AAOS Bulletin - October, 2005

Improving safety and security through standards

AAOS/ASTM issue joint statement for World Standards Day

By the AAOS Biomedical Engineering Committee

Each year, World Standards Day is celebrated on October 14. On that day, the international community celebrates the importance of standards-related activities and pays tribute to the collaborative efforts of the thousands of individuals that give their time and expertise to this important work.

Ultimately, the goal of World Standards Day is to raise awareness of the importance of international standardization to the world economy and to promote its role in helping meet the needs of all business sectors.

The American Academy of Orthopaedic Surgeons and the American Society for Testing and Materials International (ASTM) have worked together for more than 40 years to develop appropriate standards for medical and surgical devices.

The AAOS Biomedical Engineering Committee reviews and monitors scientific regulatory developments in the field of biomedical engineering as they relate to orthopaedic surgery and interacts with scientific (such as the ASTM) and regulatory bodies (including the Food and Drug Administration) to promote developments beneficial to orthopaedic surgery. Members of the AAOS Biomedical Engineering Committee are also members of the ASTM. More information about the committee’s efforts can be found on the AAOS Web site.

In recognition of World Standards Day 2005, the AAOS and the ASTM issued the following joint statement:

AAOS/ASTM joint statement

As essential components to the global standards infrastructure providing for enhanced safety in medical materials and practices, the ASTM International Committee F04 and the AAOS are pleased to jointly announce their support for the theme of World Standards Day 2005. The cooperative and mutual support of the two groups provide for international medical standards that with “safety and security as their foundation can foster a better quality of life.”1

World Standards Day aims to raise awareness of the importance of global standardization to the world economy and to promote its role in helping meet the needs of business, industry, government and consumers worldwide. This international event pays tribute to the thousands of volunteers around the world who participate in the development of standards.

The AAOS has been an active participant in ASTM standards development initiatives related to medical devices for many years. Orthopaedic surgeons and researchers have continually volunteered their time and expertise to the development of consensus standards since ASTM International Committee F04 on Medical and Surgical Devices was created in 1962. Notably, the AAOS Biomedical Engineering and Biological Implants Committees, along with the Orthopaedic Device Forum, have been instrumental in recruiting and providing the scientific and technical orthopaedic expertise optimal for the development of appropriate standards for medical and surgical devices.

Sharing in the World Standards Day focus of encouraging and paying tribute to volunteers involved with standards development, the AAOS is proud to support the participation of orthopaedic surgeons and researchers in the ASTM International Committee F04. As providers of current technology and “end users” of the standards process, their contributions, made possible through the AAOS’ relationship with the ASTM International Committee F04, are critical to ensuring that the standards provide a higher quality of care for patients.

Orthopaedic surgeons, researchers, and industry leaders find within ASTM an opportunity to collaborate in the development of the highest quality standards for patients. AAOS fellows and the orthopaedic community are currently involved in the development of ASTM standards endeavors, such as those related to computer assisted orthopaedic surgery, tissue-engineered medical products, advanced materials, and joint replacements. AAOS Fellows have recently participated in the development of standards that include:

• F2451-05 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage

• F2383-05 Standard Guide for Assessment of Adventitious Agents in Tissue-Engineered Medical Products (TEMPs)

• F2346-05 Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

• Ongoing drafting of WK5350 - Standard Practice for Accuracy Measurement in Computer-Assisted Orthopedic Surgery

The continued participation of orthopaedic surgeons in the development of standards for medical and surgical devices will ensure that for generations to come, these F04 standards continue to lead the world in transferring higher technology and safer practices to the marketplace.

The AAOS and the ASTM Committee F04 congratulate and thank those orthopaedic surgeons and researchers who, over the years, have graciously volunteered their time and expertise to craft medical and surgical device standards that ultimately benefit our patients and the medical community.

References

1. The area of emphasis put forward by the Standards Engineering Society and the American National Standards Institute with respect to the 2005 WSD theme: http://www.ses-standards.org/displaycommon.cfm?an=1&subarticlenbr=57


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