Nephros (OTC:NEPH) said today it signed a distribution agreement with CS Medical to distribute Nephros’ DSU-H ultrafilter as an option with CS Medical’s TD 100 automated trans-esophageal echocardiogram probe disinfector.
The DSU-H filter from Nephros has FDA 510(k) clearance and is designed to provide ultrapure water as an aid in infection prevention and control, CS Medical said.
“We are very excited about our partnership with CS Medical and our opportunity to help protect patients undergoing a TOE or TEE procedure. Our FDA cleared ultrafilters are able to meet the water purity needs of a number of specialized medical devices, including CS Medical’s market leading device, the TD 100,” Nephros N.A. sales director Shane Sullivan said in a press release.
CS Medical’s TD 100 automated TEE probe disinfector is designed to provide high-level disinfection for TEE probes to minimize potential for patient exposure to improperly reprocessed probes, the company said.
“Waterborne bacteria are an ever-growing challenge in healthcare facilities. The effects of these contaminates continue to cause an increasing rise in healthcare costs. Rinse water quality can affect a properly high-level disinfected medical device by introducing bacteria, viruses and endotoxins. CS Medical’s partnership with Nephros will provide a solution that provides ultrapure bacteriologically-filtered water during the rinse cycles of the TD 100 and help aid in the prevention of healthcare association infections. We are pleased to work with Nephros as CS Medical is committed to providing quality and reliable solutions for TEE ultrasound probe disinfection,” CS Medical prez Mark Leath said in a prepared statement.
In April, Nephros said it received a notice from the FDA closing out a warning letter the company received last May concerning issues with the manufacturing of a variety of its filtration systems.
The warning from the federal watchdog to River Edge, N.J.-based Nephros included warnings on a failure to document and evaluate potential suppliers and a failure to include required information in records and complaint investigations.
Nephros responded to the initial warning letter and received a response from the FDA in August outlining what corrective actions would be required.