Innovation and risk assessment discussed

At the 10th annual educational symposium for clinical and biomedical engineers, ‘Completing the Picture’, Dr Paul Dark, senior lecturer at the University of Manchester and honorary consultant intensivist at Salford Royal NHS Foundation Trust, set out to define health technology and to consider the range and complexities of ‘assessment’ of new technologies. Put simply, health technology provides a range of technologies for health promotion as well as offering tools to prevent and treat disease and improve rehabilitation and long-term care. The Department of Health (DH) considers Health Technology Assessment (HTA) as being policy driven research aimed at supporting decision making at all stages of healthcare delivery. The HTA programme is part of the National Institute for Health Research (HIHR), which produces independent research information about the effectiveness, costs and the broader impact of healthcare treatment and test for those who plan, provide or receive care in the NHS. Health Technology Assessment should consider the broad impact and consequences of a technology and looks at its medical, economic, social and ethical implications. However, Dr Dark stressed the importance of remembering that the patient should always be at the centre. He said: “This should not be a single process. We need to assess the impact of technology during its lifecycle, from intervention to adoption through to obsolescence.” Dr Dark went on to explain that the key stakeholders in HTA – the commissioners of HTA, investigators, sponsors, reviewers and the consumer – will often have opposing drivers, and he spoke about the need to be aware of the inherent risks of HTA and the potential for bias and conflict of interest. “Transparency of the HTA process is crucial,” he said. Key stages in the HTA process include the formulation of a question, the development of a project, data collection and synthesis, reporting and dissemination and HTA transition. “Throughout all the elements of the HTA process it is important to consider whether the technology is fit for purpose,” said Dr Dark. It is also important to consider the difference between efficacy and effectiveness of a product under assessment. Efficacy means ‘can it work, under ideal trial conditions?’, while effectiveness means ‘does it work in everyday conditions?’ “It is always important to consider whether the product will actually be able to work in the real world,” said Dr Dark. When the DH commissions HTA on behalf of the NHS it is primarily done via the HTA programme, in one of two modes. The commissioning mode is primarily driven by a direct response to an establishment such as the National Association for Health and Clinical Excellence (NICE), or the responsive mode, which looks for solutions to existing problems in a wide variety of areas: Dr Dark highlighted areas of relevance to his clinical focus, such as trauma and emergency care; healthcareassociated infection; and biomarkers of health and disease. The DH has set a goal of establishing the NHS as an internationally recognised centre of healthcare research excellence. However, to achieve this goal there are issues which need to be addressed, said Dr Dark: “In my view, research and development is not a core business priority in many NHS Trusts today and this is just one of the challenges that needs to be overcome when delivering HTA/innovation from within the NHS. The regulatory framework also poses challenges.” However, Dr Dark did concede that, today, the National Research Ethics Service has much more clearly defined boundaries. “In general though, gaining approval for research and development projects still contains too much unproductive paperwork. I believe that the process still needs to be more streamlined,” he said. In conclusion, Dr Dark said that although there have been significant attempts to develop the NHS as a marketplace for innovation, aligned with attempts to develop HTA around key NHS services, this wish has not yet been realised. “Significant barriers remain in place,” he said “including NHS Trust priorities and regulatory issues. These need to be tackled before progress in this area can be made. The biotechnology industry is crucial to ensure UK growth and financial stability, and we do need to be able to compete with technologies being developed in other countries, so it is vital that these issues continue to be addressed.”

Risk assessment

Paul Blackett, medical engineering operations manager at Lancashire Teaching Hospital NHS Trust, went on to discuss the management of medical equipment risk in the NHS. He started by defining the meaning of ‘risk’ as it relates to the medical engineer, using a quote from ISO 14971:2007 Medical devices – Application of Risk Management to Medical Devices, saying “risk, in our profession, relates to a combination of the probability of occurrence of harm and the severity of that harm.” Using Reason’s Swiss Cheese Model, which relates to a trajectory of accident opportunity, he explained that, between a hazard, and a patient being harmed, there are a variety of barriers. However, all these barriers have weaknesses, and if all these weaknesses line up, there could be a consequence. The risks associated with medical devices are many, including the risk of devices not being available when needed; the risk of a device failing in use; the risk of an unknown device inaccuracy or a calibration error; risk induced by maintenance itself, risk of incorrect operation or use, and risk to the patient, service or organisation. “There are many risks,” said Mr Blackett, “and, as the experts in equipment management, we need to risk assess equipment from our point of view, using the data that we have available.” He went on to explain several methodologies that are available to help achieve this. “The Australian/New Zealand Risk calculation method1 for example, has been around for many years. This is a widely used method for the calculation of many types of risk, using a simple, but subjective calculation to assess the risk factors of a product. Risk = Probability (1-5) x Consequence (1-5). In the US, the ECRI Institute, a non-profit making organisation with over 40 years experience in healthcare safety, suggests three categories for risk assessment.2 High risk includes mostly therapeutic devices that support life, resuscitation, critical monitoring and other devices whose failure or misuse is reasonably likely to seriously injure patients or staff. Medium, includes mostly diagnostic devices whose misuse, failure or absence would have a significant impact on patient care but would not be likely to cause direct serious injury. The third category is Low, which includes devices whose failure or misuse are unlikely to result in serious consequences, such as opthalmoscopes and thermometers. The Institute of Physics and Engineering In Medicine (IPEM) model3 proposes a risk model that considers inputs such as technical complexity, invasive or non-invasive; diagnostic or therapeutic; statutory instrument compliance; user type and location; general reliability; organisational importance. The output is calculated and ranges given for infrequent periodical maintenance, increased periodical maintenance frequency or maintaining the status quo. “This model brings in the consideration of organisation requirements,” said Mr Blackett. The Swedish model4 is based on a variation of the Australian/New Zealand method of risk. Risk = Likelihood x Severity of risk (calculated between 1 and 5) and includes the maintenance needs of the equipment and ‘mission critical’ functions. “The Swedish model serves as a method of prioritising maintenance. If this method is used to depart from the manufacturers recommendations, then any further risk assessment needs to take into account historical data,” said Mr Blackett. “Whichever method we choose to use, we will never get a definitive outcome. There will always be an element of subjectiveness,” he said. “For this reason any risk calculations should only be used for guidance, providing a way of prioritising risk, if it is applied consistently. “Whichever risk calculation method is chosen, it is important to get the model agreed, and then apply it consistently to your inventory. This will ensure that you have a list of equipment, prioritised in risk order. It is also possible to add value to your risk rating. The IPEM model, for example, includes an input of ‘reliability’. You can then start using your data to make decisions. Value can be added by introducing historical data relating the devices. This can be done by consulting the historical record of work done in order to document changes to the maintenance schedules, internal or external contactors. “Equipment databases will generally contain a vast amount of data but it can be time consuming to find the necessary information as it is often not recorded systematically, and is often recorded in a format that is difficult to understand. Data sharing is a good solution to this problem, but this can present a whole new set of problems as often we do not even give the product the same name across the healthcare sector. Is it an ECG monitor, a cardiac monitor, a vital signs monitor or a multi-parameter monitor? We should all be looking to reduce risk through the introduction of a common naming convention, such as is employed by the Global Medical Device Nomenclature (GMDN) from ISO 15225:2010 which uses set terms for all equipment.” Taking standardisation further, Mr Blackett also went on to suggest that common codes should be introduced to classify work. He quoted from an article published in The Journal of Clinical Engineering, which suggests a range of codes that could be used to make comparing failures easier between organisations.5 In conclusion, Mr Blackett suggested that managed risk leads to reduced risk, which results in less liability. Finishing on a note of caution, he warned that risk assessment should not be used as a way to reduce the amount of time or money spent on maintenance. Safety should always be the driver, not finance. It should be used to prioritise equipment maintenance so that the medical devices get the most appropriate amount of time and money. :