Medical devices are ubiquitous in healthcare and thus likely to be involved in hospital adverse events. And while a defective or malfunctioning medical device may play a key part in facilitating an incident, it may not be exclusively to blame for the patient's injury. Taking a systems approach to medical device forensic investigation can uncover exactly how a medical device contributed to a patient's injury including systemic and human factors that may be involved.
Too often, medical injury investigations place emphasis on device defects or user error rather than system defects. A systems approach recognizes that the healthcare system is inherently complicated and risky, and it is the people, processes, and technology that mitigate this risk. Patient incidents often have many contributing factors, each part of the patient care system. Rather than focusing blame solely on a medical device defect or human error, system factors that contributed to the incident are analyzed. Of greater significance, proactive medical device systems investigations examine what goes right and anticipate potential failure modes. Preventing recurrence is important but preventing an event in the first place is paramount. Proactive and reactive systems investigations are critical to achieve high reliability in healthcare.
Objectives of any medical device injury investigation include:
- Determining the root cause(s) of the incident from a systems perspective.
- Developing an action plan to prevent recurrence at the incident facility and other facilities.
- Implementing improvements in device design, how it is used, or the system in which it is used.
While it might seem onerous to investigate the entire system, if this forensic process is defined ahead of time, it can be methodical, comprehensive and rather simple to implement. This also benefits all involved since the true root causes are revealed and more appropriate corrective actions are implemented.
Medical Device Systems Investigation in Practice
Consider the following example. There have been incidents where patients with atrial flutter have died during administration of synchronized cardioversion. This can occur if a defibrillation shock is delivered at the T wave on the electrocardiogram instead of at the peak of the R wave. Consequently, disputes have arisen between healthcare providers and device manufacturers regarding whether these injuries were due to a defective device or medical error.
In situations like these, a medical device systems investigation of the adverse event is necessary to uncover all factors that contributed to the incident. Such an approach would involve investigation of the defibrillator itself, defibrillator accessories, patient factors, doctors and nurses involved in the procedure, facility in which the procedure was being performed, associated workflow and clinical engineers responsible for defibrillator maintenance.
Ultimately, both device design and human factors were discovered to be at the root cause of these adverse cardioversion incidents. For the most part, injuries were facilitated by a problematic defibrillator design which placed the “sync” button adjacent to the “shock” button (a design issue). In addition, the defibrillator can default to either sync or shock mode after a shock is delivered, which can lead to confusion if not appreciated (a training issue). In one case, though, the location of the defibrillator was such that the provider could not directly see the screen and instead relied on touch to locate the sync button (a process and user issue). These factors resulted in the shock button being pressed inadvertently instead of the sync button.
Had delivery of care, device design, training, and process issues been considered in isolation without looking at the entire system, the nuances of human factors would not have been realized and the system would not have improved.
We must think of investigations as an opportunity for improvement and dedicate the necessary resources to accomplish medical device injury investigations from a systems approach. Lessons learned should be implemented immediately into a performance improvement model to prevent recurrence locally and outside of the incident facility. Zero complacency is the key attitude in system safety and a requirement to reach zero preventable harm. Learn more about medical device forensic investigation.
