Medical Device or Medical Service?

Healthcare providers have had to mobilise and evolve quickly in response to COVID-19, but that shouldn’t be to the detriment of quality care and patient safety.

The Care Quality Commission (CQC) is the independent regulator of health and social care in England whose remit is to monitor, inspect and regulate UK healthcare services to ensure they meet fundamental standards of quality and safety.

The provision of cardiac Holter analysis (continuous ECG monitoring for 24 hours plus) is regulated by the CQC under the category Diagnostic and Screening Procedures. Registration is a legal requirement under the Health and Social Care Act 2008. Perhaps less well known, is the provision of these services in the UK without registration is a criminal offence.

The current Covid-19 crisis has seen a number of private sector companies (predominantly from overseas) marketing cardiology diagnostic services to NHS trusts and the UK independent healthcare sector. Clinical services are often bundled with the sale of disposable Holter monitors with the clinical workforce offshore and sometimes subcontracted out again to developing companies where labour is cheap. By selling their services as single-use medical devices, these overseas companies are evading the scrutiny of the UK healthcare regulators.

At ECG On-Demand®, we find this genuinely alarming. Not only is the company selling the service, committing a criminal offence but it also severely compromises the position of its customers.

ECG On-Demand® from Techomed Limited has been at the forefront of 12-lead ECG Interpretation and Holter monitor analysis for the last decade. Our proprietary traffic light ECG risk rating system has been constantly refined since its launch in 2010. Not ones for sitting on our laurels, since our Innovators of the Year accolade at the General Practice Awards in 2012, we have continually embraced digital data processing technologies to improve reporting precision. All of this is underpinned by a first-class team of physiologists who are on hand seven days a week.

Back in July 2019, we were subject to our own CQC inspection receiving a good rating overall with outstanding for well-led. As the inspection summarised:

“The service had established and effective governance systems to deliver sustainable high-quality ECG tracing and Holter assessments with minimal notice. They employed operational resilience within their clinical team and IT systems…Peer and clinical supervision was readily accessible to all staff and they commissioned external Cardiac consultants to audit 5% of their judgements on a rolling cycle. Any disparities were discussed monthly at clinical meetings, judgements and rationales recorded and where appropriate processes and clinical software amended to reflect the decisions and ensure consistently precise future clinical assessments.”

Fully compliant with General Data Protection Regulation (GDPR) in the processing of sensitive personal data, ECG On-Demand® has also completed the NHS Data Security and Protection Toolkit (DSP) a mandated by NHS England for the handling of NHS data.

At ECG On-Demand® we are proud of the service we provide so we not only actively seek scrutiny of our services, we embrace it because this is how we make our services even better.

Mark

Click here to read our CQC report.

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