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September/October 2009

Another Kind of Health Care Challenge

It seems quite timely to be publishing an issue of SN on the subject of health care at this moment in U.S. history, when the phrase “health care” itself haunts top news headlines daily. The subject of those headlines — the management of health care costs — is a daunting national challenge. Well, this issue of SN does not address that particular subject, but it does address other practical challenges that have been met by stakeholders in the health care industry who have come together within ASTM International to develop standards for some of the most sophisticated and critical devices and systems used in our society.

Take, for example, the complex task of integrating the “clinical environment.” In the context of a new standard promulgated by ASTM International Committee F29 on Anesthetic and Respiratory Equipment, the clinical environment comprises all the devices and machines used to monitor a patient or deliver medication or ventilation. Currently, those devices are not all interoperable. In complex and fast-paced real-world situations, clinicians need devices that can work in concert — a ventilator that can restart automatically when a heart-lung bypass machine is turned off during surgery, for example. The purpose of this new standard, to be issued this fall, is to create a way for manufacturers and users of these medical devices to employ “plug-and-play” interoperability, wherein the machines can work in concert and be programmed to meet intricately intertwined clinical requirements.

As any standards developer knows, the various requirements of producers, users and other stakeholders can make the creation of even the most basic norm quite a challenge. In addition to the complex subject of the integrated clinical environment, this issue describes the work of technical committee members who have come together for decades to develop standards for medical devices and medical packaging. Committee F04 on Medical and Surgical Materials and Devices creates standards on the cutting edge of the medical device industry, with newer activities that include standards for tissue engineered medical products and computer-assisted orthopaedic surgery. Committee F02 on Flexible Barrier Packaging develops standards for the packaging of medical devices, which must meet stringent criteria for sterility. And the standards of Committee D10 on Packaging — long a developer of standards for the various forms of packaging we come across in our daily lives — are also used by the medical industry in shipping specially packaged devices and for pharmaceutical applications.

At a time when national legislators have been struggling with one aspect of the vast health care industry, it’s good to know that stakeholders have been able to come together behind the scenes, under the ASTM International umbrella, to help ensure ever increasing levels of compatibility and safety in other aspects of health care of equal importance to consumers.

Maryann Gorman
Editor in Chief