FDA Issues New MDDS Rule
Besides the obvious question of whether the FDA is really serious about regulating MDDS, a few things jump out as areas that need clarification.
FDA Raises Bar on Medical Device Software Testing
Blog Medical Devices Today did a post last week on the FDA’s adoption of a relatively new software testing technology in the CDRH’s software forensics lab.
In the past year or so, the forensics lab, housed within the Office of Science and Engineering Laboratories, has used high-power instruments and techniques to analyze “source code” in roughly […]
Cisco Stumbles in Health Care
Cisco has aggressively marketed their “Medical Grade Network” that promotes the value of managing clinical data (especially from or between medical devices). Many have asked Cisco just what makes a network “medical grade.” When pressed, what was described to me was a mission critical network, which is fine for patient accounting, but inadequate for life […]
AAMI 2007 - Final Thoughts
I was in hog heaven at this year’s AAMI meeting. Connectivity was a major theme, and during every time slot in the program there was at least one presentation dealing with connectivity. During my presentation Monday afternoon, there was one I really wanted to see that dealt with alarm notification.
Lots of discussion centered around the […]
Comments on FDA Wireless Medical Device Guidance
After reading the above guidance document I was struck by how it provides such a good review of the quality system regulation (QSR). If you’re not a regulatory person and you want to get a high level view of the QSR, and especially how it might apply to wireless medical devices, check it out (updated link).The […]
Networked Medical Device Study Group Adjourns, Plans Next Steps
It seems that something like the existing ISO 14971 risk management standard for medical device manufacturers will be used to address networked medical devices. Several major revisions will be required, not the least of which is the kind of risk. The potential harm that ISO 14971 tries to mitigate is risk of injury to patients. […]
Study Group Explores Networked Medical Device Risk Management
There were about 25 attendees today; mostly regulatory, quality and security experts along with a few representing hospitals, and a connectologist or two. We ran from 11am until almost 7pm. (You can read my run up to this meeting here.)
As security expert and clinical engineer Steve Grimes noted, we are an industry in transition with […]
Regulatory Bodies Contemplate Regulating the Deployment and Use of Networked Medical Devices
I’m on my way today to an interesting meeting being held at FDA offices in Rockville, MD. The regulatory groups ISO TC210 and IEC SC62A are convening a formal study group to look at safety requirements relating to installation, configuration and maintenance of networkable medical devices. This is a two day meeting and I’ll be […]
