HHS updating health care emergency preparedness guidelines
The Department of Health & Human Services' Office of the Assistant Secretary for Preparedness & Response (ASPR) is seeking feedback on its 2017 Health Care Preparedness and Response Capabilities draft.
The draft is an update to its 2012 guidance, and outlines objectives for the nation’s health care delivery system to prepare for, respond to and recover from emergencies. ASPR’s Hospital Preparedness Program is the only source of federal funding that promotes a sustained national focus to improve patient outcomes, minimize the need for supplemental state and federal resources during emergencies, and enable rapid recovery.
The four capability goals outlined in the guidance are:
- Establishing a foundation for health care and medical readiness
- Health care and medical response and recovery coordination
- Continuity of health care service delivery
- Timely and efficient care during a medical surge
CDC study shows improved hand hygiene associated with decreased HAIs
Researchers have looked into what effect increasing hand-hygiene compliance from high to very high could have on health care-associated infections. During the 17-month period, the research team at the University of North Carolina Health Care made 140,000 unique hand-hygiene observations as the health system increased its compliance from 82.6 percent to 95.9 percent.
Researchers say they “noted a significant increase in overall hand-hygiene compliance rate and a significantly decreased overall HAI rate, supported by 197 fewer infections and an estimated 22 fewer deaths. These reductions resulted in an overall savings of U.S. $5 million.”
The study will be published in the September issue of the Centers for Disease Control and Prevention’s Emerging Infectious Diseases journal.
NIOSH proposes increasing risk level on cleaning agent used in health facilities
The National Institute for Occupational Safety and Health (NIOSH) has proposed to raise the Immediately Dangerous to Life or Health (IDLH) Value Profile for peracetic acid. Peracetic acid is used in products as a cleanser and disinfectant. It has been used in health care facilities and for disinfection of medical supplies.
In its proposal, NIOSH referred to a study that shows exposure to the chemical in certain quantities for as little as 12 minutes can cause slight to mild irritation. Prolonged exposure for 60 minutes can cause extreme discomfort, including lacrimation and mucous membrane irritation.
NIOSH posted a notice in the Federal Register to seek further comments on the draft IDLH Value Profile for peracetic acid.
AAMI enters Phase 2 of national clinical alarm management initiative
The National Coalition for Alarm Management Safety, part of the Association for the Advancement of Medical Instrumentation, has developed its Phase 2 goals to provide best practices and resources to hospitals in clinical alarm management.
During Phase 2, the group plans to:
- Develop a mentorship program in which hospitals with more mature alarm management practices can advise other hospitals.
- Add ventilator alarms to the group’s scope of work.
- Create resources to help hospitals develop alarm defaults for particular profiles of patients and develop rules/algorithms to improve alarm notification from the primary device or through middleware to reduce clinician alarm fatigue.
- Help hospitals to implement American College of Cardiology and American Heart Association guidelines to prevent unnecessary telemetry monitoring.
- Address alarm sounds to be used in future iterations of the IEC 60601-1-8 design standard.
- Develop basic guidelines to help clinicians understand the parameters and defaults better for physiological monitors and ventilators and why, when and how to customize default parameters for particular patients.
Dräger recalls VentStar Oxylog 3000 pediatric patient breathing circuit
On May 31, Dräger sent an Urgent Medical Device Recall letter to customers regarding its VentStar Oxylog 3000 disposable pediatric patient circuit, which the Food and Drug Administration has identified as a Class I recall.
The company discovered that the product’s check valve may leak, resulting in the patient's rebreathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This can lead to serious health consequences, which could result in death.
ASHRAE standard to unify building energy-rating systems
The American Society of Heating, Refrigerating, and Air-Conditioning Engineers is creating Standard 214P, Standard for Determining and Expressing Building Energy Performance in a Rating Program, to provide a unified approach for determining and expressing building energy performance in a rating program. The standard also will establish minimum requirements for rating-program documentation.
The proposed standard is open for public comment until Sept. 19.
FDA updating recommendations on submitting 510(k) for device modifications
The Food and Drug Administration (FDA) issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” says Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”