A report commissioned by the MHRA to look at their inner workings once again shows the way that government health agencies are able to avoid facing up to their failings in their Duty of Care to their patients.
The Stephenson Report published in April 2014 by an external panel including Professor Stephenson and a long list of health professionals reads like yet another 'whitewash', just like the 2012 Department of Health Report by Lord Howe on the PIP implant scandal.
Both the Stephenson Report and the Lord Howe Report are able to show the areas where the MHRA can improve (more qualifiied staff, faster reaction to Adverse Incident Reports, ongoing monitoring of patients). However neither Report seems able or willing to point out just who is responsible for the disastrous consequences of the many failures in regulation by the MHRA (including Surgical Meshes, Hips and PIP implants).
Somehow, after a year working through 2013, Professor Stephenson and his colleagues managed to look at the internal workings of the MHRA and produce a 78 page report without pointing out that despite the clear and legal requirements for the MHRA to regulate and then monitor the ongoing performance of medical devices, the MHRA totally failed, for over at least six years, to make any proper investigation into the increasing level of Adverse Incident Reports (AIR) of the fraudulent PIP implants, other than suggesting that surgeons might be to blame for the ruptures on the implants because of incorrect medical procedures.
Also how is it that the Stephenson Report highlights the need and recommends, several times, for improved ongoing monitoring of both Medical Devices and patients with a register (for the lifetime of the device and/or the patient) without questioning, let alone investigating, the fact that there actually was a Register of Breast Implants which was dropped by the Department of Health/MHRA in 2006. For the next six years, as the illegal PIP implants continued to leak and rupture, causing major health problems for tens of thousands of British women, there was no coordinated register of these health problems.
" How come the Stephenson Report failed to comment on why the original Breast Implant Register was dropped in the first place and who made the decision? "Even more incredible, considering the clear recommendations of both Lord Howe and Professor Stephenson, is that the MHRA are still debating whether they should have a Register of PIP implants and be monitoring the health of affected women. Meanwhile tens of thousands of British women everyday face the prospect of leaking and explosive illegal PIP implants that the MHRA continue to maintain are perfectly safe.See here
From the Stephenson Report
Section 6
Although outside the remit of the MHRA, the Group made an observation that the commissioning of clinical services should include mechanisms to measure relevant outcomes in order to ensure that the quality of interventions is measured over the long-term in order that both clinical practice and product development are informed and driving continuous improvement. They should include on the part of clinicians obligations to fully participate in quality assurance systems such as registries where they are appropriate and exist and to report adverse incidents in a systematic and complete manner.
Secion 7
Working with all participants across the healthcare system to improve adverse incident reporting is critical to the early detection and resolution of potential problems. Working with clinicians, in particular, to remove the barriers to reporting adverse incidents and device incidents to ensure that those reporting understand that receiving multiple reports is the driver for intervention will be key to the Agency’s ability to take timely regulatory action to minimise risk to patients.
Without systematic collection, analysis and transmission of data it is impossible for the MHRA and professional organisations to fulfil their role in managing patient safety issues.
A “one-click” reporting system such as a stand-alone, free MHRA app that sits on all the major ‘tablets’, smart phones, pads, PCs, etc, would overcome some of the practical barriers to reporting adverse events in real time and is recommended for consideration of introduction. There must be as few mandatory questions as possible – the minimum information is the event; that the device can be identified; and the reporter is contactable.
Section 8
Access to high quality and reliable data about the performance of devices and clinical interventions over the full life of either the device or patient are critical to making effective clinical and regulatory decisions. This is becoming increasingly important because patients live longer and the number and variety of devices is increasing.
Section 9
It is essential that the information that the Agency and manufacturers hold in relation to adverse incidents should be shared more effectively with professional organisations so that, where appropriate, training and education programmes can be developed to mitigate risk to patients.
The Devices Division depends on the Adverse Incident reports it receives and the majority of these are from manufacturers, who have a legal obligation to report incidents that have happened in the UK to the MHRA.
Read the full Report here:
