Considering patient safety in autonomous e-mental health systems - Detecting risk situations and referring patients back to human care

Background: Digital health interventions can fill gaps in mental healthcare provision. However, autonomous e-mental health (AEMH) systems also present challenges for effective risk management. To balance autonomy and safety, AEMH systems need to detect risk situations and act on these appropriately. One option is sending automatic alerts to...

An extended protocol for usability validation of medical devices: Research design and reference model

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a...

Task analysis of information technology-mediated medication management in outpatient care

Aims Educating physicians in the procedural as well as cognitive skills of information technology (IT)-mediated medication management could be one of the missing links for the improvement of patient safety. We aimed to compose a framework of tasks that need to be addressed to optimize medication management in outpatient care. Methods Formal task...

Pediatric Mïcrodose and Microtracer Studies Using 14C in Europe

Important information gaps remain on the efficacy and safety of drugs in children. Pediatric drug development encounters several ethical, practical, and scientifîc chaflenges One barrier to the evaluation of medicines for children is a lack of Innovative methodologies that have been adapted to the needs of chiIdren This article presents our...

The ecometric properties of a measurement instrument for prospective risk analysis in hospital departments

Safety management systems have been set up in healthcare institutions to reduce the number of adverse events. Safety management systems use a combination of activities, such as identifying and assessing safety risks in the organizational processes through retrospective and prospective risk assessments. A complementary method to already existing...

With how many users should you test a medical infusion pump? Sampling strategies for usability tests on high-risk systems

Usability testing is recognized as an effective means to improve the usability of medical devices and prevent harm for patients and users. Effectiveness of problem discovery in usability testing strongly depends on size and representativeness of the sample. We introduce the late control strategy, which is to continuously monitor effectiveness of...

Impact of the physical environment of psychiatric wards on the use of seclusion

BACKGROUND: The physical environment is presumed to have an effect on aggression and also on the use of seclusion on psychiatric wards. Multicentre studies that include a broad variety of design features found on psychiatric wards and that control for patient, staff and general ward characteristics are scarce.AIMS: To explore the effect of...

Patient safety in midwifery-led care in the Netherlands

Objective: to describe the incidence and characteristics of patient safety incidents in midwifery-led care for low-risk pregnant women. Design: multi-method study. Setting: 20 midwifery practices in the Netherlands; 1,000 patient records. Population: low-risk pregnant women. Methods: prospective incident reporting by midwives during 2 weeks;...

Methods for studying medical device technology and practitioner cognition: The case of user-interface issues with infusion pumps

Purpose : The aims of this study were to investigate how a variety of research methods is commonly employed to study technology and practitioner cognition. User-interface issues with infusion pumps were selected as a case because of its relevance to patient safety. Methods : Starting from a Cognitive Systems Engineering perspective, we developed...

The electronic locum record for general practitioners: Outcome of an evaluation study in the Netherlands

Background: A locum practitioner is an out-of-hours general practitioner who needs access to the electronic health record of visiting patients. The electronic locum record is a summary of the electronic health record available to the locum practitioner and includes the most significant health problems, the most recent records of the patient's...

Human factors in the operation room

Strategies for the prevention of MP3-induced hearing loss among adolescents: Expert opinions from a Delphi study

OBJECTIVE. To identify parties involved in the prevention of MP3-induced hearing loss among adolescents and potentially effective prevention strategies and interventions. METHODS. Thirty experts in fields such as scientific research, medical practice, community health professions, education, youth work, music entertainment, and enforcement...

Teams and cardiac surgery

Motivation - Our study is designed to identify human factors that are a threat to the safety of children with heart disease. Research approach - After an initial observation period, we will apply a major safety intervention. We will then re-measure the occurrence and types of human factors in the operating room, and the incidence of adverse...

Electromagnetic interference from radio frequency identification inducing potentially hazardous incidents in critical care medical equipment

Context: Health care applications of autoidentification technologies, such as radio frequency identification (RFID), have been proposed to improve patient safety and also the tracking and tracing of medical equipment. However, electromagnetic interference (EMI) by RFID on medical devices has never been reported. Objective: To assess and classify...