Can you trust used medical devices?

Refurbished medical imaging devices and the circular economy

A new standard has been published, IEC 63077, that specifies the process for ensuring the performance and safety of refurbished medical imaging equipment.

Image of a person entering a CT scan
Medical imaging devices are an essential part of our healthcare system

Healthcare costs are rising across the world. As populations age and healthcare services become available to a greater number of people, the demand for services is increasing. Maximizing the value of medical equipment by reusing it can be one way of reducing costs. Refurbishment provides a process for ensuring that used medical equipment complies with the manufacturer’s specifications.

The IEC has recently published a new standard IEC 63077, Good Refurbishment Practices for Medical Imaging Equipment, that defines a systematic process for refurbishing used medical imaging equipment. The safety and performance of the medical equipment can be guaranteed without compromising the equipment’s performance, safety specification or intended use. IEC Subcommittee 62B: Diagnostic imaging equipment, developed this standard based upon an industry specification.

Markus Braun, the Convenor for Working Group 53, which was responsible for the preparation of the standard, has participated in standardization work related to refurbished medical equipment for many years. He notes that "safety and performance are the most important aspects to be considered with medical equipment and this is no different when reutilizing used medical equipment. Refurbishment is a method to ensure the continued safety and performance of used equipment as it moves from one medical facility to another".

Medical imaging equipment, which includes X-ray, computed tomography (CT), magnetic resonance imaging (MRI) and ultrasonic equipment, requires a significant financial investment. According to Braun, "for complex and expensive equipment, it makes sense not to waste all of the inherent work and value. Generally, such equipment can be used for as long as service support is provided".

Circular economy

Interest is emerging for a circular economic model that calls for a change in current production and consumption. It reassesses how resources are managed throughout the entire lifecycle of a product from its initial design to its use, repair, refurbishment and, eventually, to the recycling of its materials.

The European Union has encouraged a shift towards the circular economy as it seeks to generate economic benefit for the region while also remaining mindful of wasting resources. In a recent report, it has noted that refurbished medical equipment is applicable to the circular economy as it "contributes to creating access to quality healthcare and growing the economy while conserving resources".

Several initiatives have been taken in Europe that address the requirements of the circular economy by maintaining products in the economic cycle for as long as possible. However, existing medical device regulations place stringent rules on the safety of the equipment. The processes defined in IEC 63077 prepare medical imaging equipment for future medical use. This allows the equipment to remain within the economic cycle while also ensuring its safety and performance as required in the medical device regulatory framework.

History of the standard

IEC 63077 is the final milestone in a process that started more than 10 years ago. Braun notes, "it began with an agreement by international industry associations to develop a document setting out the basic requirements for refurbishment. The aim was to ensure that the refurbished medical imaging equipment is safe and performs as when it was new".

Without such requirements in place, many national regulatory authorities have placed bans on the import of refurbished medical equipment given the questions regarding their quality and safety. According to Braun, "these bans usually fail to distinguish between high-quality refurbishment based on the original manufacturer’s specifications and used equipment of undefined quality, with the effect that patients could be denied access to safe and economical medical equipment".

COCIR, the European trade association representing electromedical industries, recognized the need to address the regulatory vacuum on refurbishment. It issued a Green Paper in 2007 followed by a so-called COCIR Industry Standard entitled Good Refurbishment Practices in 2010. The industry standard was also adopted by the US-based medical imaging association Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), and submitted to the IEC where it became a Publicly Available Specification (PAS) in 2016.

In October 2017, the US National Committee proposed a new work item to promote IEC PAS 63077 to become a normative standard. Using their knowledge of quality assurance for refurbishment, the experts in WG 53 successfully completed the process of standardizing IEC 63077 in less than two years’ time. WG 53 benefitted from the support of the Japan Medical Imaging and Radiological Systems Industries Association (JIRA).

In addition, ISO standards have also been considered in IEC 63077, such as those linked to quality management (ISO 13485) and risk management (ISO 14971).

A growing market

The refurbishment of medical imaging devices has been an established practice for nearly two decades. According to analysts, the market for refurbished medical equipment is growing and will exceed USD 16 billion by 2024. The North American market, comprised of the United States and Canada, represents the largest market for refurbished medical devices and is projected to have high growth rate in the coming years.

According to Braun, "refurbishment addresses the high demand for affordable and reliable products. Customers of refurbished medical imaging equipment are not only small hospitals with limited budgets but also leading medical institutions. Refurbishment is a well-established element of the global healthcare economy".

As an international standard, IEC 63077 allows companies to get certified through an auditing process to check the integrity of the refurbishment process. "This standard is intended to give regulators confidence on the well-established processes in the refurbishment", concludes Braun.