Breast implant situation highlights crucial value of registry and clinical audit data in identifying risk for patients, HQIP says

The current situation regarding the PIP breast implants has highlighted the lack of suitable data available to monitor the safety of medical devices and also clearly shown the value of those registers that exist currently, such as the National Joint Registry for England and Wales (NJR).

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The NJR – a register commissioned and managed by the Healthcare Quality Improvement Partnership (HQIP) as part of the National Clinical Audit and Patient Outcomes Programme (NCAPOP) on behalf of the Department of Health and closely organised with professional and clinical groups – contains more than one million patient records for prosthetic hip, knee and ankle joint replacements and is the largest database of its kind in the world.

The performance of every device – and the surgeons who implant and operate on them – is monitored across the life cycle of the prosthesis and its components, allowing the NJR to benchmark performance and report on any outlying devices or individual surgeons.

The Health Secretary Andrew Lansley, in relation to the current issues with breast implants, has highlighted the role registers and audits have in providing the kind of data needed to offer adequate safeguards and assurances about safety of medical devices.

Asked whether the PIP situation means there should be a system of formalised data available on breast implant performance in the mould of the National Joint Registry, he said: “It does raise that question. There was a [breast implant] register before 2004 and it was given up as substantial number of women did not want to have their data entered. We have demonstrated with likes of the National Joint Registry that it is clearly possible to have an effective register and anonymised databases to enable us to be much more confident and clear for the public and professions about the quality and safety of what we do.”

Recent examples of the efficacy of the NJR include the worldwide withdrawal of manufacturer DePuy’s ASR metal-on-metal hip device in September 2010 following the release of NJR statistics.

HQIP Chief Executive, Robin Burgess, said: “It is without doubt that device registers such as the National Joint Registry are fundamental in alerting clinicians and manufacturers as to the performance of devices at a stage early enough to prevent many issues occurring or before they become very serious. While no monitoring system can be said to be perfect, it can clearly be said that if a similar system had been in place for breast implants, the PIP situation may have been avoided.”

 

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