From the Guidelines
Medical equipment is generally serviceable even if you did not purchase it directly from the manufacturer, but it is crucial to ensure that any service provider is properly certified and follows regulatory standards, as emphasized in the European Union's revised guide to the clinical evaluation of medical devices 1. When considering the serviceability of medical equipment, it is essential to weigh the potential risks and benefits. The European Commission's revised guide highlights the importance of performance data, including sensitivity, specificity, and reproducibility, in the clinical evaluation of medical devices 1. This suggests that medical equipment can be serviced by third-party providers, as long as they adhere to these standards. Some key considerations include:
- Checking if servicing by non-manufacturer technicians would void any remaining warranty
- Ensuring that service providers are properly certified and follow regulatory standards, such as those outlined in the European Union's Regulations on in vitro diagnostic devices 1
- Researching the reputation and credentials of any service provider before proceeding
- Maintaining documentation of all maintenance and repairs for compliance purposes, as recommended by the Association of Anaesthetists of Great Britain and Ireland 1
- Considering manufacturer servicing for life-supporting or critical diagnostic equipment to ensure proper functionality and safety.
From the Research
Medical Equipment Serviceability
- The serviceability of medical equipment is not necessarily dependent on whether it was purchased from the manufacturer or not 2.
- A study found that 72% of out-of-service medical equipment in resource-poor hospitals could be placed back into service without requiring imported spare parts, using only locally available materials and basic knowledge in six domains: electrical, mechanical, power supply, plumbing, motors, and installation or user training 2.
- However, the lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices, including those cleared through the 510(k) process, can make it difficult to determine the serviceability of certain medical equipment 3.
Maintenance and Repair
- The assessment of medical equipment condition is an important activity during maintenance and management to increase availability, performance, and safety 4.
- A systematic review identified eight categories of medical equipment reliability attributes, including equipment features, function, maintenance requirement, performance, risk and safety, availability and readiness, utilisation, and cost, which can be used to assess the reliability of medical equipment 4.
- Nursing practice requirements for meeting the challenges of the Safe Medical Devices Act include identifying and reporting medical device-related incidents and tracking medical devices through the user facility 5.
Accessibility and Availability
- Accessible medical equipment for patients with disabilities is often lacking in primary care clinics, with practice administrators' lack of knowledge about accessible equipment being a significant factor 6.
- The cost of accessible medical equipment may also be a barrier, although this was not conclusively determined in one study 6.
- Educating practice administrators about the availability and importance of accessible equipment is necessary to improve the accessibility of medical equipment for patients with disabilities 6.