Proof of concept testing of a positive reference material for in vivo and in vitro sensitization testing of medical devices.

In vivo skin sensitization tests are required to evaluate the biological safety of medical devices in contact with living organisms to provide safe medical care to patients. Negative and positive reference materials have been developed for biological tests of cytotoxicity, implantation, hemolysis, and in vitro skin irritation. However, skin sensitization tests are lacking.

Practice and Safety of Static Balloon Atrial Septostomy Based on a Nationwide Registry Data.

Background: Balloon atrial septostomy (BAS) is an essential catheterization procedure for congenital heart lesions. Recently, a balloon catheter for static BAS was approved for the first time in Japan as an alternative to the conventional pull-through BAS. Despite the expected increase in the use of static BAS, reports on its safety are scarce worldwide.

Japanese Regulatory Considerations for Interoperability of Medical Devices.

With the rapid technological innovations of the Internet of Things (IoT), the situation surrounding medical devices and medical systems has been changing. Interoperable medical devices-medical devices capable of interoperating in a clinically significant way with other medical devices-have been developed, and interoperable medical systems consisting of two or more interconnected interoperable medical devices are being used in clinical settings. However, general points that need to be considered to ensure safe and effective interoperability have yet to be fully established in Japan.

In Vitro Measurement of Contact Pressure Applied to a Model Vessel Wall during Balloon Dilation by Using a Film-Type Sensor.

Objective: As an important evaluation index of vascular damage, the study aims to clarify the value of contact pressure applied to blood vessels and how it changes with respect to balloon pressure during balloon dilation.

Methods: The contact pressure was evaluated through an in vitro measurement system using a model tube with almost the same elastic modulus as the blood vessel wall and our film-type pressure sensor. A poly (vinyl alcohol) hydrogel tube with almost the same elastic modulus was fabricated as the model vessel.