I have been off the grid the last week at CWD’s Friends for Life conference. Sorry I am late to respond to some comments. Much of this was written standing in lines at Disney in my iPhone.
Some have asked for information on specific meters. Some information can be found in citations linked here:
http://www.stripsafely.com/?page_id=75 – Specifically the Freckmann papers.
As I learn more about copyrights (one of the areas of law specifically mentioned in the Constitution) I am becoming increasingly careful about how I share material that is the intellectual property of others. Some have been critical of papers behind pay firewalls. I believe that valid information is not always free to copy. I am privileged to have some access to good libraries. I have tried to respect the rights of others in the citations used by limiting my fair use to small, cited quotes used in an educational context.
This meter accuracy issue is complex and certainly there are pitfalls in trying to communicate it in common language. That I use folksy, snarky, double entendre is not a mistake but a calculated means to try to engage people with diabetes, to exercise their first amendment right to address the government for a redress of grievance. I am not a reporter. I am an advocate for my kids and others with diabetes.
I would prefer a independent third party doing post market evaluation but none exists. Nor does, as far as I can tell, does authority for the FDA to require post market evaluation of meter accuracy or take action based on a third party study.
I am concerned that there is not a free market that can allow participants to choose value based on price and performance. Price is hidden form users, who are not the buyers. Band can not assert a marketing campaign based on accuracy as medical companies are legally prohibited from superiority claims. Brand x can’t say we are better than brand y.
We need a market or a regulatory function that insures apple to apples rules and can remove non compliant devices. Thank all for you sharing concerns. I apologize for an unfortunate lack of clarity. I have attempted be non partisan in my effort to support safe, accurate measure of blood glucose by the 4 million Americans who use insulin. That said, it does bother me that US manufacturers are held to a different regulatory standard than overseas manufacturers can be.
Specifically to the comments about Asian manufacturers. I struggled with that point as it does seem to create a valid criticism on ground of race. The fact is that the source documents specifically call out some Asian manufacturers as a source of problems. The FDA does acknowledge that they can not inspect these facilities unannounced as they do with manufacturers in the USA. There apparently are grounds to think that the documentation they do review when they inspect these facilities, with forewarning, may be too perfect.
Let me once again say I could care less who makes the strips and meters. I want a level playing field that includes, similar inspection processes and post market evaluation of all makers of strips in the real world, bought from the actual retail supply chain. I want to know that medical device reports (MDR) are being completed in consistent fashions by all players.
With that we can StripSafely.
My kindest regard fo all who challenge the accuracy of my calls for accuracy, I try to communicate in an engaging, slightly provocative but well researched way.
The conversation is an opportunity to be clearer.
p.s. For Disney freaks like me, the new Fantasy Land exceeded my expectations.