Safety recommendation
HSSIB recommends that the British Standards Institution engages with international standards committees to influence the inclusion of human factors, including usability and environment of use requirements, in medical device and medical electrical equipment standards.
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:
- The BSI standardisation committees team will identify what international standardisation committee(s) are responsible for human factors, alarms and infusion pumps, and work to influence development of an international standard.
- BSI will convene other national standards bodies to discuss patient safety investigations and feeding the recommendations back into the standards, thereby closing the feedback and continuous improvement loops.
Response received on 13 February 2024.