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ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing two new proposed standards that will be used in the field of arthroplasty. Arthroplasties are surgical procedures that resurface, remodel, rebuild or replace arthritic or dysfunctional sites of the body with optimal goals including pain alleviation, a return to full range of motion, improvement in…
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ASTM E2369 Provides Means for Healthcare Workers to Collect and Transfer Patient Data The Office of the National Coordinator for Health Information Technology (ONC), part of the United States Department of Health and Human Services, has included an ASTM International standard as part of its formal certification criteria for electronic health record (EHR) technologies. The standard, ASTM E2369…
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In order to address highly variable labeling within the orthopedic implant industry, ASTM International Committee F04 on Medical and Surgical Materials and Devices is developing a proposed new standard that will create a uniform labeling system for implant manufacturers. The proposed new standard, ASTM WK27458 , Guide for Presentation of End-User Information on Implant Package Labeling, is under…
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An ASTM International standard used for effective and timely electronic messaging of health care records has now been adopted as a standard for structured summary health record exchange included in new regulations associated with the Health Information Technology for Economic and Clinical Health Act provision of the American Recovery and Reinvestment Act of 2009 (ARRA/HITECH). ASTM E2369 ,…, Technical Contact:, Dr. David C. Kibbe, The Kibbe Group L.L.C., Pittsboro, N.C. Phone: 913-205-7968; kibbedavid@mac.com, ASTM Staff Contact:, Dan Smith, Staff Manager , Phone: 610-832-9727; dsmith@astm.org, ASTM PR Contact:, Barbara Schindler, Phone: 610-832-9603; bschindl@astm.org Release #8451/Jan2010
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Hydrogels are highly hydrated polymer networks that can be used in the regenerative medicine field as “scaffolding” for the repair of tissue. A proposed new ASTM standard will provide those working in regenerative medicine with a means of characterizing hydrogels. The work item, ASTM WK21927 , Guide for Characterization of Hydrogels Used in Regenerative Medicine, is under the jurisdiction of…
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Each year, approximately 400,000 healthcare workers (HCW) in the United States suffer accidental injury from needles and other medical sharps while tending to patients. These injuries can result from injections, drips, infusions, blood-taking, surgery, biopsy and research, among other causes. Each of these accidents carries a small but documented risk of transmitting more than 60 blood-borne…
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With the proposed new standard, WK11023 , Practice for Life and Reliability Testing Based on the Exponential Distribution, ASTM International Committee E11 on Quality and Statistics is continuing its program of preserving U.S. government military standards on acceptance sampling. WK11023 is an adaptation of the DoD quality control and reliability handbook document H-108, Sampling Procedures and…
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Participation is welcome in a task group that is developing a proposed new ASTM International standard for manufacturers of vascular graft tissue engineered medical products. WK21657 , Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs), is being developed by a task group under the jurisdiction of subcommittee F04.04 on Tissue Engineered Medical…
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Subcommittees F04.41 - F04.46 , which deal with Tissue Engineered Medical Products (TEMPs), part of ASTM International Committee F04 on Medical and Surgical Materials and Devices, will meet Oct. 27-28 at the National Physical Laboratory in Teddington, United Kingdom. The meeting will focus on the ongoing development of several proposed TEMPs-related standards. Several TEMPS standards are…
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ASTM International Committee E31 on Healthcare Informatics notes the innovative use of the Continuity of Care Record within the Google Health application launched on May 20. Formally known as ASTM E2369 , Specification for Continuity of Care (CCR), the CCR standard is an XML-based format for access to, transport of and interoperable exchange of core summary health information. The CCR is intended…