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Functional Safety for Medical Devices

Medical devices are complex products, and patients' lives can depend on them functioning correctly. It is crucial that the risks of device failure, and the severity of the harm that could result from that failure, is minimised. Paulo Pinheiro, a senior consultant at technology development company Sagentia, suggests some ways this can be achieved in this article from the June issue of Clinica.

The complexity of medical devices makes it difficult to fully determine every failure mode that may cause physical injury or damage (hazard) to the health of people, property or environment. The consequences of not meeting functional safety requirements in a medical device can be disastrous to a device manufacturer. The highly publicised case of the Therac-25 radiation therapy machine is a good example. Due to loss of functional safety, patients were given massive overdoses of radiation with fatal consequences, which resulted in at least 6 accidents between 1985 and 1987. More recently, the FDA ordered the recall and destruction of a specific volumetric infusion pump in use in the USA with an estimated cost to the manufacturer of approximately $500m in 2010.

The issue of functional safety compliance is of particular importance right now because the harmonised standard for medical electrical equipment, the IEC 60601-1:2005 is being updated. This standard, the so-called third edition of IEC 60601-1, will become the new “Bible” of all medical electrical equipment safety with mandatory adoption from 1st June 2012 in Europe and Canada, and from the 1st July 2013 in the USA.

Read the full article on the Clinica website.