Right now, the tiny needles that poke our fingers for blood sugar tests are one of the few diabetes supplies not scrutinized by FDA, which makes it easy for us to get them by the box-load without much hassle.
But that may soon be changing.
Lancets appear to be on the way to getting more regulatory review, as the FDA considers if they perhaps aren't safe enough as currently labeled or produced. In a June 26 meeting, the 13-person sub-panel of the FDA Medical Devices Advisory Committee discussed lancets and the potential risk these finger-pokers pose to patients, whether in hospitals and medical facilities or when used at home by individual PWDs (people with diabetes).
That panel is now recommending that FDA beef up regulatory protocols, possibly increasing the cost and effort companies would have to go through to get their finger-pokers approved.
Let's face it: many of us PWDs don't change our lancet needles as often as recommended, so sure, they're probably not as hygienic as they could or should be.
But why has this suddenly become an issue for the FDA, after they've virtually ignored lancets for so long? Back in 1994, the FDA determined that it did not need to review lancets before they go to market to protect public health.
So what's changed?
At least a partial catalyst seems to have been lobbying from a company called Intuity Medical, that developed an "all-in-one" glucose meter with built-in lancet cartridge called Pogo, and has desperately been trying to get this product approved for a number of years now. FDA has continually pushed back on the possible safety concerns of built-in lancet needles, that could potentially be used by multiple patients and therefore spread bacteria.
Actually, the CDC (Centers for Disease Control) and FDA have both been issuing safety warnings about using lancets on more than one patient since the early 90s, and since then rising concerns about reported cases of spreading bacteria as a result of these multiple-use lancets has fueled renewed concern. Both agencies are worried about bloodborne pathogen transmission due to lancet misuse, sharp object injuries, local skin infections, and adverse skin reactions even beyond infection.
"But contamination could be a concern with any lancet needle, not just the all-in-one varieties. Why hasn't FDA looked at the category as a whole and been more stringent on safety standards for everyone?" Robin Gaffney, director of marketing at Intuity told us at the ADA annual meeting in June. "We pressed the agency to look at the category as a whole," she added.
Lancets are currently considered "Class I medical devices" that need only "general controls," meaning all that's required is appropriate basic labeling and safety assurances from the manufacturers before they are allowed to be sold to people. Items in that category include supplies like surgical gloves and bandages. You know, items that aren't particularly complicated or make any medical changes on their own accord...
Now that FDA attention has turned to lancets, the agency says it's considering changing most lancets over to "Class II medical devices" that require more evidence of safety. Here's a rundown on the official happenings at the June meeting, along with the 17-page brief prepared ahead of time that they considered and mostly agreed with.
Panel members concluded that lancets are not "life-supporting or life-sustaining" medical supplies, and they aren't "of substantial importance in preventing impairment of human health." But the panel did recognize that lancets are "an integral component of preventing impairment of human health in diabetic patients" (Yup! What else are we gonna use to draw blood for fingerstick tests? Safety pins?).
Overall, the panel decided that they think lancets do require more scrutiny than the "general controls" they currently have. The FDA is now breaking down lancets into four categories:
- A single-use-only blood lancet with an "integral sharps injury prevention feature," which the FDA says would allow the lancet to be used only once and it would then be rendered inoperable and incapable of further use.
- A single-use-only blood lancet without an integral sharps injury prevention feature.
- A third category of multiple-use blood lancets for single-patient use would also go into the Class II category with those special controls.
- Multiple-use lancets for more than one patient would require the highest level of FDA oversight and would need Premarket Approval (PMA). The panel determined that these lancets present a "potential unreasonable risk of illness or injury," and right now the technology doesn't exist to adequately mitigate the risk. As the FDA sees it, this tech would need to provide for "rigorous, thorough cleaning plus a disinfection or sterilization process capable of complete elimination of all bloodborne pathogens between each use in a different patient to be safe for this intended use." The cleaning/disinfection/sterilization process would need to be effective in spite of likely healthcare provider noncompliance with manufacturer's Instructions for Use. More importantly, as the FDA states, the device technology would most likely need to be modified to block use of the unit more than once until the necessary thorough cleaning and disinfection process has been properly completed.
For the first two categories of "at home single-patient use lancing devices," the FDA panel agreed that the risks and benefits don't present "a potential unreasonable risk of illness or injury." So, a reclassification would still happen, it would not require the more stringent 510k approval. These types of lancets would be put into the Class II category, which is what devices like wheelchairs and surgical drapes are considered. The lancets would require "special controls" that might include increased labeling and post-market examination.
These so-called "special controls" aren't entirely clear -- other than detailed labeling and disposal instructions and some mention of "biocompatible design that is structurally sound" (really, it's a lancet?!). But one of the main points the FDA is trying to drive home is that labeling for lancets must include the following statement in a promiment place:
"For use only on a single patient. Discard after use."
The final fourth reclassification is what could add significant burdens for the lancet-making industry, as this strict level of regulatory oversight is typically reserved for devices that "support or sustain human or life" or are "substantial importance in preventing impairment of human health," or those that pose a "potential, unreasonable risk of illness or injury."
The question is what impact this could have on lancing devices that include more than one lancet, or have drums or cartridges that rotate and provide for more finger-picking action, like the popular Accu-Chek FastClix created by Roche Diagnostics. Neither the vendors nor FDA were able to provide details now on how this stricter strutting might play out -- and certainly there was no indication that this might be beneficial in any way to the still-unapproved Pogo device.
Curious about the possible "fallout" of these proposed changes, we reached out to a handful of established lancet manufacturers and medical directors at the bigger companies; most either weren't aware of the issue or said they weren't comfortable making any comments.
But diabetes device expert Dr. Barry Ginsberg, who's internationally known as a go-to source on glucose monitoring technology, sees no issue with this proposed change for lancets. Pointing out that he is a consultant for Facet Technologies that does make lancets and lancing devices, Ginsberg told us that he's never liked the Class I classification for any medical devices, including lancets.
"My personal opinion is that no medical device, even a band-aid, has been properly tested until has been tested in the target population: people," he said. "Thus, I have always believed that lancers, lancets, and thermometers should be Class II devices."
Since many large manufacturers already have the infrastructure in place to handle these special controls, he sees the biggest impact being a positive one for PWDs because the smaller manufacturers that produce their products overseas would also be held to a higher standard.
So, what's next?
FDA public affairs specialist Morgan Liscinsky, who was at the meeting, said the next steps are that the federal agency will issue a proposed order based on the panel's recommendations and that will be opened up for public comment. Then, the FDA will consider all the evidence, panel discussion and public discussion before issuing a final order. There's no timeline on when that might happen, she said.
What do you think about this lancet reclassification? Is it a good or bad thing that the simplest of diabetes tools will now be more entangled in the FDA review process?