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Are medical device regulations safe?

Photo by Svilen Milev from FreeImages

 

Existing provision of regulations for medical devices may be insufficient for the digital age.  In our recent paper, we argue that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards.

National Institute for Care Excellence (NICE) guidance from 2015 promoted the use of QRISK2. This computerised tool calculated someone’s risk of having a heart attack or stroke in the next 10 years. It was designed, developed and approved in accordance with the safety guidelines at the time. But by 2016, the regulatory agency in the UK raised an alert about the use of the computerised tool in some practices.

Thankfully, the errors in the risk calculated by QRISK2 were minimal. The UK’s commitment to electronic health systems were leveraged to track down the source of the problem and follow up with patients. Although the connectivity of the UK’s increasingly-digitised healthcare system helped to remedy some safety concerns, its connectedness can also be a cause for concern.

What’s the problem?

Perhaps the biggest problem faced by regulators of medical devices is that there isn’t just a single problem to solve. Healthcare is an ever-changing and complex system, where not only the parts need to be considered, but their interactions, too. With so many dynamic interacting parts, it can be practically impossible and hubristic to think we can observe and control everything.

Designed by vector_corp, available at Freepik

 

Many standards are available but are not compulsory. For example, decisions made by the European Union in the 1980s separated law and technical standards, which makes it difficult to enforce standards (1). Even if standards were enforceable, they often don’t acknowledge the contemporary systemic and connected ecology of medical devices in the age of digital health and Healthcare 4.0 (2).

Are regulations safe for patients?

It has become increasingly apparent that existing regulation of medical devices is insufficient for the digital age, despite progress in the European Union’s Medical Device Regulation (3). In our paper, we argue that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards (4).

Medical device regulations were initially created for hardware devices rather than software and offer one-shot approvals rather than supporting iterative innovation and learning. Such iterative development has been the keystone to agile methods in product and service innovation that enable timely responsiveness to emerging contexts. A further issue with many medical device regulations is the bias toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful. This often manifests as bias toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system.

What’s being done about it?

Despite the aforementioned concerns, many theoretical and practical strategies have been proposed to improve the provision of effective medical devices in a safe and timely manner. In our paper, we summarise nine recommendations that focus on embedding less-reductionist and stronger systemic perspectives into regulations and standards (4). These recommendations include a Safety II perspective of risk (5), systemic models of accident and safety (6–8), realignment of standards and regulations, and gradual approval of devices. Frameworks like Idea-Development-Exploration-Assessment-Long-term-study (IDEAL) are examples of gradual approval processes that have shown some effectiveness (9).

Advocates for digital health care about its speed, coverage, and capacity but perhaps without considering its own suite of challenges (10) and safety concerns, e.g. underuse, misuse or abuse due to lack of training and improper integration. Future development of regulations should make it easier for clinical and academic institutions like the NIHR PSTRCs to produce healthcare information technology in a way that contributes state-of-the-art patient care and safety science insight.

How can I get involved?

What other recommendations would you like to see? What other ways are there to foster the production of healthcare products that are simultaneously effective and safe? Let us know your thoughts by commenting below or joining in on the conversation on Twitter.

References

  1. Altenstetter C. EU and member state medical devices regulation. Int J Technol Assess Health Care. 2003;1(2003):228–48.
  2. Aceto G, Persico V, Pescapé A. Industry 4.0 and Health: Internet of Things, Big Data, and Cloud Computing. J Ind Inf Integr [Internet]. 2020;18(February 2019):100129. Available from: https://doi.org/10.1016/j.jii.2020.100129
  3. Medicines and Healthcare products Regulatory Agency. An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR) [Internet]. 2020. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf
  4. McInerney CD, Scott B, Johnson OA. Are regulations safe? Reflections from developing a digital cancer decision support tool. JCO Clin Cancer Informatics. 2021;353–63.
  5. Hollnagel E. Safety-I and safety-II: the past and future of safety management. Ashgate; 2018.
  6. Ravitz AD, Sapirstein A, Pham JC, Doyle PA. Systems approach and systems engineering applied to health care: Improving patient safety and health care delivery. Johns Hopkins APL Tech Dig (Applied Phys Lab. 2013;31(4):354–65.
  7. Underwood P, Waterson P. Systemic accident analysis: Examining the gap between research and practice. Accid Anal Prev [Internet]. 2013;55:154–64. Available from: http://dx.doi.org/10.1016/j.aap.2013.02.041
  8. Leveson NG. A new accident model for engineering safer systems. Saf Sci. 2004;42(4):237–70.
  9. Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, et al. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019;269(2):211–20.
  10. Sittig DF, Wright A, Coiera E, Magrabi F, Ratwani R, Bates DW, et al. Current challenges in health information technology–related patient safety. Health Informatics J. 2020;26(1):181–9.

 

Introducing the AC-FRAIL tool: a novel tool to proactively identify older people with frailty for medication reviews

By David Mehdizadeh and George Peat.

Medicines are often thought of in terms of their ability to help manage and treat health conditions. Indeed, medicines are the most commonly used health intervention. However, if we are to continue to use medicines safely and appropriately, it is important that we also acknowledge that medicines can also lead to avoidable harm.

Anticholinergics are a class of medicines used to treat a wide range of conditions, from diseases of the lung to Parkinson’s disease. Despite their wide use they can be high risk and potentially inappropriate, particularly for older people living with frailty. Frailty can be understood in terms of the decline in body systems that typically occurs in later life, reducing resilience to stressors such as an infection, or indeed a medicine [1]. Everyone can potentially experience some side effects from medicines, however older people with frailty are more sensitive to medicines, and are less likely to tolerate adverse effects [2]. In particular, it is thought they are more susceptible to the adverse effects associated with the accumulation of anticholinergics, known as anticholinergic burden. These include physical impairments, falls and cognitive decline [3-5]. Consequently, it is important that patients living with frailty who are prescribed medicines with anticholinergic properties have their medicines routinely reviewed to ensure that they continue to be safe and appropriate [2].

Structured Medication Reviews or ‘SMRs’ are part of the national service specification delivered by Primary Care Networks (PCNs) in England. A priority patient cohort to attend an SMR are older patients living with frailty who may also have been prescribed high-risk medicines, such as those with anticholinergic properties. To ensure these patients are appropriately targeted, guidance on SMRs encourage the use of tools and technology. However, a paucity existed in appropriate tools to identify patients living with frailty who were also taking anticholinergic medicines.

To address this gap, the safe use of medicines theme in collaboration with the digital innovations theme, both of the NIHR Yorkshire and Humber Patient Safety Translational Research Centre, have developed the AC-FRAIL tool. This unique tool proactively identifies patients across a GP surgery’s patient population with high anticholinergic burden, and who live with frailty. This offers a useful and efficient tool for primary care clinicians to prioritise the most vulnerable patients for SMRs. The tool is designed to be easily installed within IT systems used by GP surgeries, with the output being a user-friendly platform which stratifies the practice population (aged 65 and over) by their estimated frailty severity, and number of anticholinergic medicines they are being prescribed. The outcome is a list of patients who are considered at greatest risk of adverse effects from their medicines, and should be prioritised for a SMR.  This is a proactive approach to the identification of patients, rather than reactive care.

Evidence of associations between anticholinergic burden and adverse outcomes in older people underpins the AC-FRAIL tool [1-3], in addition to literature highlighting how the frail are particularly vulnerable to stressors such as high-risk medicines [4-5]. Based on this evidence, we hypothesise that older people with advancing frailty are at greater risks from anticholinergic burden, compared to fitter older people, and hence why the AC-FRAIL takes a population stratification approach to identifying the most frail. However, evidence is limited in this field, and further research is required to investigate the extent of risks of anticholinergic burden across the frailty spectrum. Researchers within the safe use of medicines and digital innovations themes within the centre are conducting a variety of mixed-methods studies to further these investigations. These studies aim to understand the associations between anticholinergic medicines and adverse outcomes in frailty, and which anticholinergic medicines in particular may be of greatest concern to these populations. These include literature reviews, and analyses of patient datasets. Additionally, we have conducted interviews with 25 health care professionals to gather their perspectives of anticholinergic burden, frailty, and the use of tools to support safer prescribing decisions. These studies will help inform further development of the AC-FRAIL tool, as well as other tools to support safer prescribing.

We aim to continue to test and evaluate the AC-FRAIL tool as part of our ‘Deciding to Deprescribe’ study.  To find out more about our AC-FRAIL tool please read our recently published article at https://wchh.onlinelibrary.wiley.com/doi/full/10.1002/psb.1877

This research was funded by the National Institute for Health Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre (NIHR Yorkshire and Humber PSTRC). The views expressed in this blog are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

 

References

  1. Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. The lancet. 2013 Mar 2;381(9868):752-62.
  2. Hilmer SN, Gnjidic D. Prescribing for frail older people. Australian prescriber. 2017 Oct;40(5):174.
  3. Welsh TJ, van der Wardt V, Ojo G, Gordon AL, Gladman JR. Anticholinergic drug burden tools/scales and adverse outcomes in different clinical settings: a systematic review of reviews. Drugs & aging. 2018 Jun;35(6):523-38.
  4. Salahudeen MS, Duffull SB, Nishtala PS. Anticholinergic burden quantified by anticholinergic risk scales and adverse outcomes in older people: a systematic review. BMC geriatrics. 2015 Dec;15(1):1-4.
  5. Richardson K, Fox C, Maidment I, Steel N, Loke YK, Arthur A, Myint PK, Grossi CM, Mattishent K, Bennett K, Campbell NL. Anticholinergic drugs and risk of dementia: case-control study. bmj. 2018 Apr 25;361.

Modelling winter pressures at the NHS-R conference

A conference report by Tom Lawton

 

Simulating the processes of a hospital can help us foresee challenges to which we can proactively respond. The Digital Innovation theme is working on simulations of how patients flow through the hospital to improve foresight relating to increased patient pressures, like what might be expected from the current COVID-19 virus. Our colleague, Tom Lawton, presented his work at a conference of analysts and statisticians associated with the National Health Service (NHS).

Who are the NHS-R community?

The NHS-R community is a network of NHS staff that use the R programming language to do healthcare analysis. The second NHS-R conference was a sell-out event, twice as large as 2018’s inaugural event, and represents an excellent opportunity for the community to come together and share ideas.

 

What is the ‘Winter Pressures’ project about?

The Winter Pressures project, supported by the Health Foundation, presents a novel data-driven modelling technique to simulate a virtual hospital. As patient-safety specialists, we are using state-of-the-art simulation techniques to improve our understanding of what might contribute to winter pressures, and hopefully uncover potential mitigations. What we learn from this work has implications for how we model patient flow in general, which could help us make informed preparations for events such as the COVID-19 outbreak.

 

How can simulation contribute to patient safety?

The more we know about what might happen, the better we can plan the best care. Simulation modelling can be used to safely test out scenarios/decisions and ideas to help alleviate unwanted circumstances, like the pressures caused by spikes in admissions. Modelling allows us to test even the strangest ideas without ever putting a patient at risk by making changes in a virtual hospital rather than a real one.

You can try something similar by playing the 1997 computer game Theme Hospital (or more recently, Two Point hospital, which I beta tested!). The game simulates a hospital in which your task is to treat patients against the clock. Our Winter Pressures project created a more complicated and specific simulation to understand how patient flow is affected by a variety of interventions.

For example, what happens if we run a “hotel” to assist patients who were clinically well but had stayed for social reasons? What is the effect of expanding the use of the diagnostic virtual ward, whereby patients are able to wait at home but have their investigations prioritised as if they were in the hospital?

– Image sourced from https://i.ytimg.com/vi/KvgifLGujDU/maxresdefault.jpg

 

How is the Digital Innovation theme making use of simulation for safety?

Our hospital simulation can be scaled up from a single ward to model an entire hospital at once. We have released the computer code in the hope that we can drive further use of this powerful technique in the NHS.

As part of the NHS-R conference, I led two workshops on simulation modelling using r-simmer. These sold out quickly, demonstrating how much interest there is in doing this kind of work in the NHS. We started with a basic model of an Intensive-Care Unit using more traditional techniques and built it up until it was fully data-driven.

It was difficult for those not already versed in R programming and what is known as Discrete Event Simulation. This showed the need for further training in simulation modelling and we are already in discussions about setting up training so more people can learn how to use these powerful techniques.

 

The importance of sharing for safety

These kinds of conferences are extremely important to allow projects like this to “touch base” with others, and ensure that the outputs are useful both in terms of what is needed in the NHS, and what can drive the state-of-the-art without being too complex to use. They also serve as a great opportunity to promote the benefits of this kind of improvement work, so it can be used across the NHS for patient benefit. Safety is a property of our healthcare systems so it can only be ensured through healthy and effective connection and communication between us all.

 

How can I get involved?

We in the Digital Innovation theme would like to know what healthcare project ideas you might have that could benefit from event simulation. Let us know in the comment section below.

And don’t forget to tell us how you get on running your own Theme Hospital.

 

 

 

Acknowledgements

The Winter Pressures project is part of the Health Foundation’s Applied Analytics programme. The Health Foundation is an independent charity committed to bringing about better health and health care for people in the UK.

Digital Innovation for Patient Safety, on the international stage

The International Society for Digital health was launched this year and the Digital Innovation theme are intricately involved to contribute the patient-safety perspective.

On the 25th September 2019 at the University of Leeds, the International Society for Digital Health had its official UK launch. The launch was attended by over 70 international delegates from as far as Indonesia, China, India, the Gulf and neighbouring EU countries. Members of the Digital Innovation theme were not only in attendance but our theme Lead, Owen Johnson, hosted the event; Moreover, Owen is a founding member and part of the society’s Executive Committee.

 

Leading the way on the international stage

In June 2019, Owen Johnson was invited to speak at the International Society for Digital Health 2019 conference, with a talk entitled “Patient safety: the opportunities and risks of using AI in medical diagnosis and care”. At the event, he spoke about the motivation for a patient-safety agenda in healthcare information technology. In part, the motivation arises from the consequences of a mixture of over-reliance and under-utilisation of automation. It is concerns like these that the Digital Innovation theme are addressing in our Micronarratives project, wherein we are asking how real-time intelligence is created via human sensor networks.

The difficulty in finding the balanced path of appropriate use of IT and artificial intelligence is somewhat explained by the V, and T challenges that Owen spoke about during his invited talk, at the June conference. The V challenge refers to the five Vs of big data:

  • Volume – How do we safely handle the very large amount of healthcare data being produced?;
  • Velocity – How do we safely handle the frequency with which healthcare data is updated and made obsolete?;
  • Variety – How do we safely handle the diversity of data types, formats, and delivery?;
  • Variability – How do we safely handle the differences in the way healthcare care is generated and used?; and
  • Value – How do we safely filter and prioritise the best healthcare data?.

The T challenge refers to safely handling the temporal effects of intervening with healthcare information technologies. Work by McLintcok et al. in 2014 showed how rates of coding and prescribing for incentivised conditions suggest anomalous prevalence and incidence during incentivised periods, but tend to reset to baseline values. It can be inferred that the timing of digital healthcare interventions can have anomalous effects with varying transience. These factors are front-and-centre for us in the Digital Innovation theme as we study the design and implementation of clinical decision-support tools (see Very Smart Cancer RATs).

 

What next for digital innovation of patient safety?

With these challenges in mind, the Digital Innovation theme continue to work in the overlap of digital technology, healthcare service, and safety science. Our member’s involvement in discussions at the international level facilitates collaboration and innovation for the promotion of patient safety in healthcare. The increasing digitisation and automation of society requires us to actively engage with the leading edge of our progress, and to take pre-emptive action to ensure our collective safety and effectiveness.

 

How can I get involved?

If you would like to keep up to speed or get involved with the International Society for Digital Health, join the LinkedIn open forum at https://www.linkedin.com/groups/10490340/.

You can also apply for membership by checking out http://www.theisdh.org/membership.php.