Recommended Actions
 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