The medical procedure pathway

摘要

In 2011, the UK Department of Health published ‘A Framework for Technology Enhanced Learning’, which states that health professionals ‘should learn skills in a simulation environment … before undertaking them in supervised clinical practice’.1 In the context of a global attempt to move from time-based to competence-based medical training,2 this poses an important challenge to those with responsibility for the performance of medical procedures. It could also offer an opportunity to decrease the incidence of procedure-related patient harm by examining the ‘procedure’ as a system, which should place the patient at its centre.3,4 Today, those stakeholders who might lessen the incidence of such harm view ‘the medical procedure’ differently. Medical trainees, doctors, the medical device industry, medical educators, licensing bodies, health facility architects and health service managers do not share a common view of medical procedures. We propose that every medical procedure should have an associated ‘pathway’ based on detailed definitions of what it is, its intended outcome, its associated risks and standards for its training and performance. Acquisition and maintenance of proficiency, standards of practice, design of medical and training devices, curricula and clinical trials should be based on these definitions. The medical procedure pathway (MPP) should become a global standard methodology (Fig. 1).Fig. 1: A schematic representation of the Medical Procedure Pathway. *GHTF, Global Harmonisation Task Force for regulation of medical devices.Medical procedures are fundamental effectors of modern healthcare. They are performed for diagnostic, therapeutic or prophylactic purposes; all are associated with a risk of patient harm and failure. One half of adverse events are the result of an invasive procedure4 and (at least in the USA) the number of such events has not decreased since the publication of the Institute of Medicine's ‘To err is human’ in 2000.4 Longstanding models that separate performance of doctors in the simulated from that in clinical environments, medical devices from training devices and licensing of doctors from that of devices, should now be re-examined. For cultural and legislative reasons, the number of clinical learning opportunities available to trainee doctors is much less than previously. To date, the challenges that these changes pose are not being addressed or are addressed in a disparate way by different stakeholder groups (e.g. trainee, medical device manufacturer, medical licensing body) or by procedure type (surgical, anaesthetic). This heterogeneity of approach is itself an obstacle to both the optimisation of the patient benefit available through well tolerated, effective procedural care and to comparing studies of effectiveness. Currently, there is no standard form of answer to such fundamental questions as ‘what is the procedure?’, ‘what is it for?’ and ‘how proficient must one be to perform the procedure on a patient or on this specific patient?’. The answers to such questions should influence how training, assessment and maintenance of proficiency, design of medical devices and even design of healthcare delivery and healthcare facilities are undertaken. This has some similarity to the approach of the Global Harmonisation Task Force for regulation of medical devices (http://www.ghtf.org). We suggest that a framework (or model) is required on which these questions can be answered in a manner that is comprehensible and relevant to all stakeholders; derives from best scientific principles; takes advantage of current technical, pedagogical and clinical innovation; and maximises patient safety and benefit. This framework would minimise the deleterious effects of a trainee's transition from a virtual (or simulated) environment to the clinical environment. It could take advantage of the technical advances in navigation systems and robotics to make new medical devices that serve as excellent training tools.