Clinical engineering
therefore these high-risk devices should be on a planned maintenance schedule.
Risk Evaluation
Inspection, calibration and replacing parts. There are also high-risk devices that require replacement parts, as part of the inspection and calibration process. This is the deepest level of planned maintenance. For example, this could be annually replacing parts on an anaesthetic machine, as well as the calibration and inspection checks. Many healthcare organisations ‘blanket test’ their medical equipment and end up failing to achieve the scheduled maintenance goals due to lack of resources. I often hear the phrase “we are firefighting”, meaning that they are not delivering against their own maintenance targets. One way to improve an organisation’s key performance indicators is by creating a risk assessment tool for maintenance. Risk-based maintenance prioritises maintenance resources toward assets that carry the most risk if they were to fail. It is a methodology for determining the most economical use of limited resources. This approach is used so that the maintenance services across the organisation are optimised to minimise risk and maximise efficiency. Once the inventory data is collected, a risk- based maintenance strategy is based on two main elements: a) The risk evaluation b) The maintenance plan (based upon the risk evaluation for high, medium and low devices)
When considering how to carry out medical equipment maintenance, managers often face complicated decisions. These complications increase when they must reflect on their conflicting objectives – such as clinical need, technical resources, cost, risk, and customer expectations. Managers should consider whether regular scheduled maintenance benefits patient safety and/or clinical efficiencies. Assets that carry a lower risk
Collect data Medium risk Low risk Figure 1
are subjected to less stringent maintenance. Implementing a risk-based maintenance process means that the total risk of failure is minimised across the organisation in the most economical way. The development of smarter maintenance strategies for medical equipment can deliver improved efficiencies, lower costs, and better use of staff time. When reviewing an inventory of medical equipment, managers must decide how often, if ever, regular planned preventive maintenance is needed. These decisions must be pragmatic. Healthcare organisations have finite budgets and resources. Some organisations unnecessarily maintain equipment. There are some organisations where medical equipment is routinely stripped down to carry out unnecessary testing. These outdated practices date back to the 1980s when medical equipment being used contained analogue components with circuits that could drift out of tolerance, due to the nature of those component and the circuit designs. Since those times, medical equipment has become digital, with built-in internal ‘watchdog’ circuitry that is designed to keep the equipment within set calibration tolerances. Product reliability has been constantly improving, with many devices now being sold as ‘maintenance free’, but many clinical engineering departments carry out planned inspections and calibration checks on maintenance free devices.
To routinely maintain or not? Some medical equipment does require periodic routine maintenance and calibration checks, but many don’t. The reason for maintenance is to ensure equipment is safe and available for clinical use. It can also improve the reliability and sometimes extend the life of devices. If devices are not maintained, there should be a risk evaluation to show there in no risk for patients or clinical users. 1. Does the service manual specify that a service is necessary or recommended?
l If necessary, it must be done. l If only recommended it can be assessed for need and risk.
Consequence factor Figure 2 50
www.clinicalservicesjournal.com I January 2024
2. What is the likelihood of increased risk (without testing)?
l Is there any need to electrically safety test?
l i.e. double insulated equipment / physical inspection only?
l Unnecessary calibration testing of digital devices with built in ‘watchdog’ circuitry. l Is there an actual risk associated with calibration drift that will make the device fail or become unsafe?
When making decisions, managers must look at the complete picture. This will include the impact on: l Clinical services l Technical performance l Scheduled maintenance activity l Resources l Costs
There are many different types of medical equipment, but many of these can be allocated into common technology groups related to the clinical use of the equipment. For example, an electrocardiograph (ECG) is used for monitoring the activity of the heart and is one type of technology group. There can be many ECG machines, of different makes, models, and age, that are all fulfilling the same functionality. Should we stop testing medical equipment that is deemed by the manufacturer to be maintenance free and relatively inexpensive to replace? For example, a simple ward based electronic automatic blood pressure machine. These blood pressure devices could be left off the scheduled testing and be re-classified as ‘repair only’. Every technology group should be evaluated to decide whether the equipment should or should not be maintained. From a financial standpoint this approach can deliver cost savings. Additionally, it eliminates placing the item on the maintenance schedule and the associated record keeping functions that go along with that. Figure 3 is a simple example of a risk matrix
to illustrate whether devices should be checked by the user, or also require scheduled testing by a clinical engineer.
What do the regulators say? The healthcare organisation’s medical device management policy must cover the provision of maintenance and repair of all medical devices,
High risk
Likelihood factor
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