19 Dec Why are Safety Lancets Regulated When Other Lancets are Not?
JUST BECAUSE A LANCET IS CALLED “SAFE” DOESN’T MEAN THAT IT’S A “SAFETY LANCET”
The Needlestick Safety and Prevention Act (NSPA) (HR.5178) was signed into law on November 6, 2000. It required employers to provide safety-engineered medical devices to employees that are at-risk for exposure to bloodborne pathogens.
The NSPA requires employers to:
- Identify, evaluate and implement safer medical devices.
- Maintain a sharps injury log.
- Involve healthcare workers in deciding which devices are used.
- Implement engineering controls for sharps disposal containers, self-sheathing needles, safer medical devices (e.g., sharps with engineered injury protections and needleless systems). It also requires those engineering controls to be used to eliminate or lessen employee exposure to bloodborne pathogens.
- Train employees in the proper usage of the engineering and work practice controls to help keep them safe.
The NSPA quickly spurred the development of medical devices with sharps safety engineered features, which improved healthcare workplace safety conditions. For example, The New England Journal of Medicine reported “a drop of about 38 percent in 2001 when the NSPA took effect” and that “subsequent injury rates, through 2005, remained well below pre-NSPA rates.” The Centers for Disease Control and Prevention (CDC) further reported a 31.6-percent reduction in sharps-related injuries in non-surgical hospital settings during 2001–06 following the NSPA’s enactment.
Regulating Safety Medical Devices: FDA
As the safety medical device market expanded, the U.S. Food and Drug Administration (FDA) has identified the risks to health generally associated with the use of sharps injury prevention features, and it requires a Premarket Notification (510k) be submitted before the device can be marketed. The FDA has developed a guidance document to assist the industry in preparing premarket notification (510k) submissions for medical devices that incorporate a sharps injury prevention feature.
The FDA’s guidance document recommends the following:
- Design Controls
- Bench Testing
- Simulated Use Testing
After the FDA clears the 510(k) application, the safety medical device can then be marketed as a device with sharps injury prevention features. A medical device that does not have 510(k) clearance, even if it appears to be designed to protect the user from a sharps injury, cannot be labeled as a safety medical device.
Examples of Safety Medical Devices:
MediPurpose’s babyLance™ Safety Heelstick and SurgiLance™ Safety Lancet
MediPurpose™ manufactures and distributes two safety medical devices that have received FDA 510(k) clearances with sharps safety preventions: babyLance™ safety heelsticks and SurgiLance™ safety lancets.
babyLance is MediPurpose’s newest safety device. The new babyLance was launched in August 2012 as the “babyLance heelstick” (a Class I device without any safety claims) as it awaited clearance of its 510(k) for sharps prevention feature indications. It received babyLance’s 510(k) clearance in February 2013, permitting it to market its new infant heelstick incision device as the babyLance safety heelstick.
MediPurpose recently published a white paper, Obtaining a U.S. FDA 510(k) with Sharps Prevention Features, which describes how the company identified and met the requirements for babyLance’s 510(k) application.
To date, babyLance is believed to be the only infant heelstick marketed in the United States with 510(k) clearance for sharps prevention features.
Regulating Blood Lancets
The U.S. FDA classifies blood lancets—including fingerprick lancets and heelsticks as class I medical devices that are exempt from the FDA 510(k) requirements.
However, as discussed above, the U.S. FDA regulates safety blood lancets by requiring a Premarket Notification (510k) be submitted before any safety lancet can be marketed. Although it is prudent to regulate safety lancets more stringently because of the safety features claim, it is ironical that regular blood lancets without any safety feature are not regulated at all. Manufacturers of safety lancets have to comply with more onerous regulatory requirements, while manufacturers of regular lancets without safety features do not.