Necessity of “MDIC” registration system from the point of view of a hospital MDIC

Abstract

Here we present a case of emergency breakdown of the general anesthesia ventilator, which took place after one hour of usage although an inspection by medical device information communicators (MDIC) of both the medical manufactured company and the hospital was performed before using according to the guideline “Inspection sheet of anesthesia ventilator before starting” by Japan Society of Anesthesiology. The trouble was caused by falling out of motor brush in ventilator, then several times of information exchange between the hospital MDIC and the company MDIC led to the improvement of the same anesthesia ventilators as a troubled one. Questionnaires for company stuffs in charge of medical information (n=20) revealed that the acquisition rate of MDIC certification was extremely low and its recognition was also very subtle. MDIC is so important system to ensure the post-marketing security of medical instruments that we should let medical company stuffs know MDIC system and suggest them to get MDIC certification. Authors recommend that medical companies in both production and distribution should endeavor to let MDIC be a standard system like as medical representatives (MR) in pharmaceutical companies.