Why aren’t medical devices regulated like drugs?

The principle of non maleficence is at the origin of clinical medicine since Hippocrates: first do no harm (primum non nocere). This principle was revisited with the concept of quaternary prevention(1) a core value of the Wonca, the World Organization of Family Doctors. This principle can be extended to all Health Care Professionals (HCPs). There is also a socio-political dimension of this principle(2) : for this reason HCPs are engaged together with Patients’ Associations to improve European regulations on Health Technologies at the level of European Commission Health Technology Assessment Network(3) and at the European Network for Health Technology Assessment (EUnetHTA(4)). We welcome your editorial and hope it will contribute to improved safety and transparency. In a public health approach, safety necessitates better evidence before the introduction of a device into the market, better follow-up of side effects in a centralised manner, in relation to drug-device combinations, or companion diagnostics, and device entry procedures that would encompass involvement of the European Medicines Agency (EMA). We consider that transparency is important for informed decision making for both patients and doctors. For this reason, diminishing transparency to protect commercial secrets and to avoid scaring the public is an untenable argument.

For the EC - HTA network stakeholder pool :
Health care professionals - HCP :
European Union of General Practitioners, Family Physicians, UEMO, Daniel Widmer
European Public Health association, EUPHA, Carlo Favaretti
European Forum for Primary Care, EFPC, Elena Petelos
European Hospital and Healthcare Federation, Hope, Pascal Garel
European Society of Cardiology, ESC, Piotr Szymanski
European Association of Hospital Pharmacists, EAHP, Petr Horàk
Standing Committee of European Doctors, CPME, Frank Ulrich Montgomery
European Society for Medical Oncology, ESMO, Josep Tabernero
Patients/Consumers :
European Patients Forum, EPF, Katie Gallagher
European Cancer Patient Coalition, ECPC, Kathi Apostolidis
Rare Diseases Europe, EURORDIS, François Houÿez

References.

1 Martins C, Godycki-Cwirko M, Heleno B, Brodersen J. Quaternary prevention: reviewing the concept: Quaternary prevention aims to protect patients from medical harm. European Journal of General Practice. 2018 Jan;24(1):106–11.

2 Jamoulle M, Roland M, Bae J-M, Heleno B, Visentin G, Gusso GDF, et al. Ethical, pedagogical, socio-political and anthropological implications of quaternary prevention. Revista Brasileira de Medicina de Família e Comunidade. 2018 Oct 10;13(40):1–14.
3 EC - HTA network stakeholder pool. List of participants. https://ec.europa.eu/health/sites/health/files/technology_assessment/doc...
4 EUnetHTA. https://www.eunethta.eu

The need for medical devices registration and regulation: A view from developing countries and users’ perspectives

Dear Editor,

Very recently, there have been calls for compulsory registration and regulation of medical devices [1]. These calls are coming not only from research and academic communities but also from the healthcare providers especially from the surgeons who use medical devices the most and know adverse issues associated with medical device technologies (MDT) [2]. These calls coming from the developed countries in Europe are welcome because these countries have the means, mechanisms and resources that can help and ensure effective medical device governance systems including registration and regulation of MDT. These steps will definitely help and ensure MDT governance in developed countries and equally in developing countries where there are weak regulatory systems and poorly resourced healthcare systems. In addition, effective registration and governance of medical devices is critical because MDT are not only used by clinicians; but also by patients and their lay carers [3], who need assurances that medical devices they use are safe, effective and properly regulated. These steps could enhance users’ trust in MDT and ensure patients’ safety.
[1] Godlee F. Why aren’t medical devices regulated like drugs? BMJ 2018;363:k5032.
[2] Coombes R. Surgeons call for compulsory registers of all new medical devices. BMJ 2018;363:k5010.
[3] Shah SGS, Robinson I. Medical device technologies: who is the user? IJHTM 2008; 9(2);181-97. DOI: 10.1504/IJHTM.2008.017372

Dear Editor,
Much of the insightful material in your articles about medical devices also applies about diagnostic devices. I wrote previously about no-contact forehead thermometers, which are widely sold, though known to be unreliable in adults1. Home glucose meters are another example. They should be designed to “fail safe”. Twice in the past I have come across models that give a progressively higher reading as they begin to fail. As a result, the patient may increase his hypoglycaemic drugs until a hypoglycaemic come ensues. Both with the thermometers and the glucometers entwinement between the hospital and the device manufacturers made investigation and the achievement of change very difficult.
As is already the case in Scotland, NHS England should have a central body that investigates and licences medical devices before they are procured,
Dr Gervase Vernon

Reference List

(1) Vernon G. Inaccuracy of forehead thermometers (letter). BMJ 2013; 346:f1747.