Almost three years ago, we reported that the FDA was considering changes to how it regulates the fingerpoking lancets that are essential to living with diabetes.
Traditionally, there was little regulatory oversight of these little needles, so they've been easy for us to get our hands on (pun!) and use -- even though many of us don't typically change them out as regularly as we should (which is kind of a running joke in our community).
But now, a few years after holding their initial meeting on this issue -- and building upon 20+ years of growing concern about blood-borne disease and infections -- the FDA has proposed concrete changes that could mean more difficulties for patients getting access to these little lancets and possibly even rising costs going forward.
On Feb. 25, the FDA issued a 46-page proposed order that would reclassify lancets from the most lenient Class I to the more stringent Class II and Class III groups.
As the FDA explains:
- Class I devices are deemed to be low risk and are therefore subject to the least regulatory controls (example: dental floss)
- Class II devices are considered higher risk and require greater regulatory controls (example: condoms)
- Class III devices are the highest risk, and subject to the highest level of regulatory control; they must typically be approved by FDA before being marketed (example: replacement heart valves)
As you can imagine, upping the class of a device requires more time, research and money to get the item to market.
We can't say exactly what this will mean for the lancet-making industry, but the possibilities are a bit concerning. Please read on for the details we have uncovered.
And be aware that the public comment period is roughly 90 days, so our D-Community has until June 1, 2016, to share opinions on this move; leave a comment on the Federal Register here.
As we reported back in 2013, the FDA proposes sorting lancets into four different categories for purposes of regulation:
- A single-use-only blood lancet with an "integral sharps injury prevention feature," (like a cover) which the FDA says would allow the lancet to be used only once and it would then be rendered inoperable for further use.
- A single-use-only blood lancet without an integral sharps injury prevention feature.
- Multiple-use blood lancets for single-patient use (going into the Class II category).
- Multiple-use lancets for more than one patient, which present a "potential unreasonable risk of illness or injury" with no technology currently in place 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. These high-risk lancets would require the highest level of FDA oversight and would need Premarket Approval (PMA).
For that final category, the FDA is mandating that the cleaning / disinfection / sterilization process will need to be effective in spite of likely healthcare provider noncompliance with manufacturer's Instructions for use. More importantly, the FDA is emphasizing that 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.
What's big from our end is the fact that with the proposed changes, the first two types of single-use (home use) lancets listed above would now fall into the Class II category, along with items like wheelchairs and surgical drapes. The lancets would require "special controls" that include increased labeling and post-market examination.
These so-called "special controls" include detailed labeling, disposal instructions, and some mention of "biocompatible design that is structurally sound" (really, it's a lancet?!). But the main point the FDA is trying to drive home is that labeling for lancets must include the following statements in a prominent place:
"For use only on a single patient. Discard after use."
“Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
FDA Evaluation for All
The agency believes that 510(k) premarket approval may also be necessary now for these at-home lancets -- a lengthy and costly process that most Class I devices are typically exempt from.
As to enforcing the new rules, the FDA proposal states that even lancets already on the market would have to get a new 510(k) approval. While there would be a six-month lag before the new rules go into effect, it appears that all lancet manufacturers will have to go back and retrospectively get the OK before continuing to sell these fingerpoking needles.
We can only imagine that lancet-makers are not happy about this, although our industry contacts declined to comment, saying they're still forming their own official input to submit to the FDA docket.
Meanwhile, bumping up the classification of multiple-use lancets in healthcare facilities and other clinical settings to Class III means these lttle needles will now have pretty much the same amount of regulatory oversight as insulin pumps and new glucose monitors. That seems a bit much, in our opinion!
WHY Reclassify Lancets?
FDA is concerned about the public health risks, including transmission of Hepatitis B and C, of multiple patients using the same blood lancet, as is sometimes common practice in assisted living facilities and other group care settings.
So the hope is to eradicate the potential for disease transmission with products designed "such that repeat operation of the device is not possible until the device has been thoroughly cleaned and disinfected, using validated processes, by the health care user," FDA writes.
And the rationale behind pushing single-patient use lancets into the Class II category? The FDA states that it "believes that general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness for these devices, and that there is sufficient information to establish special controls to provide such assurance" -- a very bureaucratic way of saying they think there are health risks here, too.
No doubt that FDA has been concerned about the potential spread of illnesses due to multiple-patient blood lancets for years. They published initial guidance on lancet labeling in November 2010 before holding that meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee in June 2013 to discuss the possibility of reclassification. This week's proposed order follows that panel's recommendations.
A year ago, FDA also issued a safety communication to add a warning against patient sharing to the label of pens used to inject insulin and other diabetes medications.
Even though most of us may feel like home-use lancets are the absolute least of our worries and the FDA is probably overreacting here, our friend and fellow patient advocate Christel Aprigliano did her homework on Hepatitis B and C and infection outbreaks, and found some pretty shocking results -- scary stats on tens of thousands of cases in care facilities. And the clincher, as Christel notes, is the CDC report finding that 82% of the outbreaks were associated with infection control breaks during assisted monitoring of blood glucose (AMBG). Yikes!
So yes, it matters. Safety first. But then again, how much scrutiny is too much for even the simplest of devices...?
We'll be watching this debate with keen interest... as well as the frequency of our own lancet changes.