Needle Manufacturing, Quality Control, and Optimization for Patient Comfort
January 2021 | Volume 20 | Issue 1 | Original Article | 44 | Copyright © January 2021
Published online January 2, 2021
Farah Moustafa MDa, Kara Hoverson MDa, Jeffrey S Dover MD FRCPCa,b, Kenneth A Arndt MDa
aSkinCare Physicians, Chestnut Hill, MA
bDepartment of Dermatology,Yale School of Medicine, New Haven, CT
There is an increasing rise of cosmetic injectables. We sought to understand the manufacturing, quality control process, and needle selection of hypodermic needles for fillers. Objective:
To understand the process of manufacturing and quality control of hypodermic needles and the relevance to an aesthetic clinician. Methods:
We conducted a search of the internet and contacted medical device companies to understand the manufacturing process. We then collaborated with the Executive director of global pharmaceutical technology from Abbvie as well as the packaging and device engineer at Galderma and summarized our findings. Finally, we reviewed the literature and summarized existing recommendations on techniques to minimize pain related to injection. Results:
Hypodermic needles undergo an extensive manufacturing and regulatory process. Many considerations are taken into account in needle manufacturing as well as the selection process with commercially available hyaluronic acid filler products. Needle manufacturers are held to universal standards though the International Organization for Standardization (ISO). Filler companies perform their own testing to evaluate suitability of needles for their product including leakage force, penetration force, extrusion force, etc. Finally, parameters such as needle length, needle diameter, and wall thickness are considered for selection of needle/hub with individual filler viscosity. Conclusion:
There is extensive consideration that goes into needle manufacturing, quality control, and optimization for hyaluronic acid filler. Understanding the technical process helps inform the clinician and guide patient care for maximum comfort. J Drugs Dermatol.
Over 16 billion injections are performed annually worldwide administering lifesaving vaccines and medications.1 The first hypodermic needles were invented in 1853 by Alexander Wood and Charles Gabriel Pravaz.2 In 1954, they became mass produced attached to disposable syringes for the vast immunization campaign against polio. Hypodermic needles have since revolutionized medicine and the delivery of drugs. They are used numerous times in any given dermatology clinic – for the injection of intralesional steroids, local anesthesia, neuromodulators, fillers, and biologic medications. With regards to cosmetic injection, in 2018 alone, a total of 3.7 million injectable procedures (neuromodulator and filler) were performed.3
These medical devices are used many times a day, often without much thought. We regularly use the needles that are provided to us either through our clinics or pre-packaged with filler. In order to deliver the best care and cause the least discomfort for our patients, we sought to further understand the process by which hypodermic needles are manufactured, how quality control is maintained, and how they can be optimally used to minimize pain felt by the patient with injection.
We conducted a search of the internet and contacted medical device companies to understand the manufacturing process. We then collaborated with the executive director of global pharmaceutical technology from Abbvie as well as the packaging and device engineer at Galderma. Both are experts who specialize in the optimization of operations technology and manufacturing support a within their respective companies on the needle selection and optimization process for filler products. Finally, we reviewed the literature and summarized existing recommendations on techniques to minimize pain related to injection.
Hypodermic needles are hollow bore medical devices. To produce a hypodermic needle, a flat strip of stainless steel is first rolled into a tube shape using a milling machine, and a laser then welds the seams together. The tube then is passed through a die several times in a process referred to as “tube drawing.” Each die reduces the inner and outer diameter until the desired size is obtained.These first steps take several days to complete. Next, the stainless tubing gets processed to its final length (eg, 1⁄2 inch L) and from a blunt tip to a needlepoint with a bevel.