IOM tells FDA to develop new regulatory pathway for medical devices
- ADVANCED SAFETY IN TIVA-TCI. // Operating Theatre Journal;Aug2012, p12
The article reports the launch of the new dedicated range of TIVA-TCI Multiple-Infusion Administration Sets by Global Components Medical Ltd, and several safety issues raised are highlighted.
- How can we get high quality routine data to monitor the safety of devices and procedures? Campbell, Bruce; Stainthorpe, Andrew C.; Longson, Carole M. // BMJ: British Medical Journal;5/11/2013, Vol. 346 Issue 7907, p21
The article informs that medical devices and new procedures are introduced using very few result documents from clinical trials and observational data. It states that it is absolutely necessary to gather sufficient information about the adverse events of these devices and procedures. It is...
- NICE publishes positive final guidance on device for use luring electro surgery. // Journal of Perioperative Practice;Jan/Feb2013, Vol. 23 Issue 1/2, special section p22
No abstract available.
- Industry News. // MLO: Medical Laboratory Observer;Aug2015, Vol. 47 Issue 8, p4
The article reports on the draft guidance released by U.S. Food and Drug Administration (FDA) on requirements for direct marking of medical devices with a unique device identifier (UDI), and once finalized, will help labelers and FDA staff understand direct marking requirements of devices with UDI.
- Reviews. Safeguarding Adults and the Law -- Second edition. Jones, Simon // Nursing Standard;12/11/2013, Vol. 28 Issue 15, p30
The article reviews the book "Safeguarding Adults and the Law," second edition by Michael Mandelstam.
- INFECTION PREVENTION. Innovative medical devices improve patient safety. Cantrell, Susan // Healthcare Purchasing News;Mar2012, Vol. 36 Issue 3, p22
The article presents an overview of he challenges that health care facilities face when choosing new products and medical devices to be used in patient care. A discussion of products from several companies, including Medline Industries, H+H System Inc. and Tronex International, that can improve...
- Safety standards for care equipment: an overview. Leckie, Frances // Equipment Services;Jul2013, p60
The article describes the standards that are updated of equipment for medical care including hospital beds, mattresses and walkers. It states that bed frame should be designed to fit the mattress 12.5 deep in it. It mentions that charity organization Modern Humanities Research Association (MHRA)...
- Knee replacement: lessons from the airline industry. Logan, James; Moonot, Pradeep; Harvey, Adrian // British Journal of Healthcare Management;Sep2013, Vol. 19 Issue 9, p452
In the current global financial situation, the NHS is under pressure to cut costs and increase productivity without affecting patient outcomes. One area that has been targeted is the procurement of joint replacement hardware. In this article, the authors describe the process for change of total...
- Post-market scrutiny sought. Lee, Jaimy // Modern Healthcare;1/21/2013, Vol. 43 Issue 3, p4
The article reports that the U.S. Food and Drug Administration's (FDA) proposal to require metal-on-metal hip implant manufacturers to prove their devices are effective and safe has resulted to calls for an improved post-market surveillance system for all medical devices.
- How a fake hip showed up failings in European device regulation. Cohen, Deborah // BMJ: British Medical Journal;10/27/2012, Vol. 345 Issue 7880, p19
The article reflects on the incompetence of the European system of regulating medical implants after a series of high profile device failures and recalls, necessitating additional investigations and revision surgery for a large number of patients. It opines that the weakest link in this system...