The United States, however, is not the only country struggling with this issues. The comparable database in Europe — European Databank on Medical Devices (EUDAMED) — is not even accessible to the general public.
The big concern by many clinicians is that it is not possible to know how many adverse events are occurring annually and how many are involving user errors or lack of user education, according to Peters.
In one study, researchers said that the FDA received five adolescent death reports associated with the use of insulin pumps from Jan. 1, 2005, to Dec. 31, 2005, raising concerns about use of this device in adolescents.2 This prompted them to analyze medical device adverse event reports from Jan. 1, 1996, through Dec. 31, 2005, involving insulin pumps or patient-controlled analgesic pumps used by patients aged 12 to 21 years.
The researchers identified 1,674 reports, with 1,594 for insulin pumps and 53 for patient-controlled analgesic pumps. Problems with compliance, education, sports-related activities, and dropping or damaging the pump were identified as potential contributors to the insulin pump-related adverse events.
“The users themselves don’t troubleshoot the devices. Patients need to know a lot of different steps. There is a lot of education required and we don’t know how many problems are due to a lack of education. If there is an education problem, then we need to know that and make changes,” said Dr. Peters.
Additionally, the working group found that the clinical studies required by regulators prior to marketing are small and rely entirely too much on bench testing.
The working group states that once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real-world setting. If data on long-term use in a real-world setting were widely available, care could be improved, they wrote.
Consequently, the working group calls for the European Union (EU) and the FDA to harmonize the standards that will be required for pump manufacturing companies at both the premarketing and postmarketing stages. The group would also like to see a single publicly accessible international database for reporting all adverse events with insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII).
Peters and colleagues believe that pump manufacturing companies should be required to provide, with transparency, annual estimates of the number of individuals who use their insulin pumps and the results of clinical research conducted on the “human factors” and potential for user error associated with newly introduced features of the various pump designs.
There is a need to update the data available for clinicians on the compatibility of insulin pumps with specific insulin formulations and infusion sets, said Peters.