Question-based development of high-risk medical devices: A proposal for a structured design and review process.

Introduction: The recent introduction of the European Medical Device Regulation poses stricter legislation for manufacturers developing medical devices in the EU. Many devices have been placed into a higher risk category, thus requiring more data before market approval, and a much larger focus has been placed on safety. For implantable and Class III devices, the highest risk class, clinical evidence is a necessity.

Haptic Intracorporeal Palpation Using a Cable-Driven Parallel Robot: A User Study.

Objective: Intraoperative palpation is a surgical gesture jeopardized by the lack of haptic feedback which affects robotic minimally invasive surgery. Restoring the force reflection in teleoperated systems may improve both surgeons' performance and procedures' outcome.

Methods: A force-based sensing approach was developed, based on a cable-driven parallel manipulator with anticipated seamless and low-cost integration capabilities in teleoperated robotic surgery.

Using surgical wrapping material for the fabrication of respirator masks.

Given the current shortage of respirator masks and the resulting lack of personal protective equipment for use by clinical staff, we examined bottom-up solutions that would allow hospitals to fabricate respirator masks that: (i) meet requirements in terms of filtering capacities, (ii) are easy to produce rapidly and locally, and (iii) can be constructed using materials commonly available in hospitals worldwide. We found that Halyard H300 material used for wrapping of surgical instruments and routinely available in hospitals, met these criteria. Specifically, three layers of material achieved a filter efficiency of 94%, 99%, and 100% for 0.