In the first two parts of this series on insulin pump safety, European and U.S. health officials called for better and more uniform insulin pump safety standards. In this third part of the series, we explore how the FDA tracks insulin pump problems.
It can be said that the FDA regulates every stage of the life cycle of an insulin pump. It’s in charge of the oversight of pre-market studies testing the safety and effectiveness of insulin pumps before they can be offered on the market. It also has a role in monitoring post-market performance of cleared pumps.
The FDA’s authority doesn’t go so far as to govern the minute details of each manufacturer’s product development and assembly operations, or their quality assurance or customer service policies. Regulators oversee pump safety using generalized electrical and manufacturing quality control standards, not specific standards for medical devices like pumps. And although the FDA has at its disposal experts in device therapies for diabetes, it doesn’t have a stable of software engineers, code writers and insulin pump assembly specialists to hover over the laboratories and factories where pumps are being developed and made.
That means manufacturers are ultimately the architects of what can and can’t be done in a commercially reasonable way to assure that their devices operate safely and effectively. Moreover, since neither the regulators in the United States or abroad maintain constantly updated logs of who has purchased what device and how well, or how poorly, it has performed, the ins and outs of tracking performance is pretty much left to manufacturers. Critics contend this method lacks consistency and can make for lax oversight. In recent years, the FDA regulators have begun to solicit feedback from the diabetes community about how to tighten up this reporting practice.
Here’s how the reporting process for insulin pump problems currently operates:
First, all medical device manufacturers are required to have product identification and traceability capabilities, so that users can be notified of product recalls. With a recall, defective or malfunctioning equipment can be remedied, discontinued, or pulled from market. When manufacturers become aware of any product failures that could lead to actual or potential injury, they must report that information to the FDA and then follow a schedule of supplemental reports that chronicle the steps to fix the problem. Manufacturers and distributors always have the option to remove a device from the market or recall it for replacement or repair. At any stage in the reporting process, the FDA may order a mandatory product recall, or suspension of the product’s sale or distribution within the United States.
Since 2002, according to the FDA’s reporting system, there have been 10 insulin pump-related U.S. recalls, the most recent in January of 2014. Of the 10 U.S. recalls between 2002 and 2014, five were related to infusion sets, two to power supplies, and two to the pumps themselves (one due to a malfunction in bolus dosing and the other due to false warning alarms). The final recall was for potentially leaking insulin cartridges for the Tandem t:slim pump.
That recall offers a good example of how the system is supposed to work. The lots of defective insulin cartridges were numbered and traceable to distributors and retailers. Tandem was able to quickly issue notices and offer replacements by overnight mail and couriers. Tandem’s internal manufacturing controls were sufficient to correct the problem. There have been no patient-reported or clinician-reported adverse effects related to the leaky cartridges, even after the recall was expanded to include more cartridges.
The problem is that this smooth recall may be the exception and not the rule, and much of that has to do with a lack of searchable information about potential pump problems. The FDA does maintain a registry of reported issues of concerns from pump users, but it may not be stringent enough to keep people safe. Also, the database of reported problems isn’t optimized for easy search, and it’s voluntary for doctors and patients to report pump problems. This reporting strategy could mean that many pump problems simply are never reported.
Here’s a case found in the database of pump issues that illustrates the shortcomings of the reporting system: In January 2015, a user of a sensor-augmented insulin pump was hospitalized for diabetic ketoacidosis (DKA). The pump manufacturer received a complaint call from the user, but the user’s blood glucose levels at time of hospitalization were not recorded in the report. The pump manufacturer promptly complied with its mandate to report the potential problem to the FDA, but the user did not return the pump to the manufacturer for examining or bench testing. Because of this, there is no information to deduce whether the problem was user error, a clog caused by outdated or incompatible insulin, an empty cartridge or reservoir, a burned-out motor, a dead battery, or a hose chewed through by a puppy. All that can be concluded from the report is that the patient owned a particular brand and model of pump and that he or she went to the hospital with a case of DKA and did not die.
Better reporting is the cornerstone of a proposal by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) to improve international insulin pump safety standards. The EASD-ADA Technology Commission’s Statement on Insulin Pumps states that “in the US, relatively little useful clinical data on long-term pump use/safety is available.”
Luckily, there are signs that this ineffective reporting system might change. Diabetes advocates are partnering with the FDA to allow for more patient-centered input when it comes to insulin pump safety. We’ll be discussing that in the next part of our series.
To read other parts of this series, go to:
Part 4 – Speaking Up to Make Pumps Safer
Part 5 – Why Pumps in the EU May be Less Safe
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