Regulations/Standards
Smiths Medical (St. Paul, MN) has issued a recall for its BCI Remote Alarm Cables, designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) System.
The Joint Commission (TJC) has issued a Sentinel Event Alert regarding excessive medical alarms. The recommendations include preparing an inventory of alarm-equipped medical devices and tailoring alarm settings and limits for individual patients.
A rebuttal to the November 2012 “Soapbox” column by Eliezer Kotapuri on the Interpretive Guidelines revised by CMS in December 2011.
The Food and Drug Administration has issued a proposed order that would require manufacturers of automated external defibrillators to submit pre-market approval (PMA) applications.
The FDA advises biomedical engineering, anesthesiology, and risk managers of the Class I Recall Spacelabs anesthesia workstations and service kits due to a defect in CAS I/II absorbers.
Joint Commission Resources (JCR) makes available a guide that includes a compliance checklist for all hospital standards and Elements of Performance (EP).
The Enforcement Report for the week of March 20, 2013 lists the continuing recall of the Elekta Synergy XVI, a radiation therapy digital imager.
Joint Commission Resources (JCR) has completely revamped its standards tome for 2013.
The FDA Enforcement Report for the week of March 13, 2013, lists the ongoing recall of the Philips digital Diagnost stationary radiographic system.
Beckman Coulter Inc, Brea, Calif, continues its Class II Recall of the Beckman Coulter AU5800 clinical chemistry analyzer.
