How can we get high quality routine data to monitor the safety of devices and procedures?BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f2782 (Published 07 May 2013) Cite this as: BMJ 2013;346:f2782
- Bruce Campbell, chair of the interventional procedures advisory committee 1,
- Andrew C Stainthorpe, associate director 2,
- Carole M Longson, director 2
- 1National Institute for Health and Care Excellence, London SW1A 2BU, UK
- 2Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, UK
- Correspondence to: B Campbell
Difficulties with medical devices and discussions at the European Commission about new regulations have focused attention on how to introduce devices and procedures safely.1 2 Both medical devices and new procedures are typically introduced with little evidence from clinical trials or observational data. The regulatory requirements for research evidence on the efficacy and on the short and long term safety of new devices are universally less stringent than those for medicines.3 To protect patients from harm we need to gather as much information as possible about adverse events; for implanted devices the data should be over the long term.4 Recent events such as the Poly Implant Prothèse (PIP) breast implant scandal show that data gathering is still not happening as it should. We examine the reasons for inadequate collection of data and explain what steps might be taken to improve it.
Why is the evidence on safety so limited?
Many medical devices are produced by small specialist companies that lack the finance and experience to conduct adequate research, and the relatively short “market life” of many devices also militates against continuing research. Within Europe, regulations require manufacturers to obtain a CE mark for a new device from any of the many “notified bodies” throughout the European Union. The degree of scrutiny for CE marking depends on the type of device, but the amount of clinical evidence needed is typically small.
Not all new procedures use a new medical device, and vice versa. For example transcatheter aortic valve replacement (TAVI) was a new procedure generated by production of a specially designed valve and delivery system. By contrast, injection of autologous blood to treat tendinopathies or fasciopathies is a novel procedure but involves …