Posted by Sten Westgard, MS
Recently, the AACC held an excellent webinar where an Dr. Courtney Lias, PhD from the FDA discussed the intentions of the new guidances and then fielded a LOT of questions. I don't want to step on what Dr. Lias and the AACC accomplished during their webinar. There was useful information in that presentation and I encourage others to consider getting those materials once they become available on the AACC website.
However, while reading through the guidances and talking to laboratories these past few months, I thought I might share a few observations...
- Labs are really, really confused about glucose meters
- There’s a reason for that…
- There are multiple issues and guideline changes and regulatory drafts and memorandums occurring right now, among them…
- The new regulatory enforcement of “off-label” use of glucose meters, which affects
- Taking measurements on patients in the ER and ICU and other “critically ill” populations that were not included when the glucose meters were originally cleared.
- Also, there are new requirements about cleaning and disinfection of glucose meters,
- Because the FDA has found that when glucose meters are used on multiple patients, diseases can be transmitted from patient to patient by the meter itself.
- Finally, the FDA has issued new guidance requirements for manufacturers about obtaining clearance of new glucose meters.
- These FDA guidelines are for manufacturers, not laboratories.
- These FDA guidelines significantly raise the bar for clearance and performance.
- There will be a need for more studies, including 350 patients for each clinical care setting.
- That means a manufacturer that wants to sell a glucose meter to ERs, ICUs, pediatric ICUs, health fairs, and non-critically ill settings will need to do a 350-sample study for each of those care settings. This adds up to thousands of samples.
- And that’s not even all of the requirements. The FDA guidelines also recommend doing studies of 50 “high and low” samples, which may be artificially generated samples, to test the full range of the glucose meters (because getting 350 "normals" might not adequately test the range).
- The FDA is recommending some interesting quality requirements, including that 99% of all values fall within +/- 10% of the reference method for glucose concentrations > 70 mg/dL, and within +/- 7 mg/dL at glucose concentrations < 70 mg/dL. Further, to avoid critical patient management errors, no individual result should exceed +/- 20% of the reference method for samples >70 mg/dL or +/- 15 mg/dL <70 mg/dL.
- Those quality requirements are different from all the other requirements that are currently out there, even though this is similar to the format introduced by ISO 15197.
- The NY State DOH didn’t help clarify the issue when inspectors began to cite laboratories for using their meters “off label” in the ER and ICU, etc., and then pointed to the FDA draft guidelines and suggested that laboratories conduct studies of that scope.
- Labs are feeling like the rug is being pulled out from under them.
- Manufacturers are somewhat to blame. They should have been doing these studies a long time ago – and these new FDA guidelines are an attempt to shift the burden of responsibility for validating devices for their intended use back to the manufacturers.
- Instead of forcing each lab to conduct extensive validation studies.
- These FDA guidelines are only draft guidelines right now – they are seeking comments, suggestions, criticisms, and compliments (if there happen to be any). So until April 6, 2014, labs and manufacturers and all interested parties have a chance to comment and try to affect the final shape of these regulations.
- This list doesn’t even cover the guidelines for glucose meters that want to get clearance as Over-The-Counter (OTC) devices. That's a different set of FDA draft guidelines and that would generate an entirely different list!