Wednesday, April 24, 2013

Technology and the Keogh Report - Ensuring safe products

How can iConsultAesthetic support the recommendations for ensuring safe products?

Recommendation 18 

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.

iConsultAesthetic has sections where HCP can sign to demonstrate their acceptance of their responsibilities for each patient and every patient consultation. This information is added to the patient record and made available to the patient. 

Recommendation 19 

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. 

iConsultAesthetic has the functionality to restrict products listed on the system that have achieved certain criteria. 

Recommendation 20 

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. 

Recommendation 21 

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. 

Recommendation 22 

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. 

Recommendation 23 

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.

Recommendation 24 

A system should be set up 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. HES should be a CQC registration requirement.

Recommendation 25 

Until such a system is developed, a National Breast and Cosmetic Implant Registry needs to be established and this should be 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 would be expected to include details of the implant, the surgeon, the hospital and 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. 

Recommendation 26 

People who have undergone implant surgery should be able to compare their own personal data, and aggregated data from the registry for the implant, surgeon and provider.

Recommendation 27 

Full participation of providers in national registries and databases should be an essential component of the Care Quality Commission (CQC) registration and assessment, and full participation by surgeons should be an essential component of their annual appraisal and revalidation. 

24 - iConsultAesthetic automatically links all product data to the patient record, enabling HES collection and facilitating product tracking/tracing and patient follow up. The system can link to a National Breast and Cosmetic Implant Registry providing realtime data electronically and enabling easy access online for all stakeholders. 

25 -Using Tablet Computing (iPads) Patient images are captured in theatre before surgery, and the product numbers are recorded at the moment of implantation, minimising risk of mistakes. Patient images are captured post surgery, which would be a valuable record in the event of a claim. 


26 - Patients are given an access level, and provided with their notes in PDF format but can login to the system to be able to compare personal and aggregated data. 


27 - Adapting this system to this task would be a fraction of the cost of developing a bespoke solution, and could be operational within 6 months. Data would be stored on dedicated servers and password protected. 


Recommendation 28 

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

Recommendation 29 

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. 

Recommendation 30 

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. 

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