U.S. regulations may be based on world standardsRepresentatives from standards organizations around the globewill meet in late October to discuss how the ISO 9000 series ofquality standards will be applied to the medical device community.The
Representatives from standards organizations around the globewill meet in late October to discuss how the ISO 9000 series ofquality standards will be applied to the medical device community.The meeting of International Organization for Standardizationtechnical committee 210 (ISO/TC 210) could have an enormous impacton medical equipment vendors in the U.S. With the globalizationof the medical market, world standards will become de facto U.S.standards, potentially changing the way devices are made and used.
"The objective is to reach worldwide agreement on theserequirements, thereby facilitating trade and, hopefully, servingas the basis for harmonizing regulations to the benefit of regulators,as well as manufacturers and their customers," said ElizabethBridgman, secretary of ISO/TC 210 and executive vice presidentof the Association for the Advancement of Medical Instrumentationin Arlington, VA.
The meeting will be held October 24 to 26 in Arlington. Toprepare for the meeting, members of the U.S. medical device industryand the Food and Drug Administration will gather as part of aU.S. technical advisory group to hash out mutual concerns pertainingto the international committee's agenda.
The ISO/TC 210 meeting is the first-ever gathering of the committee,as well the first truly global gathering of government and privatemedical device experts who focus on international quality standards.
The meeting will also include discussions on applying riskanalysis to medical devices and will attempt to nail down thefundamental requirements that will be placed on medical devicecompanies for regulatory approval of their products.
The Association for the Advancement of Medical Instrumentation(AAMI) is playing a central role in this process, on both theinternational and the U.S. sides. Playing the part of secretariat,AAMI is organizing the international technical committee (TC)within the ISO Council.
In an equally important role as administrator, AAMI is facilitatingdevelopment of the U.S. technical advisory group, which will formulateU.S. positions on issues to be considered by the TC. The groupalso provides U.S. delegates to the international committee.
The technical advisory group was formed specifically to representthe interests of U.S. companies on standards harmonization issuesthat will be decided by the ISO/TC group. A meeting held in Junewith some 60 participants was primarily informational.
"The U.S. views are still evolving," Bridgman said."A well-defined U.S. perspective should emerge from the Octoberadvisory group meeting."
The ISO/TC is still in its first year, having been ratifiedonly last February by the ISO. Its goals are to harmonize globalstandards and define how the ISO 9000 quality system will applyto the worldwide medical device industry.
Members of this committee represent standards organizationsfrom about 20 nations, including the U.S., Canada, and countriesin Europe, the Pacific Rim and Asia. The American National StandardsInstitute (ANSI) officially represents the U.S. in ISO, but ANSIhas delegated its responsibility foradministration to AAMI.
Three primary issues will be discussed at the ISO/TC 210 meeting.One will be the ISO 9000 series quality systems and how they willapply to the medical device community, according to AAMI's Bridgman.The committee is expected to look at EN 46001 and 46002, standardsdeveloped in Europe for the application of ISO 9001 and 9002 tomedical devices.
FDA to participate. The committee will also likely considerthe proposed revision to the good manufacturing practices (GMPs),which is still working its way through the FDA (SCAN 9/14/94).The FDA will participate in both the technical committee and thetechnical advisory group, and will probably come away from themeeting with ideas for changes to its regulations, according toBridgman. The agency's participation is expected to be limitedto discussions about quality.
Another issue to be discussed will be risk analysis.
"It's intended to address the potential hazards of theuse of a device and how you address those hazards in the contextof clinical investigations, regulatory review or design considerations,"Bridgman said.
Discussion is likely to focus on a European standard, prEN1441, Medical Devices -- Risk Analysis, still in draft form, whichconsiders whether device design or manufacturing processes couldplay a role in increasing safety.
The document proposes that risk analysis be carried out aspart of a quality system put in place by manufacturers. This proposalhas been circulated to participants of ISO/TC 210 and will likelybe a central focus of the international committee's discussionabout risk analysis.
The third issue is the prerequisites that will be requiredfor medical device manufacturers to sell their products on theworld market. These requirements are likely to include considerationsother than just quality, Bridgman said, although quality willbe a major focus.