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Standards Give Health a Booster Shot during National Immunization Awareness Month

In the United States, more than 90% of children between the ages of nineteen months and three years receive the full schedule of vaccinations for polio, chickenpox, and measles, mumps, and rubella, part of a long term, ongoing public health effort to encourage parents to protect their children's health and health of others in their communities. Widespread vaccination currently prevents the premature death of two to three million people around the world each year, according to the World Health Organization (WHO).

August marks the annual observance of National Immunization Awareness Month, highlighting the important role that vaccinations play in protecting the health of infants, children, adults, and the elderly from the threat posed by preventable illnesses. The American National Standards Institute (ANSI) and its Federation of members are proud to support the development of standards and other documents that support immunization efforts and public health as a whole.

For most people, getting immunized against serious illnesses is a process that begins when they're a small child and continues—in the form of booster shots, which are required to maintain immunity to some diseases—into their golden years. And the bulk of those immunizations will involve the injection of a vaccine into the body using a hypodermic needle. ISO 7886-3:2005, Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization, sets down properties and performance guidelines for syringes, including those used for vaccinations, that become automatically unusable after delivering a single dose. This International Standard was developed by International Organization for Standardization (ISO) Technical Committee (TC) 84, Devices for administration of medicinal products and intravascular catheters. The U.S.'s Harold Yaeger, senior advisor for devices and diagnostics at Eli Lilly and Company, serves as the chair of ISO TC 84 and the Association for the Advancement of Medical Instrumentation (AAMI), an American National Standards Institute (ANSI) organizational member and accredited standards developer, administers the TC's ANSI-accredited U.S. Technical Advisory Group (TAG).

Most vaccines include a suspending fluid, such as saline or sterilized water, stabilizing compounds, and preservatives to allow the vaccine to last as long as possible and maximize its effectiveness. These compounds can also contain protein from chicken eggs, a leftover from the process of culturing the relevant bacteria or virus in a lab to create the vaccine. To support the poultry and egg farms that provide these eggs, the National Pork Producers Council has developed a helpful American National Standard (ANS). ANSI GELPP 0001-2002, Good Environmental Livestock Production Practices (GELPP): Concentrated Livestock Operations - General Site Conditions, sets down environmental guidelines for the operation of commercial agricultural sites containing egg-laying chickens, among other types of commercial animals, and focuses on animal feeding operations at these types of facilities.

Once a hypodermic needle has been used to deliver a dose of vaccine, careful steps need to be taken to ensure that this and other medical waste is properly disposed of. Thankfully, CSA Group, an ANSI organizational member and accredited standards developer, has developed a standard that can help. CSA Z317.10-2009 (R2014), Handling of waste materials in health care facilities and veterinary health care facilities, provides preventive measures intended to safeguard staff, patients, and others from the risks of potentially hazardous medical waste. The standard includes requirements for the collection, storage, and disposal of relevant waste materials, among other guidelines. In addition, a standard developed by ANSI member and audited designator ASTM International provides useful guidance when it comes to determining whether medical gloves used by practitioners during vaccinations and other medical activities are providing sufficient protection. ASTM D5151-06(2011), Standard Test Method for Detection of Holes in Medical Gloves, provides a test method for determining whether gloves used for medical purposes contain holes through the use of a water leakage test.

To learn more about National Immunization Awareness Month, or to access resources to help spread the word about the important role immunizations play in supporting public health, visit the U.S. Centers for Disease Control and Prevention (CDC)'s official National Immunization Awareness Month webpage.


Jana Zabinski

Senior Director, Communications & Public Relations


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Beth Goodbaum

Journalist/Communications Specialist


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