tag:blogger.com,1999:blog-9076190155284676524.post8911844484737285311..comments2024-03-28T18:51:35.450-04:00Comments on Your Diabetes May Vary: Moo II / Moo Too. Keep Meters in the ER. Unknownnoreply@blogger.comBlogger7125tag:blogger.com,1999:blog-9076190155284676524.post-19101416026629909872014-03-19T18:35:46.044-04:002014-03-19T18:35:46.044-04:00Wait in reality currently ISO 2013 for meter syste...Wait in reality currently ISO 2013 for meter systems market around the world. In the USA Iso 2003 I'd the approval standard. So a new meter can be approved to 2003 and sold as FDA approved. Then cms say that is good enough for them. <br /><br />Confusing enough yet? Bennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-26732705480209984902014-03-19T18:29:13.924-04:002014-03-19T18:29:13.924-04:00As I understand it ISO 2003 rules for everyone.
...As I understand it ISO 2003 rules for everyone. <br /><br />Also as I understand it no meter is approved to dose insulin. <br /><br />Hence the suggestion StripSafely makes for a designation to dose insulin for only the meters approved by the new guidance. Bennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-67208151292607294772014-03-19T17:07:30.538-04:002014-03-19T17:07:30.538-04:00Bennet, maybe I'm misunderstanding, but aren&#...Bennet, maybe I'm misunderstanding, but aren't "hospital class" devices already at the proposed standard or better? It seems that the cost of those devices might dramatically reduce if they are mass produced, not to mention that any strip company will give you a meter just to get you 'hooked' on their strip.<br /><br />Is there a separate test strip for the hospital class devices?<br /><br />Thanks!Scott Strangehttps://www.blogger.com/profile/05631349520282171319noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-47154067053278035212014-03-19T12:18:01.688-04:002014-03-19T12:18:01.688-04:00Fair comment Scott.
This split proposal segments ...Fair comment Scott.<br /><br />This split proposal segments the market into two parts. What FDA calls Over the Counter and Prescription. That is a little confusing but what matters is the creation of a in hospital class of device. FDA has said this is a far smaller market segment. The comments noted by diaTribe make it clear there is significant difficulty meeting the proposal. That translates to cost associated with R&D. <br /><br />The huge market gets segmented out. One has to question the investment in the new, higher standards of hospital use strips and the limited market it represents. <br /><br />I agree 'no meters' is extreme but not impossible consequence of the market forces of high investment and limited potential return. <br /><br />Unless the FDA makes chafes to the drafts. <br /><br />Feel free to disagree, just comment to FDA.Bennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-90804077977728116152014-03-19T11:49:58.767-04:002014-03-19T11:49:58.767-04:00I really find the "no meters" comment to...I really find the "no meters" comment to be overly sesationalistic and makes me cast a scant eye on the piece. <br /><br />Test strips are a huge market and will continue to be so. If the current tech will not meet new standards then new tech will be developed that does. <br /><br />The business side of this equation ensures that the demand will continue to be met.Scott Strangehttps://www.blogger.com/profile/05631349520282171319noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-27477836736247462432014-03-19T10:04:04.350-04:002014-03-19T10:04:04.350-04:00Thanks Scott
I think the question is in part econ...Thanks Scott<br /><br />I think the question is in part economic. If the requirements for a meter to be approved in the hospital setting require significantly higher R&D than home use meters and they are a small % of the market (which FDA says they are) it become real easy to exit that smaller market, save the R&D and do not produce the hospital meter. Then the hospital is in a bind, using a consumer meter could expose them to liability for using a device that fails meet FDA accuracy standards for in clinic use. <br /><br />I totally agree with your conclusions: realistic and better. <br /><br />Thanks for you insights. <br /><br />PLEASE, send you views into both dockets while they are still open!<br /><br />Best. <br /><br />BBennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-6232926988883944652014-03-19T09:58:13.394-04:002014-03-19T09:58:13.394-04:00This is a big part of the reason activities such a...This is a big part of the reason activities such as lobbying exist. While many think of lobbying simply as ways to influence political policy to increase corporate profit, the experts in various fields need to have some input to make sure the legislation being considered is reasonable and practical.<br /><br />After all, what do politicians know about the technology behind blood glucose meters? Probably less than the meaning of the results they produce. (This campaign is aimed at educating them more towards the latter).<br /><br />I doubt manufacturers will pull out of the meter market altogether -- it's simply too profitable. But when the Trans-Fat ban came to NYC, restaurants considered compromising taste, increasing costs, or changing their menu to comply (shutting down was not an option). So my fear is that manufacturers will make drastic changes to comply with the new rules -- maybe a larger sample size, a two-minute wait period for a result, or a cumbersome procedure requiring blood to be drawn from multiple points on the body. (I blogged about the sample size issue last week). Somehow, we need to make sure the rules are realistic ... and they don't leave us with something that is wholistically "less than" what we have today.Scott Ehttps://www.blogger.com/profile/00259475635753627498noreply@blogger.com