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Leading diabetes associations recommend overhaul of European, US medical device safety
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The European Association for the Study of Diabetes and the American Diabetes Association have made recommendations for a comprehensive evaluation of diabetes medical device safety to involve regulators, manufacturers, health care providers and the associations.
The position statement, published simultaneously in Diabetologia and Diabetes Care, comes after a review by the joint Diabetes Technology Committee of the systems in place for assessing the safety of insulin pumps from a clinical perspective.
“Pumps are used by an increasing proportion of people with diabetes,” John R. Petrie, MD, PhD, of the Institute of Cardiovascular and Medical Sciences, University of Glasgow, told Endocrine Today.
John R. Petrie
Worldwide, approximately 1 million patients are currently receiving continuous subcutaneous insulin infusion, according to a news release. Although most have type 1 diabetes, some patients with type 2 diabetes also use pumps.
“They offer a greater level of flexibility in lifestyle but, at present, are still associated with an unacceptable level of failure,” Petrie said. “One in every four people using a pump for a year may experience pump failure.”
Insulin infusion errors can occur due to pump failure, insulin infusion set blockage, infusion site problems, insulin stability issues, user error or a combination of these, the researchers highlighted in the statement.
Hyperglycemia and ketoacidosis could result from interruption of insulin infusion and hypoglycemia from excessive insulin delivery.
With a relatively low bar for device approval based on similar functionality to products already on the market, the researchers contend that oversight is not adequate.
“Technology is evolving rapidly for treating diabetes,” Anne Peters, MD, CDE, of the Keck School of Medicine, University of Southern California, said in the statement.
“While that’s certainly a good thing, we don’t have very good postmarketing surveillance for devices such as insulin pumps, particularly in Europe where manufacturers often introduce products prior to releasing them in the United States,” she said. “We need to make sure we have sufficient data about how the devices are working once they hit the market, so that we can support patients by helping them understand how to prevent errors in using them.”
Although adverse events appear to be attributable to human factors or user error, the requirement for manufacturers to consider user interaction with technical features is limited, according to researchers.
The investigators determined that useful information held by the manufacturing companies is not sufficiently shared in a transparent way; the availability of adverse event reports in the U.S. database is not widely utilized due to system configuration, and the Europe database is not even publicly accessible.
The associations call for additional funding for both registry “real world” studies and formal clinical trials, such as the ongoing Relative Effectiveness of Pumps Over Multiple Daily Injections and Structured Education (REPOSE) trial in the U.K., to prevent future adverse events.
“People with diabetes should know that the professional societies in Europe and the U.S. are working together to lobby the industry and the regulators to set higher standards around the approval of pumps in the marketplace and transparency of data on adverse events,” Petrie said.
Such data could help health care providers educate and support users.
The associations ask that pump users report to the manufacturer any adverse events they think might be attributable to their pump.
“This will help ensure that any problems, such as those due to ongoing changes in design and specifications, are detected as early as possible,” Petrie said. – by Allegra Tiver
For more information:
John R. Petrie, MD, PhD, can be reached at the Institute of Cardiovascular and Medical Sciences, University of Glasgow, 126 University Place, Glasgow G12 8TA - 0141 330 3325; email: john.petrie@glasgow.ac.uk.
Disclosure: Most of the researchers report work with industry but consider industry to have had no influence on the statement.
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