We previously discussed how flaws in the FDA medical device reporting system have made it impossible to know how many adverse medical events have been caused by malfunctioning insulin pumps. There are moves to fix the system, but change comes slowly.
In April 2013, the FDA published a report entitled “Strengthening Our National System for Medical Device Postmarket Surveillance.” The report announced goals of establishing a unique device identification system, incorporating collection and analysis of electronic health information, and developing national and international device registries for selected medical devices. Recently, the FDA has also launched an app to support its Medwatch reporting system; this will make it easier for patients and doctors to report device and drug problems.
There also are diabetes advocates working with the FDA to raise the standards of diabetes devices, and to push the FDA to do more to ensure quality control of diabetes devices and supplies. One of them is Bennet Dunlap, a diabetes care product safety advocate and founder of the Strip Safely campaign. He’s helped lead a lobbying effort to persuade Congress to require Medicare to pay for the services of certified diabetes educators and to cover the expense of continuous glucose monitors. While both efforts may be doomed to fail during this congressional session, according to bill watchers on Capitol Hill, the lobbying efforts of Dunlap and others have gotten more sophisticated and drawn more attention than such efforts have done in the past.
Dunlap knows how important it is to gather data from adverse events reports. Anything that can be done to make insulin dosing safer is vitally important, Dunlap says. He points out that the number of emergency room hypoglycemia cases relating to erroneous insulin dosing have now surpassed admissions for illegal drug overdoses in the U.S. He says some pump companies are working to get more customer feedback about when pumps go wrong. Medtronic, he says, has worked with the FDA “to develop a program that helps train users [in the reporting process] and helps maintain contact between users, the manufacturer, and the FDA.”
Dunlap strongly encourages people who manage diabetes with pumps and continuous glucose monitors to learn how to file medical device reports. Any educational effort about how to report adverse medical outcomes from pumps must help patients to clarify what is the pump’s fault and what is user error, he says. With the current system, there is little to prevent a user from submitting a report simply out of frustration over a new device or therapy change. On the flip side, many problems never get reported because the patient may mistakenly believe the pump is only tangentially related to the medical emergency, says Dunlap. However, he says, training insulin pump users to be smarter about reporting adverse outcomes can’t be the entire equation.
“While more data and more complete reporting can only help, I think it is also fair to point out that good diabetes care requires a fair amount of mental capacity from individuals. [Adding to it] the responsibility for device reporting to some extent seems unfair,” he says.
The FDA may some day succeed in optimizing its reporting protocols to reduce or eliminate accumulation of extraneous and erroneous data, and essentially turn these device issue reports into true quality assurance research resources. Until then, it’s best for users of diabetes care devices to stay vigilant, study the manufacturer’s manuals, and, when in doubt, report an issue.
To report an adverse effect, go to https://www.fda.gov/safety/medwatch/howtoreport/ucm053074.htm
To read other parts of this series, go to:
Part 5 – Why Pumps in the EU May be Less Safe
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