Skyline Medical has secured a medical device establishment license from Health Canada to sell STREAMWAY system and associated disposables.
The STREAMWAY, which also secured approval from the US Food and Drug Administration, is an automated direct-to-drain medical fluid disposal system designed specifically for medical procedures including radiology, endoscopy, urology and cystoscopy.
It can be connected directly to the facility’s plumbing system to automate the collection, measurement and disposal of waste fluids.
Skyline said the system reduces human intervention and enhances compliance with occupational safety and health administration and other regulatory agency safety guidelines.
It also offers unlimited capacity for improved efficiency in operating rooms, resulting in better profitability.
As on September this year, about 96 STREAMWAY systems have been installed in 50 facilities in 19 states in the US.
Skyline Medical says that it has received proposals from distributors to sell STREAMWAY in Canada. The company has started talks with several of them.
It expects to come to terms with one or more distributors in the coming few weeks, covering around 1500 hospitals in all the 13 provinces in the country.
Skyline Medical executive chairman Carl Schwartz said: “We look forward to bringing the STREAMWAY System and its many benefits to healthcare professionals and facilities to the approximately 10,000 operating rooms across Canada.
“This approval follows receipt of ISO 13485:2003 certification for the STREAMWAY System, which not only was a requirement for Canadian approval, but is necessary for the CE Mark and subsequent sales in the European Union."