CRL 1-hr: 9/26 Introduction to Uptime Elements Reliability Framework and Asset Management System

The hospital operates a medical retrieval service utilising motor vehicles, helicopter and fixed wing jet aircraft to retrieve or repatriate critically ill patients from within South Australia and overseas.

Founded in 1840, the RAH offers clinical services in specialist areas including Cardiovascular, Radiation Oncology, Orthopaedics, Burns, Neurosurgery, Intensive Care and Trauma.

The RAH is owned and operated by the South Australian Government through the Department of Health. Like most public hospitals in Australia, the RAH is under considerable pressure to increase inpatient and outpatient occasions without incurring additional costs.

Biomedical Engineering

The Biomedical Engineering Department (BME) is responsible for the management and maintenance of medical devices and systems, equipment used in the diagnosis, monitoring and treatment of patients, owned or operated by the RAH. Medical devices supported range from surgical instruments through to large diagnostic imaging devices such as PET/CT scanners and networks of medical devices. We support over 7200 assets made up of approximately 2600 different manufacturer/model combinations used in many different contexts across the three campuses and in the community. Compounding our task further is the rapid advance in technology, which results in an average technical life for medical devices of approximately 10 years.

While the RAH has purchased additional biomedical assets to meet patient, clinical and political expectations of access to the latest available technology, it has not been able to provide us with the additional resources required to sustain the additional assets. Having spent the early 1990's at a health farm, we were running lean and fit. We were not able to absorb the additional work and the only option for us was to look for an alternative maintenance strategy that required fewer human resources to implement while maintaining the safety, reliability and availability of devices.

Other drivers for us to pursue an alternative maintenance strategy such as RCM included:

1. Reducing the cost of ownership of medical devices.

2. Medical devices, in general, fail less frequently. However the maintenance strategies and frequency of inspections applied internationally have remained reasonably constant.

3. The Australian Council of Healthcare Standards requires hospitals to comply with Australian Standard ‘AS/NZS 3551 - Technical management programs for medical devices' to gain accreditation

· AS/NZS 3551 promoted the prescriptive maintenance practices of the 1950's and 60's which made no sense when reviewed against practical experience

· AS/NZS 3551 allows for a risk approach to developing alternative maintenance strategies

· Government funding to the hospital meant it could not afford to resource BME to comply with AS/NZS 3551.

4. The alternative risk based maintenance strategies being developed by members of the international biomedical engineering community made little more sense than the prescriptive maintenance practices of AS/NZS 3551 as they did not take into account the effectiveness of maintenance tasks in preventing failure or managing the consequence of a failure.

5. Implementing RCM sounded interesting and to our knowledge no-one else had accepted the challenge.

Journey So Far

For a number of years we had been reviewing the methods of maintenance employed by other industry sectors, primarily mining. While many of their approaches and methods were intuitively appealing, most required significant historical data - failure data - to implement effectively. The relatively short life of medical devices, the ever changing technology and the limited sharing of maintenance data within the industry meant that it was difficult to access sufficient failure data to enable these methodologies to be readily adapted to BME.

The airline industry's Maintenance Steering Group (MSG) Operator/Manufacturer Scheduled Maintenance Development handbooks were also studied. The airline industry's concern for passenger safety was similar to the health sector's concern for patient and staff safety and therefore there were obvious synergies between the work undertaking by the Maintenance Steering Group and what we were hoping to achieve.

The Logic Diagram outlined in MSG-3 was of particular interest to us as it provided a sound foundation on which we could build a logical approach to developing maintenance strategies of medical equipment.

Prior to this point we had had to be reliant on Standards Australia to provide the corner stone on which we developed maintenance strategies. However, these standards were driven by the desire of national regulators to hold the manufacturers responsible for the equipment they supplied and for prescribing the maintenance programs required to keep each device in a safe operating condition. Their emphasis was and continues to be safety. The result was the prescription of traditional maintenance programs. In many cases these are ineffective.

MGS-3 gave us the foundation on which to move forward. Our only concern was that the logic diagram appeared overly complex for our purposes.

In 2006 Rob Wiseman, Deputy Director BME, and I visited North America and the UK to meet with a number of manufacturers, our peers and representatives from The Boeing Company's Maintenance Engineering Technical Service. We were particularly keen to meet with Boeing to familiarise ourselves with how they applied MSG-3 when developing maintenance tasks for aircraft.

In the short time we had with Boeing we were able to significantly improve our understanding of MSG-3 which gave us a benchmark against which we were able to compare other approaches. We also gained insights into the strategies that Boeing employs to improve the safety and reliability of the aircraft they manufacture, many of which we believe can be transferred to the medical industry.

On our return to Adelaide, the Operations Committee, Royal Adelaide Hospital, endorsed Biomedical Engineering moving away from AS/NZS 3551 to pursue the development of maintenance programs using the principles of RCM. Given the conservative nature of the health industry this was a significant step for the Hospital. The challenge was for us to deliver and convince the Australian Council of Medical Standards' surveyors of the soundness of RCM as a methodology.

We were fortunate to engage Steve Young of Asset Partnership, to provide formal training in the application of RCM. Steve took 8 members or our staff through the 3 day ‘Introduction to RCM II' course which:

· reinforced our view that RCM offered many opportunities for improving our maintenance programs

· convinced us of how much we still had to learn

· began to open our eyes to the volume of work we had committed to undertake.

Steve was invited back to undertake training of 6 more of our staff, representatives from 2 equipment suppliers and 8 clinicians. Steve was also invited to facilitate RCM workshops on 3 medical devices.

To accommodate the time constraints of the clinicians, Steve developed a single day introductory course which focused on introducing participating clinicians to the Failure Modes and Effects Analysis component of the RCM analysis. The thinking being, that the clinicians would add significant valuable to the defining a device's functions and performance standards, and understanding the failure effects.

Again we learnt a lot from Steve over the 2 weeks, including:

· the one day training program for clinicians was too short

· the clinician's input was invaluable to the success of the RCM analysis

· simple medical devices can be deceptively complex

· the manufacturers have little understanding of the effectiveness or ineffectiveness of the maintenance tasks they prescribe - there appears to be little science applied when developing their maintenance programs

· the technical documents provided by the manufacturers often do not provide the information required to determine all failure modes

· a competent facilitator is critical to the success of any RCM analysis.

Barriers

There are a number of significant barriers to any hospital wishing to go-it-alone to implement RCM.

The most obvious is the number of devices deployed. We (BME, RAH) currently maintain an installed base of approximately 7,200 devices (excluding surgical instruments and non registered devices) made up of approximately 2,600 different models. The majority of these devices have an estimated life of between 5 and 15 years with an average of a little over 10 years. (The estimated life is dependent on a number of factors with the most significant being developments in technology and withdrawal of technical and spare parts support by the manufacturer).

Adding to the work load is the abundance of contexts in which each device is or could be used. These vary from general wards and outpatient clinics to Operating Rooms (OR) and Intensive Care Units (ICU). Each context changes the user's functional requirements and standards of operations. The Royal Adelaide Hospital operates a central equipment pool or library for devices that are commonly required in multiple clinical areas of the Hospital. Equipment managed by the central equipment pool can be deployed in a number of contexts within a short time frame depending on the demand.

While a small number of the devices supported can be described by a small number of functions and performance standards most are more complex. For example, a simple patient ventilator analysed under Steve Young's facilitation, required 42 functional statements to define the users requirements while a commonly used general purpose infusion pump required 31 functional statements. These examples were selected for the workshops because they were considered simple devices which would be easy to analyse and would give us the opportunity to gain an appreciation of the RCM process before taking on the more complex items such as an anaesthetic workstation which incorporates ventilation, multi-parameter patient monitoring, anaesthetic agent delivery system, gas monitoring and gas scavenging.

A major concern in healthcare is the safety and wellbeing of the patient. Before accepting any new methodology for maintaining medical devices, healthcare professionals have to be convinced that patient safety will not be compromised. Any proposed model must ensure patient safety and the mechanism for assess and managing the risk to patients be clearly visible.

The three analyses undertaken by the RAH clearly demonstrated the value of clinician participation in defining the functional requirements and failure effects. However, in the current environment it is difficult for the Hospital to release clinicians to participate in RCM training and workshops for the required time. It is even more difficult to coordinate the schedules of clinicians to enable all clinicians, whose contribution would add value to the analysis, to meet together for the required time within a workable time frame. Without their participation the analysis would be deficient.

The final barrier that we encountered was access to the required technical information or to the manufacturer's staff who have the knowledge to assist in completing the RCM analysis successfully. There appears to be a number of contributing factors:

1. Manufacturers and their agents see commercial benefit from withholding technical information from in-house biomedical engineers

2. Manufacturers develop maintenance strategies based on a traditional approach - perceived to be the best risk mitigation strategy by legal council - which they are not required to validate

3. In many cases manufacturers have little, if any, incentive to improve the maintenance strategies they specify for their devices.

As a result, the supplied technical maintenance manuals are bereft of all the information required to identify all failure modes and therefore to develop effective maintenance strategies. In most cases, the maintenance strategies detailed by the manufacturer demonstrate very little understanding of the failure modes that effect the device or how they can effectively manage them.

Benefits to Health Services

The greatest benefit to health services is the reduction in the cost of owning and operating medical devices which will flow from the effective maintenance strategies developed through the application of RCM.

The adoption of RCM will replace tradition and assumption with science. In our experience, those responsible for developing and maintaining the standards and strategies used to manage and maintain medical devices are often unable to give an account of why a strategy is used or a practice is prescribed. Things are done because "we've always done it that way", because, at some point in history, someone thought doing so might mitigate a risk, or because it provided a good source of revenue. For years the conservative health sector has failed to ask the question "Why are we doing this?" and "What is the benefit of this maintenance task?".

The principles of RCM provide a sound scientific platform on which to develop strategies for managing the procurement and ownership of medical devices. The principles of RCM can be developed to assist healthcare institutions to:

1. determine the best match between available technology and clinical requirements

2. identify flaws in design

3. analyse maintenance requirements prior to purchase which will allow more accurate predictions of the cost of ownership and resource requirements

4. develop and implement effective maintenance strategies which will reduce the cost of ownership and increase asset availability

5. identify technical and operator (user) training needs.

Healthcare executives and administrators are recognised as being cautious and have elected to stay with conventional wisdom - do what regulators or legal council advise - even if it is costly or makes little sense. Being scientific and logical, RCM provides healthcare institutions with a defendable alternative maintenance strategy to current maintenance programs prescribed by manufacturers and international standards..

Overcoming the Barriers

To some of our colleagues who have looked into RCM, the barriers are seen to be too high to be overcome economically. We would disagree. Yes, the barriers are significant and yes, no single hospital or healthcare institution can justify the cost of overcoming them in isolation. However, if a large number of institutions should form an alliance to share the burden and costs it is feasible.

The airline industry approached the development and implementation of MSG programs collectively with manufacturers and airlines working together to develop and implement effective maintenance programs for each aircraft. Manufacturers establish working groups which include representatives of the airlines and observers from the National Regulator to develop required and recommended maintenance schedules for each aircraft. These are provided to each airline purchasing the aircraft who use it to develop a maintenance strategy for their particular context which is then submitted to their national regulation for approval. It is this maintenance schedule to which the airline is required to rigorously comply.

We propose that the airline industry model be adopted as the model for implementing RCM in biomedical engineering. However, the pragmatist will recognise that this will not be achieved overnight or in one step. Rather it will be achieved through a process of managed change:

6. engaging members of the international biomedical engineering community in a debate on the need for change to current maintenance strategies

7. building an alliance between members of the international biomedical engineering community and manufacturers to develop and promote a RCM model for medical devices

8. establishing working groups to develop, implement, review and control a biomedical engineering RCM model for:

· determining and defining the context

· analysing a device

· recording the Failure Modes and Effects Analysis (FMEA)

· analysing the failure consequences and developing maintenance schedules

9. developing and maintaining a central ‘repository' to record and share RCM analyses and failure data

10. applying the agreed model to a cross-section of medical devices to demonstrate the benefits of RCM

11. engaging the international healthcare community and device manufacturers in a debate on the benefits of adopting RCM as the standard model for developing maintenance schedules for medical devices

12. the international biomedical engineering community using the data to influence national regulators to change regulations governing medical devices so that manufacturers are required to provide a Failure Modes and Effects Analysis (FMEA) for each of the devices they supply, together with the Mean Time Between Failure (MTBF) - theoretical and/or actual - for each component or assembly supplied as a spare part to each prospective customer.

The manufacturer's FMEA and MTBF information will provide each hospital with the core data which will enable them to cost effectively develop an effective maintenance schedule for the device in their context. The information will also enable a hospital to rationally evaluate alternative solutions to their medical technology needs.

Conclusion

RCM introduces an exciting opportunity for the healthcare sector to develop and implement a strategic risk model for the effective management of medical technology.

Cost is an impediment to any hospital considering implementing RCM in isolation. The volume of work and cost is considerable and has deterred a number of biomedical engineering departments who have considered applying RCM.

However, cost does not have to be a barrier. By cooperating, the international biomedical community can share the cost of developing and proving a suitable RCM model.

United the BME community can influence the manufacturers, regulators and accreditation agencies to adopt the developed RCM model as the standard for the technical management of medical devices.

Ultimately, our hope is that we can convince the international community of the benefits of RCM and to convince the manufacturers to provide all those purchasing their products with the FMEA and MTBF information, and recommended maintenance schedules. Each hospital would then be able to develop an effective maintenance schedule that is tailored to their needs and situation.

Article submitted by Phill Thorburn, Director Biomedical Engineering, Royal Adelaide Hospital, Central Northern Adelaide Health Service, South Australia, Australia

Phill is a member of the Association for Maintenance Professionals and may be contacted there if you are interested in learning more.

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