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Understanding the regulatory requirements for dialysate.

It is important for providers to remember that dialysate is considered by federal regulatory agencies to be a medical device, but that most of the regulations are aimed at the manufacturers. The manufacturers are subject to FDA inspection and they must comply with Good Manufacturing Practices. Once the product reaches the provider's door, the manufacturer's responsibility ends, as does most close regulation. The best way for facilities to protect themselves is to develop a good quality assurance program that establishes and maintains policies and procedures which will ensure safe and effective use of dialysate.