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FDA Rule Regarding Medical Device Data Systems Takes Effect–MMDS (Medical Device Data Systems) Rule For Class 1 Devices by Medical Quack Patient ExpertHealth Maven Posted Tue 19 Apr 2011 9:20pm Under the rule IT companies now need to register healthcare hardware devices that transmit data and this can be a small blood pressure device or a larger imaging devices.  The Class 1 rule is for devices that don’t affect a patient’s care, like an automated IV machine as an example that dispenses medications and reports data as that’s a higher ... Read on »
Today is Medical Device Patient Lobby Day –Take a minute to help protect consumer rights to safe medical devices! by Prescription Access Litigation Patient ExpertHealth Maven Posted Tue 31 Mar 2009 11:40pm 1 Comment Help reverse the medical device “tort reform” by the Supreme Court that has left thousands of injured patients without the right to sue, and puts many more patients at risk!  The following announcement and open letter to Congress was organized by the Campaign to Stop Corporate Immunity, a coalition of consumer and advocacy organizations (inclu ... Read on »
Microsoft Tags on CBS Early Show – Wake Up FDA, Pharma and Medical Device Companies –Scan Those Drugs, Medical Devic by Medical Quack Patient ExpertHealth Maven Posted Wed 31 Mar 2010 2:35pm Everybody that reads here, knows I am a fan of Tags and I have an entire series of how they can be used in healthcare, they work with RFIDs too.  Watch the video and see how they are used for entertainment.  I guess that must come first, you think?   This is all free too.  The link below explains all.  We have a huge case here of tech denial or ... Read on »
Notice of Cancellation of Meeting: December 14, 2011 Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Co by FDA Posted Mon 05 Dec 2011 12:00am Center Date Time Location CDRH December 14, 2011 8:00 a.m. - 6:00 p.m. Hilton Washington DC North/Gaithersburg Salons A, B, C, and D 620 Per ... Read on »
CDRHLearn Presentation: International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) Pilot by FDA Posted Thu 31 Oct 2013 12:00am International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) Pilot Read on »
Medical Devices Regulatory Capacity Building Training Program for AHWP, ASEAN, Latin American and Other Medical Devices Regulato by FDA Posted Fri 31 Jan 2014 12:00am The U.S. Department of Commerce and U.S. FDA invite global medical device regulators to participate in a two-day regulatory capacity building training program in collaboration with the World Health Organization (WHO) to take place on March 27-28 in... Read on »
Class I Medical Device Recall: MOOG Medical Devices Group, Curlin Infusion Administration Sets by FDA Posted Thu 31 May 2012 12:00am There is a potential for a reverse pump segment in the administration set. This malfunction could reverse the flow of fluid or medicines backwards from what was intended. This may cause blood loss, an under-delivery of prescribed medicines or fluids... Read on »
“Which Medical Device” A Website Where Medical Professionals Can Discuss Devices with Peers and Write Reviews and Op by Medical Quack Patient ExpertHealth Maven Posted Wed 19 Jan 2011 12:45am We would all one day like to see some type of national registry created on medical devices so best outcomes and problems could be recorded and researched.  A few days ago I wrote about the registry success that Kaiser Permanente is having with their registry for knees and hips.  Products can be submitted by device manufacturers to this ... Read on »
FDA Medical Device Approval Process Under Review Due to Recalls With Numbers of Implanted Devices by Medical Quack Patient ExpertHealth Maven Posted Tue 15 Feb 2011 12:41am On medical devices we are back to the sometimes controversial Fast track 510 (k) approval method to where the device can be similar to another device on the market and is intended for low and moderate risk situations.  Implants to me are not low or moderate.  If you have read here enough and seen the poll on the right hand side then you are aw ... Read on »
Stryker Medical Device Company Cutting 1170 Jobs–It’s that Excise Tax on Device Companies But Device Companies Provi by Medical Quack Patient ExpertHealth Maven Posted Tue 20 Nov 2012 2:31pm   I guess it’s time to hit this one again as our folks in Congress I don’t think have the brain capacity nor the technology investments, i.e. IBM Watson, to help them create laws.  IBM Watson is going to work at other places like Citibank so they can figure out how to get more of your money.  IBM Watson also had some good installation wi ... Read on »