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:
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, I 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)
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.
Time matters, appropriate rapid care is needed to minimize lasting harm from hypos.
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.”
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