Statement on medical device and implant safety
Following recent media coverage about the safety of medical implants, we wanted to reassure patients about the approach taken at The Royal Orthopaedic Hospital for approving the use of medical implants and devices.
The medical devices and implants used at The Royal Orthopaedic Hospital are done so in accordance with NICE guidance and quality standards. The internal process for approving the use of new medical devices at the Trust is robust and decisions are based on evidence and clinical expertise. We also routinely follow up with our patients to ensure they are medically well.
NuVasive Magec rods
The Magec rod system has been used by surgeons in our Trust and across the NHS. It has been approved by NICE and has offered a beneficial treatment option to a number of patients, decreasing the number of surgeries they have to undergo. We routinely monitor patients including their health outcomes and any complications they experience.
While no medical device or implant is without risk, we offer treatment based on the best available evidence from national bodies like NICE. Our Medical Devices Advisory Group reviews the use of any new device or product used in the Trust and we conduct longitudinal studies with patients to review the effectiveness of our treatment. We also have a robust safety alert protocol which enables us to act immediately upon recommendations from the DOH and WHO and communicate with medical device companies.
If you would like to speak with someone about the Magec rods, please call our Spinal Clinical Nurse Specialist on 07790945003.
- A statement from the Europeam Association of Medical Devices - Notified Bodies
- You can read more about medical devices conformity assessment and the CE mark here and here.