The first peer-reviewed materials database to support medical device design
has reached a significant milestone, now providing a total of 22,000 datasheets
and literature references for 10,661 cardiovascular and orthopedic devices,
380 materials and 945 specific material grades.
The Materials for Medical Devices Database helps speed the device innovation
process “by providing immediate access to key materials knowledge,”
said Pam Brown, Product Development Manager for ASM
International’s Materials and Processes for Medical Devices (MPMD)
In a major new extension to the Cardiovascular Module, information has been
added for all FDA classifications of catheters and other related interventional
devices. Records for these devices have been organized into the following database
folders and identified by their U.S. FDA Regulation Number:
Diagnostic Devices: Catheter Cannula (870.1300), Continuous Flush Catheter
(870.1210), Electrode Recording (870.1220), Guide Wires (870.1330), and Percutaneous
Catheter (870.1250). Surgical Devices: Vascular Clamps (870.4450). Therapeutic
Devices: Embolectomy (870.5150) and Septostomy (870.5175).
Characterization, numerical information and links to specific devices have
now been completed for 16 materials in the Orthopaedic Module, with bioresponse
information added for Poly(lactic Acid)/Hydroxyapatite (HAPLA). In addition,
80 new producers have been added with links to specific devices.
Fully relational and modular, the Materials for Medical Devices Database provides
a comprehensive set of mechanical, physical, biological response and drug compatibility
properties for the materials and coatings used in medical devices. The database
also draws references from 3,700 sources including journal articles, conference
proceedings, manufacturer data, USFDA CDRH 510K submissions, PMAs and FDA standards
and guidance documents.
Comprehensive reviews of the literature concerning biocompatibility of candidate
materials and coatings are peer-reviewed by 75 industry experts. The database
continues to expand into materials for neurological and dental applications,
as well as additional content for cardiovascular and orthopaedic applications.