Medical Informatics Lax on Documentation, FDA Says

An FDA inspection of Medical Informatics’ Houston, Texas facility revealed lax complaint handling and a lack of medical device reporting procedures. 

The devicemaker had recently rolled out its patient monitoring and predictive analytics platform called Sickbay, designed to reduce patient risk.  Agency investigators said the firm’s complaint handling procedures didn’t define how it evaluates, investigates, documents, trends and closes product-related complaints.

It also had not developed and maintained written medical device reporting procedures and documents included incorrect reporting requirements for MDRs.