Promoting best practice in medical devices policy

The NHS Litigation Authority (NHSLA) estimated that, as at 31 March 2012, it had potential liabilities of £18.9 billion, of which £18.6 billion related to clinical negligence claims. This figure represents the estimated value of all known claims, which may settle or be withdrawn over future years (NHSLA Factsheet 2 – published 2012). The NHS is carrying significant risk in terms of patient safety and expenditure. This is a serious issue because of the high percentage of high-risk medical devices that are being used without evidence of adequate training or maintenance. This is resulting in serious injuries and even death. Two core issues are impacting on medical devices management policy that leads to non-compliance. Firstly, training in the safe use of medical devices, and secondly maintaining and calibrating devices. This is a serious issue, as can be seen from the numerous negative news stories of which just a few examples are shown in Panel 1. NHS procurement systems and budget management processes are currently set up in a way that allows managers of individual wards and departments choice to buy medical equipment, as can be seen from the budget statement example in Figure 1, (from the Audit Commission) showing local equipment and consumable purchase ability. In a typical NHS Trust there can be 200 wards and departments with their own budget lines for equipment. This does not allow for easy equipment standardisation that can reduce costs and risks.

The risks of poor device management

The proper management of medical equipment has become an issue in the healthcare sector due to the multitude of devices in use, changes in technology, changes in regulatory requirements, and the need to manage all these issues. Government approved legislation for device management in 2010 relates to providers meeting the care quality standards described in the regulations. The Department of Health is assuring legal compliance through the Care Quality Commission (CQC). The CQC is monitoring healthcare providers to ensure they are adhering to the new legislation which relates to quality provision. The law should play an important, though not dominant, role in regulating the relationships between Trusts and various stakeholders, including patients and commercial suppliers. So, for example, there are laws specifically designed to protect patients with regard to the use of medical devices, and there are laws specifically designed to ensure suppliers provide services within an agreed legal terms of reference. There is, however, a question as to whether the CQC understands device management issues, and is really able to get to the heart of the problem. Device management is a burning public issue because it has now been enshrined in law through The Health and Social Care Act. This Act is in an area that is politically significant, impacting on levels of risk to patients, and NHS organisational reputation. The CQC has made medical devices management a priority (under regulation 16, outcome 11) and listed device management as one of the poorest performing areas of NHS management in its 2010 report. (Care Quality Commission, 2010) NHS Trusts must adhere to the CQC regulations and NHSLA standards. Over the last 30 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 procurement, use, maintenance, and governance, in accordance with regulatory standards of medical technology. A 2011 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 report states that: “The medical technology market is estimated to be worth £150-£170 bn worldwide with growth rates forecast at 10% per annum over the next five to six years and a market size approaching £300 bn 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.” The NHS is struggling to manage devices it owns due to their 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 new devices. 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. The demand for new technology is insatiable, and this can result in unnecessary cost, additional risk, and practical constraints of how to procure equipment, how to train staff to use the equipment, and how to maintain such a wide variety of equipment. Alongside these internal demands, are the demands of the Government, through regulators, to ensure that equipment is managed to the highest standards for the well-being and safety of the patient. Although a great deal of technology is available for patient care, the quantity and variety of devices available can introduce risks of misuse, risks of overspend, and risks when equipment is unavailable due to lack of maintenance. The Government has, therefore, decided to regulate in order to mitigate these risks. 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. Some of these external influences are shown in Figure 2. The NHSLA sets the risk management standards for the National Health Service. (NHSLA, 2010). The Medicines and Healthcare products Regulatory Agency (MHRA) regulates specific medicines and healthcare products (MHRA, Managing Medical Devices: Guidance for healthcare and social services organisations, 2006). The European Union (EU) regulates the manufacture of medical devices (EU Commission, 1993). These are the four key external governance and regulatory areas that influence the hospital’s medical devices policy. A 2004 project paper from the National Patient Safety Agency (NPSA) shows that many organisations were operating inefficient device management policies, as can be seen from the following extract. Many organisations are still facing similar problems today. ‘These audits established the following averages across the six pilot sites: