Safety knows no boundaries

Prepare for a busy year ahead on safety and regulation issues in the independent sector, says David Hare.

Much work around further improving patient safety and reforming healthcare regulation was understandably put on hold last year while the health system responded to the Covid emergency.

But 2021 looks set to see several key changes which will have significant impacts for independent healthcare and those who work in the sector.

Firstly, at the beginning of this year, the Government published its response to the Independent Medicines and Medical Devices Safety Review (IMMDS), led by Baroness Cumberlege. 

This was set up to examine the use of three medical interventions – the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate, and surgical mesh – and, more broadly, how the healthcare system can improve its response to concerns raised about medicines and medical devices in the future. 

With increasing numbers of implantable devices being used in modern medicine and growing numbers of patients using a mix of NHS and private healthcare, it is vital that the independent sector is fully integrated into any measures to improve safety in this area.  

We therefore welcome the Government’s response to the IMMDS review, which included a commitment to amending the Medicines and Medical Devices Bill currently going through Parliament to include the creation of an independent patient safety commissioner role. 

The commissioner will act as an independent advocate for patients and help promote the importance of the views of patients in relation to medicines and medical devices. 

Critically, the commissioner’s remit will cover both NHS and independent providers, and the post holder will have the ability to make reports and recommendations to both sectors. 

Central database

The Government has also taken onboard Baroness Cumberlege’s recommendation to create a central patient-identifiable database to collect key details of the implantation of all medical devices. This will support research and auditing of the device safety and patient-reported outcomes measures. 

Demonstrating the Govern­ment’s commitment to a ‘whole systems’ approach to patient safety, work is now in progress to establish a UK-wide medical device information system.

This will facilitate the routine collection of medical devices, procedure and outcome data from all NHS and private provider organisations across the UK, ensuring that no patient – regardless of where they access their care – falls through the gaps. 

As outlined in my previous columns, this year will also see a step change in healthcare regulation with the Care Quality Commis­sion (CQC) developing its new five-year strategy to enable it to better regulate individual providers as well as assess local healthcare systems. 

Watchdog inspections

At the start of this year, the CQC also launched an additional consultation looking at specific changes to help enable it to be a more ‘dynamic, proportionate and flexible regulator’. This will have key implications for independent sector providers and practitioners in the sector. 

Proposed changes include moving away from a fixed inspection schedule and inspection visits to a greater use of wider sources of evidence, tools and techniques. 

Other proposals include changing the frequency of ratings reviews with the move away from site inspection as the mechanism through which a rating can be changed. 

The move to a more flexible system is welcome, but the devil is in the detail and it is as yet unclear what data and information the regulator will use to base its judgements. 

The Paterson Inquiry

Of course, 2021 will also see the long-awaited Government response to the Paterson inquiry. 

The former Bishop of Norwich’s report in February last year made over 15 recommendations directed at all parts of the healthcare system. 

These included healthcare professionals, the NHS and independent sector, professional and systems regulators, a wide range of issues looking at safety and quality of care, responding when things go wrong, working with others to keep patients safe, and governance, accountability and culture. 

Reading the testimonies of the individuals affected by Paterson’s appalling crimes, one cannot fail to be moved by their suffering. The Independent Healthcare Providers Network (IHPN) is committed to supporting the Government’s implementation of the Paterson inquiry’s recommendations.

This will including working with those in the sector to further embed the principles from our Medical Practitioners Assur­ance Framework – which stake­holders tell us is having added real value to governance. 

2021 will clearly be a busy year for safety and regulation, not least as we continue to adapt to the ‘new normal’ post-Covid world with an ongoing focus on stringent infection control and prevention. 

The IHPN has long advocated a ‘whole-systems’ approach to patient safety and healthcare regulation issues and 2021 looks like the year this will bear fruit.

We are committed to working with and supporting all clinicians in the sector so that we can continue delivering the safe, effective and joined-up care our patients expect and deserve.

David Hare is chief executive of the Independent Healthcare Providers Network