Medical Devices (MDs) are by definition safety-critical and increasingly also become security-critical when interoperating, i.e., when communicating in some form. Finding errors, inconsistencies, or vulnerabilities in MDs before deployment can significantly decrease costs, and increase quality and reliability. In this paper, we present a rigorous “correct-byconstruction” approach for modeling a...

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focuse...

BACKGROUND Unlike medical lasers, intense pulsed light (IPL) devices are largely unregulated and unclassified as to degree of safety hazard. With the exception of most of the USA, the United Kingdom and parts of Europe, the Far East and Australia, the sale of IPLs is generally unrestricted, with the majority being sold into the beauty therapy and spa markets. Standards are only imposed on manuf...

SUMMARY Non-safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting agile practices. Through performing a literature review, this research has identified the perceived barriers to following agile practices when developing medical device software. A que...

The insulin pump is a safety-critical embedded medical device used for treatment of type 1 and insulin treated type 2 diabetes. Malfunction of the insulin pump will endanger the user’s life. All countries impose some regulation on the sale and use of medical devices. The purpose of such regulation is to protect the public by imposing standards of safety for medical devices, including insulin pu...

Background: Today, patient safety is an important issue in providing hospital services. Any failure in this area can cause undesirable consequences. Objective:  The present study evaluated the status of patient safety culture in Educational Hospitals of Tehran, Iran. Methods: This cross-sectional study surveyed 205 therapeutic and d...

IMPORTANCE Under the 510(k) process, the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is "substantially equivalent" to a device or devices already on the market (predicate...

1136 The US Food and Drug Administration (FDA) is among the oldest agencies in the federal government. Its origins can be traced back to 1862, when President Abraham Lincoln appointed a chemist, Charles M. Wetherill, to serve in the Department of Agriculture. One of the key early pieces of legislation that initiated the evolution of the FDA into its modern form was the 1906 Pure Food and Drug A...

Our goal is to improve patient outcomes and safety through medical device interoperability. To achieve this, it is not enough to build a technically perfect system. We present here our work toward the validation of middleware for use in interoperable medical cyber-physical systems. This includes clinical requirements, together with our methodology for collecting them, and a set of eighteen ‘des...