StripSafely is the ultimate grassroots patient advocacy initiative. Basically, some leaders in the diabetes community got together, created a logo and website, and started shouting from the social media rooftops about a letter-writing campaign calling on authorities to crack down on the accuracy of glucose test strips. In particular, the call is for better "post-market inspection of the accuracy expected" in order to ensure our safety, especially when making insulin dosing decisions based on test results. We contributed our call-for-action letter here.
And guess what? The FDA responded to us patient-bloggers! Personally. Yup, I was surprised to be contacted to set up a phone call with TWO of their top diabetes directors -- Courtney Lias, Director of the Division of Chemistry and Toxicology Devices at FDA, and her colleague Katie Serrano, Diabetes Branch Chief in the same division.
We spoke on the phone for about an hour yesterday, and it was clear they wanted to convey a message to the diabetes community at large: that they're listening, they care, and they're workin' on it.
Specifically, here's a compilation of what they had to say:
DM) What's FDA's basic response to this patient-led product safety campaign?
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FDA) We're very pleased with the response — we've gotten lots of letters and media attention on this topic. We're very supportive.
But coming out of the last Diabetes Technology Society (DTS) meeting, we feel that there was a general misperception in the media coverage that we were aware of the problem but didn't have a plan.
In fact, we were trying to be frank about the challenges, and what we are trying to do.
So what is FDA doing to address inaccuracy of glucose meters and strips?
We're always working on performance issues with meters. Right now this is mostly on the pre-market side, before a product is cleared. We participated in the 2003 ISO standard, and had always been on record saying the standards are not tight enough and we need more accuracy.
Recent discussions of new ISO versions will push the industry towards tighter standards (than the current requirements of within ±15% at glucose levels of 100 mg/dL or above, and within ±15 mg/dL at glucose levels below 100 mg/dL).
We don't think those numbers are tight enough, and the documents are under administrative review. We not at liberty to say exactly what the new parameters are until approved, but they will be tighter.
On the post-market side, which was the topic of the DTS Meeting in May, we currently have three tools in place:
- adverse event reporting - but the challenge here is that the quality and amount of reporting varies from company to company, so data analysis can be a case of "garbage in, garbage out." There's also not a set limit of events that would trigger investigation.
- product recall — this can result from just one or two unusual, serious events that could trigger investigation, or the company itself notices a quality issue and institutes a voluntary recall.
- inspections of companies — we do this more so with glucose monitoring products than with other FDA reviewed products, because of the risk and seriousness at play. But the challenge with this process is that domestically, we can do unannounced inspections, while with foreign firms we must announce, due to trade agreements. The quality is different with a pre-announced inspection.
What about actual post-market surveillance of products, which of course is the topic of the upcoming special DTS meeting on Sept. 9? (there's even a twitter campaign asking patients to call on legislators to attend, to lobby on our behalf)
There's a lot of discussion in the community about alternative post-market ways to address the potential process of testing these over time by a third party. At the Sept. 9 DTS meeting, there will be an initial discussion basically exploring other devices that have similar programs and whether voluntary versus mandatory testing is called for, what kind of testing, etc.
For example, A1C products do undergo post-market testing in a program called NGSP certification. The leaders of that program will be at the DTS meeting to discuss applicability to daily monitoring products.
Now it is required for A1C tests, particularly if used for diagnosis (two are cleared now as diagnostic tests).
That program is voluntary for the most part, and it's even become popular with manufacturers — it's become like a 'badge of legitimacy' for vendors. It takes some time for these tests to become established (among industry).
At the Sept. 9 meeting, the people who run NGSP will present on ... whether or not such a program is applicable here. It's up in the air.
Also, the process for making testing mandatory through FDA is not a fast process. Discussions with payers and patients will help (move things along).
So is this patient-led initiative to get legislators to that meeting a good move in your eyes? Will it help or hinder the process?
The patient discussion has definitely created some momentum here. If manufacturers are unsure or unsupportive, they can see how important this is to their customer base. Also, they may be anxious but want a program -- want to show that they have high quality. This will push them to take action.
If we start hearing from Congress, things will start moving faster.
Great news that we can help "move the needle" and that our voices are being heard! ... Speaking of needles, what about the recent news that FDA may start requiring review and approval of lancets? Isn't that a waste of efforts when the needles have no direct impact on treatment?
In 2010, we were invited to CDC to meet with members of industry regarding another series of outbreaks of hepatitus B from sharing lancets, often from assisted testing in nursing homes and at screening facilities. After that, we required a lot of changes in the cleaning and disinfection of needle products.
Now with we're putting in these products in place:
- If you create lancets not meant to be shared, you don't need to go through FDA
- If the product is meant for multiple uses by the same person, there are specific labeling and disinfection standards that are already in place — and no FDA review is required
- If it's meant for multiple use by multiple patients, review as a Class II medical device will be required
Needle sharing is not an insignificant risk — there have been some fairly large outbreaks, mostly in assisted testing facilities. But the actual impact on patients is going to be nothing, as most lancets will not have to come to FDA.
We don't think your community should be concerned that we're taking away resources from things they care about.
Especially in diabetes area, community support has pushed the field forward... this community support is very important and helpful.
Great to hear, and we'll have our eyes on the upcoming DTS Meeting (9/9/13 at the Hyatt Regency, Bethesda, MD), where Courtney Lias will speak on behalf of FDA.
Meanwhile, if you are artistically inclined, you can show your support for the StripSafely campaign by participating in a special, glucose test strip-focused edition of Diabetes Art Day this coming Monday, Aug. 26.