Packager: Chadds Ford, PA-based Now Medical Inc. describes its mission "is to provide innovative solutions that will protect today's clinician from blood-borne pathogen exposure.
Challenges: "Huber needles have been around 20 years or more," says Dean Iwasaki, Now Medical's director of business development. "Years ago, needles or 'sharps' legislation was passed to help protect healthcare givers from being exposed to biohazards. This Huber needle device is used primarily for infusion purposes, often for chemotherapy for cancer patients. Patients are given an implantable vascular access port (IVAP) that is placed under the skin. The needle goes through the skin, then through the septum of the port. From there, you can infuse chemotherapy drugs or actually draw blood. The needle can be left in the port in the patient for several days in the hospital.
"When [a healthcare worker is] pulling the needle out of the port there's what's called a rebound effect," Iwasaki continues. "As you pull the needle out, you encounter resistance and all of a sudden it just snaps or gives. That's when people inadvertently stick themselves. We were the first company to address the safety needs about five years ago with the HuberPlus."
New developments: Now Medical recently introduced a thermoformed tray made of Klöckner Pentaplast's Pentamed PETG film. It holds a patented right-angle HuberPlus safety needle to better protect healthcare professionals from accidental needlestick injuries when inserting or retracting a needle from a patient. Sterilized packs of needles are shipped to hospitals and outpatient clinics throughout the United States. Each clear tray holds a single needle. In all, there are upwards of 20 different needles, in various gauges, needle lengths from ½" to 1½", and combinations that may include tubing or valve connectors. Two tray sizes are used for the different configurations: 3½"x3½"x1½" deep and 4"x4" x not quite 2" deep. The trays have no compartments. A polyvinyl chloride sheath or tube is manually slipped onto the needle to prevent it from puncturing the lidding, DuPont's 1059B Tyvek, a medical-grade material coated on one side with a heat-seal adhesive that adheres to the tray.
Now Medical's newest safety needle packed in the tray, the HuberClear, uses a collapsible clear-wing design, audible click, ergonomic grip, and small footprint. When it's extracted from the IVAP, the wings fold over the needle and lock in place, making an audible click. That helps prevent accidental sticks that can lead to the transmission of blood-borne pathogens, which can cause diseases such as hepatitis B and C and HIV (human immunodeficiency virus).
Tray manufacturing hurdles: "There needs to be some rigidity in the tray because of how the device is designed," says Iwasaki. "We can't put it into a flat package because there's the possibility that if any pressure was applied to the package, the device could breach that package. So that was the purpose of putting it into a tub with rigidity. Also, the product is sterile and must maintain its sterility for up to two years."
Trays are thermoformed by Flexpak Corp. Ed Berger, Flexpak's vice president for business development, says, "Now's previous [supplier] was acquired by a bigger company and opted out of the thermoforming business. We took over the existing thermoforming."
Since Flexpak assumed thermoforming responsibilities for the tray, it has used the Pentamed films in 25-mil thickness for both tray sizes. "We use Klöckner Pentaplast medical film almost exclusively for all designs," says Berger. "We have a long-term relationship stretching over many years. In this instance, we use Pentamed rollstock for its impact strength, formability, and clean die cutting."
Now Medical's Iwasaki explains that the needle maker chose to work with Flexpak based on the recommendation of Integra Biotechnical LLC, the firm that assembles and packages Now's safety Huber needle in Tijuana, Mexico (though the company's main headquarters are in Vista, CA). Only two tray-design concepts went back and forth between Now Medical and Flexpak before the right one was achieved. Read the remainder of this story.
--By Jim Butschli, Editor