Portable medication device alarms may fail to effectively alert healthcare staff that medication isn't being delivered as it should, putting patients at risk of avoidable harm, an independent health care investigation watchdog has warned.
A report from the Health Services Safety Investigations Body (HSSIB) focused on the delivery and monitoring of medication via ambulatory infusion pumps, which allow continuous delivery of fluids, such as medication, and are widely used in hospitals, hospices, patients' homes, and other settings.
The investigation found that even when these devices are functioning properly, staff may not notice a visual alert or hear an audible alarm in a busy and noisy working environment.
Among the potential problems highlighted were:
- Staff checks on these devices being delayed or not carried out
- The ability of a patient to interact with the devices and silence them while the alarm is activated
- Device alarms not being heard and/or responded to by healthcare staff
The investigation found that NHS staff are not always guided on how to use specific medical devices in different working environments, and they do not always understand how this might affect patient safety. In addition, current national reporting systems are complicated and don't support the capturing and sharing of medical device-related incidents across appropriate national bodies.
Reference Case of Patient Stephen
Some of the safety risks identified in the report were illustrated by a 'reference case' examined during the investigation. Stephen, a 45-year-old cancer patient on palliative care in hospital, failed to receive pain relief medication for 6 hours after his pump became blocked. Despite an audible alarm, a red light, and a repeated warning message displayed on the pump's screen, staff caring for him were unaware of the problem.
Later that night Stephen was found on the ground, one floor down from the ward, outside of an open window. He was transferred to a nearby emergency department and then to a critical care ward where he was treated for injuries.
The investigation highlighted that when the blockage alarm sounded, there was an opportunity for Stephen to interact with the device and intermittently silence the alarm. It also showed that Stephen's syringe pump couldn't be seen or heard from the nurses' station due to the hospital infrastructure and the working environment.
Senior Safety Investigator at the HSSIB, Craig Hadley, said: "Our investigation brought human factors squarely into focus when it comes to the medication safety risk around ambulatory infusion pumps.
"We found that there are issues relating to the design and usability of the device, and factors within the environment of a busy ward that make it more challenging to spot when medication is not being delivered as it should. We considered the hazards and looked at the safety controls in place to manage them and why that might not be effective—for example staff routines, capacity, and perception of risk contribute to the risk that 4-hourly checks of the infusion pump may be delayed or not happen at all."
Mr Hadley noted that, as was the case with Stephen, infusion pumps are often used to provide crucial pain relief medication for people with advanced or terminal illness. "These devices are often used in settings where patients could be very unwell, on palliative care, or are vulnerable, and it is vital that there is no gap or delay in the management of their symptoms," he said.
Recommendations to Improve Patient Safety
Three safety recommendations and three safety observations were made in the report.
The recommendations were focused on developing national 'human factors' guidance; ensuring that human factors were considered in international medical device standards; and developing a mechanism for sharing medical device incident data, including when devices function as designed.