Safety recommendation
HSSIB recommends that the British Standards Institution engages with appropriate stakeholders to develop national human factors guidance, including consideration of usability and environment of use, for medical devices. This is to support international medical device standards and help manufacturers and healthcare staff to recognise these elements for the improvement of patient safety.
Response:
BSI, as the UK’s National Standards Body (NSB), supports the safety recommendation 2023/007 made by the HSSIB in report NI-004899, addressing accurate dosing and reliable delivery of medication via ambulatory infusion pumps.
The problem surrounding the use of alarms in the clinical setting as highlighted in the report is exacerbated by factors relating to healthcare staff workload, multiple alarm sources in the patient care environment, and patient and caregiver awareness of hazards and alert technologies.
We are committed to engaging with the relevant standards committees and working groups to consider development of national guidance on human factors for medical devices and influence further discussions at the international level.
Detailed actions and timescales for completing this work are outlined below. We will keep the HSSIB informed of the progress and results of these actions.
Actions planned to deliver safety recommendation:
- BSI will identify the appropriate standards committee(s) to review the report and assess what human factors guidance is needed for medical device manufacturers when designing medical devices incorporating alarms and other alert technologies.
- BSI will ensure that human factors experts participate in the development of the national guidance.
Response received on 13 February 2024.