INEMI And US FDA Plan Forum On Component Reliability For Medical Electronics

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 20 Oct 2008 - 0:00 PDT

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Meeting to be held November 14 at FDA's White Oak Campus in Silver Spring

The International Electronics Manufacturing Initiative (iNEMI) is planning a medical electronics forum to discuss requirements and recommendations developed for the electronics industry to ensure reliability of components used in medical products. The event, which is scheduled for Friday, November 14, 2008, will be hosted by the US Food and Drug Administration (FDA) at their White Oak campus in Silver Spring, Maryland.

"Life-critical medical products - particularly implantable devices - require a high level of reliability, which means that medical applications often require rigorous testing," said Anthony Primavera, Fellow R&D, PG Process Development, Boston Scientific-CRM, and chair of the iNEMI Technology Integration Group (TIG). "The performance requirements for electronic components used in a pacemaker, for example, are much more stringent than those used in an MP3 player. However, there are currently no widely accepted guidelines for the electronics component and circuit board suppliers to follow for production of medical grade units. Instead, each medical device manufacturer has its own set of requirements that suppliers must meet."

"For two years, iNEMI's Medical TIG has been working to identify and clarify guidelines for the supply chain for medical electronic components," Primavera continued. "This forum will report on our work to date, serving as a 'sounding board' to get industry feedback and beginning the process of building industry support for wide adoption of the recommended guidelines and methodologies."

The first phase of iNEMI's Medical Components Reliability Specifications Project defined a set of requirements for life-critical medical components based on use conditions and supplier risks. The team developed test and extrapolation methodologies, specifically focusing on surface mount multi-layer chip capacitors (MLCCs). Work is currently underway to validate these requirements against accelerated test methodologies established in Phase II of the project.

"The iNEMI guidelines are intended to encompass many different components, including boards, resistors, ICs and more. Our initial evaluation, however, is being done with capacitors," explained Primavera. "This same process must be followed for other types of components and we hope this forum will give us the opportunity to identify additional industry collaborations to validate requirements for other components."

Forum topics will include:

-- Existing and related standards and test methods
-- Use conditions for life-critical medical components
-- Test and extrapolation methodologies
-- Sampling population assessment
-- Range and conditions of applicability
-- Test methodologies and criteria
-- Medical grade guidelines
-- Failure modes and effects analysis (FMEA) of MLCC failures
-- Accelerated life test methods to determine long-term leakage and breakdown failures of MLCCs

Registration Information

The forum is planned for Friday, November 14, 2008, 9:30 a.m. to 3:30 p.m. It will be held at the FDA White Oak Campus, 10903 New Hampshire Avenue, Building 2, Room F2047E, Silver Spring, Maryland.

There is no registration fee; however, registration is required for security reasons. Please register by October 31, 2008. Click on one of the following links to register:

-- US Citizens
-- Foreign Visitors (download Word document)

Click Here for additional information.

About iNEMI

The International Electronics Manufacturing Initiative's mission is to identify and close technology gaps, which includes the development and integration of the electronics industry supply infrastructure. This industry-led consortium is made up of more than 65 manufacturers, suppliers, industry associations and consortia, government agencies and universities. iNEMI roadmaps the needs of the electronics industry, identifies gaps in the technology infrastructure, establishes implementation projects to eliminate these gaps (both business and technical), and stimulates standards activities to speed the introduction of new technologies. The consortium also works with government agencies, universities and other funding agencies to set priorities for future industry needs and R&D initiatives. iNEMI is based in Herndon, Virginia, with regional offices in Shanghai, China and Limerick, Ireland. For additional information about iNEMI, visit www.inemi.org

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