'Prescribing unapproved medical devices? The case of DIY artificial pancreas systems' by Joseph T.F. Roberts, Victoria Moore and Muireann Quigley in (2021) 21(1) Medical Law International 42-68 comments
In response to slow progress regarding technological innovations to manage type 1 diabetes, some patients have created unregulated do-it-yourself artificial pancreas systems (DIY APS). Yet both in the United Kingdom (UK) and internationally, there is an almost complete lack of specific guidance – legal, regulatory, or ethical – for clinicians caring for DIY APS users. Uncertainty regarding their professional obligations has led to them being cautious about discussing DIY APS with patients, let alone recommending or prescribing them. In this article, we argue that this approach threatens to undermine trust and transparency. Analysing the professional guidance from the UK regulator – the General Medical Council – we demonstrate that nothing within it ought to be interpreted as precluding clinicians from initiating discussions about DIY APS. Moreover, in some circumstances, it may require that clinicians do so. We also argue that the guidance does not preclude clinicians from prescribing such unapproved medical devices.
The authors argue
Healthcare technology innovation in type 1 diabetes (T1D) management has until recently been a relatively slow process. Patients have become tired of waiting for commercial companies to produce effective, accessible technological solutions that fully meet their needs. As a result, some patients (sometimes called ‘loopers’) are taking matters into their own hands and constructing do-it-yourself (DIY) systems to better manage their diabetes (encapsulated by #WeAreNotWaiting used to describe the movement on social media). Utilising two increasingly available technologies – continuous glucose monitors (CGMs) and insulin pumps – patients are creating hybrid closed-loop ‘artificial pancreas’ systems (APS). They do this by connecting their pumps to their CGMs using software installed on either a small computer or their smartphones. These systems calculate and deliver the required insulin doses automatically in real time. The main aims of ‘looping’ are to optimise blood glucose and insulin control and reduce the manual (and mental) input required by patients to manage their disease. For many patients, ‘looping’ represents a welcome step forward in the management of T1D. Users of DIY APS report experiencing improved amount of ‘time in range’ (time spent with blood glucose in optimal range), reduced anxiety surrounding sleep, and reduced time spent doing diabetes-related tasks such as checking blood glucose levels and calculating insulin doses. Nevertheless, it raises a number challenges for clinicians treating patients who loop or are thinking about looping.
These challenges, which this article will outline in detail, are exacerbated by the lack of regulatory approval for these devices. Although this article focuses on the implications of this in the United Kingdom (UK) context, the issue is an international one. No regulatory body has approved the use of these DIY devices; indeed, two have issued statements actively discouraging their use. Both the French and US regulators warn patients of the safety implications and tell healthcare professionals to be vigilant (the latter’s statement followed the report of a serious adverse event in which a DIY APS user received an excess of insulin). As such, many of the arguments in this article will be of relevance to clinicians, patients, and regulators in other jurisdictions.
Within the UK, there is an almost complete lack of ethical or regulatory guidance for clinicians who provide care to patients using DIY systems. This results in significant uncertainty with regard to their ethical and professional obligations in this respect. Practically speaking, this has led to clinicians adopting a precautionary approach in the clinic. Generally, even clinicians who are aware of the existence of DIY systems do not discuss them as an option unless the patient raises the issue themselves.
In this article, we do three things. First, while we acknowledge clinicians’ concerns that legal or regulatory body actions could arise if they initiate discussions around DIY APS with patients, we argue that the current approach is ethically suboptimal and stems in part from a misinterpretation of regulatory guidance. In particular, we note that the current approach may be creating a lack of transparency in clinic. Such a lack of transparency is ethically undesirable since it inhibits both clinicians’ and patients’ abilities to openly discuss the availability and benefits, as well as the potential risks associated with looping. Secondly, we examine relevant guidance from the UK regulator – the General Medical Council (GMC) (including Good Medical Practice, new consent guidance, and prescribing guidance) – and demonstrate that there is nothing in it which ought to be interpreted as requiring clinicians to refrain from discussing DIY APS with, or recommending them to, their patients. Indeed, the latest iteration of the GMC’s consent guidance, published in September 2020, could be interpreted as requiring such discussions in some circumstances. Thirdly, we go one step further and argue that, although a high degree of caution might be needed (especially as the technology diffuses out from the current core of highly expert users), GMC guidance does not preclude or prohibit clinicians from prescribing medical devices which lack regulatory approval (‘unapproved medical devices’); and to conclude otherwise is a misinterpretation of the guidance.
In making these arguments, it is important to note that we do not include either adults who lack capacity to make treatment decisions or children. While similar issues may arise for each of these groups, there are significant differences in relation to both the legal and regulatory landscape and the ethical arguments. For example, with regard to both of these groups, consideration of whether DIY APS is in the patient’s best interests is paramount. This is likely to further influence doctors’ decision-making processes and deserves careful consideration. As such, these patient groups are outside the scope of this piece. Our primary focus within this article is on regulatory matters surrounding prescribing; this particular focus reflects concerns raised among clinicians. It should, however, be noted that although GMC guidance is designed to be consistent with UK law, it is not intended to be a statement of legal principles. Nevertheless, we acknowledge that clinicians have concerns regarding legal liability and make some brief comments on this later in ‘Discussing DIY APS: What counts as a prescription?’ and ‘Professional judgement, clinical discretion and prescribing DIY APS’ sections.