Nicole Denjoy
COCIR Secretary General,
European Coordination Committee
of the Radiological,
Electromedical and Healthcare IT Industry (COCIR), Brussels, Belgium
Increased interest in refurbished medical equipment led COCIR to launch the first industry standard on the refurbishment of medical equipment (Good Refurbishment Practice; GRP). The drivers behind setting up this standard include:
- Hospitals striving to advance their technology before the end of the useful life of their equipment
- Governments working to extend healthcare coverage to their citizens within challenging budgetary parameters
- Policymakers and providers wanting to act more responsibly and sustainably.
Yet, despite these drivers, countries around the world differ greatly in how they handle secondhand equipment. Regulations are vague, resulting in wide variations in the standards of equipment on the market.
The GRP Standard aims to provide guidance to both customers and policymakers as they assess the role of refurbished equipment in their overall healthcare plans, while clearly differentiating and defining high-quality refurbishment.
To understand the need for refurbished equipment and how the COCIR standard begins to address the issue, we need to look in more detail at the underlying drivers.
Hospitals
As technology continues to evolve in the healthcare sector, capital assets are replaced before the end of their useful life, creating a cascade of trade based on the residual value of the original asset. To facilitate the sale of the new, higher technology product, the customer receives a value for the previous-generation product. COCIR members follow the GRP process to ensure the used product goes back onto the market in a safe and effective manner.
Governments
Governments are struggling with how to provide adequate healthcare cover to their people within their budgetary margins. GRP refurbished products are an excellent choice because the customer receives the benefit of high-quality products processed with safety and effectiveness checks and with the added benefit of a lower price compared with new systems.
Policymakers
Conserving assets is a fundamental principle of ecological thinking in a recycling economy. This approach facilitates the reuse of pre-owned medical equipment by those with less investment possibilities. Reintroducing refurbished equipment into the market, and therefore making use of existing resources while also saving energy, is not only more eco-friendly but also promotes the long-term goal of sustainability.
For example, average refurbished X-ray medical equipment is processed with 73% less energy compared with new X-ray equipment. Refurbished medical equipment contributes to a resource-conserving economy through proven energy savings and helps reduce environmental degradation.
The GRP standard is based on the experiences of COCIR member companies with global refurbishment operations. Refurbishing medical equipment is a sophisticated process, which, if not done correctly, can pose risks to patients and users.
It sets out requirements for quality, safety and effectiveness in the refurbishment of medical equipment. The GRP Green Paper, first released in late 2007, shows how COCIR member companies that are manufacturers themselves, apply these requirements in refurbishing their own equipment. The end result is a refurbished product that is as safe and effective as when it was first introduced to the market.
The five steps of the GRP
The definition of refurbishment, that is: “All actions shall be performed in a manner consistent with product specifications and service procedures defined by the manufacturer for that type of medical equipment (ME) system without significantly changing the finished ME system’s performance, safety specifications and/or changing intended use as in its original registration”, sets the basis for the five-step GRP process defined in the GRP Green Paper.
Selection of used equipment
Not all used equipment is suitable for refurbishment according to the GRP requirements. Generally, the selection of used equipment is based on the principle that the used system can be refurbished to the same quality, performance, safety and intended use as when it was new. Condition, product lifetime and availability of spare parts are some of the considerations during the selection process for a refurbished product.
Disassembly, packing and shipment
To ensure that the system will not be damaged during disassembly, the refurbisher must ensure that it will be in the same condition after disassembly as before.
Refurbishment process
This step of the process varies depending on the type of equipment.
The system configuration must be defined either by the refurbisher themselves or according to a customer order.
The final configuration of the refurbished system must be within the scope of the manufacturer’s original product registration when the system was produced and put on the market for the first time.
The refurbisher must follow specific validated procedures and acceptance testing to ensure the performance and safety of the product.
Reinstallation of refurbished equipment
Equipment processed according to the GRP Standard is intended to meet original quality, performance and safety standards, so it is essential to follow original manufacturer installation procedures, including site planning and preparation works.
Professional services
A buyer or user of GRP-processed equipment can expect after-sale services and support that is identical to that for new systems. Therefore, a GRP refurbisher will ensure that professional services and support are provided over the planned lifetime of the refurbished equipment.
Conclusions
Through the COCIR Industry Standard on GRP and the GRP Green Paper, which describes how COCIR member companies apply these requirements, COCIR aims to educate and provide confidence in GRP refurbished products to patients, healthcare service providers and governments, based on a thorough process that results in a used device that is as safe and effective as when new.
