Safety assessment of hypochlorite for disinfection of reusable urethral catheters

DHI has performed a safety assessment of a hypochlorite solution for cleaning and disinfection of reusable urethral catheters.

 

Hypochlorite, such as Milton solution, is a widely used household chemical and recommended cleaning method to avoid bacteria, and it is used for instance for cleaning of baby bottles. It has also been suggested as an efficient cleaning method when reusing catheters for intermittent catheterization. 

In spite of that, the long-term urethral and dermal exposure to hypochlorite has not been investigated with respect to cytotoxicity, nor has the environmental effects been addressed. The purpose of the safety assessment was to evaluate the potential risks and effects of long-term, up to life-long, exposure to hypochlorite with respect to cytotoxicity and environmental impact.

DHI’s assessment was prepared on behalf of the medical device company Coloplast in accordance with the assessment methodologies described in the ISO-10093 standards concerning biological evaluation of medical devices.

For more information about the project, please contact:

 

Poul Bo Larsen   
pbl@dhigroup.com 
Tel +45 4516 9478