In 1964, a young boy in a Philadelphia emergency room passed away as a result of an improperly preserved defibrillator.
His death spawned the Emergency Care Research Institute, or ECRI Institute, a non-profit organization that evaluates the safety of medical procedures, processes, drugs, products and systems via applied scientific research methods.
Aside from customized consulting, journals, resource guides, analyzing patient safety data and in-depth on-site investigations, the ECRI Institute publishes its “Top 10 Health Technology Hazards” for the following year every fall.
Power Your Practice spoke with James P. Keller, Jr., VP of Health Technology Evaluation and Safety at the ECRI Institute about the yearly list, including methodology, and why data loss wasn’t included on the list despite a high ranking in the last edition.
1. What criteria do you use to compile each year’s list? Does it change yearly? What kind of research is involved?
Each of the ten hazards on our list met one or more of the following criteria:
- It can harm or kill someone.
- It has frequently occurred.
- It can affect a large number of individuals.
- It’s had a high profile, for example, from widespread coverage in the news.
Another factor that determined if an item made our list is that there must be clear steps for hospitals to take now to minimize the risk.
Some of the research we used to help come up with our Top Ten list includes (1) review and analysis of problem reports submitted to ECRI Institute and other organizations like FDA, (2) review of our technology-related accident investigation files, (3) review of technology-related concerns covered in the clinical literature and lay press, (4) discussions among our clinical and technical experts and with those from other organizations, and (5) monitoring trends for how health technology is being used.
2. What percentage of hazards are direct results of human error? Do you think exhaustion plays a part?
I don’t have a specific percentage but I would say that well over half of the hazards on our list are use related. This is not solely due to use error. For example a poor Human Factors design in a device can contribute to a use error. I wouldn’t blame that problem on the user by calling it user error.
Exhaustion definitely plays a role in some of the problems we describe on our Top Ten list. A key example is alarm fatigue as described in Hazard Number 1: Alarm Hazards. Many nurses who care for patients placed on physiologic monitors are overworked and some carry heavy patient loads.
Their exhaustion (e.g., alarm fatigue) may impact their ability to respond to the alarms on their patients’ monitors should the patient monitors issue a large number of alarms. Alarm management is extremely complex but we offer some strategies to aid healthcare facilities in managing this risk.
3. Conversely, any examples where machines are malfunctioning that could perhaps be remedied soon?
A good example is with Hazard Number 5, or Inattention to Change Management for Medical Devices Connectivity.
One of the reasons that good change management is needed is that a software upgrade to a medical device (e.g., to add new and improved functionality and/or to fix an existing malfunction) may cause problems because that upgraded medical device is interconnected to other medical technologies or clinical information systems and the new upgrade could result in a breakdown of one of the interconnected technologies/systems.
It’s critical for hospitals to have change management processes in place to make sure that changes, such as software updates, are implemented correctly and minimize risk to patients and work processes.
4. Last year, data loss, system incompatibilities, and other health IT complications ranked 5th on the list, while this year they’re not even in the top 10. Why do you think data loss isn’t as much of an issue anymore in the industry?
Just because a problem dropped off our list from last year does not mean that we no longer consider it to be a problem. We’ve instead judged that other problems – like the inattention to change management – are more critical.
Indeed, inadequate attention to change management can be an underlying catalyst of health IT complications.
5. Do you foresee any other health IT hazards making the top 10 in the next few years? Anything ECRI may be concerned about?
I anticipate that the current rapid adoption of electronic medical records will result in problems we’re not able to currently anticipate. We’ll definitely be keeping a close eye on this technology over the next few years.