Part 1 - The need for regulation
1. Over the last 30 years there have been many attempts by government and healthcare agencies to address the issues faced when managing medical technology. In broad terms, these issues involved the procurement, the use, the maintenance, and the governance in accordance with regulatory standards of medical technology.
A recent HM Government report shows that the medical technology market will continue to grow year-on-year. Over the next five years, medical technology is expected to grow at 10% per year.
'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, p. 10).
The NHS is struggling to manage devices they own due to the variety and complexity, changes in regulations, and new devices coming onto the market, resulting in more demands from nurses and doctors to have access to these new devices.
Figure 1 - Demands on healthcare device management policy
Figure 1 indicates the internal and external demands on healthcare device management policy that will be described in more detail in this document. Government policy is produced as a result of analysis of many factors affecting patient care. This will include cost, new devices, new drugs, new techniques, and pressure from manufacturers and service providers to open up the NHS market to external providers. In figure 2 - The Chain effect of regulation, it shows the impact of new government policy on UK regulations. In 2010 the government introduced new healthcare policy which impacted on the safe use of medical technology.
As a result of this new policy, regulations were approved for implementation in October 2010. Care Quality Commission (CQC) Regulation 16, outcome, 11 specifically relates to the safety, and suitability, and safe use of medical devices.
Figure 2 - The chain effect of regulation
The Impact of regulation
The impact of the new regulations on 'Example' Hospitals NHS Trust resulted in a review and changes to the trust policy on medical devices management. As a result of these changes, it was necessary to then train the responsible managers on the revised policy to ensure the organisation could adhere to the new government policy. Once the managers were trained, it was necessary for them to cascade changes in policy to their teams. Department and Ward managers were expected to implement the changes. The trust governance team has a responsibility to monitor the revised policy for compliance. On a monthly basis, the governance team must report compliance levels to the 'Governance Committee'. This committee reports to the executive of the trust, and allows them to report upwards to the strategic Health Authority.
The Care Quality Commission act as the external monitor for the government to ensure regulations are adhered to and can visit any healthcare trust at any time without notice. This is meant to ensure compliance with regulations and government policy, and thereby allow the government to review and improve policy.
There are many other areas which impact on the organisation's policy for managing medical devices. These are a mixture of external influences, and internal influences. The external influences are shown in 'Figure 3 - External Governance and Regulatory Demands' below.
Figure 3 - External Governance and Regulatory Demands
The National Health Service Litigation Authority sets the risk management standards for the National Health Service. The Medicines and Healthcare Products Regulatory Agency regulates specific medicines and healthcare products (MHRA, Managing Medical Devices: Guidance for healthcare and social services organisations, 2006). The European Union regulates the manufacture of medical devices, (EU MDD 93/42). These are the four key external governance and regulatory areas which influence the hospital's medical devices policy. If any one of these four external organisations issue new standards or regulations, 'Example' NHS Hospitals Trust must change their medical devices policy, and then implement those changes as shown in figure 2.
Part 2 - Factor impacting on the medical devices policy
The Medical devices policy is important to the organisation to ensure selection, use, and maintenance of all devices is carried out to meet the clinical needs of the patient, but must also meet the external regulatory demands. 'Example' Hospitals NHS Trust must address the staff needs for required device types for their professional practice demands, and the internal governance demands to ensure safe practice and policy compliance as shown below in figure 4.
Figure 4 - Internal NHS Trust demands
The regulations concentrate on the use and maintenance of medical devices. In my experience, improved procurement delivers cost savings, but is also the KEY to improving training, governance, and maintenance practices. Therefore, the trust medical devices management policy must include procurement practices, if the trust is serious about meeting its regulatory goals.
Good procurement of medical technology can reduce the size of the inventory, reducing the value of the inventory, and thereby reduce the annual spend on replacing assets. It can also result in improved utilisation of the assets, resulting in improved outcomes for patients, and improved throughput of patients, resulting in improved revenues for the trust.
The procurement of medical technology has an impact on the organisation in terms of cost, availability, and suitability, and strategic needs.
Good management of training can results in better use of the assets, reducing the risk of misuse on patients, and improving outcomes for patients. The use of medical technology has a major impact on the business of the trust and the outcomes for patients.
Training is considered a high risk by government, and as a result of this they have introduced the regulations previously discussed. Policymakers at a government level may not understand the practical difficulties of implementing training across 600 technology groups, especially when there was limited standardisation across many of the technology groups in use.
Maintenance of medical technology is important to the efficient running of the organisation, aiding therapeutic and diagnostic care of patients, and also to the volume of equipment required by the organisation.
Governance of medical technology is carried out in accordance with the requirements of the trust policy for medical devices management, which must meet the requirements of the regulators.
I have been improving and implementing medical devices policy working with governance, procurement, clinical and nursing teams at many organisations. I have been developing medical devices management policy that encompasses all the areas discussed in the four illustrations.
i.e. procurement, training, maintenance, and governance. My goal must be to produce an improved practice model that answers the internal policy questions shown in figure 5 below, thereby assisting the trust to comply with the demands of the regulators.
Figure 5 - Medical Devices internal policy questions
I have worked with NHS Trust's to improve and implement policy in an iterative fashion, authoring the first policy in collaboration with key stakeholders, then implementing that policy, and finding through implementation where it worked well, and where it worked less well. Through the implementation process, I was able to speak to many staff, and improve the policy and methods for its implementation. I find that developing policy in this participatory way results in continual improvement and implementation of policy.
I am currently involved in device management policy which is at the heart of the four key areas discussed earlier. I.e. Procurement, Training, Maintenance, and Governance. Therefore, I am carrying out a case study using participatory methods on policy and policy implementation at 'Example' NHS Hospitals Trust, which involves the review of external demands, organisational demands, and patient demands. If the trust is able to get the policy to be understood, implemented, monitored, and updated on a regular basis, it can deliver a more efficient, cheaper, and safer service to its patients.
The value of this case study project is that the methods could be replicated in other NHS trusts at a later stage, and the model of best practice which arises from this hospital can then be further tested in other hospitals, so that eventually many healthcare organisations can benefit from this best practice model, thereby encouraging a large cooperative and comprehensive learning cycle, ultimately lead leading to further improvements in the best practice model.
This research also tests the current model against external governance and regulatory demands from the following organisations:
This case study has a focus on the organisational medical devices policy, but is also professionalising and empowering. Findings of the case will be discussed at the EBME Seminar on 1st May 2013, and the published in June 2013.
John Sandham IEng MIET MIHEEM