Past, Present, and Future Regulatory Aspects of Ventricular Assist Devices

Patel-Raman, Sonna; Chen, Eric A.

doi:10.1007/s12265-010-9225-3

Cited by 4 publications

(3 citation statements)

References 8 publications

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“…This has resulted in the formulation of norms and directives concerning the man–machine interface, usability, and risk analysis of possibly erroneous device management (5,9). Deficiencies in handling and man–machine interfacing could have massive impact on the success of devices, and missing communication has already been proven as a hidden technical source of subsequent medical problems (6,8,10).…”

Section: Discussionmentioning

confidence: 99%

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Intuitive Use and Usability of Ventricular Assist Device Peripheral Components in Simulated Emergency Conditions

et al. 2011

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Ventricular assist devices (VADs) are now increasingly used to prolong the lives of end-stage heart failure patients. These patients vary greatly in age, alertness, activity, and home environment. In daily routine, but especially in emergencies or in conjunction with non-VAD-correlated diseases, the untrained, intuitive use and application of VAD peripherals by relatives, laypersons, and paramedics becomes important. Correct intuitive use may be a matter of life and death. The aim of this study was to evaluate the intuitive usability of these systems and to identify key features needed to optimize intuitive use. Paramedics (n=96) were confronted with a simulated emergency situation involving VAD peripherals mounted on a dummy. Three conditions were simulated: the VAD disconnected from its power source (n=44); both VAD batteries empty (n=44); and a discharged VAD battery mistakenly connected in place of a charged one (n=8). Two VAD systems were assessed: the Heartware HVAD and the Thoratec HeartMate II. An appropriate emergency card developed by our center was available in each case. Actions were videotaped, response times were measured, and a standardized questionnaire was completed after the simulation. The problem was solved by 71% of the participants (HVAD 83%, HMII 60%) with 87% using the emergency card. Only 4% could solve the problem without. Cardiac massage, which was unnecessary, was started by 44%, while 18% complained about unnecessarily difficult conditions (e.g., irritation from the acoustic alarm, complexity of the emergency card, error-prone procedures). Better component labeling (e.g., displays, control elements, connectors) was recommended by 56%. A thoroughly color-coded connection system was especially desired. Cable- and connector-related difficulties were reported by 23%. The study indicated that VAD systems should be self-explaining, with clear labeling of components and connectors, that a clearer emergency card is pivotal and that similar basic handling and emergency procedures for all VAD types would be desirable.

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Section: Discussionmentioning

confidence: 99%

“…In our center, we experienced over the years one fatal outcome due to misinterpretation of alarms and several critical situations (7). Also, other groups have become aware of the influences of usability of components on safety and quality of life (8–10).…”

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confidence: 99%

Intuitive Use and Usability of Ventricular Assist Device Peripheral Components in Simulated Emergency Conditions

et al. 2011

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“…Today, usability has become a common issue in the development and application of medical devices and has already led to international standardization . First studies on VAD usability were performed based on questionnaires and practical tests . In international use, the translation of messages and material, as required by European guidelines , can also cause misunderstandings with important consequences .…”

Section: Discussionmentioning

confidence: 99%

Usability of Ventricular Assist Devices in Daily Experience: A Multicenter Study

et al. 2014

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In daily life, the safe, intuitive use of ventricular assist devices (VADs) and especially their peripheral components is not only a question of life quality, but also sometimes crucial for survival. To investigate the advantages and disadvantages of different systems and to get patient feedback on preferred features, a multicenter study was initiated. Based on previous single-center studies, a questionnaire was developed to ascertain patients' experiences, difficulties with, and desires concerning use of the system. This questionnaire was provided both to ongoing patients and to new VAD patients after a minimum hospital discharge time of 6 weeks, at a regular checkup. Additionally, the patients completed a standardized questionnaire on life quality (Kansas City Cardiomyopathy Questionnaire). The centers that contributed to this study were Bad Oeynhausen, Berlin, Hannover, and Vienna. Three hundred fifty-two completed questionnaires on eight different pump types were obtained. An important result is that 42% of those questioned dropped their controller bag at least once. Depending on the device, between 2 and 55% disconnected it unintentionally. Confidence in safe use of the system decreased significantly with age, from 80% at age 20-30 years to 33% at 70-80 years. In devices with an LCD display, 94% considered the readability sufficient. Ninety-four percent considered the training adequate. Between 22 and 88% of the patients called the emergency telephone hotline, depending on the device, and 23-46% depending on the center. This first multicenter study on VAD usability reveals considerable differences among devices and centers. The comparative assessment aims to help optimize device design, patient management, and training.

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