Soapbox

FDA’s Move to Transparency in Adverse Event Reporting

By Jesse Ambrosina
July 22, 2019


• Categories: 03-Manufacturing Execution, 05-Quality/Regulatory, Market Access, Soapbox

“It is only through enlightenment that we become conscious of our limitations.” – Nikola Tesla

The FDA recently took a commendable step aimed at improving transparency and accountability in the medical device industry when it recently made public more than 20 years of reports detailing about 6 million adverse events. We believe that while this is a good start the FDA should make ALL adverse medical events public. Improving patient safety through better devices and caregiver awareness is the reason that it’s so critical to shine a light on the millions of adverse events.

Until now some medical device manufacturers have been granted exemptions under the FDA’s Alternative Summary Reporting Program (ASR) from public reporting through MAUDE, the FDA’s public database of device associated adverse events. ASR, which began in 1997, allowed certain medical device manufacturers to submit “well-known and well-established” risks in a quarterly report. This essentially kept these manufacturers’ adverse events hidden from public view. According to the FDA, 198 medical device manufacturers received exemptions during this time. The ASR program has now been formally shut down by the FDA.

When ASR was started, the ubiquitous smart phone was a decade away and you were lucky to have a laptop. The program was meant to reduce the very manual and labor-intensive process of reporting and monitoring issues for both the agency and industry. Some of the products in the database included things like catheters and implant screws—products manufactured in the 100s of millions. It seems reasonable that summary reports would be more efficient vs. adding dozens of duplicate records to a database.

I spent some time reviewing the events previously un-reported. Initially I found many minor issues—what one might expect to be given an exemption. But the more I dug in, the more serious events such as fires and death appeared. Deaths. It’s hard to understand how a death could be considered a “well-known and well-established” issue that should be exempt from public reporting. Similarly, I asked why exemptions had been given to manufacturers of very complex, potentially life-sustaining medical devices such as ventilators, insulin pumps and pacemakers.

(Note: The raw data is available on FDA‘s website. Also available is an explanation of the report format, including the failure or event codes.)

After studying the error codes, devices and the frequency of specific manufacturers, it became clear that ASR had been misused in the past. And even though recently the majority of incidents have been included in the public database, there remain many highly questionable reports. It was a good move by the FDA to end ASR.

Full public access to all adverse event reports enables innovation, leads to better, safer medical devices, and benefits the patient, caregiver and device maker. Manufacturers can improve products, clinicians can become more educated on how to use the devices safely, and patients can be made fully aware of both potential risks and what actions are being taken to mitigate them.

Using Adverse Event Data to Improve Products

The infusion industry has been held to a higher standard in medical device development and clearance since 2014 when the FDA adopted a stricter clearance process for infusion pumps in an attempt to reduce the 23 pump malfunctions and injuries reported to the FDA every day and the skyrocketing costs associated with infusion-related errors, pump recalls and security breaches. Preventable errors account for more than 50% of the 1.5 million adverse drug events reported annually to the FDA, affecting more than 7 million patients and costing more than $21 billion each year.

We used the MAUDE database and all other available reporting mechanisms to create a new product. In fact, it was an integral part of the design process. We knew where many common errors persisted and thus created a system architecture that would address these issues from the beginning. By using the databases, we were able to unearth specific, repeated problems, such as power management and battery failures—still one of the most common failure modes of infusion pumps. A sudden power loss can be very dangerous. The pump can shut down, silently depriving the patient of critical life sustaining medication with no notification or warning to the caregiver. Without having a resource like the MAUDE database from which to harvest adverse events, we never would have known how serious and frequent the issues caused by battery failure have been. We designed our system to have multiple redundant power supplies to avoid the possibility of silent failures.

We were also somewhat surprised to learn that doors used to retain tubings on some infusion pumps have led to serious use errors that result in gravity free-flow. Free flow is when the IV fluid flows into a patient uncontrolled by the pump. There have been many overdose deaths associated with defective IV pumps or mis-loaded IV sets. Our new design has no doors, the set cannot be inserted incorrectly, and the pump will not allow the caregiver to program the pump if the fluid path is not safely under the control of the device.

By poring through records of adverse events associated with infusion pumps, we were able to build a better, safer pump.

Using Data to Incite Change

The ultimate example of safety issues sparking change took place in 2010, when the FDA forced a public company to remove an IV pump from nearly one-third of U.S. hospitals over safety concerns. Hundreds of thousands of pumps were recalled, and the manufacturer was required to remove the product from the market permanently, changing the commercial landscape of the industry.

I consulted with industry expert Bob Butterfield, a retired infusion device engineer and presently principal at RDB Consulting, to glean more examples of using adverse event data to inspire product design changes. He recalled numerous examples of how adverse events were factored into product development specific to the infusion industry:

• Infiltration detection. The impetus and rationale for designing a novel pump able to measure fluid flow resistance was derived from and supported by reports in the United States and the UK detailing the prevalence and severity of infiltration and extravasation incidents and injuries.
• Key bounce. This was originally reported through the FDA and ECRI by hospitals. Analysis of the data logs of thousands of pumps showed that key bounce was a significant occurrence and could lead to serious errors. This led to the development of patented techniques to minimize its occurrence.
• Syringe startup delay. This has been identified as an issue for some time, particularly in Europe where 80% of pumps are syringe drivers. Complaints reported to the FDA led to the agency issuing exploratory letters to manufacturers and cautionary letters to all U.S. users. While resolution is still in progress, it will likely lead to improved communications of best practices for users and should help in designing alternative means to infuse low flow-rate medications and improved syringe designs.
• Unregulated gravity flow. A manufacturer was able to use public databases to help determine the root causes and take steps to mitigate the issue.

Access to all adverse medical events associated with a device gives manufacturers a better understanding of commonly reported incidents and, more importantly, focuses their efforts to build safer medical devices. We applaud the FDA for making all of this information publicly available, and we implore development teams from all medical device industries to utilize this information during the development process.