High-Risk Medical Devices: Top 20 Device Adverse Event Categories

April 10, 2019

3 minute read

This blog post is the first in a series where we’ll be sharing some statistics around medical device recalls, adverse events, and reported product problems to explore what kinds of analysis one can do by linking different medical device data sources.

Are there medical devices with inherent design characteristics which make them a higher risk to patients than others? If so, which criteria define these types of devices?

To start exploring this topic we decided to take adverse events reported by manufacturers, providers, and volunteers over a 28 year time period from 1992 to 2019 to the FDA's MAUDE database and normalized the number of events based on the total number of currently available devices within a specific device category.

There are various challenges in preparing this kind of analysis, namely:

  1. defining what is considered a currently available device
  2. categorizing devices based on their characteristics
  3. mapping these devices to adverse events where a malfunction, patient injury or death occurred

We addressed these by first defining a device as a device identifier or DI submitted to GUDID. These represent unique codes for a device make and model, so, for example, an iPhone 6s would be one device, and iPhone 7 would count as a second device.

We then categorized the device identifiers using the Global Medical Device Nomenclature (GMDN) terms submitted for each device identifier by manufacturers to GUDID. These terms group devices based on similar characteristics, and in the iPhone example both the 6s and 7 models would fit in the Smartphones category.

The last piece required reasonably mapping device identifiers to reported adverse events. We base these mappings on a combination of the company name, brand name, catalog number, device identifier, premarket number, product code, and device description. We considered events meaningful where the reporter indicated that a product malfunction, patient injury or death occurred.

The mapping process was easiest when reported events included device identifiers, and the hope is that with increased adoption of Unique Device Identifiers (UDIs) provider and manufacturer usage, more reports would contain device identifiers.

Percent Total Adverse Events per Device Identifier

Percutaneous glucose monitoring systems top the list due to malfunction events, but have lower relative injury and death events.

Taking a step back, we recognize the crucial missing context around the usage of these devices over the same time period. The usage would be one of the necessary data pieces to determine whether an event matters. For example, it wouldn't be surprising to find surgical staplers and glucose monitors having higher usage with patients than artificial hearts.

One way to track the usage would be for health insurance payers like Medicare encouraging the inclusion of UDI’s (or even DI's) on submitted charges and having public access to these usage datasets.

With these disclaimers in mind, we can see three tentative groupings within the top 20 device categories:

  1. Active implantable devices with frequent (daily or more) delivery of therapy/feedback – glucose monitors, pacemakers and infusion pumps
  2. Implantable tissue-material devices with complex interfaces – spinal fusion graft kits, artificial hearts, and surgical meshes
  3. Mechanical surgical devices with multi-modal mechanical failure mechanisms – staplers and clip appliers

An area of further analysis would be exploring comparable categories of lower-ranked devices for similar relative event activity.

The data sources used in this series of analysis include the FDA’s Global Unique Device Identification Database GUDID, Manufacturer and User Facility Device Experience MAUDE, Medical Device Recalls, and Recall Enterprise System RES.

If you have feedback, are interested in receiving the full list of events by category, or would like to be notified when we post the next part of the series, please feel free to reach out to us below.