National Survey to determine the Knowledge of IEC 80001-1

Dear Colleagues

Please see below details of some research being carried out by a clinical engineering colleague Tony Fitzgerald on the knowledge of IEC 80001. Tony is the Principle Clinical Engineer with extensive experience in both the hospital and commercial healthcare sector. He has recently been seconded from OLCHC to play a lead role in healthcare technology planning and equipping for the New Children’s Hospital. He is a graduate of Carlow RTC and currently undertaking an MSC in Health Informatics in Trinity College.

The BEAI would request that our members and colleagues read the below introduction and complete the survey to assist Tony in his studies.

 

Background

Traditionally, medical devices were designed as stand-alone devices and if they were required to be networked e.g. (Physiological Monitors in an ICU) they were placed onto a proprietary IT network provided and maintained by the manufacturer of the device. All medical devices are strictly regulated and tested however the incorporation of a medical device into an IT network can introduce additional risks, compromising the safety, effectiveness and the security of the IT network. In 2010 the IEC 80001-1 standard was developed to address these risks. The IEC 80001-1 standard recognises that overall responsibility for the medical IT network belongs with the HDO, who must work in conjunction with the manufacturer of any medical devices placed on the network and the suppliers of other products incorporated into the network, to ensure that all risks are identified and managed.

Research

The purpose of this research is to determine if the standard IEC 80001-1 "Application of risk management for IT-networks incorporating medical devices" and its Technical Report ISO TR 80001-2-7 "Guidance for health care delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1” are accessible within Irish HDOs.

Participants are required to fill in an online questionnaire developed in Qualtrics which is completely voluntary and will take approx. 10 minutes and all the data collected will be aggregated and anonymised

Outcomes

The purpose of this research is to determine a baseline of the awareness and adoption of the standard nationally and identify possible barriers to its implementation.

Link to survey

https://scsstcd.qualtrics.com/SE/?SID=SV_a41yUwD8OjFJIzj