FDA report concluded that many 3rd-party organizations provide safe, effective servicing of medical devices. The evidence also revealed that most of the reported adverse events were related to 3rd-party "remanufacturing" rather than servicing. In 2021, the FDA published draft guidance to help companies determine whether their actions constituted remanufacturing or servicing. This guidance defines remanufacturing as "the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device's performance or safety specifications, or intended use."
In the wake of the FDA's research and guidance, some facilities have shown an increased willingness to have third parties repair hospital equipment. Nevertheless, many hospitals continue to miss out on the advantages because of ongoing misperceptions. This explainer shines a light on those misperceptions, encouraging healthcare decision-makers to explore 3rd-party partnerships, which can significantly enhance savings, efficiency, clinical functioning, compliance, safety, and health outcomes.
Common misconceptions about 3rd-party parts and repair services
Despite the FDA's research and guidance, there is still a widespread belief that third-party biomedical companies provide unreliable parts and repairs. This perception is based on several common misperceptions, including:
1. Repairs performed by untrained technicians
Third-party businesses should invest significant resources into workforce development. From large Independent Service Organizations (ISOs) to regional repair companies, prioritizing expertise and competence can mean hiring skilled techs with years of experience and recent graduates of rigorous training programs. A BMET's career trajectory typically means moving through the organization's level system. Level requirements, usually based on a system such as the AAMI BMET level guidelines, ensure that only advanced techs handle complex repairs. Third-party companies can also invest in professional BMET training programs where experts provide hands-on training for specific equipment or topics.
2. 3rd-party servicing automatically voids the OEM warranty
Always read the agreement carefully before any 3rd-party performs services on a device still under warranty. Some contracts may become void because of a 3rd-party repair or replacement component, but not all of them. A warranty may specify that only the OEM can provide certain repairs or parts while allowing 3rd-parties to perform other services. If working with a 3rd-party won't violate the warranty, it could save the hospital valuable time and money. In some circumstances, OEMs may even recommend working with a specific repair business due to geographic constraints or other OEM limitations.
3. Lack of manufacturing regulatory compliance
The truth is that 3rd-party biomedical equipment manufacturers technically make "aftermarket" parts. Therefore, they aren't legally required to meet the same FDA regulations as OEMs. It’s true that some 3rd-party manufacturers take advantage of this regulatory gap to cut corners in design, materials, and other areas. However, reputable and reliable third-party manufacturers should strive to maintain similar standards to OEMs. This may include voluntarily following FDA medical device guidelines and/or participating in voluntary certification, such as ISO 13485 for medical devices, and training engineers, technicians, and factory staff in the latest regulatory expectations.
4. Zero quality assurance in parts manufacturing
Adhering to robust quality assurance practices increases the likelihood that a 3rd-party product provides the same performance and safety as the original OEM component. Achieving this level of performance requires implementation and adherence to a rigorous quality management system (QMS).
Partnering with a third-party parts and repair business that consistently meets or exceeds OEM quality can impact budgets, care delivery, and patient risk. Achieving this requires hospital decision-makers to identify potential partners whose business model prioritizes quality and patient safety rather than the bottom line.
What sets a reliable 3rd-party partner apart from less reputable companies?
Reliable 3rd-party companies take a values-driven approach to making parts and conducting medical device repairs. A values-driven partner is committed to considering safety, care quality, and customer needs in all business areas.
Such choices range from using quality product materials to providing BMETs with up-to-date training and making an unwavering commitment to their customers, even during challenging times. In contrast, less reliable businesses often base decisions on financial impact alone. Some profit-driven 3rd-party companies may choose cheaper, less durable manufacturing materials, or refuse to rectify issues with products or services. For example, in the case of an adverse event, they may abandon the customer rather than working with the customer to investigate, trace any affected products, and identify a solution.
How to distinguish a values-driven 3rd-party manufacturing partner
Hospitals and health systems will benefit from investing time and resources into thoroughly vetting potential 3rd-party partners. Decision-makers should closely examine potential third-party partners business practices to determine if they operate from a values-driven model.
Some things to look for when vetting 3rd-party medical device partners:
- Strong track record (Long-term customers, low percentage of quality return rates, and how they were handled)
- Voluntary certifications, especially ISO 13485 and 9001
- Comprehensive quality management system (ask for documentation/demo)
- Reliable supply chain
- Robust customer service
The representatives for the 3rd-party business should be friendly, informative, and easy to reach. They should welcome questions and respond to any concerns with complete transparency.
Learn how to go deeper into the process of carefully vetting 3rd-party biomedical equipment partners for quality and assurance with this helpful free guide.