New Breast Implant Tracking Device to Promote Patient Safety

Medicines and Healthcare Products Regulatory Agency (MHRA ) in UK announced details about a new tracking system that will monitor high risk devices such as heart valves, pacemakers and breast implants.

With the PIP breast implant scandal rocking the cosmetic industry back in 2011, there is a strong need for close monitoring to prevent further risks and complications.

According to the Medicines and Healthcare Products Regulatory Agency(MHRA), this will help keep an eye on the high risk medical devices. Adding to that it will also help trace those particular patients who have it in such cases where safety alerts or recalls are necessary. Tracking patients will be easier without having to rely on multiple device registries.

There are four NHS trusts who are testing the new system with the hopes of incorporating these unique device identifiers soon into hospital patient electronic records, as well as national Hospital Episode Statistics databases. They also hope to have the results included in the analysis by the Clinical Practice Research Datalink (CPRD).

In a statement John Wilkinson, who is the Director of Medical Devices of the MHRA said: “The PIP breast implants episode is believed to be a case of deliberate fraud but it highlighted areas where medical devices regulation need strengthening in the UK and Europe.”

This monitoring device is a project that is part of 11 more by the MHRA. This was a response to the review made on May of 2012 regarding the PIP breast implants issue by the Health Minister, Lord Howe. With that, it is their aim to strengthen the regulation of medical devices.

As of this writing, their progress included the establishment of a new National Breast Implant Registry. This is to assist the Department of Health in re-establishing a National Breast Implant Registry. There is also an increase in adverse incident reporting of up to 25% in 2012 with the cooperation of private health organizations, manufacturers and the public. There is also a joint audit programme that was implanted for this year to make sure that all European notified bodies consistently meet high standards when assessing these high risk medical devices before they are sold.

Although development for the new tracking system for medical devices are still in the early stages, the MRHA is already hopeful that it will help them to improve the safety information that they receive in order to promptly alert healthcare professionals and patients about the potential safety problems that should arise.

It is commendable that the UK are taking extra steps into ensuring consumers are well protected, considering breast implants remains to be among the top cosmetic surgeries requested every year.

Lord Howe said, “Protecting the health and well-being of people who have been given medical devices is vitally important. Serious lessons need to be learned from the PIP scandal. The MRHA has identified new measures to help improve the monitoring of medical devices including implants. I hope it’s going to work, and the work of the Department, will reassure the public that we have identified the lessons and have taken steps to act on them.”

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Release ID: 15985