Prescribing unapproved medical devices? The case of DIY artificial pancreas systems

Abstract

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.

Association of British Clinical Diabetologists, Diabetes Technology Network UK and Association of Children’s Diabetes Clinicians Survey of UK Healthcare Professional Attitudes Towards Open-Source Automated Insulin Delivery Systems

“…Equally, HCPs are conscious of the risks of OS-AID and the ethical grey area it may foray into with many choosing to continue to provide equipment, including consumables, but to warn about the risks or go as far as to absolve clinical responsibility for any harm that may arise. Although perhaps this is understandable for systems with an absence of MHRA approval or CE marking, more recent ethical analysis assures us we should support and perhaps even discuss the uptake of these systems more openly [ 15 ]. The sparse robust safety evidence and absence of regulatory approvals combined with HCPs reported lack of knowledge provide insight into why HCPs did not tend to initiate discussions in clinic.…”

“…These recognised the will of the diabetes community in guiding and choosing their own care and acknowledged the “frustrations” felt by many at the slow progress being made via the conventional routes. More recent works have highlighted a potential ethical duty to discuss OS-AID as an option with patients who may benefit, although without clear guidance this would go beyond what many HCPs would find comfortable [ 14 , 15 ]. Formal guidance and consensus, endorsed by an international body of HCPs and professional societies including International Diabetes Federation, ISPAD as well as ABCD DTN-UK, has just been published [ 16 ].…”

#WeAreNotWaiting DIY artificial pancreas systems and challenges for the law

“…In other circumstances, a discussion might incorporate advising or recommending, which could count as prescribing. 5 Providing information is unlikely to lead to liability issues. Indeed, the most recent iteration of the GMC's 'consent guidance' says that the exchange of information between doctor and patient is central to good decision-making.…”

“…While it is possible for a private patient who receives private healthcare to have a contractual relationship with a manufacturer from whom they purchase a pump, the re-purposing for 'looping' would likely fall outside the scope of any contract that is in place. 5 Inaccurate CGM data may also result in harm to the user. Here, we focus on the liability of pump manufacturers rather than CGM manufacturers.…”

“…These DIY systems consist of three components: a smartphone/small computer which runs an algorithm and collects data, a continuous glucose monitor (CGM) to provide glucose readings and an insulin pump to deliver insulin. Once connected, the resulting system automatically calculates and delivers insulin doses 5 . Users self‐reported benefits include improved blood‐glucose management and decreased anxiety around hypoglycaemia 6 …”