Officials from MediPurpose, a manufacturer and master distributor of medical products, announce the publication of a new white paper, “Reinventing a Better Safety Heelstick: Defining, Translating and Validating Safety Features.”
The white paper describes the redesigned babyLance safety heelstick's safety features – and the processes with which they were integrated and validated, which included:
- Gathering end-users' expectations for a safety neonatal heel incision device
- Analyzing the U.S. FDA's "Guidance Document on Medical Devices with Sharps Prevention Features"
- Translating product requirements into design specifications
- Validating safety features before launching the new device in August 2012
- Applying for U.S. FDA 510(k) with sharps safety indications in January 2013
"Safety is a crucial aspect of the device and is required to meet the needs of an increasingly safety-conscious and safety-regulated market," states MediPurpose founder and CEO Patrick Yi. "Further, without its safety features, MediPurpose could not submit babyLance for a U.S. Food and Drug Administration 510(k) with sharps prevention indications, which enables us to legally market it as a "safety heelstick."
To date, babyLance is believed to be the only infant heelstick device marketed in the United States with 510(k) clearance for sharps prevention features.
About babyLance Safety Heelsticks
After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched the all-new heel incision device in August 2012.
babyLance is available in two models, each with a specific blade penetration:
- babyLance BLP (preemie): 0.85mm depth
- babyLance BLN (newborn): 1.0mm depth
Specifically designed to meet end-user expectations for the ideal heelstick, the new babyLance provides enhanced stability, comfort, and ease of use.