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

Human Factors

What about the role of human error in device failure? Human error has been intensively studied in the aviation industry and more recently in medicine. A healthcare error has been defined as 'a mistake, inadvertent occurrence, or unintended event in healthcare delivery that may or may not result in patient injury'. In the context of devices, reducing risk is possible through careful and deliberate evaluation of the device and the application of what has been termed 'Human Factors Engineering'.[4] The first step is to acknowledge that device-related error occurs. The second step is to report events and near misses and the third is to reject devices and other pieces of healthcare technology that do not meet the needs of care delivery and demand well-designed technology.[5] To be fair, in the majority of hospitals in the UK this is already happening, but continuous surveillance is necessary. The large number and complexity of medical devices in expanding environments, such as the home, contributes to a continued and increasing risk.

In a systematic review from Ottawa, Canada, Polisena et al.[6] showed that successful management of medical risk in hospital depended on three factors: (i) risk identification, (ii) risk analysis by root cause analysis, and (iii) risk control by implementing system changes and improvement. They interrogated 30 studies and examined three major factors; recognition, reporting, and resolution (Table 1). Interestingly, 16 of 30 studies focused on personal attitudes of healthcare professionals, but none of the studies reported on resolution.

The more complex a medical device is, the more difficult it is to control the hazards associated with its use. In a study from Austria[7] medical devices (not specified) were evaluated over a 3-year period from 2005 to 2008. In an examination of over 16 000 risk reports, 5000 reports could not be attributed to the failure of a medical device. They concluded that 'the lack of an error culture seems to be a considerable problem'. The logical conclusion is that the safe and reliable development and use of medical devices requires efficient and consistent risk management.

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