Clinical engineering
OEM Maintenance HIGH RISK
Part A – 0 = No 1 = Yes Does the device have potential to cause electric shock under fault conditions? (No physical damage) Does the calibration drift, i.e. out of manufacturer’s tolerance (if digital circuitry – it’s a ‘No’)? Is periodic maintenance required by the manufacturer? Are there maintenance parts that require replacement by a qualified engineer as part of the PPM schedule? Does the device require a pre-use check? Does the device require electrical safety testing? If the device stops functioning during use, will it cause harm?
Total
Part B – 0 = unlikely; 1 = likely Failure will impact on service delivery and reputation? Not carrying out planned maintenance breaches regulations? Are there maintenance parts that require replacement by a qualified engineer as part of the PPM schedule? Does the device require a pre-use check? Does the device require electrical safety testing? If the device stops functioning during use, could it cause harm?
Total Part A * Part B: risk score Figure 3
including reconditioning and refurbishment. The healthcare organisation is responsible for ensuring their medical devices are maintained appropriately. This includes:
l How each device should be maintained and repaired, and by whom.
l Arrangements for maintenance and repair to be included as part of the assessment process.
l Arrangements for the most suitable persons/ providers to carry out the work.
l Arrangements to ensure items subject to inspection, maintenance, repair or disposal should be decontaminated beforehand.
l The timescale for planned maintenance. l The timescale for repairs to be completed. l Maintenance databases are validated for their intended use and functionality.
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 (Medicines & Healthcare products Regulatory Agency, 2021, p. 25).2
What do I pick out from the MRHA guidance? The overriding message from the regulator is to ensure that the healthcare organisation has a policy that specifies what maintenance must be carried out, and how. It does not say you must maintain annually – it leaves the decision making to the organisation, but it must be justifiable.
The regulator (MHRA) requires: l Random audits should be carried out on all
elements of maintenance, repair, record generation and storage to ensure that the correct procedures are in place and being adhered to.
l Audits should be carried out by staff with appropriate knowledge and experience of managing medical devices.
The healthcare organisation should ensure that there is a mechanism to obtain regular feedback from all users of the device on the repair and maintenance process (Medicines & Healthcare products Regulatory Agency, 2021, p. 26).2 There will always be devices, such as anaesthetic machines, that require scheduled maintenance. They are high risk devices that need to have parts replaced on a regular basis to ensure the machine remains safe and clinically operational. On the other end of the scale are low risk devices, such as nerve stimulators. A battery-operated device that can be easily checked by the user before use. As medical equipment becomes safer and more reliable, healthcare technology managers must regularly re-assess the best use of their limited resources. If the risk is deemed acceptable to stop carrying out planned preventative maintenance, then it allows resources to be focused on the higher risk assets, which usually also have the greatest impact on service delivery and organisational efficiency.
References 1. Resuscitation Council. (2019). A guide to AEDs. London: Resuscitation Council UK and British Heart Foundation.
2. Medicines & Healthcare products Regulatory Agency. (2021). Managing
Medical Devices. Retrieved from https://
assets.publishing.service.gov.uk/ media/6089dc938fa8f51b91f3d82f/Managing_ medical_devices.pdf
Class 1 – Applied parts, e.g. anaesthesia machine
1
0 1
0 1 1
0 4
Class 1 – Applied parts, e.g. anaesthesia machine
Likely? 1
1 1 1 1
5 20
Site Maintenance MEDIUM RISK
Class 1 – No applied parts, e.g. bed frame.
1
0 1
0 1 1
0 4
Class 1 No applied parts, e.g. bed frame.
Likely? 1
1 1 1
0 4
16
Class 2 – Applied parts, e.g. patient monitor
0
0 1
0 1 1
0 3
Class 2 Applied parts, e.g. patient monitor
Likely? 1
0 1 1
0 3
9
User checklists only LOW RISK
Class 2 – No applied parts, e.g. nebuliser
0
0 0
0 1
0 0 1
Class 2 No applied parts, e.g. nebuliser
Likely? 0
0 1
0 1
2 2
Class 3 battery operated, e.g. nerve stimulator
0
0 0
0 1
0 0 1
Class 3 Battery operated, e.g. nerve stimulator
Likely? 0
0 1
0 0 1 1
About the author CSJ
John has been chairman of EBME (www.
ebme.co.uk) since 1999. He is recognised as an expert in his field of healthcare technology management. John is a senior research fellow at Middlesex University. He has been instrumental in changing device management policies and processes at many NHS and private healthcare organisations and has many years’ experience of equipment management and maintenance, which includes: biomedical, diagnostic imaging, endoscopy and pathology. In addition to a proven track record in delivering improvements that advance regulatory compliance and patient care, John is also Chairman of the charity My Bridge International, a Trustee of The Amalthea Trust, and Executive Advisor, at MTS Health.
January 2024 I
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