Medical devices are essential tools for modern healthcare delivery. However, significant issues can arise if medical devices are designed for ‘work as imagined’ when this is misaligned with ‘work as done’. This problem can be compounded as the details of device design, in terms of usability and the way a device supports or changes working practices, often receives limited attention. The ways devices are designed and used affect patient safety and quality of care: inappropriate design can provoke user error, create system vulnerabilities and divert attention from other aspects of patient care. Current regulation involves a series of pre-market checks relating to device usability, but this assumes that devices are always used under the conditions and for the purposes intended (i.e. work as imagined); there are many reasons for devices being used in ways other than those assumed at development time. Greater attention needs to be paid to learning points in actual use and user experience (i.e. work as done). This needs to inform manufacturers’ designs, management procurement decisions and local decisions about how devices are used in practice to achieve co-adaptation; without these, we foster risks and inefficiencies in healthcare.
Incident reporting has long been established as a key component of patient safety in almost all healthcare and related settings. The analysis of incidents to determine why they happen and put in place corrective actions enables us to learn from things that go wrong and protect patients from harm in the future. The introduction of electronic incident reporting using web forms to replace paper has improved efficiency and increased the number of reports collected. There still remain significant barriers to learning from incidents, however. These include issues to do with the design of the systems as well as issues concerning organisational culture. This article revisits the background and purpose of incident reporting in healthcare, discusses some of the barriers to effective reporting and suggests some approaches that can increase its usefulness in protecting patients from harm.
Family doctors will regularly have patients who are admitted to hospital. On discharge, many of these patients may have alterations to the medications that require attention by their family doctor, to either start a new repeat prescription or amend previous ones. This action should be clearly documented, so it can be recognised easily that the discharge summary has been reviewed. This study looks at the action taken and coding related to hospital discharge summaries in a general practice in the United Kingdom. The practice was very accurate and safe in making correct changes to medications but had low rates of documenting and coding that the discharge summary has been reviewed and actioned as required. A uniform code was recommended, and required documentation related to discharge summaries included in the practice’s training materials for locum and training doctors.
The criminal law looks set to play a larger role in regulating healthcare. Until recently, health professionals only faced the prospect of criminal liability if it could be proved that their gross negligence resulted in the death of a patient. In such a case, the professional could face a charge of gross negligence manslaughter (GNM). Prosecutions for ‘medical manslaughter’ have generated concern among doctors worried about what is perceived as a rise in the number of doctors facing criminal prosecution and the impact prosecutions are having on healthcare practice. May more frequent resort to the criminal process damage rather than promote better health care? In seeking to try to answer this question, the first problem is that reliable data in this area about how many prosecutions are brought and how they fare are limited due to the way cases are recorded. What evidence does exist is often based on media reports or samples that are not representative. This paper will argue that, while the real risk of being prosecuted for medical manslaughter remains low, such fears should not be dismissed because, as Donald Berwick has argued, ‘fear is toxic’ – for health professionals and their patients.
The English National Health Service (NHS) announced a new programme to incentivize use of the NHS Safety Thermometer (NHS ST) in the NHS Operating Framework for 2012/13. For the first time, the NHS is using the Commissioning for Quality and Innovation (CQUIN) scheme, a contract lever, to incentivize ALL providers of NHS care to measure four common complications (harms) using the NHS ST in a proactive way on one day per month. This national CQUIN scheme provides financial reward for the collection of baseline data with a view to incentivizing the achievement of improvement goals in later years. In this paper, we describe the rationale for this large-scale data collection, the purpose of the instrument and its potential contribution to our current understanding of patient safety. It is not a comprehensive description of the method or preliminary data. This will be published separately. The focus of the NHS ST on pressure ulcers, falls, catheters and urine infection and venous thromboembolism is broadly applicable to patients across all healthcare settings, but is specifically pertinent to older people who, experiencing more healthcare intervention, are at risk of not one but multiple harms. In this paper, we also describe an innovative patient-level composite measure of the absence of harm from the four identified, termed as “harmfreecare” which is unique to the NHS ST and is under development to raise standards for patient safety.
“Failure to rescue” is the inadequate or delayed response to clinical deterioration in hospitalized patients. Rapid response systems are a set of hospital-wide interventions that attempt to reduce failure to rescue by improving patient monitoring on general wards (the afferent component) and the reliability of the response to deterioration by a dedicated Critical Care Outreach Team, Rapid Response Team or Medical Emergency Team (the efferent component). The reliability of such systems depends on the faultless functioning of a “chain of survival” consisting of: (1) high-quality recording of vital signs; (2) the education and mind-set of staff at the bedside to recognize pathological patterns; (3) the reporting of abnormality to the efferent team; (4) a timely and appropriate response by the latter. Repeated feedback loops are crucial for an effective functioning of the chain.
Reporting and learning systems are key organisational tools for the management and prevention of clinical risk. However, current approaches, such as incident reporting, are struggling to meet expectations of turning health systems like the UK National Health Service (NHS) into learning organisations. This article aims to open up debate on the potential for novel reporting and learning systems in healthcare, by reflecting on experiences from two recent projects: Proactive Risk Monitoring in Healthcare (PRIMO) and Errordiary in Healthcare. These two approaches demonstrate how paying attention to ordinary, everyday clinical work can derive useful learning and active discussion about clinical risk. We argue that innovations in reporting and learning systems might come from both inside and outside of the box. ‘Inside’ being along traditional paths of controlled organisational innovation. ‘Outside’ in the sense that inspiration comes outside of the healthcare domain, or more extremely, outside official channels through external websites and social media (e.g. patient forums, public review sites, whistleblower blogs and Twitter streams). Reporting routes that bypass official channels could empower staff and patient activism, and turn out to be a driver to challenge organisational processes, assumptions and priorities where the organisation is failing and has become unresponsive.
In healthcare, various methods are available to support risk identification in risk management process. However, there is no clear evidence on their contribution to risk identification. In this study, different methods used to support risk identification were therefore analysed to compare their contribution to overall risk identification. The study was conducted at Cambridge University Hospitals Foundation Trust, UK. Three main methods were selected to compare their support in risk identification: incident reports through their Risk Management Information System, risk registers through their Risk Registers system, and safety walkabouts through their internal patient safety assessment process. Where possible, simple comparison tests were run between the different methods of identifying risks as well as by the type of risks identified. It was found that each method has contributed to the risk identification by adding different sets of risk sources despite some overlaps. However, they produced discrete assessments from different aspects and none of them, on its own, could produce adequate results for effective risk identification. In any healthcare setting, having a system to put all risk information in one picture would help maximise the contribution of each method within the scope risk management process. Future studies may benefit from broader use of multiple and system-based risk identification approaches, and coding methods for more powerful analytical test.
EU Regulation 536/2014 (“Regulations”) is due to take practical effect across the Eurozone by the end of 2017 at the earliest and no later than October 2018 following the implementation of procedural requirements. It will replace the EU Clinical Trials Directive 2001/20/EC. The Regulations are designed to reverse what regulators described as a downward trend in the conduct of clinical trials within Europe because of the “lengthy and cumbersome application process and the failure of the pre-existing regime to accommodate the global scope of clinical trials.” The purpose of the Regulations is to simplify and harmonise the administrative provisions governing clinical trials in the EU. With pleasing Pharmaceutical companies high on the political agenda, the pertinent question that arises is whether patient and public interests will be overlooked to cater to industry concerns? This article will outline the changes effected by the Regulation. It will evaluate the impact these changes will have on patient safety in the context of Phase I or First-in-human (FIH) trials by examining the TGN1412 clinical drug trial (also known as the Northwick Park drug trial). The second part of this article will discuss whether there is a place for the Regulations in the post Brexit landscape. The continuing uncertainty surrounding Brexit means that it remains difficult to come to any definitive conclusions but there are significant issues that require closer examination at this time.
The National Maternity Review has proposed an insurance-based Rapid Resolution and Redress scheme be considered by the Department of Health. This article will outline and examine the Maternity Review’s proposals; drawing parallels and highlighting contrasts between the proposals and other schemes.
Compartment syndrome after complex bowel surgery. Claim against leading expert and centre of excellence. Adoption of unique operating position without risk analysis or peer review. New defence argument only surfacing at trial dismissed. Judge criticises defence experts. Usually, a compartment syndrome case involves an allegation of delay in diagnosis and treatment. In this case, there was prompt diagnosis aided by the immediacy and magnitude of the compartment syndrome which was described as being equivalent to a crush injury. It is probable that the increased weight on the calves while the patient was in the low Lloyd Davies position combined with a lack of perfusion and acidosis in the first part of the operation caused an ischaemic injury in a patient who was at risk due to his size and muscle structure; the Trendelenburg position adopted in the second part of the operation is known to cause compartment syndrome but this patient already had ischaemia before the operation reached that stage. Reperfusion at the end of the operation caused the immediate damage and in spite of prompt reoperation the patient suffered a desperately severe illness and subsequent permanent disability. This case illustrates how a Claimant can succeed even against a renowned international surgeon and a centre of excellence if in spite of his outstanding reputation the surgeon fails to keep abreast of medical developments or consider the impact of his ‘invention’ on a particular patient. A position of high repute within a profession, whether institutional or personal does not provide protection from the legal tests for breach of duty.