Adverse event with your medical device?
July 25, 2013
by Brendon Nafziger, DOTmed News Associate Editor
When physicians have a problem with a medical device that doesn’t involve the death of a patient — say it malfunctions or causes a serious injury — they can voluntarily report the problem to the Food and Drug Administration, through its MedWatch program. While not required by law, reporting these foul-ups is something of a medical good deed and the FDA really wishes doctors would do it. “The FDA relies on reports of serious problems with medical devices and other products as one important way to help identify and better understand the risks associated with these products,” as the agency puts it on its website. “Receiving higher quality reports more quickly helps the FDA identify and respond to safety signals and public health emergencies more efficiently and effectively.”
That’s all well and good, but in the past, doctors generally made these reports by faxing or mailing in a document, a rather time-consuming and workflow-damming process. Nowadays, while it’s true these voluntary reports can also be done online using the MedWatch 3500 form, by tapping into current technology there may be a new level of ease in reporting. The FDA, a Boston company and three research groups have teamed up on a project they say might increase voluntary reporting by doctors and even their patients: an app.
UI unfriendliness
The problem with even the FDA’s online forms, especially for patients who want to report an event that happened to them, is that they’re typically “not really set up with usability top of mind,” in the words of Clark Freifeld, one of the co-developers of the app, called MedWatcher. “(There are) lots and lots of different fields that you’ve got to fill in, and it doesn’t work in all browsers quite correctly,” he tells DOTmed News. And even though it’s meant more for clinicians, even many of them might be put off by the user-unfriendliness.
“Clinicians have a certain kind of professional obligation to report any adverse events that they see, but the result is that really they tend not to do it, because they’re already dealing with a lot of paperwork, and it’s fairly cumbersome,” says Freifeld, who’s also the chief technology officer of Epidemico, the app’s publisher and a spinoff of Boston Children’s Hospital.
This is where MedWatcher, potentially, comes in. The free app, developed by John Browstein with Boston Children’s, Nabarun Dasgupta with the University of North Carolina at Chapel Hill, and Freifeld, was originally launched in fall 2010. But a little over a year ago, the app’s creators submitted a proposal to the FDA, which decided to partner with them and is now promoting the app as part of its new surveillance system for devices. After working with the FDA’s Center for Devices and Radiological Health, a substantially revised and upgraded version of the app came out in late January, Freifeld says, for iPhone, iPad and Android devices.
How it works
The basic function of the app is as a sort of safety alert system, as Freifeld explains. When you sign up for it, you list what vaccines, drugs or devices you’re interested in. The app then aggregates news articles or safety alerts around those products. If you, as a clinician or patient, have an issue, you then file a report using the app, describing what happened and with what device or medication, which Epidemico then relays to the FDA. But the company creates its own feedback loop. De-identified reports submitted to the app will be then sent to other users who have signaled they want to follow alerts around those products, so the community of users can help keep each other aware of potential problems.
For now, though, that community is in its infancy. Freifeld says they have around 2,000 registered users, mostly consumers and not providers, and so far only 100 or so reports have been submitted to them. “We haven’t done a lot of publicity because we’re still ramping up and improving it and testing it,” Freifeld says.
But it’s possible, with the FDA backing it, the app could take off. As one real-life user apparently told the company after reporting an event: “I wanted to be heard.”
That’s all well and good, but in the past, doctors generally made these reports by faxing or mailing in a document, a rather time-consuming and workflow-damming process. Nowadays, while it’s true these voluntary reports can also be done online using the MedWatch 3500 form, by tapping into current technology there may be a new level of ease in reporting. The FDA, a Boston company and three research groups have teamed up on a project they say might increase voluntary reporting by doctors and even their patients: an app.
UI unfriendliness
The problem with even the FDA’s online forms, especially for patients who want to report an event that happened to them, is that they’re typically “not really set up with usability top of mind,” in the words of Clark Freifeld, one of the co-developers of the app, called MedWatcher. “(There are) lots and lots of different fields that you’ve got to fill in, and it doesn’t work in all browsers quite correctly,” he tells DOTmed News. And even though it’s meant more for clinicians, even many of them might be put off by the user-unfriendliness.
“Clinicians have a certain kind of professional obligation to report any adverse events that they see, but the result is that really they tend not to do it, because they’re already dealing with a lot of paperwork, and it’s fairly cumbersome,” says Freifeld, who’s also the chief technology officer of Epidemico, the app’s publisher and a spinoff of Boston Children’s Hospital.
This is where MedWatcher, potentially, comes in. The free app, developed by John Browstein with Boston Children’s, Nabarun Dasgupta with the University of North Carolina at Chapel Hill, and Freifeld, was originally launched in fall 2010. But a little over a year ago, the app’s creators submitted a proposal to the FDA, which decided to partner with them and is now promoting the app as part of its new surveillance system for devices. After working with the FDA’s Center for Devices and Radiological Health, a substantially revised and upgraded version of the app came out in late January, Freifeld says, for iPhone, iPad and Android devices.
How it works
The basic function of the app is as a sort of safety alert system, as Freifeld explains. When you sign up for it, you list what vaccines, drugs or devices you’re interested in. The app then aggregates news articles or safety alerts around those products. If you, as a clinician or patient, have an issue, you then file a report using the app, describing what happened and with what device or medication, which Epidemico then relays to the FDA. But the company creates its own feedback loop. De-identified reports submitted to the app will be then sent to other users who have signaled they want to follow alerts around those products, so the community of users can help keep each other aware of potential problems.
For now, though, that community is in its infancy. Freifeld says they have around 2,000 registered users, mostly consumers and not providers, and so far only 100 or so reports have been submitted to them. “We haven’t done a lot of publicity because we’re still ramping up and improving it and testing it,” Freifeld says.
But it’s possible, with the FDA backing it, the app could take off. As one real-life user apparently told the company after reporting an event: “I wanted to be heard.”