Delay in treatment can be deadly; analyze it carefully

There are many recalls and FDA warning letters related to delay in treatment caused by medical device malfunctions. Here are a few considerations to analyze the risk of this challenging issue.

A falsely low or a false negative result from a Troponin I assay may lead to a delayed or missed diagnosis of an imminent heart attack¹.

Incompatibility between a syringe and an infusion pump may lead to interruption or delay in therapy for patients needing life-saving medication².

Software issues causing synchronization with navigational views for precisely locating anatomical structures in neurosurgical procedures lead to interruption or delay in surgery³.

These are a few examples of how device-related issues can lead to delay in treatment or therapy, or delays or interruption in surgical procedures. These events can trigger a complex cascade of other events, which may eventually lead to patient harm, including life-threatening injuries or even death.

Since there are so many different potential outcomes, risk practitioners find it challenging to adequately address the risk(s) from delay in treatment. Should we treat “delay in treatment” as a hazard, a hazardous situation or a harm? Or something else?

In a recent LinkedIn poll⁴, I asked a simple question:

How do you characterize “delay in treatment” due to a device malfunction in your risk analysis?

As shown in the following figure, 42% of the respondents considered "delay in treatment" to be a hazardous situation. 37% thought it should be characterized as a harm, while only 13% would treat it as a hazard.

Figure 1: LinkedIn polls results (March 2024)

It is clear that there is no one way of handling "delay in treatment". Which one is the correct approach? How do we make sure our approach is both compliant and effective to ensure safety and effectiveness of our devices?