Commentary: Europe needs a central, transparent, and evidence based regulation process for devices

Research output: Contribution to journalComment/debateResearch

Standard

Commentary: Europe needs a central, transparent, and evidence based regulation process for devices. / Eikermaan, Michaela; Gluud, Christian; Perleth, Matthias; Wild, Claudia; Sauerland, Stefan; Mäkelä, Marjukka.

In: B M J, Vol. 346, 07.05.2013, p. f2771.

Research output: Contribution to journalComment/debateResearch

Harvard

Eikermaan, M, Gluud, C, Perleth, M, Wild, C, Sauerland, S & Mäkelä, M 2013, 'Commentary: Europe needs a central, transparent, and evidence based regulation process for devices', B M J, vol. 346, pp. f2771. https://doi.org/10.1136/bmj.f2771

APA

Eikermaan, M., Gluud, C., Perleth, M., Wild, C., Sauerland, S., & Mäkelä, M. (2013). Commentary: Europe needs a central, transparent, and evidence based regulation process for devices. B M J, 346, f2771. https://doi.org/10.1136/bmj.f2771

Vancouver

Eikermaan M, Gluud C, Perleth M, Wild C, Sauerland S, Mäkelä M. Commentary: Europe needs a central, transparent, and evidence based regulation process for devices. B M J. 2013 May 7;346:f2771. https://doi.org/10.1136/bmj.f2771

Author

Eikermaan, Michaela ; Gluud, Christian ; Perleth, Matthias ; Wild, Claudia ; Sauerland, Stefan ; Mäkelä, Marjukka. / Commentary: Europe needs a central, transparent, and evidence based regulation process for devices. In: B M J. 2013 ; Vol. 346. pp. f2771.

Bibtex

@article{d781cee2e41349ed9866e760615bf1c1,
title = "Commentary: Europe needs a central, transparent, and evidence based regulation process for devices",
abstract = "Last September, the European Commission published proposals to update regulations for medical devices in order to improve patient safety.1 The proposals are being discussed by the European parliament where critical debate is being led by the Committee on Environment, Public Health and Food Safety.Medical devices range from bandages to life support machines, and manufacturers classify them into four risk categories from low (such as urine drainage bags) to high risk (such as drug eluting cardiac stents) according to EU rules.2 The risk associated with the device depends on the duration of contact with the body, invasiveness, and whether it has a local or a systemic effect. Medium and high risk devices must be certified by one of the notified bodies, organisations that are accredited to assess a product’s compliance with EU legislation (CE mark).At a first glance this seems a structured process. But examples such as the withdrawal of Poly Implant Proth{\`e}se (PIP) breast implants show that the process cannot guarantee safe and effective patient care.3 The certification process is inconsistent, opaque, and operates in the interests of manufacturers. It requires insufficient evidence of efficacy of the devices and no long term follow-up of patients.4 5",
keywords = "Faculty of Health and Medical Sciences, Patients, Medical error/ patient safety, Reproductive medicine",
author = "Michaela Eikermaan and Christian Gluud and Matthias Perleth and Claudia Wild and Stefan Sauerland and Marjukka M{\"a}kel{\"a}",
year = "2013",
month = "5",
day = "7",
doi = "http://dx.doi.org/10.1136/bmj.f2771",
language = "English",
volume = "346",
pages = "f2771",
journal = "B M J",
issn = "0959-8146",
publisher = "BMJ Publishing Group",

}

RIS

TY - JOUR

T1 - Commentary: Europe needs a central, transparent, and evidence based regulation process for devices

AU - Eikermaan, Michaela

AU - Gluud, Christian

AU - Perleth, Matthias

AU - Wild, Claudia

AU - Sauerland, Stefan

AU - Mäkelä, Marjukka

PY - 2013/5/7

Y1 - 2013/5/7

N2 - Last September, the European Commission published proposals to update regulations for medical devices in order to improve patient safety.1 The proposals are being discussed by the European parliament where critical debate is being led by the Committee on Environment, Public Health and Food Safety.Medical devices range from bandages to life support machines, and manufacturers classify them into four risk categories from low (such as urine drainage bags) to high risk (such as drug eluting cardiac stents) according to EU rules.2 The risk associated with the device depends on the duration of contact with the body, invasiveness, and whether it has a local or a systemic effect. Medium and high risk devices must be certified by one of the notified bodies, organisations that are accredited to assess a product’s compliance with EU legislation (CE mark).At a first glance this seems a structured process. But examples such as the withdrawal of Poly Implant Prothèse (PIP) breast implants show that the process cannot guarantee safe and effective patient care.3 The certification process is inconsistent, opaque, and operates in the interests of manufacturers. It requires insufficient evidence of efficacy of the devices and no long term follow-up of patients.4 5

AB - Last September, the European Commission published proposals to update regulations for medical devices in order to improve patient safety.1 The proposals are being discussed by the European parliament where critical debate is being led by the Committee on Environment, Public Health and Food Safety.Medical devices range from bandages to life support machines, and manufacturers classify them into four risk categories from low (such as urine drainage bags) to high risk (such as drug eluting cardiac stents) according to EU rules.2 The risk associated with the device depends on the duration of contact with the body, invasiveness, and whether it has a local or a systemic effect. Medium and high risk devices must be certified by one of the notified bodies, organisations that are accredited to assess a product’s compliance with EU legislation (CE mark).At a first glance this seems a structured process. But examples such as the withdrawal of Poly Implant Prothèse (PIP) breast implants show that the process cannot guarantee safe and effective patient care.3 The certification process is inconsistent, opaque, and operates in the interests of manufacturers. It requires insufficient evidence of efficacy of the devices and no long term follow-up of patients.4 5

KW - Faculty of Health and Medical Sciences

KW - Patients, Medical error/ patient safety, Reproductive medicine

U2 - http://dx.doi.org/10.1136/bmj.f2771

DO - http://dx.doi.org/10.1136/bmj.f2771

M3 - Comment/debate

VL - 346

SP - f2771

JO - B M J

JF - B M J

SN - 0959-8146

ER -

ID: 98849329