These are not been the best of times for healthcare regulators, or the regulated for that matter.
Social media, a phenomenon unheard of seven years ago, makes everyone a regulator or critic, and encourages clients for personal injury and human rights lawyers.
Add in a government and a parliament that thinks it is media savvy – but is actually influenced by the media’s agenda – and any risk and quality management regime without a strong communication management obligation becomes the regulation of failure and an exercise in recrimination.
Abuse in care homes, deaths in hospital wards, metal on metal hip replacements, and the PIP breast implant scandal provide a landscape of woe for patients.
Select committee hearings, ministerial and expert group reviews castigate failure in regulators, criticise process and procedures, and set out to make healthcare products and services safe for patients without, apparently, looking hard at the patient communication failure that is part of every incident.
Until now. “Action by the government and a health regulator to communicate with women over the PIP breast implants scandal was ‘inadequate’,” says the health select committee. It is a start, but will health minister Lord Howe’s investigation also address the fundamental failure of producers and providers, clinics and clinicians, to undertake any assessment of the implications for patient communication?
No-one has yet used the phrase “fit for purpose” when looking at the performance of regulators and government departments. The chair of the public accounts committee came close, but not close enough to trigger serious consideration about the quality assurance process and the management and communication of risk by regulators – healthcare regulators in particular.
It is as difficult to see a clear patient-centred approach to health regulation in the remit of the health regulators as it is to find an obligation to inform and communicate with patients. Is it too much to ask a regulator to ensure that every organisation and every individual medical professional in a complex manufacturing-to-delivery supply chain fulfil their duty of care through communication with their customer – the patient?
The moment the whistle blower calls, the abuse is identified, or the advice on prosthetics or implants is issued to surgeons that a risk to patients has been identified, it should be the trigger for a risk communication assessment.
Where were the public relations professionals working for the clinics and clinicians and the NHS in the PIP scandal, for example?
Is it easy to be wise after the event? Well, not really. Any risk industry, from pharmaceuticals through food and drink, motor or wheelchair manufacture to the oil and gas industry, has a risk and issue plan with customer communication at the centre in their incident and emergency folder and business continuity plan. Over the next few months the new Health and Social Care Act will be scrutinised and reviewed as the changes in the delivery of health and social care are rolled out. Secondary legislation will be drafted and put on the statute book. Perhaps this is an opportunity to ask the question whether the structures imposed on health regulators –which have been established by a series of enforced mergers –are fit-for-purpose.
The legislative requirement of assuring safety and quality has become a website proclamation of checking to ensure that government standards are met and findings reported to the public.
Enhancing and safeguarding public health simply by ensuring that devices work and are acceptably safe has become an evidence-driven, technical and mechanical notification and advisory process. No-one has a stated responsibility for patient communication and wellbeing.
This is a world where medical science has devised and developed implants, prostheses, surgical restorative and reconstructive techniques that contribute to the quality of life of every age group. It is the same world that has made communication personal, individual and a perceived right.
We need to put in place the same standards of risk analysis and communication management that we have developed for matters of public health, infection and contagion and apply them to these invasive techniques and surgical procedures, particularly where manufactured products are involved. This is not a private versus public healthcare provision issue – this is about effective risk regulation and communication management in the interests of the patient.