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

Abstract and Introduction

Introduction

Air travel is remarkably safe but the recent crashes of two Boeing 737 (Max) aircraft and the disaster of the plane crash over Alderney in the English Channel serve as a reminder not to be complacent. The investigation of aviation disasters is extremely thorough, robust, and transparent and is often held up to doctors as a model.

How do we fare when devices fail in cardiology or cardiac surgery?

In the UK, the cornerstone is the Medicines and Healthcare products Regulatory Agency (MHRA). This is an executive agency sponsored by the Department of Health and Social Care. In the field of cardiology, it ensures that 'medicines, devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy'.[1] There is an established procedure for the investigation of overt device failure via the MHRA which generally works well. The accident is reported to MHRA within 24 h of the event, and the device is returned to the manufacturer for analysis. But the situation is complex. It is often only the manufacturer who is equipped to meaningfully analyse a device which has failed. As such the manufacturer is conflicted: on the one hand, they have a statutory obligation to accurately report what happened and whether it has implications for both patients about to undergo implantation and those with similar implanted devices. In the former, the product must be recalled while in the latter a decision has to be made about their treatment. However, the manufacturer reporting device failure will be mindful of the potential commercial damage associated with the disclosure of bad new and that this may render them liable to litigation. This means that such reports tend to downplay the magnitude of the problem.

Implantable pacemakers (PM) and cardioverter defibrillators (ICD) have been proved to extend survival in selected subgroups of patients with cardiac arrhythmias. Since their introduction, the main focus has been careful candidate selection for initial implantation. But the replacement of ICDs in particular may give rise to significant clinical consequences, the importance of which is underrated by the medical community. Replacement-related adverse events are difficult to identify and require monitoring of both short-term complications and long-term patient outcome. Detailed data on complications related to ICD replacement in current practice are lacking. Replacement is sometimes required to meet the changing physiological needs of the patient but may also be required when there is a fault in the generator or the leads. Unlike ordinary PM the leads are more complex, and defects can be difficult to diagnose and correct. There is a need to assess complication rates after ICD replacement in a real-life setting which will help to estimate the actual long-term cost of ICD treatment and assess the real impact of increasing ICD longevity on cost-effectiveness.

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