Under-reporting of adverse events related to medical devices
Editor - In their article Amoore and Ingram quote figures of 400
people a year seriously injured or killed as a result of adverse incidents
involving medical devices (1). We believe that this figure merely
represents the tip of the iceberg, and that many more cases occur which
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 hospitalised
patients are peripheral intravenous catheters. In our trust alone,
approximately 32% of all in-patients have a peripheral intravenous
catheter (PVC) in situ at any one time. The risk of serious complications
associated with these devices is generally perceived to be low. However,
over the last year we have documented 19 cases of Staphylococcus aureus
bacteraemia resulting from infection of PVCs. Data from the Nosocomial
Infection National Surveillance Service (NINSS) suggests that at least 7%
of all nosocomial bacteraemias are related to PVC use (2). A study of 146
PVCs in our Trust demonstrated a serious complication rate of 5.5% (3), a
level much higher than that quoted in other studies where PVCs are
inserted by dedicated teams (4).
We have performed two studies of PVC insertion and care which have
sought to identify those factors responsible for these complications. An
observational audit in the emergency areas demonstrated that 63% of
healthcare workers made no attempt to decontaminate their hands and 13%
failed to clean the skin adequately prior to inserting PVCs. 20% of all
PVCs inserted and remaining in situ were not used at all in the next 48
hours. A snapshot survey of PVC care showed that a third of all PVCs were
not in use and 9% had never been used since insertion. 60% of all PVC
insertion sites were not visible, usually a result of them being obscured
A number of simple measures have been identified which could reduce
the risk of complications occurring as a result of PVC insertion,
including the immediate removal of PVCs no longer in use, daily inspection
of PVC insertion sites for local complications, and attention to the use
of asepsis when inserting PVCs.
It is easy to perceive that failure of medical equipment per se
requires reporting and action to be taken to prevent adverse consequences.
Yet failure of simple good practice measures, 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.
1. Amoore J, Ingram P. Learning from adverse incidents involving medical
devices. BMJ 2002; 325: 272-275.
2. Nosocomial Infection National Surveillance Service (NINSS).
Surveillance of hospital-acquired bacteraemia in English hospital 1997-
2000. PHLS 2002.
3. Greig J.M., Ellis C.J., Smith E.G. Septic discitis and other
complications of peripheral venous cannulation. QJM 2002; 95(6): 412.
4. Maki D.G., Ringer M. Risks of infusion related phlebitis with small
peripheral venous catheters. Ann Intern Med 1991; 114: 845-854.
Dr Nicola Baker
Department of Microbiology, Birmingham Heartlands Hospital, Bordesley
Green East, Birmingham, B9 5SS.
Infection Control Project Nurse
Infection Control Department, Birmingham Heartlands Hospital.
Dr C.J. Ellis
Department of Infection and Tropical Medicine, Birmingham Heartlands
Competing interests: No competing interests