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Response to Editorial by Professor Kesselheim
BMJ 2014;349:g5303
Nieuwenhuijse’s paper has highlighted that the orthopaedic community need to be careful that the widespread introduction of new technologies does not lead to causing harm to patients (1). Professor Keselheim’s editorial has then recommended that new products and devices should be introduced using post-market surveillance to ensure their effectiveness and safety (2).
Articles such as these may cause significant cause for concern that new orthopaedic devices lack regulation. We feel that it is important that the medical community are aware of the steps that are already being taken by orthopaedic surgeons within the UK to counter the problem of unregulated new technologies.
Championed by the British Orthopaedic Association (BOA) and the specialist orthopaedic societies, orthopaedics within the United Kingdom (UK) is now one of the most open and highly regulated specialities. The England and Wales National Joint registry was introduced in 2002 and is by far the largest joint registry in the world and last year in 2013, surgeon-level mortality and outcome data was publicly released (3, 4). Another initiative, named Beyond Compliance was introduced in 2013 in the UK to regulate and support the introduction of new orthopaedic devices (5). It is well understood that registry data may stifle innovation through promoting conservative practice. Beyond Compliance was introduced as a collaboration with orthopaedic surgeons, the governing body (BOA with the Orthopaedic Data Evaluation Panel (ODEP)) and implant manufacturers to regulate the introduction of new hip and knee technologies (5). This initiative aims to promote innovation in a controlled environment though careful and close independent post-market surveillance. There are now seven new hip or knee implants that are currently being introduced to the orthopaedic market under the ‘umbrella’ of Beyond Compliance (5). Outcomes of these implants are being independently evaluated through Beyond Compliance in order to ensure the implant is safe and effective for patients prior to open release.
In our opinion, it is important that the readers of the British Medical Journal are made aware of the pioneering steps that are being taken to regulate and monitor innovation in orthopaedics within the UK. Orthopaedics within the UK is already one step ahead of the regulations that Professor Kesselheim has suggested.
1. Nieuwenhuijse MJ, Nelissen RG, Schoones JW, Sedrakyan A. Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies. BMJ (Clinical research ed). 2014;349:g5133.
2. Kesselheim AS, Rajan PV. Regulating incremental innovation in medical devices. BMJ (Clinical research ed). 2014;349:g5303.
3. NJR. National Joint Registry of England and Wales Surgeon Hospital Profile [17/9/2014]. Available from: http://www.njrsurgeonhospitalprofile.org.uk/.
4. NJR. 11th Annual Report. 2014.
5. Beyond Compliance [17/9/2014]. Available from: http://www.beyondcompliance.org.uk/.
Competing interests:
No competing interests
18 September 2014
Jonathan R Phillips
Arthroplasty Fellow
Mr Peter James, Consultant Orthopaedic Surgeon
none
Department of Orthopaedics, City Hospital Campus, Nottingham University Hospitals, Hucknall Road, Nottingham
Creativity cures crisis. So let's be visionaries and missionaries, who value creativity and view crises as painful, but productive, prerequisites and preludes to progress and success. Intimidating and aggravating, but stimulating and animating, our copious social, political, financial, and scientific crises are cris de coeur for creativity and vivid, viable overtures to invention. Innovation deserves a standing ovation.
Re: Regulating incremental innovation in medical devices
Response to Editorial by Professor Kesselheim
BMJ 2014;349:g5303
Nieuwenhuijse’s paper has highlighted that the orthopaedic community need to be careful that the widespread introduction of new technologies does not lead to causing harm to patients (1). Professor Keselheim’s editorial has then recommended that new products and devices should be introduced using post-market surveillance to ensure their effectiveness and safety (2).
Articles such as these may cause significant cause for concern that new orthopaedic devices lack regulation. We feel that it is important that the medical community are aware of the steps that are already being taken by orthopaedic surgeons within the UK to counter the problem of unregulated new technologies.
Championed by the British Orthopaedic Association (BOA) and the specialist orthopaedic societies, orthopaedics within the United Kingdom (UK) is now one of the most open and highly regulated specialities. The England and Wales National Joint registry was introduced in 2002 and is by far the largest joint registry in the world and last year in 2013, surgeon-level mortality and outcome data was publicly released (3, 4). Another initiative, named Beyond Compliance was introduced in 2013 in the UK to regulate and support the introduction of new orthopaedic devices (5). It is well understood that registry data may stifle innovation through promoting conservative practice. Beyond Compliance was introduced as a collaboration with orthopaedic surgeons, the governing body (BOA with the Orthopaedic Data Evaluation Panel (ODEP)) and implant manufacturers to regulate the introduction of new hip and knee technologies (5). This initiative aims to promote innovation in a controlled environment though careful and close independent post-market surveillance. There are now seven new hip or knee implants that are currently being introduced to the orthopaedic market under the ‘umbrella’ of Beyond Compliance (5). Outcomes of these implants are being independently evaluated through Beyond Compliance in order to ensure the implant is safe and effective for patients prior to open release.
In our opinion, it is important that the readers of the British Medical Journal are made aware of the pioneering steps that are being taken to regulate and monitor innovation in orthopaedics within the UK. Orthopaedics within the UK is already one step ahead of the regulations that Professor Kesselheim has suggested.
1. Nieuwenhuijse MJ, Nelissen RG, Schoones JW, Sedrakyan A. Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies. BMJ (Clinical research ed). 2014;349:g5133.
2. Kesselheim AS, Rajan PV. Regulating incremental innovation in medical devices. BMJ (Clinical research ed). 2014;349:g5303.
3. NJR. National Joint Registry of England and Wales Surgeon Hospital Profile [17/9/2014]. Available from: http://www.njrsurgeonhospitalprofile.org.uk/.
4. NJR. 11th Annual Report. 2014.
5. Beyond Compliance [17/9/2014]. Available from: http://www.beyondcompliance.org.uk/.
Competing interests: No competing interests