World Health Day on April 7 is dedicated to scaling up awareness efforts for the prevention, care, and enhanced surveillance of diabetes. The campaign—which serves to highlight the anniversary of the World Health Organization (WHO) with a different annual theme to drive health awareness—urges people worldwide to take preventative diabetes measures with tips for better eating and ways to get the community involved to support the effort. The American National Standards Institute (ANSI) proudly supports the prevention and treatment of diabetes through standards developed by various members and accredited standards developers that support medical supplies and tools.
Diabetes is a noncommunicable disease (NCD) that impacts millions: It ranks as a leading cause of death by WHO. Furthermore, the Centers for Disease Control and Prevention (CDC) reports that the number of Americans diagnosed with the disease has increased fourfold, from 5.5 million to 22.0 million, from 1980 to 2014. Diabetes is also a worldwide health epidemic, with 422 million people living with the disease, a number likely to more than double in the next 20 years, WHO reports.
Undiagnosed and recorded new cases of diabetes are also surging, and to help lessen the severity and spread useful information about diabetes, WHO has released helpful tools, including an educational quiz, and a registration page for organizations to host an event.
ANSI supports spreading awareness with a reminder that standards can assist healthier lifestyles for people of all ages.
Standards play a vital role in diabetes prevention and treatment. The International Standard ISO 15197:2013, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, specifies requirements for monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures, and for the validation of performance by the intended users. These systems are intended for self-measurement by lay persons for management of diabetes mellitus.
ISO 15197 was developed by the International Organization for Standardization (ISO) Technical Committee (TC) 212, Clinical laboratory testing and in vitro diagnostic test systems. The U.S. holds the chairmanship and the secretariat of this TC, with David Armbruster, Ph.D., serving as chairman and the Clinical and Laboratory Standards Institute (CSLI) as secretariat. CSLI, an ANSI organizational member and accredited standards developer, is also the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator to TC 212.
Another ISO standard provides specific requirements and test methods for syringes used to inject insulin. ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin, specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. The standard covers syringes intended for single use only in humans and with insulins of various concentrations.
The standard was developed by ISO Technical Committee (TC) 84, Devices for administration of medicinal products and intravascular catheters. The ANSI-accredited U.S. Technical Advisory Group (TAG) administrator for this TC is the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI organizational member and accredited standards developer.
Medical device interoperability ensures that all patients can rely on accurate and continual information about their treatment. For example, a standard from the Institute of Electrical and Electronics Engineers (IEEE), an ANSI member and accredited standards developer, helps to enable device communication and plug-and-play interoperability. IEEE 11073-10419-2016, Health Informatics-Personal health device communication-Part 10419- Device Specialization: Insulin Pump, makes it possible for personal insulin pumps to communicate with other devices, like phones and computers, so that diabetics may track their numbers more effectively.
Find out more standards related to diabetes and other medical solutions on the ANSI webstore.