MHRA medical device alert over polyaxial heads
Zahra Nanji considers the latest alert about a medical device in light of concerns about the MHRA highlighted by the Cumberlege Review
Posted on 14 July 2020
The Medicines and Healthcare Regulation Authority (MHRA), the UK regulator of medicines and medical devices, has issued a Medical Device Alert (MDA) about USS II Polyaxial Heads.
The device is used worldwide, including in the UK, and is designed to provide stabilization of the spine in adult patients.
The MDA warns that cracking of the 3D Head rings may result in loosening of the fixation system before bones have healed in patients implanted with the device.
Johnson & Johnson's DePuy Synthes initially voluntarily recalled its USS II Polyaxia3D Heads –in November 2019. The implants are manufactured by Synthes GmbH which specialises in instruments, implants, for surgical fixation, correction and regeneration of the human skeleton and soft tissues.
Its Field Safety Notice issued on 13 November 2019 advised that the company was initiating a voluntary removal of the device from the market due to identifying that intra-operative or post-operative breakage of the USS II Polyaxial 3D Head rings which may result in loosening of the rods, cause non-union or malunion, pain, dislocation, and/or loosening of the medical device.
At the time of the recall, the company advised that it was not recommending pro-phylactic removal of the device but advised surgeons to perform routine clinical follow-up and discuss potential clinical implications and risks with symptomatic patients who received the affected implants.
The MHRA Device Alert (MDA), comes almost seven months after the initial recall. The MHRA states that following obtaining expert clinical advice, it now recommends that all patients (whether they are symptomatic or not) receive additional follow-up with advice that all patients who have had the device implanted for less than two years should be contacted within three months to discuss if the patient has symptoms which may indicate implant failure.
If the patient does not have symptoms, they should be reviewed annually for symptoms for a minimum of two years after the date of implantation. If the patient is symptomatic, imaging such as X-ray or CT scans can be used to confirm this and the patient should be reviewed annually for up to five years.
It is anticipated that both NHS and private hospitals and clinics across the UK will now be required to contact patients implanted with this device by 2 October 2020 for follow up so that advice in the issue can be relayed and the patients can be monitored and followed up with imaging if they are symptomatic.
In November 2018, an investigation by the International Consortium of Investigative Journalists (ICIJ) reported that health authorities across the globe have failed to protect millions of patients from poorly tested implants, in a global examination of the medical device industry.
The ICIJ’s reporting called into question whether the medical device industry was putting millions of patients at risk of serious harm in its quest for profit. The report highlighted that the device industry and its hospital customers often can’t find people with implants.
On 8 July 2020, a Review by a team led by Baroness Julia Cumberlege published its findings in the First Do No Harm Report.
One of its nine recommendations was that there needs to be substantial revision of the MHRA, particularly in relation to adverse event reporting and medical device regulation: The Report highlighted that the MHRA should be a system-wide healthcare intelligence unit to facilitate early detection.
As a product safety lawyer with considerable experience of these kinds of cases I believe it is clear from both from the ICIJ report in 2018 and now the Cumberlege Report that the MHRA as the regulator of medical devices, needs to act swiftly and decisively to protect patients from potential harm.
It is clear that the current system within which the MHRA operates does not adequately protect the patients it is supposed to serve and that there is very often a significant time delay between the MHRA being notified of an issue with a device and advice and a programme of action being provided to practitioners and the public as to how to deal with issues that they have been alerted about.
The Cumberlege Review in particular has called for significant reform to the MHRA and I hope that once the recommendations are implemented, that the MHRA is provided with the powers and authority envisaged, and that the MHRA will be able to act both proactively and expeditiously to protect patients and provide timely guidance to practitioners.