EASD VIENNA — Diabetes experts in the U.S. are joining their European colleagues in a call for better regulation of diabetes devices.

A joint committee of the American Diabetes Association and European Association for the Study of Diabetes announced here that they’ll soon be issuing a statement on insulin pumps and the need for better pre-market approval pathways and postmarketing surveillance.

The move by U.S. experts comes on the heels of insulin pump recalls by Medtronic and Tandem.

”So much of pump safety is in the hands of pump manufacturers,” Anne Peters, MD, of the University of Southern California, who was tasked with looking into U.S. regulation of insulin pumps, said during a press briefing. ”The FDA can’t deal with all of the information that comes in.”

Peters said the FDA’s current system for tracking problems with insulin pumps and devices in general — Manufacturer and User Facility Device Experience (MAUDE) — has several limitations, including the fact that it is self-reported by device makers who contribute on varying levels.

She noted, for example, that some 80% of pump filings in MAUDE come from the Johnson and Johnson company Animas, which likely indicates ascertainment bias in the data, she said.

In June 2013, Medtronic initiated a Class I recall of the infusion sets in its MiniMed Paradigm insulin pump. A faulty connector could potentially block the vents that allow the pump to prime itself, which could result in too much or too little insulin being delivered, according to the FDA.

That, in turn, could lead to hypoglycemia or hyperglycemia and subsequent risks of serious illness, the agency said.

At the beginning of this year, Tandem also recalled ”leaky” insulin cartridges used with its t:slim Insulin Pump, which also could potentially result in hypo- or hyperglycemia.

Peters noted that the insulin infusion set components of the pumps seem to be particularly problematic, and that, in her research, she couldn’t find a convincing answer as to who officially regulates them. Pump companies said the infusion set manufacturers are in charge of them, while the FDA said the pump manufacturers oversee them, she said.

Peters, who is now consulting to the FDA by reviewing proposals from device companies on how better to monitor devices, added that clinicians have no way to access data that can help paint the big picture for these pumps. There’s little information on how many are sold and returned, how long they last, and how reliable they are, she said.

European counterparts are evaluating the European Union’s regulatory system for devices — although this road has already been well traveled. The EASD has, for the past several years, pushed hard against a lack of an equivalent of the European Medicines Agency (EMA) for devices.

In 2012, the European Commission put forth a proposed regulatory framework for devices, but the EASD said these reforms did not go far enough because they only pertained to Class III devices and diabetes pumps were included in Class II.

EASD President Andrew Boulton, MD, of the University of Manchester in England, said those reforms were recently rejected by the last Parliament, and the arrival of a new Parliament means advocates will have to start all over again, at square one.

”There’s an EMA, so why don’t we have a centralized European Devices Agency?” Boulton said during the press briefing. ”It’s going to be a long time before we see that, but it needs to change.”

Some of the principles that will be included in the upcoming EASD/ADA statement on insulin pumps are the need for more testing of reliability and durability in the long term, a deeper look at the interaction between pump design and human factors, better approaches to tracking adverse events, more support for long-term data collection within registries, more well-controlled clinical trials under real-world conditions, and harmonization of the approach between international regulatory bodies.

Following the insulin pump guidance, the committee also plans to draft statements on standard blood glucose monitors, continuous glucose monitors, and other diabetes devices.

From http://www.medpagetoday.com

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