Lancet Overview

The FDA has proposed new guidance increasing the regulation of lancets.  Citing detailed  cases of infection through cross-contamination involving lancets in clinical care settings over the past three decades, they suggest stricter rules.

 

Home and hospital use lancets would be subject to new regulations to limit infection transmission.
FDA’s draft outlines cases of patients harmed by cross-contamination in hospitals and care facilities.
FDA wants to hear public comment. DPAC has draft comments you can copy and paste into FDA portal.
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.

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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.

DPAC’s Statement on Lancet Guidance

In the clinical setting, cross contamination through lancet use and lancing devices is a serious issue. The best clinical option is disposable single-use lancets that automatically shield the sharp. Regulation and labeling should combine to clearly define the distinction between home use devices black box labeled “not for clinical use” and devices specifically regulated and labeled for clinical use.

There is evidence that other items, including testing supplies, are potential paths for the transmission of infections including test strips and their containers. We encourage the FDA to work with CDC and consider all potential infection paths, sharps, lancing devices, meters, and supplies.

FDA has presented no evidence supporting the upregulation and associated cost increases for individual use lancets.

Comment by June 1, 2016

FDA is listening to the public through a formal comment process. Every comment matters. The more FDA comments FDA receives from the diabetes community, the more the needs and concerns of the diabetes community will be heard. Other interests will lobby for their views. We must speak up for our own. Our health is more at stake. After all, people with diabetes will experience more in-clinic lancet assisted testing than anyone else.

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DPAC Copy & Paste Comments to Lancet Draft Guidance

Please Feel Free to Add Your Personal Comments

Thanks to FDA for keeping patients safe from hospital acquired infection.

Section VII “Summary of Data Upon Which the Reclassification Is Based,” details cases of infection transmission. These involve hundreds of patients around the world over three decades. In many situations, human error facilitated infection transmission.

As well as the cases cited in this FDA guidance, other evidence points to additional cases of disease transmission.  In diabetes, notably glucose meters and other materials can transmit infection. FDA has rasied concern over clinical use meters. CDC has detailed that test strip containers are one such other means of passing infection from one patient to another. FDA should consider the total risk, not piecemeal responces.

ALL of the evidence presented in the docket is of transmission in professional care facilities. It is clear that healthcare facilities are where FDA should address the problem of lancets infection transmission. Don’t fix what isn’t broken. The draft presents no evidence to support the proposed up-regulation of personal lancet devices.

I appreciate FDA efforts to protect people in the clinical setting. That is a setting where we, as patients, have no way of knowing if we are getting fresh blades and disinfected devices. In some cases, we may not even be conscious to ask.

FDA’s 2013 draft meter guidance is instructive to this docket. While the final guidance is not yet out, the draft made a clear distinction between the setting of professional use and individual over the counter home use. Separating devices based on these environments is a logical precedent to follow with lancets.

FDA should be addressing documented problems. All of the evidence FDA presents is in clinical settings. Therefore, FDA should be using guidance and labeling to address the clinical setting where we need protection and device design that can minimize human factors that contribute to risk.

Section VII shows that multiple patient devices in-clinic use are a particular risk. The proposed up-regulation to class III of such devices is an indication of FDA’s appreciation of that risk. FDA should be clear how unique device identifiers will usefully implement with replaceable blade devices and how both components will be tracked.

I support FDA taking reasonable regulatory precautions and labeling steps to guide health care providers to use single patient, one-time use, disposable devices. Specifically, those that have blade protection as outlined in section V part B. Multi-patient devices should discourage through regulatory and labeling measures. FDA should address the real risk of transmission and create a clear delineation that safe, single-use, disposable lancets are the best practice.

Labeling is a tool FDA can use to differentiate between use devices intended for home use and professional settings.

Devices for a single patient, over the counter, with replaceable blades, should carry a black box label NOT FOR CLINICAL USE. One time use disposable lancets, with blade protection as outlined in section V part B, should be labeled APPROVED FOR CLINICAL USE.

Price is a driver of purchasing behavior. Third party purchasers, other than the caregiver and patient, may assume that any FDA-approved device is safe in all settings. Clear labeling, as suggested above, will create an economic liability for clinical purchasing agents and insurance payers who require anything for clinical use but lancet devices explicitly approved for clinical use.

Price driven purchasing is a documented source of safety disruption related to blood testing. The Journal Diabetes Care recently detailed the disruption of testing supplies as a source of increased hospitalization and mortality in diabetes patients served by Medicare. I fear a similar economic driven disruption will occur with lancet access driving use of less expensive devices not intended for clinical settings. FDA labels can protect patients with labels.

A way for FDA to decrease the clinical diabetes-related cross contamination, clearly detailed in the proposal, is to promote innovations in self-care to help people with diabetes to stay out of the hospital. An article in JAMA estimates ninety-seven thousand Americans each year go to the emergency room for insulin-related hypoglycemia. Far more than the number impacted by the evidence presented in this proposed regulation. FDA upgrading the post-market surveillance of the accuracy of meters may help mitigate those ER visit and limit potential cross-contamination opportunities.