Abstract
Contact between plastic medical devices and medicine causes damage to the medical device and liquid medicine leakage because of physicochemical reactions. These phenomena are listed as contraindications and precautions on individual package inserts of medical devices and drugs; medical device package inserts draw attention to such as interactions. We carried out a questionnaire survey of medical-, drug-, and device-safety managers in hospitals that examined the management system for medical device package inserts, responsibility for dealing with the occurrence of drug and medical device interactions, and at desirable system to avoid such occurrence. Drug package inserts are managed by pharmacists. The medical device package inserts are managed mainly by the device safety managers, as well as by other personnel, including the clinical engineer, doctor, nurse, and clinical radiographer. The survey confirmed that interactions occurred at many phenomena; the procedure involved detailing such occurrences by various medical staff to a medical-safety manager in an incident report. Our study revealed that there were many problems with the package inserts management system for medical devices. Cooperation between safety managers within hospitals is necessary to avoid such incidents.