IOM Calls for New Regulatory Framework To Replace Flawed 510(k) Medical Device Clearance Process
Washington, DC, July 29, 2011—The U.S. Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new report from the Institute of Medicine.
CDC Issues Infection Prevention Guidance for Ambulatory Care
NQF Releases Updated Serious Reportable Events
Awarepoint Corporation Announces Acquisition of PCTS
The Joint Commission Launches Advanced Certification in Palliative Care Program
New Product is the Only FDA-Cleared Wound Debridement and Cleansing Solution Containing Chlorhexidine Gluconate
Atlanta, Georgia, March 7, 2011—Hospitals finally have an alternative to saline irrigation with the introduction of IrriSept®, the first and only FDA-cleared wound debridement and cleansing system containing chlorhexidine gluconate (CHG).
Interoperability and Actionable Intelligence: Future Requirements, Current Possibilities
Interoperability and Actionable Intelligence: Future Requirements, Current Possibilities
Government requirements for “meaningful use” of electronic health records (EHRs) have focused national attention on the need to integrate and computerize a patient’s medical records to improve performance and support patient care processes.
Standards for Medical Device Interoperability and Integration
Standards for Medical Device Interoperability and Integration
At the point-of-care, medical devices provide clinicians with real-time status of the patient’s condition, including the patient’s vital signs. This data is vital for treatment and can be a critical aspect of patient safety since it provides near real-time surveillance of patient status to locations beyond the patient’s bedside.
The Case for Regulating EMRs
The Case for Regulating EMRs
Papers reporting serious adverse events (Nebeker, 2005; Yong, 2005) relating to the use of commercial healthcare IT (HIT) applications received significant publicity in 2005. Many of the reports at that time focused on the configuration of decision support systems used in computerized physician order entry (CPOE) systems.
FDA Working to Prevent Radiation Overdoses During CT Scans
The U.S. Food and Drug Administration has been investigating reports that patients undergoing computed tomography (CT) brain perfusion scans were accidentally exposed to excess radiation.