Diabetes Device Recalls (Part 4): How to Improve the System

 - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - 

Tracking the trends of diabetes device recalls is no easy task, whether you're a regulator, manufacturer, patient or provider -- or even a casual observer of medical device safety.

As we've reported exclusively for this DiabetesMine series, we experienced for ourselves just how complicated the system is -- making it nearly impossible to get a clear picture of how safe our devices really are, and what happens if and when a product is recalled.

Conspiracy theories sometimes get tossed into the mix (i.e. industry puts "profits over people"), we don’t believe anything nefarious is going on. Rather, most of the failings come with the size and complexities of the system, and the traditional ways that FDA and manufacturers communicate with the public about potential problems and recall actions.

It's reassuring to know that FDA really is trying to improve this process.

In fact, one of our D-Community peers is involved with a number of FDA committees and has an inside view on what's happening there: fellow type 1, data entrepreneur and advocate Anna McCollister-Slipp, who says the agency is working on the device surveillance issue behind the scenes and making progress in how product safety is overseen.

Creating a National Medical Device Evaluation System

Anna tells us one of the many hats she wears is sitting on the "executive operations committee" for the Medical Device Epidemiology Network Initiative (MDEpiNet) within the FDA, which has been a driving force in efforts to create a better medical device surveillance and tracking system over the past few years.

"Progress has been slow for a variety of reasons, but it’s beginning to pick up now," she says. "Most of their focus to date has been on implantable devices, but I’ve been pushing them on many fronts about the need and opportunity for doing REAL diabetes device monitoring."

One of Anna's presentations at meetings last year came on the heels of a task force report about how to set up device registries for a few select device categories. Anna tells us she pointed out it was a good start and a step in the right direction, but was only scratching the service of collecting data on device failures and inaccuracies. Coincidentally, this also came as she was personally dealing with insulin pump failures, hypo crashes and even some DKA herself.

"So the issue was very real and top of mind to me," she says. "All of the leaders of CDRH were there, and based on some of their recent communications and conversations, they are listening to us!"

This is all part of creating a National Medical Device Evaluation System (see NMDES) and from what we can tell, it looks like that's moving along. See this report for more detail.

We think this is a great step and it's a huge undertaking, so we're not surprised to hear it's been in the works for a few years already.


As we reported earlier, information about product failure reports and recalls is currently spread across multiple FDA databases that are tough to understand.

So the agency's been working on a way to improve public access and "digestibility": a new FDA open-source database of medical device safety and related info. This is in Beta testing at the moment, meaning FDA's is evaluating its usability and looking for tweaks it can make to improve that.

We were fortunate to get a quick review of this new open system, and certainly agree that it's a big improvement over the existing databases.

For example, we tried searching "adverse events" for medical devices, and were able to pull up data showing 4.8 million entries since 1991. The term "diabetes" brings 122,219 reports, with 36,279 of those involving personal devices used in someone's home. You can also see how many reports involved malfunctions, injury or death.

As of now, these MDRs (medical device reports) can't be applied to show how many relate directly to Recalls, and the searchability is in computer coding-mode that isn't always the easiest to understand. If you search the separate Recall database within OpenFDA for that specific recall information, you can't find the term "diabetes," but search term "glucose" brings up 878 reports divided into FDA product code categories -- with the largest category at 32% being the "NBW" code for glucose monitors (don't ask us why "NBW"?).

We like the relative ease of use and improved search within this new OpenFDA repository, but like most beta-developments it has its shortcomings and is still materializing.

Focus on Detailed Reports

The bread and butter of these databases is how patients report the issues they're experiencing with diabetes devices.

This is known as the Adverse Event Reporting (MDR) system. Several hundred-thousand of these come in every year, and the FDA is required to sift through all of them, with an eye towards whether individual reports may be part of a widespread problem.

Manufacturers and healthcare facilities are also required to send the FDA reports on any notices they get about issues with products. Patients are not required to, but encouraged to do so of course.

According to Dr. Courtney Lias at the FDA, the trouble is that many reports are quite vague and therefor unhelpful in demonstrating any actual product problem:

"Many reports might say, I got a 68 and then three hours later, a 120.' That doesn’t tell us very much. It’s easier if we have something else to go by, like comparison with another meter that makes this particular issue distinct. Often, a company may not do anything if they can’t determine it’s a problem," Lias says.

The FDA is also quick to draw a line between reported events and Recalls, because many Recalls actually result from manufacturers' internal testing that reveals a problem. "The conversation on Recalls is very different than the one we’ve been having on MDRs," Lias says. "Those are distinct issues and I wouldn’t want to link them up too much."

Lias says her FDA division has been internally implementing new ways to look for trends among MDFs, and making good progress. They're also developing a more consistent approach to how companies report MDRs, but Lias says that's still in the works and not something she can discuss in detail at this point.

When it comes to reporting a product issue as a patient, Lias suggests these action items:

  • Report to the company. This is important because it triggers an MDR logged into their
    system to track or investigate.
  • Report straight to the FDA. Lias says often when the agency hears from a customer directly, it’s because
    the individual isn’t getting a sufficient response from the device manufacturer or the issue isn’t
    being resolved. It's important for FDA to hear about these failings so they can potentially take action.
  • Be specific. The more information you can provide in your report the better.
  • Use the mobile app. They encourage folks to use the MedWatcher Mobile App to report these issues. You can also sign up for their MedWatch system to get safety alerts.

"The more that’s in the reports, the better," Lias says. "To show that there may actually be a problem. I think that's hard for patients to always do, but it makes it more compelling for the companies and for us. If we see a lot of similar reports trending, that's a red flag for something we need to pay attention to."

Note that while it can be frustrating when you call a company to report an issue, and they have someone reading a script that doesn't seem to help, this is actually part of the process. Companies have set up these scripted questions specifically to avoid inadequate and vague reporting, which doesn't help pinpoint what's going on with the particular device.

Tracking Litigation Like TSA

One other idea floated by some experts to improve the Recalls system is setting up a system to monitor product liability litigation relating to medical devices, as a way to better track the consumer impact of these device safety issues. It's one thing to have multiple reports within a massive database, but we're often left to trust that manufacturers or regulators are connecting dots and not missing the signs of potential problems even when they're reported.

The national Transportation Safety Administration (TSA) has started doing this with vehicle lawsuits, and we think it could work well in the universe of medical devices. Obviously, you'd have to balance the litigation with other reports and data, and not just blindly trust that any lawsuit is automatically valid and showing an unaddressed problem. But if one national agency is using this method successfully, there's no reason it can't be mimicked for medical device safety trends.

Pharmacists Can Help

We're also encouraged to learn that you can turn to players outside of FDA and D-Industry to get answers when a recall occurs, such as local pharmacists or third-party distributors who are on the front lines dealing with patient prescription orders.

The National Community Pharmacists Association -- representing 22,000 pharmacies across the U.S. -- says pharmacists can be a resource in helping PWDs deal with recalls. The group's public relationships director John Norton offered this statement:

"Independent retail pharmacists are eager to cooperate with drug recalls and other efforts intended to ensure the integrity of the drug distribution system and protect the public health. NCPA urges manufacturers to adopt drug recall policies that facilitate pharmacists fulfilling their obligations in this regard. Manufacturer recall policies should include full credit, cash adjustments, coverage of shipping and handling costs as well as indirect costs, and prompt payment within 30 days." 

He added that pharmacists are ideally positioned to recover recalled products from patients, while also cutting off the distribution of recalled products for new prescriptions. The group supports device makers developing guidelines for voluntary recalls that allow pharmacists to assist in keeping flawed products out of patients' hands.

Incremental Improvement

We know patients are often left frustrated by the Recall system when dealing with manufacturers. Rest assured that the FDA is working on ways to improve the system now, however incremental these changes may be.

Remember that the FDA doesn’t actually have the authority to dictate how companies communicate with customers on Recalls, but it does oversee the processes to assure an adequate response. If the response is not adequate, then FDA can jump in with sanctions (like fines) to the offending company. We hope to see as little of this in the future as possible!

At the end of the day, we're encouraged to see these efforts to fix the system -- or at least, to make it suck less than it does now.

- - - - - - - - - - - - -

Written by Michael W. Hoskins and originally published at DiabetesMine


Popular posts from this blog

COVID-19 Vaccine Researcher with Type 1 Diabetes Wins Nobel Prize

Why We Need Diabetes Awareness Month... More Than Ever

Flapping the Gums