Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system.

Objectives: This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement. Design: This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency. Setting: Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA. Participants: Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement. Main outcome measures: To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied. Results: The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems. Conclusions: This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied.

Current status of medical device malfunction reporting: using end user experience to identify current problems.

INTRODUCTION: The current under-reporting of medical device malfunctions, difficulties with the current system and absence of continuous good-quality data has removed the possibility for constant data interrogation and trend recognition to identify evolving issues. This research used end user experiences aiming to understand causes for the lack of data and knowledge on device performance and associated patient risks. This approach was used to identify existing barriers and methods for improvement. METHODS: This is a qualitative study involving semistructured interviews and surveys with clinicians (15 interviews, 39 surveys) and manufacturers (13 interview participants, 5 surveys). Multiple sources of recruiting were used. Data collected were thematically analysed. Interview results were used to design the surveys. Standards for Reporting Qualitative Research was used. RESULTS: Medical device use is based on personal experience rather than evidence which is scarce. Multiple barriers to reporting were identified alongside patient safety and system related aspects. Furthermore, the acceptable level of error was variable as were effects on working practice. Many workarounds have been developed to overcome problems and have become normalised in daily work. These factors were found to have a limiting impact on improvements and learning. Greater system transparency, feedback on submitted reports, a more efficient system of reporting and better communication with manufacturers were reported as some of the required improvements. CONCLUSIONS: This study has identified numerous complex issues affecting reporting of medical device performance and their subsequent effect on patient safety and clinical staff. The focus on incidents has created many limitations to learning and development. The rich experience of end users should be appropriately used to identify system weaknesses and seek improvement methods. Better communication methods should be developed between healthcare and MedTech (Medical Technologies) industry.

Usability challenges in the use of medical devices in the home environment: A systematic review of literature.

BACKGROUND: Home care medical devices are the fastest-growing segment of the medical device industry with associated safety and usability challenges. Human factor studies in the home environment present many difficulties resulting in limited knowledge of device use in this setting. This systematic review aims to identify usability challenges reported directly by end-users in the home environment. METHODS: A systematic review of the literature was conducted concentrating on studies involving end user reporting. Reported challenges were grouped into a) device-user, b) device use environment and c) device-user interface challenges. RESULTS: 3471 studies were screened and 202 underwent full-text review. Only twelve studies had direct involvement of end users. Multiple challenges were identified, with device-user interface problems being the most common. No effective, standardised method was found to collect patient/user feedback on usability challenges in the post-market stage, leading to a knowledge gap. CONCLUSIONS: This study brought together multiple usability challenges reported by individual studies. Involvement of medical device end-users in usability studies is essential and their experiences must be effectively utilised in device design.