When help is needed KIHOMAC responds
Since the outset of the COVID-19 pandemic, there has been a national shortage in testing, specifically a shortage of the nasopharyngeal (NP) swabs required for collecting samples from patients. Requirements for a swab include flexibility for comfort, a bristled tip that allows for wicking of sample material, the length to reach the back of the nasal cavity, and a breakpoint to allow it to be placed in a vial. The vials are combined with a culture solution, creating what’s known as a Universal Transport Medium (UTM). The NP swab with a UTM creates a full test kit.
The Utah Governor’s Office of Economic Development (GOED) reached out to KIHOMAC to help supplement their projected shortfall of NP swabs for test kits, specifically asking if additive manufacturing (AM) was an option. Our rapid response was based on our experiences with AM, specifically with stereolithography (SLA), as well as pivoting to new quality requirements and system development approaches to manufacturing. First, we navigated the Food & Drug Administration’s requirements for registering as a Medical Device manufacturer. Next, we selected an available and clinically tested NP swab design that was compatible with our 3D printing SLA capability and upscaled that system to create an initial manufacturing line, complete with material traceability, cleanliness requirements, and other quality controls. KIHOMAC was able to respond to Utah’s request for help within 3 weeks.
About Making 3D Printed Nasopharyngeal Test Swabs
The SLA printers we use to produce the swabs are optimized for biocompatible materials and popular in the dental industry. They use a precise UV laser to cure the resin and build continuous layers for a smooth surface and with consistent isotropic properties - extremely critical in this application. After the swabs are printed, they are washed in a bath of isopropyl alcohol and fully cured in a UV oven. The swabs are quality inspected throughout the process and tested for flexibility. The process is fully traceable and repeatable. Our production system is currently designed to produce 10,000 swabs per week, but the facility and process designs allow it to easily be scalable to 100,000 or more if necessary.
Our 3D printed NP test swabs are produced from a medical grade photopolymer resin that is non-cytotoxic, non-irritating, not a sensitizer, and ISO 109933-1:2018 compliant. They are packaged in autoclave pouches and are sterilization ready. Sterilization instructions for chemical or steam autoclave are available below. They are a standard length of 150 mm with a 70mm break point. The swabs appear translucent but are still flexible and their tip design is optimized for sample collection. Personal handling may be different when compared to traditional swabs due to the type of construction, but when used as intended, they will perform as well or better. These are Class I medical devices exempted from premarket notification requirements. KIHOMAC is registered with the FDA and our NP swabs are listed.
KIHOMED 3D Printed NP Swab Specifications
- Length: 151mm (5.94”)
- Head Diameter: 3.3mm (0.13”)
- Head Length: 17.5mm (0.68”)
- Break Point: 77mm (3.03”)
- Material: ISO 109933-1:2018 compliant, biocompatible photopolymer resin
- Packaging: Autoclave resistant sterilization pouches
- Quantity: 25 swabs per pouch (unsterilized)
NP swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR § 880.6025 Absorbent tipped applicator.
The FDA requires medical device manufacturers to register their facility and list their products according to 21 CFR § 807.20.
KIHOMAC, Inc. is registered: 3016753609
KIHOMAC’s 3D Printed NP Swabs are listed: FDA listing data.
Contact us at firstname.lastname@example.org for questions, quotes or product requests.
Face Masks and Face Shields
Rapid Response to an Immediate Need
On 13 March 2020, the President of the United States declared a national emergency in response to Coronavirus Disease 2019 (COVID-19). The virus that causes COVID-19 has the ability to spread rapidly with significant impacts on our healthcare system and to our general day-to-day activities. In response to this pandemic, the Centers for Disease Control and Prevention (CDC) has recommended the use of masks in public along with other hygienic practices. This call for public mask use combined with the personal protective equipment (PPE) needed for healthcare workers worldwide has resulted in a supply shortage for face masks and face shields across the nation.
In response to this supply shortage, the U.S. Navy released a request to its vendors asking how they could support Naval Air Warfare Center Aircraft Division’s (NAWCAD) response to COVID-19 demands for mask-type coverings and face shields. The face mask design provided by the customer is a Do-It-Yourself (DIY) mask which includes a 3D printed frame (small, medium and large), filter material, cotton and elastic bands. The face shield design consists of a 3D printed head band and a clear face plate (short and long). Due to our experience with Additive Manufacturing (AM), specifically Fused filament fabrication (FFF); our in-house waterjet cutting capability; and our experience cutting fabrics for use with composite parts; KIHOMAC was able to respond quickly, able to provide a detailed plan within 24 hours after receiving the request. KIHOMAC’s ISO9001:2015 and AS9100 Rev D certified quality management system also supports the type of quality processing this work requires.
Face Mask Manufacturing
The face mask comprises a frame, filter material, cotton material, and elastic bands. KIHOMAC is using FFF process 3D printers to produce the frames. The filament used to print the frames is made from Polyethylene terephthalate glycol (PETG). PETG is a thermoplastic polyester material that provides chemical resistance, is easily formable and is very durable, which makes it a good candidate for use as a face mask frame. The filter material we chose is an electrostatically charged filter media which is effective in attracting dust particles in the air. This filter material has a Minimum Efficiency Reporting Value (MERV) rating of 15, exceeding the requirement with a reported 99.50% filtration efficiency for 0.3 µm particles at 32 LPM. The cotton is purchased commercially and is used to cushion the face mask against the face while providing a barrier between the skin and the filter material. The elastic bands are also purchased commercially and are used to keep the face mask in position on the face.
While these masks are useful for everyday use, these masks are not N95 masks and use of this item must be in accordance with FDA policy for use of non-medical, non-surgical PPE during the COVID-19 emergency only. The FDA has not evaluated the effectiveness of this item for protection against COVID-19 transmission.
Specifications for the face mask frames:
- Length: 5.29” for large, 4.79” for medium, 4.44” for small
- Width: .41” for large, 3.80” for medium, 3.24” for small
- Thickness: 0.08”
Face Shield Manufacturing
The face shield comprises a head band, a face plate, and elastic bands. KIHOMAC is using FFF process 3D printers to produce the head bands. The filament used to print the frames is made from Polyethylene terephthalate glycol (PETG). PETG is a thermoplastic polyester material that provides chemical resistance, is easily formable, is very durable and has high damage resistance, which makes it a good candidate for use as a head band. The face plates are made in two lengths (long and short) and attach to the head bands using holes positioned on the face plates to match up with tabs printed on the outside of the head bands providing a tight fit. The face plates are cut in-house at KIHOMAC on our waterjet, cut from naturally clear 0.030” thick PETG sheets. The elastic bands are purchased commercially and attach to the head band around the back of the head to keep the face shield in place.
Specifications for the head band:
- Front to Back: 5.66”
- Side to Side: 7.52”
- Top to Bottom: 0.79”
Specifications for the face plate:
- Length: 7.48” (short), 9.45” (long)
- Width: 13.39”
- Thickness: 0.03”