Faulty Devices: How Does Cardiology Compare to Aviation?

John Pepper OBE MA MChir FRCS FESC

Disclosures

Eur Heart J. 2019;40(25):2103-2106. 

In This Article

Legislation

A Conformite Europeene (CE) mark signifies that a product conforms with all EU directives or EU regulations that apply to it. CE marking is required for a wide range of product types; therefore, the presence of a CE mark does not imply that equipment is suitable for any use in a medical setting but for a particular application. If used outside this application, the device is considered 'off-label'. Manufacturers must check which EU legislation they need to conform with for their products. The product may be placed on the market as medical equipment only if it complies with the provisions of all applicable directives and regulations and if the conformity assessment procedure has been carried out accordingly.

The CE marking means that a manufacturer is declaring, on his or her own responsibility, that the product conforms with the relevant essential requirements in the Directives, and that it is fit for its stated, intended purpose. Once satisfied that the device meets the relevant provisions of the Directives and that the relevant assessments have been carried out, the manufacturer signs a 'Declaration of Conformity' prior to affixing the CE marking to his product before it is placed on the market.

In a recent Health Policy article in the Lancet,[2] Fraser et al. argue for much needed transparency in the provision of all medical devices in Europe. Little evidence has been available concerning the approval of medical devices in Europe when compared with new drugs in Europe or with medical devices in the USA. The recently introduced EU law on medical devices of 5 April 2017 declares that adequate access to information is essential to enable healthcare professionals to make informed decisions. In their article they summarize this legislation and test the provisions of the Regulation against the need to inform healthcare individuals and patients. EUDAMED is an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission's Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. A small task force of regulators and stakeholders has recommended what information should be included in the summaries of safety and clinical performance and which components of the EUDAMED database need to be open to public access. These recommendations are now under revision. The European Commission has been delegated authority to translate them into further legislation. Any member of the public or any organization with an interest in these issues should therefore make representations now to the European Commission. The medical device regulations will take effect from 2020.

Many devices are associated with very specific medical treatment, for example ventricular assist devices (VADs) and the problem tends to be that the importance of this medication is not well understood outside the specialized unit. A recent review of recommendations and algorithms designed to guide ambulance clinicians has been published.[3] This relates specifically to patients with implanted rotary left ventricular assist devices (LVAD). There are increasing numbers of LVAD recipients in the community. These patients are vulnerable to device failure, stroke, bleeding, systemic infection, and LVAD thrombosis, all of which can be life-threatening and a significant challenge for the ambulance clinicians. The use of multiple LVAD designs has rendered comprehensive, device-specific training of ambulance clinicians impractical. A strategy was therefore adopted to develop emergency algorithms generalizable to different LVAD designs so as to avoid potentially counterproductive complexity. Units which implant LVADS provide device-specific information to local emergency services when a patient leaves hospital, but this has resulted in inconsistent availability and content of information, risking delayed or inappropriate decision-making in an emergency. But in situations where there are implications for other patients with the same device, product recalls tend to be handled well and there is good communication between the European competent authorities.

Figure 1.

Patient survival after long-term ventricular assist device insertion. Cumulative incidence of each outcome for third generation long-term first devices, 1 April 2006 to 31 March 2016. (From National Health Service. 2015. Annual report on ventricular assist devices. UK: National Health Service Blood and Transplant.)

Presently, the logistic challenge is the plethora of all cardiac devices which are now being pushed into the community. This means that adequate, recurrent, device-specific training of community based, and District General Hospital services are very challenging. The implanting unit assumes responsibility but the provision of relevant information to others who have patient responsibility (GP, Emergency rooms, ambulance) remains an issue. The use of Smartphone technology should help in the provision of appropriate information, but further work is required in a number of areas. It may be that we should develop a central database of patients with devices manned 24/7 similar to that which exists in the UK for Toxicology.

Within our own Trust, we have formed a Medical Devices and Safety Group consisting of relevant professional groups and a patient representative. We have developed a Medical Equipment Policy which outlines the systems employed for managing the lifecycle of this equipment to ensure a safe environment for patients and staff as required by the Clinical Quality Commission (CQC), and to comply with the provisions of applicable English law such as the Health and Safety at Work Act and the Medical Devices Directive. The CQC is an independent regulator of health and social care services in England.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....