March 19, 2014

Moo II / Moo Too. Keep Meters in the ER.


Will there be a blood glucose meter in the Emergency Room? 


I have borrowed ideas from Christel’s blog post on posting comments to the FDA open meter docket. The one with this great picture: 


Articles published last week are timely and relevant to the the professional / in hospital use FDA Meter guidance. Some of the stuff last week was rather startling. What's got me worrying is the remote possibility there will be no blood glucose meter in the ER. 

FDA's in hospital guidance proposes very tight variance standards. There are interesting comments about FDA’s in hospital use guidance posted at diaTribe. I liken the comments to something approximating, "Hey theses are so tough that nobody may make the meters, then what are ya gonna do?" That, combined with the article on emergancy room visit for hypos, wrote about in this post, are the basis for the following additional comments to the "Prescription Point-of-Care Use" guidance docket. 

Please, feel free to copy them, add you 2¢, and post them to the FDA docket here:
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use (this refers to the meters healthcare providers use at the office or in the hospital)

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I am concerned the proposed standards for "Prescription Point-of-Care Use" blood glucose meter may not be not feasible. If so the the result could be a deterioration of in-hospital care for people with diabetes. 

Dr. David Sacks of NIH, Bethesda, MD is quoted by diaTribe saying, “These are incredibly stringent [standards]…I hope that the FDA listens to the complaints, because clearly there will be lots… I think that it’s going to be very difficult for manufacturers to meet these criteria. If they don't make them more lax, there will be no glucose meters approved in the future.”1 

“No glucose meters approved in the future,” is very concerning. 

I worry that if the standard for in clinic/hospital blood glucose meters use is not reachable there will not be devices for inpatient care. No meters may cause delays in emergancy department treatment for people with diabetes. These delays could stem from the need to use slower draw-blood-and-take-it-to-the-lab processes to meet these "incredibly stringent" requirements, as opposed to reasonably rapid finger stick devices in the treatment of patients needing emergancy care. 

Geller et al in a March 10 2014 JAMA article, National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations, estimate over ninety-seven thousand insulin-related hypoglycemia and errors induced emergancy room visit in the United States annually. Of these 29% result in hospital admission. Additionally "Severe neurologic sequelae were documented in an estimated 60.6% (95% CI, 51.3%-69.9%) of ED visits for IHEs" 2

Time matters, appropriate rapid care is needed to minimize lasting harm from hypos. 

FDA should avoid rules with such possible unintended consequence. Result from this guidance that should be improved accuracy in clinical settings from meters. Maters are a valuable tool in professional care setting just apatients need for accuracy in dosing the very dangerous drug insulin outside the is clinical setting. Both need accurate, economical  and timely devices. 

I agree with diTribe’s conclusion on personal use meters, “We are glad to see the FDA trying to improve glucose meters and look forward to formal adoption of the standards in whatever form they ultimately take... the home use accuracy standards are fairly reasonable and should enhance patient safety.”  I also share their concern that if, “... no meter can meet these new accuracy requirements for healthcare facilities, we will not see any of these innovations make it to the market.”


1 http://diatribe.org/issues/61/new-now-next/3

https://archinte.jamanetwork.com/article.aspx?articleid=1835360

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Moo.

7 comments:

Scott E said...

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.

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).

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.

Bennet said...

Thanks Scott

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.

I totally agree with your conclusions: realistic and better.

Thanks for you insights.

PLEASE, send you views into both dockets while they are still open!

Best.

B

Scott Strange said...

I really find the "no meters" comment to be overly sesationalistic and makes me cast a scant eye on the piece.

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.

The business side of this equation ensures that the demand will continue to be met.

Bennet said...

Fair comment Scott.

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.

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.

I agree 'no meters' is extreme but not impossible consequence of the market forces of high investment and limited potential return.

Unless the FDA makes chafes to the drafts.

Feel free to disagree, just comment to FDA.

Scott Strange said...

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.

Is there a separate test strip for the hospital class devices?

Thanks!

Bennet said...

As I understand it ISO 2003 rules for everyone.

Also as I understand it no meter is approved to dose insulin.

Hence the suggestion StripSafely makes for a designation to dose insulin for only the meters approved by the new guidance.

Bennet said...

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.

Confusing enough yet?