Adverse events with medical devices may go unreported

Editor—Amoore and Ingram report that 400 people a year are seriously injured or killed as a result of adverse incidents with medical devices.¹ We believe that this figure is the tip of the iceberg and that many more cases occur that are simply not recognised. Infectious complications of medical devices are often not considered in the context of reporting, and so the possible lessons that can minimise recurrence remain unlearnt.

One of the most commonly used medical devices in hospital patients are peripheral intravenous catheters. In our trust alone 32% of all such patients have a peripheral intravenous catheter in situ at any one time. The risk of serious complications associated with these devices is generally perceived to be low. Over the past year, however, we have documented 19 cases of Staphylococcus aureus bacteraemia resulting from infection of such catheters.

Data from the Nosocomial Infection National Surveillance Service (NINSS) suggest that at least 7% of all nosocomial bacteraemias are related to use of peripheral intravenous catheters.² A study of 146 catheters in our trust showed a serious complication rate of 5.5%, a much higher rate than that quoted in other studies in which catheters are inserted by dedicated teams.³,⁴

We performed two studies of catheter insertion and care to identify the factors responsible for these complications. An observational audit in emergency areas showed that 63% of healthcare workers made no attempt to decontaminate their hands, and 13% failed to clean the skin adequately before inserting peripheral intravenous catheters. Twenty per cent of all catheters inserted and left in situ were not used at all 48 hours later. A snapshot survey of catheter care showed that a third of all catheters were not in use, and 9% had never been used since insertion. Sixty per cent of all insertion sites were not visible, usually because they were obscured by bandages.

Several simple measures have been identified to reduce the risk of complications occurring as a result of catheter insertion, including the immediate removal of catheters no longer in use, daily inspection of insertion sites for local complications, and the use of aseptic techniques when inserting catheters.

Failure of medical equipment should obviously be reported and action taken to prevent adverse consequences. Yet failure of simple good practice, leading to serious complications of commonly used devices, is not being addressed. The simple scheme described by Amoore and Ingram needs to be extended to encompass a wider range of events, including infectious complications of medical devices, so that these can be highlighted.