AXREM Statement – Why Customers Must Maintain Equipment
06 May 2025
AXREM members understand the difficulties in making equipment available for routine service (preventative maintenance) given the demands for patient throughput. However, the need to maintain equipment, at the intervals specified by the manufacturer, is essential to ensure medical devices and associated equipment are safe, reliable, and perform as intended (i.e., meet their performance specifications). This is underpinned by the following requirements for healthcare providers:
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 15:
- a. The intention of this regulation is to make sure that the premises where care and treatment are delivered are clean, suitable for the intended purpose, maintained and where required, appropriately located, and that the equipment that is used to deliver care and treatment is clean, suitable for the intended purpose, maintained, stored securely and used properly. Providers retain legal responsibility under these regulations when they delegate responsibility through contracts or legal agreements to a third party, independent suppliers, professionals, supply chains or contractors. They must therefore make sure that they meet the regulation, as responsibility for any shortfall rests with the provider. NOTE: The CQC cannot prosecute for a breach of this regulation or any of its parts, but they can take regulatory action. The CQC must refuse registration if providers cannot satisfy them that they can and will continue to comply with ‘Regulation 15’.
- MHRA guidance of “Manging Medical Devices 2021” clause 8.1:
- a. The healthcare organisation’s medical device management policy must cover the provision of maintenance and repair of all medical devices, including reconditioning and refurbishment. The healthcare organisation is responsible for ensuring their medical devices are maintained appropriately. The frequency and type of planned preventive maintenance should be specified, in line with the manufacturer’s instructions and taking account of the expected usage and the environment in which it is to be used.
- Health & Safety at Work Act 1974; in particular:
- a. the provision and maintenance of plant and systems of work that are, so far as is reasonably practicable, safe and without risks to health
- Provisions and Use of Work Equipment Regulations 1998, which require that:
- a. all work equipment be maintained in an efficient state, in efficient order and in good repair
- b. where any machinery has a maintenance log, the log is kept up to date
- c. maintenance operations on work equipment can be carried out safely
- Medical device manufactures instructions for use (IFU) always stipulates that routine maintenance is required to keep the device in a safe and regulatory compliant condition. Failure to adhere to this requirement means the device is not being used in accordance with the specified intended use, which leaves the device owner open to litigation in the case of any incident.
Therefore, please do not delay routine maintenance or ignore requests to book such visits. This is also extended to any requests to book safety or performance updates that are the subject of field corrective action notices. Safety, performance, and reliability of medical devices are paramount to AXREM members, so please support swift booking of work when requested.
Download the statement here