Extracts from:
Achieving a Model for Improving Medical Devices Management Policy
Dr John Sandham CEng FIHEEM MIET

Hospitals have always faced fundamental questions of patient safety, care, and budgetary concerns. There has been increasing recognition recently of the serious issue of medical devices management, covering the areas of procurement, training, maintenance, and governance. This issue, documented by the National Audit Office, National Patient Safety Agency, Medicines and Healthcare Products Regulatory Agency, National Health Service Litigation Authority, and World Health Organisation, impacts on healthcare costs and patient safety. It has led to new Health and Social Care Act Regulations, enforced by the Care Quality Commission.

As a result of my work as a consultant in the field of medical devices management, I constructed a policy model based on my own specialist experience and knowledge. This research sought to improve that model through participatory research conducted at an NHS Hospital in London. It took the form of a case study that specifically explored the core policy areas, but this time in collaboration with participants with expertise in one or more of the four interrelated policy areas of procurement, training, maintenance, and governance. This collaboration involved researching and analysing the external demands from regulatory agencies and internal demands from the organisation, centred on procurement, budgetary, and policy issues.

The action research informed changes in policy, especially around procurement, leading to improvements in practice. The challenge of keeping policy up to date, and consistent with the external regulations and internal operational demands, is discussed in the case study. The Hospital’s internal politics and culture were found to be a help when starting up the case study, but a hindrance when it came to getting agreement and approvals to change the policy content, because of multiple committees and competing interests.

The overall outcome of the project was an organisationally approved best practice policy model for medical devices management within a governance framework that meets the needs of the external regulators, and the management of the organisation. More specifically it was discovered that the use, maintenance, and governance of medical equipment were all reliant on a central issue, namely procurement practice. Procurement conduct for the organisation was redefined within the Hospital policy, and is making training, maintenance, and governance easier to achieve, thereby reducing risk and cost. A major consequence is that all budget holders need to be trained in procurement itself. Moreover, it is anticipated that the model could be used at similar healthcare organisations, ultimately leading to a contribution to knowledge and practice which assists in patient safety and meeting budgets.

The problem of device management policy is that hospitals face fundamental questions of patient safety, care and budgetary concerns, which have been identified in research and reports from reputable organisations such as the National Audit Office (NAO), the National Patient Safety Agency (NPSA), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the World Health Organisation (WHO). The issues identified by these organisations have concerned the government to such a degree that they introduced new health and social care regulations in 2011. To enable me, as a specialist healthcare consultant, to assist the Hospital to meet the new regulations, I agreed to carry out a case study specifically exploring improvements in the core policy areas related to the regulations. This involved working with participants exploring the four interrelated policy areas of procurement, training, maintenance, and governance. I use the term ‘case study’ descriptively (i.e. A ‘particular case’ rather than in a methodological sense).

Over the last thirty years there have been many attempts by government and healthcare agencies to address the policy issues faced when managing medical technology. In broad terms, these policy issues have always involved the procurement, use, maintenance and governance of medical technology.

A 2004 National Patient Safety Agency project report stated that:

uncontrolled purchasing and device management, in the absence of competency-based training, were contributing factors in causing incidents. (National Patient Safety Agency, 2004, p. 2)

Moreover, the literature discussed later in this study confirms that this is a nationwide issue, in fact a worldwide issue, that impacts on patient care, professional practice and costs. For instance, a recent HM Government report, ‘Strength and Opportunity 2011’, states that the medical technology market will continue to grow year-on-year, potentially putting further pressure on NHS funding:

The medical technology market is estimated to be worth £150–170bn worldwide with growth rates forecast at 10% per annum over the next 5–6 years and a market size approaching £300bn by 2015. This growth is driven by the ageing of the world’s population and the per capita income increases in healthcare expenditure across developed countries. (HM Government - Strength and opportunity, 2011)

These cost pressures on the NHS will continue to grow owing to an ageing population. There are also cost pressures from negligence claims. As at 31 March 2012, the NHSLA estimated that it had potential liabilities of £18.9 billion, of which £18.6 billion related to clinical negligence claims (see Appendix 6, NHSLA Factsheet 3).

Medical devices policy is important to patient safety, to patient comfort and to other patient health needs. Although all this technology is available for patient care, the quantity and variety of devices available can introduce risks of misuse, risks of overspend and risks where equipment is unavailable due to lack of maintenance. The government has therefore decided to regulate, in order to mitigate these risks.

There are common themes in the literature that lead me to believe that there is an opportunity to introduce policy change into public sector organisations through research in collaboration with the participant practitioners. In the context of this study, these changes to Hospital policy will aim to meet the needs of the Hospital executives, the patients, the staff (stakeholders), and the politicians (voters). The current focus, in this NHS hospital context, is cost savings and improvements in quality. My belief from working in hospitals is that delivering change and innovation in policy to bring about change and subsequent improvements can only be done with the ‘buy-in’ of front-line staff, supported by senior management. As an internal change agent (and after reading the literature in this field), I believe there is an opportunity to introduce policy change that involves both policy formation and implementation which is both systematic and effective.


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Achieving a Model for Improving Medical Devices Management Policy




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