The purposes of this study were to determine whether registered nurses are familiar with the Health Canada Medical Device Problem Report Form, and if so, how often they use it to report problems and concerns compared to how often they experience problems and concerns with medical devices. A survey was mailed to a random sample of 1,000 Ontario nurses to collect demographic information and to de...

Wearable blood processing devices offer an attractive solution to problems inherent in clinic-based, intermittent end-stage renal disease therapies. What is involved in transitioning even a part of the current clinic-based population to ambulatory therapy has not been clearly enumerated. This paper addresses what a first-generation wearable device might accomplish, how issues of safety will nee...

introduction : pre-hospital emergency systems provide service by franco-german and anglo american models. this study was carried out to compare the iranian emergency medical service (ems) with the two models regarding timing and equipment. methods : in this cross sectional study, response time, scene time, and transport time to hospital as well as ambulance equipment of five hundred thousand te...

background: understanding the nature and causes of medical adverse events may help their prevention. this system­atic re­view explores the types, risk factors, and likely causes of preventable adverse events in the hospital sector. methods: medline (1970-2008), embase, cinahl (1970-2005) and the reference lists were used to identify the stud­ies and a structured narrative method used to synthes...

This paper presents a holistic methodology for the design of medical device software, which encompasses a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to pr...

T he Food, Drug and Cosmetic Act of 1938 (the Act) required manufacturers to provide evidence of safety to the Food and Drug Administration (FDA) before drugs could be marketed. Amendments to the Act in 1962 added the requirement of demonstration of effectiveness to the condition for approval (21 CFR 314).1 The Medical Device Amendments of 1976 extended these controls to devices, establishing a...

BACKGROUND Machine learning methods may complement traditional analytic methods for medical device surveillance. METHODS AND RESULTS Using data from the National Cardiovascular Data Registry for implantable cardioverter-defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used...