Ensuring effective device management

There have been many attempts by Government and healthcare agencies over the years to address medical technology management issues. The issues being addressed have always, broadly, involved the procurement, use, maintenance, and governance of medical technology in accordance with regulatory standards. Evidence shows that effective healthcare technology management can improve utilisation of medical equipment and reduce costs. The World Health Organization (WHO), states that poor management leads to a lack of standardisation, and the purchase of sophisticated equipment for which operating and maintenance staff have no skills.1 A recent Government report, Strength and Opportunity 2011 states that the medical technology market will continue to grow year-on-year, saying ‘the medical technology market is estimated to be worth £150 bn-£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 population and the per capita income increases in healthcare expenditure across developed countries’. This statement highlights the growing need to acquire technology, and alongside that increased costs, risks, and regulations. It is, therefore, imperative that the procurement of devices is done in a way that reduces risk and cost. In 2004, a National Patient Safety Agency (NPSA) project report across multiple NHS sites identified links between purchasing and clinical incidents. It said: ‘The project identified that uncontrolled purchasing and device management, in the absence of competency-based training, were contributing factors in causing incidents.’2 A National Audit Office report in 1999 also raised concerns about equipment management and stated that Trusts should introduce a standardisation policy to deliver safe devices management and financial savings.3 Uncontrolled purchasing and device management, in the absence of competency-based training, were found to be contributing factors in causing incidents, according to an NPSA research project. Concerns about medical devices management and policy are not new, but, since 2010, they have been regulated under The Health and Social Care Act, regulation 16, outcome 11, which specifically relates to the safety, and suitability, and safe use of medical devices.4 As can be seen from Figure 1, it can be extremely difficult to manage standardisation of devices into a hospital if the routes for acquisition are not carefully managed. The NPSA medical devices research project showed that many organisations were operating an inefficient device management policy. It also highlighted the medical device technology risks from poor management, stating: ‘The purpose of this review is to highlight the relationship between the numbers of faults reported (120) and the episodes where no fault was found (30). The findings highlight that in 25% of the episodes the device was wrongly reported as faulty. The data for the remaining 75% did not reveal the nature of the fault and it is likely that the device ‘fault’ was not a failure issue but more probably a user/handling problem. This is indicative of poor training and device management. The data also highlighted that the incidence of devices being damaged is extremely high. This is indicative of poor device management systems such as nonstandardised stock and decentralisation. It was also highlighted that nearly one-fifth of all infusion device stock, across all pilot sites, was more than ten years old. This could have serious patient safety implications if such devices are used for applications that require a high specification device.’2

Hospital management responsibility

 The hospital needs to be able to deal with internal and external demands on device management by implementing a systematic approach that can deliver best practice through an effective policy. This is important to ensure that selection, use, and maintenance of all devices is carried out to meet the clinical needs of the patient, and the external regulatory demands. The Care Quality Commission (CQC) and the NHS Litigation Authority (NHSLA) both refer to The Medicines and Healthcare Regulatory Agency (MHRA) within the standards and regulations, specifically with regard to ‘Managing Medical Devices – Guidance for Healthcare and Social Services Organisations’.5 As shown in Figure 2, all hospitals must operate in accordance with UK and EU laws to implement and monitor a medical devices policy to: procure equipment that is safe and meets the European manufacturing regulation EU MDD93/42; train users; maintain equipment; and have a medical devices committee. According to the WHO ‘Data shows that policies, strategies, and action plans for medical devices are being developed in member states… Recommendations from the first global forum on medical devices in 2010 will continue to raise awareness of the crucial role that medical devices play in the prevention, diagnosis, and treatment of disease and rehabilitation. The hope is that the higher profile of medical devices will translate into better healthcare for the global population, allowing them to enjoy a better quality of life.’6 Organisational responsibilities are described by the MHRA in Managing Medical Devices – Guidance for healthcare and social services organisations, which says ‘Responsible organisations should appoint a director or board member with overall responsibility for medical device management. There should be clear lines of accountability throughout the organisation leading to the board. These lines of accountability should be extended, where appropriate, to include general practitioners, residential and care homes, community based services, independent hospitals providing services for NHS patients, managed care providers, PFI organisations and other independent contractors. It is important to establish who is accountable, and where there is a need for joint accountability arrangements.’5 The device management policy needs to cover the selection, acquisition, acceptance and disposal of all medical devices, training of all those who will use them, decontamination, maintenance, repair, monitoring, traceability, record keeping and replacement of reusable medical devices. The hospital also needs to carefully manage the acquisition of medical devices. With regard to procurement and acquisition of medical equipment, the MHRA says that policy should include the need to: