ISO takes major step toward uniform medical device standards

FDA watchers should pay attention

The medical device industry has established a technical committeethat will define how the ISO 9000 quality systems standards willbe applied in the medical device industry. Technical committee(TC) number 210, provisionally entitled General Aspects for HealthCare Products, was established last month by the Geneva-basedInternational Organization for Standardization (ISO).

"Any company subject to FDA regulation should pay attentionto the work of TC 210," said Elizabeth Bridgman, executivevice president of the Association for the Advancement of MedicalInstrumentation (AAMI) in Arlington, VA. "With the issuanceof its proposed revision of the Good Manufacturing Practices (GMPs)regulations based on ISO 9001, FDA served notice that it attachesgreat importance to international standards."

That point was driven home by Philip White, director of theFDA Office of Standards and Regulations in the Center for Devicesand Radiological Health.

"Creation of ISO/TC 210 offers tremendous opportunitiesfor worldwide regulatory harmonization," White said. "Weview this as a valuable forum that medical device manufacturersand regulators from around the world will use to reach agreementon what is necessary to provide the public with safe and effectivemedical devices."

AAMI is managing U.S. participation in the new TC through abroad-based U.S. Technical Advisory Group (TAG). This TAG, madeup of representatives from the Food and Drug Administration, medicaldevice manufacturers and other interested parties, will determineU.S. positions on standards developed by TC 210. Harmonizationis needed because of the variations in standards and regulationsadopted by different governments and groups around the world.

"The feeling is that if we can have worldwide agreementon the standards, it will be an important contributor to ultimatelyharmonizing the regulatory requirements," Bridgman said.

International standards will be a major determinant in thesuccess of medical products in the future, she believes, sincemeeting them will determine whether products gain access to variousinternational markets.

A very important part of AAMI's role, said Bridgman, is toensure broad-based U.S. input to the committee. That will encompassparticipation by the National Electrical Manufacturers Association,Health Industry Manufacturers Association, "and anyone elsewho has a legitimate interest in the committee."

"But it is important to remember that AAMI has two roleshere," she said. "The other is to run the internationalcommittee. So it is not just U.S. input to the process. Othercountries will be involved."

The scope of the new committee will likely be very broad. InitiallyAAMI wanted to establish the technical committee as a means ofaddressing quality systems and applying the ISO 9000 standardsto the medical device industry. However, the ISO Technical Boarddecided that the new technical committee should also address fundamentalrequirements for health-care products. These fundamental requirementscould go well beyond quality systems, Bridgman said.

"Because the scope of this TC's work will go beyond qualitysystems, there is real potential for harmonization of other medicaldevice regulatory requirements," said FDA's White. The actualscope of the new committee will be defined by the committee itselfat its first meeting, which should be held later this year.

When the committee begins looking at standards, the first tobe considered will be EN 46001 and 46002, the European standardson the application of ISO 9001 and 9002 to medical devices. Thecommittee will also take into account changes proposed in theGMPs by FDA, changes that affect the design requirements thatincorporate major elements found in ISO 9001.

Establishment of the technical committee was the culminationof more than a year of effort by AAMI, the U.S. medical deviceindustry and the FDA to establish a worldwide forum for the developmentof quality systems standards applicable to medical devices.

With the support and participation of the FDA and corporatemembers, AAMI proposed the new technical committee in late 1992.Throughout 1993, AAMI worked on getting the support necessaryto get the committee formally approved by ISO.

"The committee will create within ISO the means for establishinga global agreement on quality systems standards," Bridgmansaid. "The European standards were written to meet Europeanneeds and we will now have a mechanism to ensure that they meetglobal needs."

IIE moves into the digital realmMultiformat camera supplierInternational Imaging Electronics of Bollingbrook, IL, is gearingup its U.S. marketing effort for fullView, an ultrasound imagemanagement system. The digital image display technology, whichdebuted at the December RSNA show last year, has Food and DrugAdministration clearance.

IIE has installed the product at four Canadian sites and isinitiating its first U.S. installations, according to presidentSteven Silver.

FullView grabs both color and black-and-white images from anyultrasound system, the company claims. Images are displayed ontwo 21-inch monitors either during or after exams. They can bearchived on any digital medium, allowing ultrasound departmentsto eliminate film, said Silver.

OEC wins appeal of jury verdictSpecialty x-ray supplier OECMedical Systems has had a $3.1 million jury verdict against thecompany reversed on appeal. The litigation was brought by a terminateddistributor of the company's x-ray products in 1986. A jury trialin May 1992 rendered an unfavorable verdict against OEC (SCAN10/6/93).

OEC established a reserve for the judgment in the second quarterof 1992. The company said it would leave the reserve in placeuntil all appeals in the case are exhausted.

OEC Medical Systems split off from Diasonics last year in atransaction that created three independent companies: OEC, DiasonicsUltrasound and ultrasound therapy developer Focal Surgery.