Keogh Cosmetic Interventions Review

The Royal College of Surgeons (RCS) should establish a Cosmetic Surgery Interspecialty Committee. This should consist of representatives from all the relevant specialty associations and professional associations and societies, including plastic surgery, ENT surgery, maxillofacial surgery, ophthalmology, breast surgery and gynaecology. Its task should be to: • set standards for the training and practice of cosmetic surgery. • make arrangements for the formal certification of all surgeons regarded as competent to undertake cosmetic procedures, taking account of training and experience. • establish and oversee a clinical audit database for cosmetic surgery, working with the Healthcare Quality Improvement Partnership (HQIP). • work with the Parliamentary and Health Service Ombudsman (PHSO) on dispute resolution (see recommendations regarding accessible resolution and redress). • meet the General Medical Council (GMC), Care Quality Commission (CQC), and the Medicines and Healthcare products Regulatory Agency (MHRA) regularly and, when appropriate, with provider representatives, to discuss current issues and share information and intelligence on the quality of care being provided. • develop a specific code of ethical practice for cosmetic surgery, in collaboration with the GMC, to include guidance on advertising, insurance requirements and the psychological assessment for patients.

Data on performance should be made publicly available at surgeon and provider level.

Providers should be required to notify the public on their websites of any CQC inspection concerns or notices.

All providers must keep full patient records, including clear operative records and precise details of any implant or device used. Providers should also be able to access data of implant cohorts readily and this should be available to regulatory authorities. Details of the surgery and implant used must be sent to the patient and to the patient's GP.

'Independent healthcare providers should only allow practising privileges to those cosmetic surgeons who can demonstrate that they have achieved and are able to maintain competence in the procedures which they offer'.

Those training to be non surgical practitioners should have a clear understanding of the requirement to operate from a safe premises, and the responsibilities involved. The training curriculum should include topics such as infection control, treatment room safety and adverse incident reporting. The code of conduct for those on the register should include an obligation to abide by certain clearly defined minimum standards for premises.

The scope of the EU Medical Devices Directive should be extended to cover all cosmetic implants, including all dermal fillers. UK legislation should be introduced to make fillers a prescription only medical device.

The EU General Product Safety Directive (GPSD) should be revised so that products used as part of a professional service are no longer exempt from product safety legislation.

All European Notified Bodies should be regularly and rigorously assessed and audited, to ensure they all work to the same high international standards; and reports of these assessments should be made public.

There needs to be unannounced inspections of manufacturers of class III and IIb medical devices to ensure production is compliant with the regulations. Reports of such inspections should be made public where possible.

Manufacturers should inform the MHRA when bringing a new product to the UK market and the MHRA should publish a list of the cosmetic devices available in the UK.

The RCS Interspecialty Committee should work with the CQC and the new Chief Inspector of Hospitals to ensure that providers follow the standards developed. In the meantime, the Review Committee recommend that only doctors on a GMC Specialist Register should perform cosmetic surgery, and that those doctors should work within the scope of their Specialty specific training.

A system should be developed by the MHRA to link the Unique Device Identifier for all implants to the patient's electronic record, enabling routine collection through Hospital Episode Statistic (HES) data. This information would enable assessment of implant performance, and the tracking and tracing of patients in case of a safety alert. The use of HES in the private sector hospitals which implant devices into people should be a CQC registration requirement.

Until such a system is developed, a National Breast and Cosmetic Implant Registry should be established and operational within 12 months. All cosmetic surgery providers need to keep a minimum data set that should be defined by the RCS Interspecialty Group. This should include details of the implant, the surgeon, the hospital and appropriate outcomes, and these data need to be held in electronic format until the registry is operational. These data should be easily accessible in the case of a product recall.

The Director of Patient Safety for NHS England should develop a framework to encourage and support the reporting of suspected device failures to the MHRA.

Formal relationships need to be developed between the MHRA, and professional organisations such as the Academy of Medical Royal Colleges and the Specialist Associations whose members implant medical and cosmetic devices and deal with the consequences of failure.

Assessment of systems for reporting adverse events should be part of CQC's registration and assessment of providers. Adverse incident reporting should be a standard component of professional appraisals and revalidation.

Evidence-based standardised patient information should be developed by the RCS Interspecialty Committee on Cosmetic Surgery. This should be done with input from patient organisations. This information should be available on NHS Choices and the Parliamentary Health Service Ombudsman (PHSO) website.

Patient Decision Aids (PDAs) should be developed for cosmetic procedures and these should be piloted by the RCS Interspecialty Committee on Cosmetic Surgery.

The RCS Interspecialty Committee on Cosmetic Surgery should develop and describe a multi-stage consent process for operations. This consent process should be undertaken by the operating surgeon and its use should be mandated as part of the Code of Practice.

For non-surgical procedures, a record of consent must be held by the provider.

The RCS Interspecialty Committee should develop a code of ethical practice developed for all practitioners of cosmetic interventions, and this should include standards to ensure that any advertising is conducted in a socially responsible manner

The RCS Interspecialty Committee should be responsible for developing clear, credible outcome measures for cosmetic surgery that are published at individual surgeon and provider level on the NHS Choices website.

CAP should extend its guidance note on cosmetic surgery advertising to cover non-surgical cosmetic procedures, and the sponsoring of TV and other programmes

The Review Committee considers that the following advertising practices are socially irresponsible and should be prohibited by the professional registers' codes of practice: o Time-limited deals o Financial inducements o Package deals, such as 'buy one get one free' or reduced prices for two people such mother and daughter deals, or refer a friend o Offering cosmetic procedures as competition prizes.

Providers and practitioners should provide continuity of care. Patients should be offered appropriate follow-up and after-care, rather than stand-alone procedures.

All organisations providing cosmetic surgery should have a doctor on the Board as Medical Director who is professionally accountable for all work carried out by the provider organisation and for its procedures, practices and wider activity.

The remit of the Parliamentary and Health Service Ombudsman (PHSO) should be extended to cover the whole private healthcare sector, including cosmetic procedures and ophthalmology. Providers should offer advice on their complaints procedures to their patients, and where appropriate this advice should be available on their websites.

Complaints against providers that are investigated and upheld by the Ombudsman should be publicly available.

All individuals performing cosmetic procedures must possess adequate professional indemnity cover that is commensurate with the type of the operations being performed.

Device manufacturer risk pools should be established. The Department of Health should work with the EU and industry to help support this. This risk pool would meet the costs of complications or corrective surgery in the event of wholesale problems with a device.

Patients' rights should be protected even when a provider goes out of business. Providers of cosmetic surgery must either enter a risk pool or have appropriate insurance/financial arrangements to provide treatment following certain complications. The NHS should be able to recoup costs for management of certain complications following cosmetic procedures if the provider has been found to have failed the patient following surgery. A similar arrangement already exists following motor vehicle accidents.

The insurance status of all practitioners should be displayed on the practitioner register.

All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures.

In order to ensure that all patients are adequately protected, overseas surgeons operating in this country should have the same level of professional indemnity as UK-based surgeons.

Non-healthcare practitioners who have achieved the required accredited qualification may perform these procedures under the supervision of an appropriate qualified clinical professional.

The Government's mandate for Health Education England (HEE) should include the development of appropriate accredited qualifications for providers of non-surgical interventions and it should determine accreditation requirements for the various professional groups. This work should be completed in 2013.

All practitioners must be registered centrally. The register should be independent of particular professional groups or commercial bodies, and should be funded through registration fees.

Entry to the register should be subject to: • achievement of accredited qualification • premises meeting certain requirements • adherence to a code of practice that covers handling complaints and redress, insurance requirements, responsible advertising practice and consent practices • continued demonstration of competence through an annual appraisal.

The CQC should work with professional organisations to produce inspection guidelines for cosmetic surgery providers. • Full participation in all clinical audit and data collection programmes that have been recommended by the RCS Interspecialty Committee should be part of CQC registration requirements and full participation by surgeons should be an essential component of their annual appraisal and revalidation. The CQC should use this data and clinical audit findings to analyse outcomes and assess risk, and this data should be used to guide inspection teams. • Risk-based and unannounced CQC inspections should be performed. • The inspection teams should have appropriate expertise and experience in this sector.