Why simply tracking the use of implantable medical devices in surgery is wholly inadequate for patient safety

Summary

This blog from Matthew Bacon, CEO of TCC-CASEMIX Ltd, looks at why a multi-factorial dataset is needed to create holistic understanding of medical device performance and is the only effective means for determining the multi-factorial causes of failure.

Content

The Department of Health and Social Care has proudly announced that it has mandated the tracking of high-risk medical devices within NHS trusts – all in the name of avoidance of harm to patients.

So, the Cumberlege report is now sorted!

Advocates of patient safety need to be far more critical. I for one am astonished by the nativity of this simplistic strategy.

A recent article in the New York Times suggesting that medical device makers have bankrolled a cottage industry of doctors and clinics that perform artery-clearing procedures that can lead to amputations is a great example of why I hold this opinion. 

The central point of failure here was not so much the failure of the medical devices (for example, stents, guidewires and catheters), but the procedural method associated with use. There will also be patient risk factors that are pertinent to the failure as well. The loss of a limb is the direct consequence of the surgical intervention.

At TCC-CASEMIX Ltd we do not only identify each use of the device (Class IIb & Class III), but we also acquire a multi-factorial dataset to create holistic understanding of medical device performance. A few examples of the datasets that we consider are critical are:

1. Patient risk factors (a few pointed out in the article New York Times article). We correlate these factors presented through the electronic patient record, with post-intervention outcomes following a procedural intervention tracking the use of the medical devices. This is how patient learning becomes part of the feedback loop to inform which devices, aligned to specific methods and outcomes, enable predictive safety.
2. Procedural method. The best medical device used inappropriately (often with lack of evidence to inform the decision making by the health professional) can substantially increase the risk of harm to the patient. In many different interventions there are a variety of alternative procedures and associated medical devices available, each of which can be correlated to different patient complexities (risk factors).
3. Human factors. Research shows that there can be repeated failures of the devices because of the incorrect/ inappropriate medical device selection. For example, for the less experienced healthcare professional, the choice of the correct size of stent, guidewire or catheter will be critical to the success of the outcome. Incompatibility between any of these devices can lead to an adverse event. Literature clearly identifies that the majority of device failures go unrecorded. 

This data acquisition platform records exactly what happens during a specific (atomic level) procedure associated with a specific devices or multiple devices used for it and is an effective means for determining the multi-factorial causes of failure.

Routine data acquisition beyond simply identifying which device has been used with which patient is clearly insufficient. It will do nothing to improve patient safety.