Information for Hospitals
As a service evaluation, Beyond Compliance is designed to protect patients and support the introduction of innovative orthopaedic implants. Many patients can benefit significantly from implants with better design, newer technology and improved performance that device manufacturers develop and surgeons wish to use. Maintaining patient safety is paramount and we hope that Beyond Compliance will go a long way to “Protecting Patients and Supporting Innovation”.
Why are hospitals supporting Beyond Compliance?
To encourage innovation and improvements in patient outcome, whilst maintaining patient safety, leading hospitals are seeking more cost-effective delivery of care over time. Hospitals are supporting their surgical teams in offering these new implants to appropriate patients by supporting Beyond Compliance, which provides independent monitoring with expert risk assessment and ongoing risk review. Less likelihood of revision, lower costs.
Why is Ethics Committee approval not required?
The NHS Health Research Authority recognizes Beyond Compliance to be a service evaluation. As such, NHS Research Ethics Committee approval is not required. For more background, please review the linked document from the NHS Health Research Authority which explains the position clearly.
Why is patient consent important?
Patient consent seeks permission for the Beyond Compliance service to view information about each procedure with personal identification information removed. With patient consent, independent assessors from the Beyond Compliance Advisory Group, other surgeons and the manufacturers of the implant, will then be able to view detailed information about each procedure, as necessary. The consent for Beyond Compliance is in addition to consent for data to be stored on the National Joint Registry. Every implant being monitored by Beyond Compliance already has a CE mark (i.e. they are legally compliant) so can be used throughout the European market. Retrospective consent for Beyond Compliance is acceptable, as surgeons often have to make the decision about which implant to select at the time of operation. All implant information collected by Beyond Compliance 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. All personal information will be handled confidentially and shared only with healthcare professionals involved directly in the patient’s care.
What extra administration is required? The Beyond Compliance system builds upon data about the patient and the procedure which has been collected routinely by the National Joint Registry (NJR). The only extra administration required is for each surgeon to ask each patient once to permit Beyond Compliance to view the NJR and any additional data using a standard consent form. Patient consent should then be recorded on the system using a simple checkbox and the form stored with the patient's surgical notes. Surgeons should also invite each patient to provide their email address so that they may be contacted about longer-term PROMs (Patient Recorded Outcome Measures) follow up surveys. All other additional data is optional and at the discretion of the surgeon. Surgeons may be invited to upload the operation notes, pre-operative and post-operative X-rays, and operation video (if available) to the secure Beyond Compliance system. If so, any patient identifiable data should be removed prior to upload. Should a patient have a complication, then additional data may be requested by the risk and safety assessors on the Beyond Compliance Advisory Panel.
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