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Regulations around Refurbished and Pre-owned Devices
Medical devices are regulated by several governmental bodies to ensure patient safety. Refurbished and pre-owned devices must meet the same safety and efficacy standards as new devices. The main regulatory bodies that oversee pre-owned medical devices include:
– US Food and Drug Administration (FDA): The FDA regulates both new and pre-owned devices to ensure they are substantially equivalent to the original device model. Refurbished devices must go through the same review process as new devices for safety and effectiveness.
– European Union Medical Device Regulation (EU MDR): The EU MDR regulates medical devices placed on the EU market, including refurbished devices. Refurbished devices are subject to the same conformity assessment procedures as new devices to verify they meet essential requirements for safety and performance.
Cost Savings Without Compromising Quality
One of the major appeals of pre-owned medical equipment is the significant cost savings compared to purchasing new devices. While new technologies continue advancing, older devices remain fully functional for their intended use. Refurbishing extends the usable lifetime of devices while offering a more affordable option. Some estimates indicate pre-owned devices can be 30-50% cheaper than identical new models. This cost differential is substantial for health systems working within tight budgets.
Rigorous Refurbishment and Certification Processes
For hospitals and patients to feel confident in pre-owned devices, refurbishment must be a rigorous process restoring devices to like-new condition. Leading medical equipment refurbishers use trained technicians and original manufacturer replacement parts when possible. Every system, circuit, and component is inspected, cleaned, repaired or replaced as needed.
Refurbishers also perform extensive testing to verify all device functions meet original specifications. Testing may involve electrical safety, radiation output, imaging quality, and functional performance standards. Any device failing to meet specifications is not released for resale. Refurbished devices also come with a warranty matching new devices to give customers peace of mind.
Strict Quality Standards Throughout Lifecycle
Major refurbishers maintain stringent quality management systems comparable to original manufacturers. Their facilities and processes are ISO certified to ensure consistent, high-quality work. Pre-owned devices have documented service histories and any prior issues are addressed during refurbishment. Serialized tracking systems allow full traceability of each device through acquisition, refurbishing, distribution, and final sale.
Rigorous change management and configuration control prevents mix-ups and ensures the correct device model, options and accessories are handled as a full system. Customers receive comprehensive operating and service manuals just like new devices. Strict transport and handling specifications protect devices in transit. Overall, refurbished medical equipment undergoes a more rigorous “re-manufacturing” process than a simple overhaul.
Expanded Access to Critical Technologies
As new technologies cycle through hospitals and medical offices, pre-owned medical equipment helps keep older but still dependable technologies in circulation longer. This expanded access benefits uninsured or under-insured patients who might not otherwise receive needed care due to cost barriers. It also ensures technologies remain available in rural areas or developing countries that cannot afford every new advancement.
Pre-owned options may provide access to specialized technologies like MRI, CT, or ultrasound machines for clinics and hospitals that could not initially justify the high expense of new capital equipment purchases. Refurbished devices keep hospitals equipped and able to deliver appropriate types of diagnostic imaging and treatments that benefits patient outcomes.
Growing Role in Sustainable Healthcare
Along with cost savings, pre-owned medical devices promote more circular, sustainable approaches within healthcare. Refurbishing conserves valuable resources by recovering maximum value from existing medical technologies through repair and upgrades. It reduces waste generated by devices discarded prematurely due to being fully depreciated but still functional.
A robust secondary market for refurbished medical equipment lessens reliance on energy-intensive new manufacturing. It cuts transportation and packaging impacts compared to shipping new devices globally. Overall, pre-owned devices align with the healthcare industry’s increasing focus on environmentally responsible operations and reductions in clinical carbon footprints over the long run.
Safety Assured with Rigorous Refurbishment
While medical products must always put patient safety first, refurbished devices can deliver this standard of care at a lower cost point when properly handled. Studies show failure rates of refurbished medical equipment do not meaningfully exceed those of new devices. With full documentation, testing and quality assurance programs in place, there is no compelling evidence refurbished products pose any elevated safety risks.
Proper refurbishment is as much an exercise in quality management as technical restoration. The most reputable refurbishers treat each incoming device as an opportunity to add value through repair, upgrades and rigorous functional confirmation. Their goal matches that of original manufacturers—ensuring technologies perform reliably and benefit patients for years to come, regardless of devices’ prior usages and service lives. For hospitals seeking lower acquisition costs without compromising standards of care, well-refurbished pre-owned medical devices present a viable and responsible purchasing option.
*Note:
- Source: Coherent Market Insights, Public sources, Desk research
- We have leveraged AI tools to mine information and compile it
