The Role of Remanufacturing and Servicing in Medical Devices

Understanding Remanufactured Medical Devices

Remanufacturing of medical devices means according to 21 CFR Part 820.3(w) "To process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance"
In short this means that whenever you do to a device that affects its performance, falls under remanufacturing. It is considered to be a different activity than servicing. 

A key reason and benefit for remanufacturing medical devices is reducing the cost for healthcare. However, this also comes with the risk that the original safety and effectiveness might be compromised. This is why there are clear guidances such as the one by FDA, that instruct organizations that remanufacture medical devices. 

Furthermore there is a considerable impact on waste management and the environment when the amount of single-use devices can be reduced. The NHS shares in its report from May 2023 that 62% of the NHS carbon emission occurs in the supply chain. It aims to reduce this by implementing 13 measures, including promoting remanufacturing of medical devices.

In order to understand the benefits and risks related to remanufacturing, it's important to understand the process itself.

The Remanufacturing Process

Remanufacturing processes of medical devices involve restoring used devices to like-new condition, ensuring they meet original equipment manufacturer (OEM) specifications and regulatory standards. This process includes thorough cleaning, disassembly, inspection, and replacement of worn or defective components with new or refurbished parts.

Advanced diagnostic testing is performed to verify the device's functionality and safety. Once reassembled, the devices undergo rigorous performance testing to ensure they meet the same standards as new devices. Quality control is key, with remanufactured devices undergoing stringent validation processes to guarantee they are safe and effective for clinical use. This approach not only extends the lifespan of medical devices, reducing medical waste and environmental impact, but also offers cost savings for healthcare providers.

By adhering to regulatory guidelines, remanufactured medical devices provide a sustainable, reliable alternative to purchasing new equipment. The remanufacturing process supports the circular economy by minimizing resource consumption and promoting the reuse of valuable materials, ultimately contributing to more sustainable healthcare practices.

Applications of Remanufactured Medical Devices

Many medical devices can be remanufactured. Some examples are surgical equipment and patient monitoring devices, each contributing significantly to healthcare delivery.

• Surgical Equipment: Remanufactured surgical equipment, such as surgical instruments and devices, are integral to operating rooms worldwide. These include tools like scalpels, forceps, and endoscopic instruments, as well as complex devices like surgical robots and electrosurgical units. The remanufacturing process involves thorough cleaning, disassembly, inspection, and replacement of any worn or damaged components, followed by rigorous testing to ensure safety and functionality.

• Patient Monitoring Devices: Continuous patient care is significantly enhanced by remanufactured patient monitoring devices, such as vital signs monitors and infusion pumps. These devices are crucial for monitoring patients' heart rates, blood pressure, oxygen levels, and administering medications or fluids accurately. The remanufacturing process for these devices includes comprehensive functional testing, software updates, and replacement of any worn-out parts to ensure they operate reliably and safely. For instance, remanufactured vital signs monitors provide real-time data that is essential for managing critically ill patients in intensive care units (ICUs). Infusion pumps, which are used to deliver controlled amounts of fluids and medications, must function with high precision to avoid dosing errors. By opting for remanufactured patient monitoring devices, healthcare providers can maintain high standards of patient care while managing costs effectively. These devices also contribute to the continuity of care in resource-limited settings where access to new equipment may be restricted due to financial constraints.

These examples show that there are benefits in remanufacturing medical devices. However these benefits also compare to certain risks.

Benefits and Challenges

In general, remanufacturing of medical devices has benefits in terms of reducing waste and lowering the impact on the environment, but as well in reducing costs and making healthcare solutions available in more markets. According to a publication by the WHO, there is an opportunity for low- and middle-income countries for both having more access to devices, but as well to diversify into this sector.

However, there are several challenges as well that come with the remanufacturing of devices. First of all there is the question of responsibility. When bringing a medical device to the market, the manufacturer of that device has the responsibility over its safety and performance. It's the manufacturer that needs to ensure that all regulatory requirements are fulfilled. When remanufacturing takes place, one can ask the question whether that responsibility should be fully transferred to the remanufacturer or whether it should be a shared responsibility and how that would be arranged from a regulatory point of view. This is where clear regulatory guidances and instructions are paramount. Not only to ensure the continuity in the supply chain but also to ensure all actors are aware of and take their responsibilities.

Another challenge is that when it comes to medical devices, the label of remanufactured or refurbished is not always perceived well. It could be that patients and users doubt whether the same level of quality can be maintained. Also here, clear regulatory requirements and testing  are needed.

Regulatory Considerations of Remanufactured Medical Devices

In general, most countries allow remanufacturing of medical devices and import of such devices, but they will have to comply with the same regulatory requirements as new medical devices. This means for Europe that refurbished medical devices need to comply with the requirements of the 2017/745 Medical Device Regulation. In the US, a remanufactured medical device similar to a new medical device must possess a relevant premarket clearance or authorization to be placed on the USA market e.g. 510(k) premarket notification for class II (that is, devices with moderate to high safety risk) or a premarket approval for class III (that is, devices with high safety risk).

As mentioned before, certain regions like the US, have specific guidance documents regarding the good practices and expectations of remanufacturing of medical devices. There are standards such as IEC 63077:2019 which describe good remanufacturing practices.

In general, there are quite some benefits in remanufacturing medical devices, but the industry can benefit from more extensive and harmonized regulatory guidelines.

Future Trends and Opportunities of Remanufactured Medical Devices

Remanufacturing of medical devices got a global boost during the COVID-19 pandemic. This specific has grown very fast during that time. However, there is little reason that remanufacturing of medical devices is going to decrease again.

Healthcare costs continue to rise, increasing the need for affordable medical equipment. This is one area where remanufacturing of devices can contribute.

As technology advances, there are more and more possibilities to better refurbish medical devices, which adds to a higher quality and more reliability. This will also contribute to more acceptance of these products and growing this market.

With more and more focus on the environment, also here remanufacturing of medical devices is a way for hospitals and healthcare facilities to reduce waste.

Taking into account the positive impact on both the availability of medical equipment to patients everywhere and the positive impact on the environment, it's very probable that the market of remanufacturing of medical devices will continue to grow in the future.