FDA Proposes Stricter Reclassification of Lancets

Marie Thibault

In a proposed order set to be published Thursday, FDA explains its justifications for its suggested reclassification of blood lancets from Class I to the more stringent Class II and Class III groups. Lancets, which seem, at first glance, to be uncomplicated devices used for diagnostic fingerpricks (often by patients with diabetes), have been the subject of a few FDA reviews. The agency's latest proposal divides lancets into four categories: single-use only lancets with built-in sharps injury prevention, single-use only lancets without built-in sharps injury prevention, multiple-use lancets for a single patient, and multiple-use lancets for multiple patients. 

It is this last category, the multiple-use lancets for multiple patients, that seems to cause FDA the most consternation. These lancets would become Class III devices under the proposed order because they "present a potential unreasonable risk of illness or injury and insufficient information exists for FDA to determine that special controls would provide reasonable assurance of safety and effectiveness of the device," according to the proposed order. 

FDA is concerned about the public health risks, including transmission of Hepatitis B and C, of multiple patients using the same blood lancet. These multiple-patient lancets are sometimes used in assisted living facilities and other group care settings. The potential for such transmission would need to be eradicated by a product 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 wrote. 

The other types of blood lancets, all intended for single-patient use, would be classified as Class II devices under the proposed order. This is because the agency "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."

FDA has been concerned about the potential spread of illnesses due to multiple-patient blood lancets for years. The agency published guidance on lancet labeling in November 2010 and held a 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 issued a safety communication to add a warning against patient sharing to the label of pens used to inject insulin and other diabetes medications. 

The comment period for the proposed order will be open for 90 days, starting March 3. 

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]