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. Your 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.
Your personal information will be handled securely, and will only be shared with healthcare professionals involved in your care. Your data will be stored in a secure facility managed by Northgate Information Solutions Limited (Northgate). Northgate 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.
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.