A qualitative study exploring policy-amenable factors influencing medical device-related patient safety from a lifecycle perspective

Abstract

Thesis Title: A qualitative study exploring policy-amenable factors influencing medical device-related patient safety from a lifecycle perspective

Author: Kathleen Rose Harkin

Abstract Introduction: Medical devices are essential to healthcare, but they are not always as safe or effective as they could be, and this lack of effectiveness also causes harm to patients. Furthermore, the evidence needed to determine if a particular device is safe and clinically effective is often not available at market entry. Consequently, it is argued that a lifecycle approach to the evaluation of medical devices is needed to identify long-term outcomes and any unexpected or late adverse effects. The aim of this research was to improve medical device safety by identifying policy-amenable factors affecting the safety of medical devices from a lifecycle perspective.

Methods: The thesis consists of two studies. The first is a qualitative evidence synthesis of conceptual or theoretical models and frameworks used to evaluate medical devices from a lifecycle perspective, consisting of a comparative analysis, the development of a model typology, and a thematic analysis. The second is a qualitative document analysis of the regulatory framework applied to medical devices in the European Union (EU). This was a theory-driven multi-level exploration of how medical devices are regulated, by whom, and why.

Findings: It was found that there are three model archetypes for evaluating medical devices - new product development, diffusion, and outcomes evaluation models, highlighting the different goals for lifecycle evaluation. It was also found that the adoption by the regulators of a lifecycle approach to evaluating medical devices is the reason that there is so little robust clinical evidence available for assessing device effectiveness at market entry. The regulators’ lifecycle approach has led to the acceptance of limited and poor quality pre-market evidence, relying instead on evidence of poorly performing or harmful devices to emerge in the post-market phase. Medical device regulation in the EU is complex, fragmented, lacks transparency, and is based on the New Legislative Framework, which is intended to support trade rather than to protect patients. It utilises a risk-based system rather than an outcomes-based approach to allowing medical devices onto the market. Medical devices must carry the CE Marking, indicating regulatory compliance, but this does not mean that a device is safe or effective. This research found that there was significant evidence of regulatory capture across multiple levels of regulation, including at the global, EU, and local level.

Discussion: Regulation does not protect patients from ineffective or unsafe devices, nor does it ensure that there is a robust evidence base for each medical device. Regulators don’t demand high quality evidence of efficacy so this is not needed to gain market entry, consequently, manufacturers frequently don’t generate this evidence. ‘Lifecycle evaluation’ is proposed as a means of filling the evidence gap. However, it is also a catch-phrase that is being used by industry to deflect attention from the fact that the evidence is not available in the pre-market phase. Evidence generation is costly, and there is no return on investment from it in the pre-market phase, nor will there be in the post-market phase if the evidence suggests that a device is inferior, ineffective, or unsafe. Thus, there is little or no incentive for manufacturers to improve the pre-market evidence when they may obtain public reimbursement without it. However, this leaves the public, healthcare payers, and policymakers without the evidence they need to make their own decisions regarding healthcare acquisition, provision, or funding.

Conclusion: The regulation of medical devices in the EU cannot guarantee the safety or efficacy of the medical devices being presented for sale to healthcare providers. Therefore, regulation needs to be improved. Furthermore, since robust clinical evidence is not mandated by regulators nor generated by industry, it is essential that policymakers ensure that this evidence is generated and analysed by the healthcare service in order to determine what devices are safe and effective for whom. A national implant registry housed within the HSE and managed by a highly skilled multi-disciplinary team would best serve this purpose.