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.
Once a device enters the market (after it has been FDA cleared or approved), it has entered the “post-market” phase. When a problem occurs with a device, these problems, termed “adverse events” by the FDA, can cause injury or death. This can be due to improper application of the device, user error, improper or poor labeling, device malfunction, or faulty manufacturing.
There are numerous challenges in analyzing these adverse events submitted to the FDA by manufacturers, user facilities, distributors, patients and physicians. Adverse events, when analyzed at the macro level, can show us signals (patterns of problems) that can lead to a recall or other FDA enforcement action, but not all recalls are handled the same way. Sometimes the FDA does not mandate a recall because it could cause a device shortage—perhaps there are no true substitutes for the device. Perhaps a software change can fix the issue so the device can remain in use, awaiting the update. Perhaps the device is already implanted in a patient, and that patient is doing well. The fact remains that, although adverse events sometimes contain incomplete data about an event and are under-reported, 2/3 of FDA enforcement actions begin as an adverse event report to the FDA. No other type of data (Including outcomes data from electronic health records and device registries) comes close.
The challenge is to make adverse event data actionable. Device Events meets this challenge by cleaning and normalizing the data. There is no need to know all the different company names used by a medical device company (ex. Johnson & Johnson, Ethicon, DePuy, etc.). Device Events does the heavy lifting for you.
The FDA’s interface to adverse events, called MAUDE, only allows you to view 500 reports at a time. Device Events allows you to view all 15.5 million adverse event reports, filtered in whatever fashion you prefer. You can search by company name, device name, catalog number, or even by multiple outcomes such as contamination, sepsis or infection.
The FDA keeps its data in silos—you can’t map recall patterns to adverse events in any public FDA system. Device Events rises to the challenge by combining multiple FDA data sources into one search engine.
Need for Clear Actionable Information
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 230,000 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.
The FDA provides public access to over 15.5 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.