Ensuring effective device management

Including lack of management expertise, and insufficient commitment, that are making achieving this goal more difficult and, in the process, may be contributing to hospitals and other healthcare facilities being unable to comply with regulatory standards in this important area.

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 billion to £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, 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