On April 2, the FDA announced that respiratory equipment manufacturer Dräger has issued a recall of its optional PS500 power supply unit used with the Evita V500 and Babylog VN500 ventilators.
In response to the December 2013 CMS letter on preventive maintenance, The Joint Commission has updated its requirements. In a March 4 publication, the organization announced two new “elements of performance” on maintenance of medical equipment and utility systems.
With The Joint Commission’s mandate to improve management of alarms now in effect, hospitals are now going all out to inventory their systems. To establish alarm management as an organizational priority, top hospital leadership must set the tone.
On January 10, the FDA announced that that Covidien’s Puritan Bennett 840 Series Ventilator has been recalled due to a software problem. The agency issued the Class 1 recall because a software error could set off an alarm and disable the ventilator.
The Joint Commission has posted an overview of the 2014 National Patient Safety Goals on its website, covering topics from clinical alarm safety and patient identification to medication safety and hospital-related infections.
The 2014 edition of the Facility Guidelines Institute’s Guidelines for Design and Construction of Hospitals and Outpatient Facilities is now available for preorder on its website.
The Joint Commission has released a new National Patient Safety Goal to deal with alarm systems starting January 1, 2014. Phase 1 begins January 1, 2014, and addresses awareness of potential risks, while Phase 2 establishes safety requirements.
Sunquest is calling on fellow industry leaders and stakeholders to encourage the Food and Drug Administration to regulate the emerging field of Health Information Technology to improve patient safety outcomes.
The US Food and Drug Administration has endorsed 12 IEEE standards on interoperability and cyber security, folding them into a larger list of 25 national standards for improving medical device communication.
Acertara Acoustic Laboratories, Longmont, Colo, announced on October 1, 2013, that its quality management system has been awarded both ISO 9001:2008 and ISO 13485:2003 certifications through Orion Registrar Inc.