June 26, 2013
I am Dr. Jennifer Yttri and I am speaking today on behalf of the National Research Center for Women & Families. The Center does not take funding from device manufacturers and I have no conflicts of interest.
We use objective, research-based information to encourage new, more effective treatments, programs, and policies that promote public health. The Center achieves its mission by analyzing scientific information, and providing scientific analyses for meetings like this one.
We have a major focus on the quality of medical care and medical products, and our president is on the Board of Directors of two nonprofit organizations dedicated to helping the FDA obtain the resources it needs: the Reagan-Udall Foundation and the Alliance for a Stronger FDA.
We agree with the FDA that the documented exposure to infection through improper use of blood lancets warrants reclassification of these devices.
For lancets, the major reported safety risk is injury from malfunctioning or improper use of the lancet, including accidental sticks. The number and type of MAUDE reports for blood lancets indicate that accidental sticks are most likely when safety features malfunction or lancet blades are difficult to remove. Other reports indicate some lancet blades being too dull to pierce skin or too long to fit safety caps. FDA should require performance testing to prove that the safety features and blades themselves work consistently for all lancet, as do the mechanics of blade removal and replacement in multiple use devices.
We also recognize there is a risk of infection associated with use of blood lancets. Good manufacturing practices and facility inspections can decrease contamination during the manufacturing process. Requiring sterility testing will further reduce infections.
Unfortunately, the risk of spread of blood-borne infections through the use of multi-patient lancets is too high to justify use of these devices. While the FDA can control which devices are available to patients and physicians, they cannot regulate medical practice. Research indicates that labels and medical guides do little to ensure proper device use and patients and physicians do not always remember important information in guides. Adding components and procedures to disinfect multiple use blood lancets will be inadequate to protect patients and providers from accidental exposure to infection.
FDA and CDC have clearly documented the spread of Hepatitis from patients in medical facilities who used the same lancet holder, even with a new blade. These studies indicate that lancets should not be approved for use on multiple patients. No amount of training, labeling, or safety measures can adequately reduce the risk of exposure to infections by reusing a blood lancing device. The benefit of convenience does not outweigh the cost of a lifelong infection.
Single patient lancets are available for the same medical need. Therefore, removal of multi-patient blood lancets from market will not put an undue burden on patients or medical providers.
In conclusion, we agree that with special controls in place to ensure device sterility, proper functionality, and use on one patient, blood lancets can be cleared through a 510(k) process. We believe that blood lancets for multiple patients present a “potential unreasonable risk of illness” that cannot be adequately addressed either through a 510(k) review or a PMA, and therefore such products should be removed from the market.
We thank the FDA for recognizing the serious threat to public health and taking the needed steps to mitigate problems associated with blood lancets. The current scientific data supports reclassification of these devices.