Investigation of Medical Device Program Defects Affecting Pharmacotherapy

Abstract

Objective:Medical device malfunctions can significantly impact pharmacotherapy. With advances in digital technology, smartphone applications for the treatment of nicotine addiction have recently been released in Japan. However, it cannot be denied that the malfunction of medical devices related to such programs may affect drug treatment. Therefore, we investigated malfunctioning medical devices related to the program.

Methods: We investigated reports on malfunctions from FY 2006 to 2021, using the Pharmaceuticals and Medical Devices Agency database.

Results: A total of 94 cases of program-related medical device failures were reported in Japan. The malfunction of medical devices (such as infusion pumps and dialysis machines) associated with drug treatment were confirmed. The events included a rapid infusion of the drug and an inability to ascertain the total dose, both of which were caused by bugs in the program. Although the specifics are unknown, there was a malfunction in the contrast medium injection device as well.

Conclusion: When issues arise with the dosage setting of medical devices, it is necessary to consider both human errors by medical staff as well as program bugs. Additionally, to provide safe drug therapy to patients, pharmacists must inspect the medical devices used in drug therapy when visiting hospital wards and patients' homes.