Information Transparency Challenges
Millions of medical devices are in use around the world today, ranging from latex gloves, hospital beds, and syringes to stents, pacemakers, insulin pumps, replacement knees and hips. These devices save lives, reduce pain and suffering and improve the quality of life for patients.
However, complications or malfunctions can have severe consequences, including death, injury, or pain and suffering for patients. These problems, termed “adverse events” by the FDA, could be caused by improper application of the device or user error, improper or poor labeling, device malfunction, or faulty manufacturing.
Need for Clear Actionable Information
Healthcare organizations are routinely challenged by the inability to quickly access up-to-date medical device adverse event information. When the right information is available, they can make informed decisions that will ultimately save lives, improve patient outcomes, mitigate risk, and save money.
Many in the healthcare community believe the US FDA identifies all problem medical devices quickly and keeps the healthcare community informed through recalls and notifications. Over 70,000 medical device adverse events are reported every month, but it can take the FDA between two months and two years before problem devices are identified. Once identified, further analysis is required and, if deemed appropriate, the FDA will issue a recall notification to the device manufacturer.
The FDA provides public access to over 5.9 million redacted, HIPAA compliant, medical device adverse event reports (MDRs) through their Manufacturer and User Facility Device Experience (MAUDE) public website. However, extracting meaningful information and metrics is cumbersome and requires a great deal of time and effort.
Consequently, healthcare organizations may not have or be able to access all the pertinent information they need in a reasonable time-frame. Without it, they lack the information for optimal device selection and use – putting patients, physicians and their organizations at risk.
Metrics on Adverse Events and Recalls – Difficult to Obtain
Additionally, MDRs are often misclassified and use ambiguous, confusing language making it virtually impossible, using the FDA’s MAUDE website, to access and obtain accurate and complete metrics on all the MDRs submitted for a device.
For example – When an MDR is submitted by a device manufacturer, a healthcare organization or a patient/patient advocate, they must classify the event as either a Death, Injury or Malfunction. Many reports are classified as Injury or Malfunction even though a Death occurred, obfuscating the true result of the event.
Adverse Event and Recall Information Transparency
Device Events provides easy access to clear, comprehensive metrics, reports and signal alerts on a medical device’s adverse event history. As a result, users are empowered with the most comprehensive and up-to-date information enabling them to act decisively to reduce risk for all concerned parties.