Devices are to be better monitored

Devising a new strategy – David Hare explains what the Government’s response to the Medicines and Medical Devices Safety Review will mean for the independent sector. 

Improving how the health system responds to patients’ concerns and ‘putting patient voice at the centre of patient safety’ is currently a key focus for both Government and healthcare providers.

This is especially pertinent due to the ongoing work around responding to the former Bishop of Norwich’s inquiry into rogue surgeon Ian Paterson. 

And in July we finally saw the long-awaited Government response to last year’s Independent Med­icines and Medical Devices Safety Review (IMMDS). 

This sets out what action it is taking to support patients who have suffered because of Primodos, sodium valproate and pelvic mesh implants – and what more can be done to reduce the risk of avoidable harm from medicines and medical devices in the future. 

The Government’s response sets out several key reforms:

 Improving how the system listens to and responds to concerns raised by patients; 

 Strengthening the evidence base on which decisions are made; 

 Improving the safety of medicines and devices.

The response will have important implications for doctors and others working in the independent healthcare sector.

Patient Safety Commissioner 

One of the biggest recommend­ations the Government has accepted from the IMMDS is the introduction of a new Patient Safety Commissioner.

The incumbent will ‘champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices’.

The remit, critically, will cover care in both the NHS and independent sector. 

It is intended for the Commis­sioner to be in post in the second half of 2022 and we at the Independent Healthcare Providers Network (IHPN) will be looking to engage with them early on and work together to further support patient safety in the sector. 

Monitoring implants

This ‘whole systems’ approach to safety is also replicated in the Government’s commitment to establishing a patient identifiable database to ensure that implantable devices are effectively monitored and any issues affecting patient safety are responded to. 

It will apply to devices being used across the healthcare system.

The Government plans to hold a public consultation on a new UK-wide Medical Device Information System (MDIS), with £11m set-aside for 2021-22 to scope, test and cost options for MDIS and other medical devices patient safety workstreams. 

This more joined-up approach to recording and regulating the use of medical devices across the whole healthcare system to keep patients safe is to be welcomed – particularly at a time of rapid growth of implantable medical devices both in the UK and internationally. 

IHPN is working to ensure that independent providers are fully linked with the new networks of specialist centres that the review recommended should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh. 

Eight specialist centres have already been set up around the country and the Government has also committed to the development of a patient-reported outcome measure (PROM) for pelvic mesh procedures which will be commissioned through the National Institute of Health Research in 2022.

Manditory reporting

With regards the thornier issue around reporting payments from the pharmaceutical and medical device industry, the Government has committed to looking into this further, including whether there is a need to make reporting mandatory through legislation.

The IMMDS, along with the ongoing response to the Paterson inquiry, demonstrates the real need to ensure patients are listened to when it comes to safety.

Healthcare providers across the whole system must be open, responsive and transparent about the care they deliver. And note that women comprised the vast majority of patients involved in these two inquiries.

There is still much to do on this agenda, but we welcome the Government’s ‘whole systems’ approach which reflects the key role independent providers – and those that work in the sector – have in making sure all patients receive the safest possible treatment.  

David Hare (right) is chief executive of the IHPN