IPSM Meeting on Medical Equipment Management, York, May, 1995

This meeting was attended by three Irish delegates: Fran Hegarty, Brendan Tuohy (St. James’s Hospital) and Meabh Smith (Beaumont Hospital). It was an interesting meeting at which both Brendan and Fran presented papers. Their work was well received and in general, the Irish presence at the meeting was welcomed. I have summarised all the presentations of the day and hope that you will find them interesting.

Medical Equipment - Standards and Faults - An Anaesthetist’s View Presented by Dr. Peter Thompson

Dr. Thompson spoke on some of the implications of the Medical Devices Directive. He pointed out that the CE symbol has been obligatory on all active implantable devices since 31st December, 1994. This will be the case for all medical devices from January 1998 and we are already in the phase-in period. It was noted that harmonized standards which have been published in the Official Journal of the European Community supersede national standards. While standards are voluntary, directives are law.

An In-House Audit of Service Contracts on Mobile X-Ray Equipment B.Tuohy

An audit of Mobile X-Ray systems and their service contracts was performed. It was noted that the cost of service contracts was equivalent to just 3.3% of the capital cost of the equipment. This is a relatively small cost and required further interrogation. Quality Assurance (QA) procedures were carried out on the relevant equipment and it was found that there were some important shortfalls in the equipment performance. It was concluded that the reason for the low cost of service contracts was that the time spent on a service was inadequate and the line between Preventative Maintenance (PM) Services and QA routines should be well defined.

From the discussion following this presentation it became obvious that there is a need to audit PM services; that the details of the work to be done according to the service contract are known to in-house technical staff and it was suggested that a ‘tick-box’ form be completed by the engineer carrying out the service, so that it is known that for example, Half Value Layer has been measured.

A Strategy for Infusion Device Management V. Wotherspoon

Infusion devices make up about 70% of the electro-medical assets in a large hospital. In the last 5 years 445 incidents involving infusion devices have been reported to the Medical Devices Agency. Infusion Devices are classified as ‘high risk’ by the FDA. This presentation was based on a Risk Analysis carried out according to BS EN 1441 Medical Devices (DRAFT).

Identification of the quality and quantity of devices was carried out. This involved such considerations as intended use, device ageing, environmental interference, essential consumable, routine maintenance and calibration.

Identification of hazards included electrical, biological, environmental, user and functional.

Each hazard was assessed as low, medium or high. The greatest hazard was found to be the user. The Risk analysis emphasised the importance of anti-free-flow devices.

Three main proposals were made for Risk Reduction: the implementation of a device purchase procedure, improved operator training and the implementation of maintenance programs. The importance of incident reporting and therefore the need for a forum for clinical staff to report such incidents was also emphasised.

A purchasing policy should cover the three types of infusion devices: volumetric pumps, syringe pumps and ambulatory pumps. Depending on the needs of the user, several options should be offered to the clinician for each of these categories and he should choose from these options. The recommended service interval was discussed. If the manufacturer stated that no regular maintenance was required, then none was performed.

It was concluded that periodic operator training was more necessary than improved servicing protocols. To this end, St. James’s Hospital, Leeds are in the process of employing a nurse who will have responsibility for the training of hospital staff in the operation of various infusion devices.

The Establishment of an In-House Equipment Management Programme for Flexible Endoscopes Fran Hegarty

This presentation commenced by noting that in 1989, the 23 endoscopes in St. James’s Hospital, Dublin were costing more to maintain than CT. A major purchase was being made at that time and the possibility of in-house management of the scopes was investigated. One of the main disadvantages was the inability to provide loan scopes in the event of breakdown. The envisaged advantages included user support and shortened down-time.

The department of Medical Physics and Bioengineering was involved in scheduling the equipping of the endoscopy unit, writing specifications, evaluation of tender replies, commissioning and user training. The cost of maintenance of the equipment from 1993-1996 was examined. The suppliers proposed service contracts of the order of £1.4 M. To date, the cost of service including much in-house work is £0.61 M. A large cost-saving has been achieved. Many hidden benefits which have resulted include: user support, special projects, reduced down-time, research and training and the wider national impact of having skilled staff in-house (i.e. keeping service costs down for all).

Mr. Hegarty was questioned on Medico-legal implications of carrying out major repairs in-house. It was felt that it was of utmost importance to make hospital management aware that work previously done by commercial companies was now being done in-house. One contributor suggested that a portion of the money saved by minimally invasive surgery should be channelled back into maintenance and user support for the equipment involved.

Reliability Centred Maintenance as a Technique for Optimising Planned Maintenance J. Worsley, AEA Technology

This was the only commercial presentation at the meeting. This consultancy company was previously based in the Nuclear Power industry but is currently expanding into other areas. The presentation reflected the growth in consciousness of liability in the UK.

Scheduled Maintenance - The Unscientific Approach P. Bourne

This presentation also looked at the maintenance of infusion devices. Again it was noted that they are high risk devices and that there is a shortage of information regarding incident reporting. The speaker questioned the choice of the ‘magic’ 12 months service interval and drew parallels between service requirements for medical equipment and in the aviation and automobile industries. He noted that in aviation a maintenance factor is built into the design, that is, in the design and development of new aircraft, maintenance requirements are considered at all stages, while for electro-medical equipment it often appears that maintenance is only considered as an after-thought. The value of a document known as MSG3 was high-lighted. This document relates to the identification of an appropriate service interval for scheduled maintenance of aircraft, however, much of the recommendations could equally be applied to electro-medical equipment.

The service interval should be acceptable to the regulatory authority, to the operator and to the manufacturer.

It was recommended that at least an inspection and functional check of all equipment be carried out after a certain interval. A fault should only be acted upon if reduced resistance to failure is detectable. A consistent interval between deterioration and failure should be identified. A task carried out to repair a fault must reduce the risk of failure. The resulting risk must be acceptable.

Identification of the interval between checks should be based on prior knowledge from similar systems, the manufacturer’s test data and a working group of experienced personnel.

Electricity at work regulations require regular inspection of all electrical appliances and records must be maintained to monitor the condition of equipment. It was noted that electrical safety does not equal patient safety.

Minimal maintenance requires regular contact with all equipment, check of calibration, and check of equipment before allowing it to go out of warranty. This has implications for yearly financial planning. The risks associated with infrequent maintenance include loss of QC, failure of inventory, liability to claims of negligence. The speaker proposed that a ‘base-line’ should be developed for all electro- medical equipment maintenance; that cost-savings should be made through the establishment of a service, that the manufacturer’s agreement be reached if the service interval is not equivalent to that which is recommended; a 6-month interval is a good start.

Assessing Service-Level Requirement - The Scientific Approach P. Jones

This speaker presented some statistics regarding faults on defibrillators. It was noted that most faults found by technicians could not have been found by the user. This fact once again emphasised the importance of scheduled maintenance.

Preventative maintenance protocols must involve the clinical user. This work involved selecting 100 items of electro-medical equipment with at least three year’s service history. Each piece of equipment was assigned a weighting factor based on its complexity, age, history, and clinical use. A theoretical service interval was calculated. The theoretical service interval was compared to what is actually done and the manufacturer’s recommended interval. There was good correlation between what is actually done and the theoretical value. However, comparison with the recommended service interval implies that manufacturers recommend a service interval which is shorter than necessary. The speaker emphasises that these were preliminary results and further work remained to be done.

Discussion

The following points were made by various speakers in the course of discussion:

When involved in the purchase of electro-medical equipment, do not assume the responsibility of getting what the clinician wants, but investigate the market and inform him of what is available given current standards. Agree on the proposed purchase with the clinician.

Very few accidents occur due to electrical safety failures. Regarding risk assessment, if nothing is done, then in terms of liability and accountability, the situation is disastrous. If you do something but do not meet the manufacturer’s service recommendations, then you must show that what you did was reasonable. The question which will be asked in a coroner’s court is, "Was it serviced when it should have been?" If the preventative maintenance protocols for equipment are not according to the manufacturer’s recommendations, then the hospital CEO should be informed in writing.

There is no legal requirement to do as recommended by the manufacturer, however, if you do not, the manufacturer may lose product liability, the hospital will probably be liable under the Health and Safety at Work Act and there may also be criminal liability. To avoid these repercussions agree the maintenance protocols with the manufacturer as part of the purchase agreement. The manufacturer will then have some responsibility under The Sale of Goods Act.

It is important to agree exactly what should be done in a scheduled maintenance service, since it was the experience of many delegates, that the manufacturer’s agents do not always adhere to the manufacturer’s recommendations during service visits. Ensure that all service contractors do what they say they will do.

One delegate gave an example of an agreement made with a manufacturer: Halothane vaporisers were on a one-year service-exchange contract; a retrospective study showed that three-years was a sufficient interval, the company agreed that this was reasonable and the contract was changed.

It should be remembered that information on machine performance is in the hands of the hospital, not the manufacturers, therefore there is scope for improved communication between hospital and manufacturers in the decisions regarding maintenance protocols. The manufacturers should be asked the basis on which they recommend a particular service interval.

It was noted that ECRI is a database concerning incidents, user reports and service intervals based on North American data. It is available in the UK. Some delegates have found an ‘overload’ of information in ECRI resulting in it not being as useful as it might first appear.

Many hospitals use a commercial electro-medical database known as SEMS. This has allowed for the compilation of useful data on service requirements for electro-medical equipment in UK hospitals.

A delegate who had given a purchase order to a manufacturer’s agent for the servicing of all anaesthetic machines found that the company were servicing each quarter of each machine once per year so it required four visits for one complete service of a machine.

If it is impossible to meet the manufacturers recommendations then inform management.

It may be appropriate to cost the manufacturer’s recommendations, to compare them to those recommended by in-house staff and if these require less funding then risks may be reduced by using the savings to improve clinical support and user training for the equipment involved.

The CE mark does not require that the manufacturer’s recommendations must be followed.

There is no requirement to keep records of electrical safety tests but only to record that tests were performed. However there is a need to know the "as new" values, and if possible, these should be attached to the item of equipment.

There is a Code of Practice for Electrical Safety Testing of Low Risk and Computer Equipment. This document contains useful information pertinent to electrical safety testing in general.

In general, the three types of equipment with highest priority for scheduled maintenance and management are anaesthetic machines, ventilators and infusion devices. The importance of incident reporting and user training must not be over-looked.

Meabh Smith