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Dr. Bill's Commentaries

(Originally published March 30, 2015)

Safety of Insulin Pumps

The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recently (in 2015) issued a joint statement about the safety of insulin pumps. Titled Insulin Pump Risks and Benefits: A Clinical Appraisal of Pump Safety Standards, Adverse Event Reporting, and Research Needs, it points out that these extremely expensive devices plus supplies like reservoirs and catheters) don't have standards for reporting adverse events that would allow independent observers to assess whether one pump is better (or worse) than another.

What is an "Adverse Event"? It's a technical term in the world of drug and device safety (AKA pharmacovigilance); the lay term for the same idea is a "side effect". An AE is defined more precisely as "any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related."

In the USA, it's one of the roles of the FDA to monitor reports of adverse events and other problems with medical devices and to alert health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. These regulations contain requirements for manufacturers and certain other organizations to report device-related adverse events and other product problems to the FDA. (In other countries, similar but not identical regulations allow the local regulatory authorities to collect device data.)

Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. "Serious" has a very precise definition in pharmacovigilance: it's an adverse event that results in death, hospitalization, disability, congenital anomaly/birth defect, or it required intervention to prevent permanent impairment or damage, or is considered an important medical event.

Manufacturers must also report to the FDA when they become aware that a device that they make has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Note that this latter requirement doesn't mean that an adverse event had actually occurred, but only that it could happen and would cause serious injury or death.

Some examples of AEs with insulin pumps are pretty obvious: interruption of insulin infusion which could result in severe hyperglycemia and ketoacidosis; or conversely, delivery of excessive insulin, which could cause severe hypoglycemia. One pump manufacturer sent out an "Important Medical Device Safety Information" letter to notify pump users of a programming flaw.  And there are theoretic risks, such as hackers interrupting the wireless systems that control some pump delivery algorithms.

In the recent joint statement, experts from the ADA and EASD suggest that regulatory agencies should work together to create standards that apply equally to all pump manufacturers. One problem is that "there are significant differences in the regulatory systems between the US and European Union at both pre- and postmarketing stages." Another is related to AEs that may be attributable to human factors and/or user error, "but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited."

The recommendations in the Joint Statement are as follows:

1. The regulators (EU/FDA) should:
a) harmonize standards to be met by pump manufacturing companies at both pre- and postmarketing stages
b) provide, publicize, and maintain a single publicly accessible international database (expanded from the current MAUDE system) for AE reporting. This should be searchable according to clinically relevant keywords such as demographics, user errors, components involved (hardware, software, IIS), consequences of event (diabetic ketoacidosis, hypoglycemia, etc.), and model/year of pump manufacture.
c) publish an annual summary of regulatory activities
2. Pump manufacturing companies should be required to provide with transparency to the regulators:
a) annual estimates of the number of individuals who use their insulin pumps (including basic demographic data)
b) the results of clinical research conducted into the human factors associated with newly introduced features of pump design
c) updated data on the compatibility of their pumps with specific insulin formulations and infusion sets
d) systematic data on the durability and precision of insulin pumping over years of real-world clinical usage
e) open data on the results of testing pumps that are recalled or returned
f) open listings of changes in device function, features, and specifications reported to authorities
g) fully anonymized reports of all AEs categorized according to 1b above
3. International and national professional societies should:
a) provide updated evidence-based guidelines on indications for insulin pump therapy
b) recommend appropriate forms of structured education required for new and established pump users
c) set standards for levels of staffing and skills required by teams of health care professionals providing initial and ongoing education and support for pump users (supporting reimbursement of these activities by payers)
4. International and national research funding bodies should:
a) provide or facilitate funding for well-designed independent clinical trials of safety, efficacy, outcomes, and adherence under real-world conditions
b) provide or facilitate significant financial support for long-term data collection within new and existing registries
5. Health care teams should:
a) encourage and support pump users under their care to report all AEs
b) provide structured training/regular updates for pump users under their care according to standards set by national and international guidelines

Quite a handful, and it's clear that many of these suggestions are unlikely to be implemented anytime soon, as the mills of bureaucracy grind exceeding slowly.

However, the last suggestion is one that you, the reader who has persisted to this point should consider: if you are on a pump, or know someone who is, and there's an AE (or the possibility of one), it should be reported to the manufacturer or to the FDA. To do so, there are two routes that could be used:

1) either you or a member of your diabetes team calling the manufacturer's 800 number and inform the representative that you want to report an AE, or
2) either you or a member of your diabetes team contacting the FDA (see Recognize and Report Device Problems at the FDA's website).

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