The FDA has proposed new rules for the regulation of lancets. Citing detail cases of clinical cross contamination involving lancets over the past three decades, they suggest stricter rules. Clinical cross contamination is a risk.
Clinical cross-contamination risk
Infection transmission is a real risk and one that is increased by the more frequent exposure to potentially contaminated lancing devices needed for regular blood glucose monitoring. You can learn more about this issue as DPAC hosted CDC’s Dr. Pamela Allweiss MD in our Ask An Expert series speaking to cross contamination. We believe the clinical risk should be mitigated.
Infection can travel from patient to patient on the surface of devices. In FDA’s 2013 proposed guidance for glucose meters, the agency recognized that clinical use devices and personal use devices pose different risks and warrant different regulation. In the clinical setting, cross contamination is a serious issue. Not only are sharps and meters paths for infection, but diabetes supplies like test strip containers can be as well.
All of the evidence presented by FDA is of infection transmission in clinical settings, supporting consideration of the regulation for devices intended for care facilities. No evidence is presented on cross contamination with home use lancets. Increasing the regulation of individual use lancets may impact access and cost without evidence of a need for increased oversight.
The FDA docket is open to June 1. Easy to follow instructions and a draft comment can be found at: http://diabetespac.org/lancet/