Tristel, the UK manufacturer of infection prevention products, has entered into a manufacturing and marketing agreement with Parker Laboratories Inc. Headquartered in New Jersey (US) Parker will manufacture Tristel’s Duo chlorine dioxide foam disinfectant for the North, Central and South American markets. Parker will also market the product in the ultrasound marketplace throughout the region.
This collaboration with Parker prepares Tristel for its entry into the United States infection prevention marketplace in advance of the grant of approval by the United States Environmental Protection Agency (EPA) for Duo, which is expected during the second half of the current financial year.
A family-owned and managed business, Parker was founded in 1958. The company pioneered the development of conductive gels for use in ultrasound.
Tristel CEO, Paul Swinney, commented: “We are very pleased to conclude this collaboration with Parker, whose president and main shareholder we first met some fifteen years ago. Our collaboration will give us the platform to access the ultrasound marketplace throughout the United States and the Americas, first with our EPA approved Duo product and in due course with our FDA approved Duo.”
Parker manufactures its products in a 95,000 sq ft facility in Fairfield, and it is registered with the United States Food and Drug Administration (FDA) as a manufacturer of medical devices.
Its products are available to ultrasound practitioners in every country throughout the world. Its Aquasonic 100 gel is deemed the market leader in the United States where the company has nationwide distribution through a network of approximately 500 distributors. Parker is also known as a market leader in the ultrasound market in Canada and throughout Central and South America.
Infection prevention market
Tristel announced its intention to enter the North American infection prevention market in October 2015, when the British firm unveiled its preliminary results for the year. In pursuit of this plan, on 30 June 2017 Tristel made a submission for regulatory clearance by the EPA of its Duo chlorine dioxide disinfection foam. Following EPA federal approval, the company will need to secure state-by-state approval before sales of Duo can commence.
The EPA clearance will enable Duo to claim intermediate disinfection of all non-porous surfaces, including those of medical instruments such as ultrasound probes.
This is Tristel’s core activity worldwide and accounts for approximately 80% of the company’s revenues. Tristel continues to develop two submissions to be made to the FDA for 510(K) clearance in respect of Duo.
The 510(K) approval will permit Duo to claim high-level disinfection of medical instruments. It is important to note that in all other markets worldwide, Duo is classified as a high-level disinfectant.
