In my last post, I reported on the recent inaugural Medical Device Connectivity Conference and Exhibition. While I mentioned the IEC and ISO efforts at creating connectivity standards, it seems that I left out another group that is working on this as well: ASTM.
In the September/October edition of Standardization News, the cover article details ASTM’s recently approved standard, “ASTM F2761, Medical Devices and Medical Systems—Essential Safety Requirements for Equipment Comprising the Patient-Centric Integrated Clinical Environment (ICE), Part 1: General Requirements and Conceptual Model.”
The article quotes a local anesthesiologist (Julian Goldman of Mass. General Hospital) who headed up the effort, as saying, “This standard provides the missing framework to create ‘error-resistant’ patient care environments by enabling the integration of interoperable medical devices and other advanced technologies into smarter systems.”
Obviously, this is only the first part in a series of ASTM standardization efforts regarding connectivity, and so I wonder how different is this effort from IEC 80001-1? Is it a matter of which part of the product cycle that the standard covers as is the case with IEC 80001-1 vs. ISO 14971?
Recall that the ISO standard really only covers the initial product design and manufacturing, whereas the IEC effort covers the product’s life cycle to a much broader extent and looks at connectivity at the user location.
Or, since the committee that manages this document is F29 (Anesthesia and Respiratory Equipment), does that mean that the ASTM standard really only looks at the fairly narrow world of equipment that concerns anesthesia? Anyone out there want to weigh in? For those who are interested, the next meeting of ASTM F29 will be in December 2009.