Why aren’t medical devices regulated like drugs?
BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5032 (Published 29 November 2018) Cite this as: BMJ 2018;363:k5032All rapid responses
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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
Competing interests: All associations mentioned are members of the European Commission Health Technologies Assessment Network Stakeholder pool.
Condoms as medical device
Fiona Godlee (1) reported that medical devices should be more evaluated before their medical use.
In gynecology we hav many satisfactory medical devices. For example, intrauterine devices, transobturator tape, Bakri balloon and others.
However, I agree that for some medical devices the benefits and risks are not clearly defined. Therefore the information for patients and health professionals is lacking.
For example, condoms are delivered in pharmacies and supermarkets. However they are medical devices. They are used as contraceptive methods but also to protect against sexually transmitted disease. They protect effectively against HIV but insufficiently against Human papilloma viruses (HPV). HPV are responsible for cervix cancers and the death of many thousands of women in the World. Unfortunately, condoms dot not protect sufficiently against HPV in healthy women but also after a conisation or hysterectomy for HPV lesions. Indeed, recurrences could occur from the vagina for patients who undergo a uterine surgical treatment.
Finally, even for basic medical devices, risks and benefits should be clearly exposed: information for health professionals and patients is essential.
Condoms should be more evaluated and improved to protect against Human papilloma viruses.
References
1. Godlee F. Why aren’t medical devices regulated like drugs? BMJ 2018;363:k5032
Competing interests: No competing interests
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
Competing interests: No competing interests
Dear Editor
Just for information the same issue and scandal has appeared here in Australia via the Special Broadcasting Service doing an investigative piece. Here is the link: https://www.sbs.com.au/news/expert-calls-for-medical-implant-register-to.... There are many other stories.
Five years ago when I had a knee replacement I researched the type and material of the artificial joint. I discovered then that there were concerns with the surfacing of the metal joint and that certain brands had more of an issue than others. I asked my surgeon not to utilise these brands. It struck me then that the whole arena of artificial body parts was 1) uncontrolled on an international basis; 2) open to various types of fraud; and 3) there was no easy way for a patient to evaluate the item or to seek a performance guarantee from the manufacturer. Think seat belts and safety air bags!
Cheers, Michael
Competing interests: No competing interests
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.
Competing interests: No competing interests
It is good to read the Editor's Choice by Fiona Godlee, editor in chief, The BMJ.
The Materiovigilance Programme Of India (MvPI) is all about this.The purpose of MvPI is to monitor medical device-associated adverse events (MDAE), & it's importance among healthcare professionals (HCPs) and to monitor the benefit-risk profile of medical devices.
Regarding the regulatory requirements, the Indian Pharmacopoeia Commission (IPC), the National Coordinating Centre (NCC) of MvPI released Draft Guidance Document for Medical Devices on August 06, 2018. It is to maintain standards for medical devices for the benefit of the patients & HCPs and to improve the health care system of India [1,2].
Regards.
References:
1. http://www.ipc.gov.in/mandates/pvpi/materiovigilance-programme-of-india-...
2. http://ipc.gov.in/images/mvpi/Guidance_Document.pdf
Competing interests: No competing interests
Dear Editor
Would it be any better if they were? [1,2]
[1] Fiona Godlee, ‘A tale of two vaccines”, BMJ 4 October 2018, https://www.bmj.com/content/363/bmj.k4152
[2] Responses to Godlee, ‘A tale of two vaccines’, https://www.bmj.com/content/363/bmj.k4152/rapid-responses
Competing interests: No competing interests
Re: Why aren’t medical devices regulated like drugs?
Dear Editor
I rear the article with immense interest which has raised some pertinent issues. I would like to make a case for why there should be uniform global standards and not just regional. In my part of the world, Pakistan and south asia and other low and middle income countries , the rules are not lax ,they are virtually non existent. On top of that Pakistan and india ranked around 120 on transparency international corruption index compunds the problem. As a result even simple devices are imported from western hemisphere which after conversion of currency cost local populace 10 to 20 times local products. There is a huge influance of Chinese origin devices ,but who will bell the cat. Who will judge the quality when Pakistan and several other countries are dependant on billions of dollars investments from China. End user suffers in the whole scenario. Alot can be done if we set up a global body whose mandate is necessary before a device use. If we can have covid passport, which i personally don't support, why can't we have imposition on vendors to meet global standards
Competing interests: No competing interests