FDA Guidance on Medical Devices for Home Use

Home use of medical devices includes both prescription and over-the-counter products. Among prescription devices, some may be intended by the manufacturer to be used at home, and others may not have that intent but are provided nonetheless to patients by or through prescribers. All home use devices raise basic questions.

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Standardization of Color-Coded Alerts: Time for a National Effort

In 2005, the Pennsylvania Patient Safety Reporting System received a report of a near miss that brought up a new issue in the nursing field. It involved a nurse who worked in two hospital facilities; one facility used yellow wristbands for limb restrictions (do not use this limb) and the other facility used them to indicate DNR (do not resuscitate). This nurse had a patient with arm restrictions. So, well-intentioned, she placed a yellow wristband on the patient’s arm.

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First Databank Releases FDB AlertSpace Alert Management Solution

First Databank (FDB), the leading provider of clinical drug knowledge that improves medication-related decisions and patient outcomes, has announced that FDB AlertSpace, a web-based solution for drug knowledge alert management in CPOE systems, will be made available to Siemens Soarian Clinicals customers and Siemens Pharmacy in-house computing option (ICO) users.

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FDA Issues Proposed Rule to Determine Safety and Effectiveness of Antibacterial Soaps

 

 

The U.S. Food and Drug Administration has issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.

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90% of States Get Failing Grade for Making Consumer Information on Physician Quality Available

To shed light on the availability of information for consumers on the quality of their doctors, a new scorecard finds the vast majority of states get a failing grade – D or F. Developed by the non-profit Health Care Incentives Improvement Institute (HCI3), the State Report Card on Transparency of Physician Quality Information found that only two states received an A Minnesota and Washington – and one state, California, got a C.

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