The threat of an attack is imminent. It is critical for medical devices and systems, as well as healthcare facilities to have the right safeguards in place.
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
This pioneering area of technology comes with new risks and questions of liability.
During an outbreak, it is critical to treat reusable medical devices as potential sources of transmission.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
It’s time to address this healthcare problem.
Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.
ECRI releases its top 10 list of health technology hazards for 2018.
The agency clarifies some misconceptions about requirements.
Infusion errors, faulty cleaning of devices and missed alarms are among ECRI’s annual list of dangers surrounding healthcare products for 2017.