|
The Beyond Compliance Service has been set up in the interest of patients, to support the safe and stepwise introduction of new or modified medical implants such as joint replacements.
If you are a patient receiving an implantable medical device, where the manufacturer of that device has opted to use the Beyond Compliance Service, then we require your permission to collect and use data about your surgery and about your recovery following surgery. Your permission will be sought by either your surgeon or one of the surgical team. You will be asked to sign a Beyond Compliance Consent Form.
Patient consent is essential in order that Beyond Compliance is able to monitor and assess products in the market. This data will be used to assess the performance of the device, to measure and improve the quality and safety of similar implants, and to improve surgical techniques, materials and protocols adopted.
If you provide consent to Beyond Compliance (BC), information that is stored on the National Joint Registry (NJR) about your surgical procedure will be linked to and stored with information collected by your surgeon, hospital and healthcare team comprising:
- Your personal details (Your name, NHS number, home address and date of birth) and relevant clinical information (NJR Index Number, Operation Date, Procedure Type, Side, Hospital, Lead Surgeon, Consultant in Charge, Beyond Compliance implants used) about your healthcare including x-ray images, results of examinations and tests,
- We will send the following identifiers to NHS Digital: BC Index Number (Audit ID), Gender, Date of Birth, NHS Number and Postcode. If you have participated, your responses to Patient Reported Outcomes Measures (PROMs) surveys including those held by NHS Digital (for more information see http://content.digital.nhs.uk/proms) will be sent back to NEC, with your identifiers removed and just your BC Index Number attached.
- All information will be held until such time that the implant is no longer monitored through the Beyond Compliance Service, at which point your personal identifiers will be removed from our records.
- HQIP is the Data Controller for the National Joint Registry (NJR). NEC is the Data Controller for Beyond Compliance (BC) and, after BC consent has been recorded, will only use the information for the BC service.
If you have not provided consent to the National Joint Registry, the procedure details will be stored without any personal details. Personal details may only be added by the surgeon responsible for your care.
Confidentiality
Your data will be stored in a secure facility managed by NEC Software Services (UK) Ltd. (“NEC”). NEC will not release your personal information unless required by law or where there is a clear overriding public interest.
Information about your surgery, with your personal data removed, will be made available to the manufacturer of your implant, to independent assessors from the Beyond Compliance Advisory Group, and to other healthcare professionals.
Participation and withdrawal
Your participation is voluntary. If you do not want to take part, do not fill in the consent form. Having consented to be involved, you may subsequently withdraw your consent at any time by contacting us, at which point your personal details will be removed from our records.
If required, please contact NEC by email at enquiries@beyondcomplince.org.uk, by phone on 0845 2636376, or write to NEC, 1st Floor, iMex Centre, 575-599 Maxted Rd, Hemel Hempstead HP2 7DX.
Follow-up Questionnaires. To help us monitor and report upon the outcomes achieved following surgery, we may from time to time send you a questionnaire asking about your state of health. This will be sent in either paper or electronic format based upon your preference. Your participation in these surveys is optional, but all answers will help us to assure the safety and effectiveness of medical devices for the benefit of future patients.
|
|
 |