Denisa Lambert, vice president of quality and regulatory compliance at TRIMEDX, was recently featured in a 24x7 Magazine article on how health systems should go about choosing an independent service organization. The full article, as it appeared on March 28, 2025, is below.
Hospitals often rely on third-party service providers for medical equipment maintenance and repair—whether to supplement limited internal resources, streamline service across multiple sites, or address other operational needs.
Smaller hospitals and ambulatory centers with limited equipment volume often find third-party services more economically viable than maintaining full-time technical staff, says Dustin Telford, AAMIF, CHTM, CBET, CRES, CLES, device safety consultant at ECRI, a nonprofit focused on improving the safety, quality, and cost-effectiveness of healthcare. Certain facilities may need technical support only periodically, he says—once weekly or even quarterly for preventive maintenance with emergency coverage.
Additionally, larger organizations with multiple sites can benefit from third-party partnerships. “Hospitals are often facing thin operating margins, making effective medical equipment management essential to financial stability,” says Denisa Lambert, vice president of quality and regulatory compliance at TRIMEDX, an independent service organization (ISO). “Health systems with multiple locations require streamlined equipment management across their entire network.”
Federal regulators have acknowledged third-party service providers’ role in supporting medical device maintenance and repair. A 2018 report from the US Food and Drug Administration concluded that many third-party entities provide “high-quality, safe, and effective servicing of medical devices” and that their continued availability “is critical to the functioning of the US healthcare system.”
Selecting the right third-party service provider starts with asking the right questions—an approach that can help ensure a good fit and prevent unexpected costs, service gaps, or compliance issues.
“The best approach matches service models to organizational needs, with well-supported in-house programs typically delivering optimal service for core equipment while engaging specialized providers for targeted needs or for facilities with insufficient volume to justify full-time technical staff,” says Telford.
Certifications, service, and safety—what to dig into first
When evaluating third-party medical equipment service providers, go beyond comparing costs. Asking targeted questions about a provider’s quality management certifications, service capabilities, and patient safety practices can help ensure the provider meets both clinical and regulatory demands.
“For medical equipment rental providers specifically, it’s especially important they have a robust quality management system,” says Heidi Drafall, senior vice president of quality at Agiliti, an ISO that offers service and equipment rental services. “In fact, whether they are certified to ISO 13485:2016, the internationally recognized standard for quality management systems in the design and manufacture of medical devices, is the first question organizations should ask any prospective medical device rental or biomedical services vendor.”
Also, evaluate how well a potential vendor delivers consistent, timely service. Asking about average response times, availability of local technicians, and coverage for after-hours or emergency repairs can help determine whether the provider can minimize equipment downtime and support continuous clinical operations.
Patient safety should also be central to the evaluation process. “When evaluating third-party service providers, hospitals must pay close attention to their quality and patient safety standards,” adds Drafall. This may include reviewing the provider’s quality management certifications and incident response protocols.
- ASK: Is the provider certified to a recognized quality management standard, such as ISO 13485:2016?
- ASK: What is the provider’s average response time, technician coverage, and process for handling emergency repairs?
- ASK: What patient safety protocols does the provider follow, and how do they handle incidents or adverse events?
Check how the provider navigates OEM barriers
Some original equipment manufacturers (OEMs) restrict third-party access to equipment service materials—such as repair parts, proprietary software, or specialized training—which can create challenges for healthcare organizations seeking alternative service options. These limitations are often tied to concerns around maintaining device safety, quality, and compliance but can affect the flexibility of service arrangements for hospitals and health systems.
“At the Duke University Health System, we regularly get letters from manufacturers telling us that there are no authorized third parties that have the training needed to maintain the OEM’s equipment and do not have access to replacement parts because the
OEM will not sell those parts to an ISO,” says Ethan Hertz, clinical engineer at Duke University Health System. “However, despite that, we have found several third-party servicers who say they are able to keep the OEM equipment in good working condition.”
Because these limitations vary by manufacturer and equipment type, healthcare technology management teams should ask prospective third-party service providers how they work around restricted access and whether they have a proven track record with specific models.
“Some OEMs place restrictions on third-party service providers…in the form of lack of access to repair parts or lack of access to proprietary software and tools,” says Alec Hadley, CBET, field service manager at ReNew Biomedical, a provider of medical equipment maintenance and repair services. “This can result in slower response times for repairs and calibrations, ultimately impacting patient care.”
- ASK: How does the provider navigate OEM restrictions on parts, tools, and training—and do they have a proven track record with your specific equipment?
Know what’s covered, what’s not, and when you can walk away
Consider how the provider manages long-term cost transparency beyond the initial contract. Some providers may include hidden fees or fail to account for future expenses, leading to unexpected costs.
“Understand the asset inventory update frequency schedule (monthly, quarterly, semi-annually, etc), as this could be an unexpected increase in cost in the middle of the contract. Specify who can approve additions to the asset inventory, and determine a required sign-off procedure,” says Glenn Schneider, chief service officer at Elite Biomedical Solutions, a manufacturer of replacement parts that provides on-site service and repairs.
Schneider also emphasizes the importance of defining what qualifies as a “repair part”—which is typically covered—versus a “consumable part”—which usually isn’t. Clarifying who is responsible for each, along with confirming whether the contract includes coverage for physical damage, can help avoid disputes and financial surprises.
Clear, detailed contracts are essential for managing costs and expectations. Flexibility within these agreements is equally important. The ability to modify or terminate contracts as organizational needs change allows healthcare providers to maintain control over their service relationships and adapt to evolving requirements.
“Mutual no-fault termination options represent an important contract protection. Industry practice typically includes 60- to 90-day notice periods, allowing both parties to end relationships that no longer meet their needs while providing sufficient transition time,” says Telford.
- ASK: What is included in the contract—and how are asset changes, part classifications, and termination terms handled to avoid unexpected costs?
Don’t overlook the paper trail
Additionally, assess service documentation practices. These records are essential for operational efficiency and regulatory compliance as they provide a clear record of maintenance and repair activities.
Duke University Health System’s Hertz recommends asking prospective providers to share samples of the documentation they typically deliver after completing service. “We have run into cases where the documentation that some providers give us is not adequate to determine exactly what has been done. In addition, there should be an explicit requirement that this documentation is provided in a timely manner,” Hertz says. “We are now adding a requirement to our service agreements that a copy of the service documentation is provided to us within five business days of the work being done.”
Schneider at Elite Biomedical Solutions adds that documentation should also support compliance efforts and audit readiness. “When interviewing potential vendors, ask for sample reports for things like safety committee reporting, AEM calculation reports, root cause analysis for equipment-related incidents, or any regulatory report required during an inspection related to the equipment or services provided by the contract,” says Schneider.
- ASK: Can the provider share sample service reports—and are their documentation practices timely, detailed, and audit-ready?
Check the local track record
Some third-party service providers offer nationwide coverage, but service quality can vary by region based on factors like technician availability, response times, and expertise.
“The most important issue is how well the third-party service organization [provides] service in your particular area,” says Hertz. “While there are several companies that claim to have national coverage, we have found that they may not have a consistent level of service in all parts of the country. For that reason, it is very important to verify the capabilities of the company in your area, rather than what that company might have done for a hospital on the other side of the US.”
Conduct reference checks to evaluate a provider’s regional performance. These checks should include input from stakeholders who have directly worked with the vendor. “Ask for references of current customers and for the last two or three customers that didn’t renew their contract,” says Schneider.
TRIMEDX’s Lambert adds that it’s also important to ask about key performance metrics—such as uptime improvements, response times, and how well the provider meets service level agreements. In addition, confirm that the provider supports regulatory compliance, including requirements from HIPAA, the US Food and Drug Administration, and the National Institute of Standards and Technology.
- ASK: Can the provider share references from facilities in my region and speak to their technician coverage and response times in this area?
Evaluate cyber defenses
As healthcare equipment becomes increasingly connected, cybersecurity has become another critical consideration, as security vulnerabilities in medical devices can pose risks to patient safety and data security.
“Health systems should be asking potential providers how they handle cybersecurity threats and ensure the protection of connected medical devices,” Lambert says. “With the rise in cyberattacks targeting healthcare systems, it’s crucial to verify the provider has comprehensive cybersecurity protocols in place. This includes secure remote monitoring, proactive vulnerability management, and adherence to industry cybersecurity frameworks to safeguard patient data and ensure device integrity.”
Lambert also stresses the importance of verifying that the provider stays ahead of evolving cybersecurity threats and uses advanced security technologies—such as threat detection, encryption, and secure remote access—to protect connected medical devices and critical infrastructure.
- ASK: What cybersecurity protocols does the provider follow to protect connected medical devices, and how do they stay ahead of emerging threats?
Use data to guide vendor selection
Taking a data-driven approach to third-party medical equipment service provider selection can help healthcare organizations make more objective decisions—grounded in measurable outcomes rather than marketing claims or industry trends. According to Lambert, this leads to more successful service partnerships and better long-term outcomes.
“Hospitals should prioritize a partner with a proven track record of reliability, compliance, and proactive support,” says Lambert. “It’s essential to select a provider that not only meets regulatory standards but also delivers data-driven insights, clear communication, and scalable solutions tailored to the health system’s needs.”
When these elements are in place, working with a third-party service provider can offer operational and financial value. “Third-party service providers help reduce costs while maintaining compliance with regulatory standards,” says Renew Biomedical’s Hadley.