Standard bearers: Defining consistency in ophthalmics

Standard bearers: Defining consistency in ophthalmics

Behind the ophthalmic products doctors use daily is the work of an expert group dedicated to continually setting the standard.  

"We make sure the OD's clinical opinions are represented and optometry isn't written out of the standard."

The American National Standards Institute-Accredited Standards Committee for Ophthalmic Optics, referred to as 'Z80' (ANSI ASC Z80) oversees the voluntary consensus standards writing activity for ophthalmic optics, equipment and devices used by eye care professionals.

Standards derived from ANSI ASC Z80 influence regulations domestically—and abroad as ANSI ASC Z80 experts also participate in the International Organization for Standardization (ISO)—that govern the ophthalmic industry, making it vitally important that AOA representation ensures optometry's input.

William J. Benjamin, O.D., ANSI ASC Z80 secretary and AOA representative, says the committee works in a cooperative, multidisciplinary fashion to place clinicians, academia, industry and government on equal footing when maintaining standards. He adds that ANSI ASC Z80 is one of the few official interfaces of teamwork between ophthalmology, optometry and opticianry. 

"This is where the large majority of the tolerances and measurement standards for ophthalmic products that eye care practitioners use are derived," Dr. Benjamin says. "Optometry has a major input in this process. We make sure that ODs' clinical opinions are represented and optometry isn't written out of these national and international standards."

Below are three takeaways from this past year's committee meetings:

Reviewing 2014: 3 takeaways from ASC Z80

  1. Making the most of consensus standards. As directed by the U.S. government, federal agencies are to seriously consider the adoption of existing consensus standards drafted by entities such as ANSI ASC Z80. Dr. Benjamin points out how this saves both time and money, while also generating a general agreement for standards used by the federal government. However, the committee is currently concerned with attempts to circumvent the voluntary consensus standards process. Additionally, the committee is working to resolve a proposed revision to federal documentation that would require standards cited in federal guidelines to be made available free-of-charge to the public; standards are currently available via a fee that supports ANSI ASC Z80 and its standards activities.

  2. Expert insights. Eight subcommittees—each tasked with different areas of ophthalmic issues—make up ANSI ASC Z80 with industrial, academic, governmental and clinical experts lending their knowledge in each field. Among other areas, subcommittees are working to update standards to reflect the rise in adjustable-power prescription spectacle lenses and 'ready-readers' with bifocal additions, revise standards for intraocular lenses and implantable glaucoma devices, update standards on tonometers, and review contact lens standards, especially regarding acanthamoeba infections. 

  3. International connection. Members of the ANSI ASC Z80 committee also helped defer a regulatory action internationally that could have cost the sunglass industry about €130 million had it been implemented too soon. Although Europe is bound by law to accept ISO standards, it can take up to 4 to 5 years to make these standards law, Dr. Benjamin says. In a departure from the norm, the European standards body unexpectedly adopted new standards regarding sunglasses that would have made much of the existing product stock nonconforming and illegal for sale in Europe. Working in conjunction with other entities, members of ANSI ASC Z80 aided in delaying the law's implementation by one year to allow the global sunglass community to deplete current stock. 

The committee will reconvene in March 2015. Click here to learn more about ophthalmic standards, and find a current listing of ANSI and American Society for Testing and Materials (ASTM) standards.

January 12, 2015

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