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Webinar on Designing Alarms in medical Devices to Address the Hospital Concerns

3/6/2014 10:00 AM - 11:30 AM

Overview:

Different strategies have been used to provide constant monitoring to sick patients in hospitals. Equipment and system designs have often incorporated the use of alarm systems, which alert the clinician when a certain value is outside its target range. Alarm systems, in general, were designed to signal the presence of a potential hazard requiring urgent attention and to summon the assistance of medical personnel. In the critical care setting, numerous monitoring systems are in place to manage each patient's complex - and often changing - hemodynamics and physiology. These include alarms from cardiac monitors, intravenous pumps, dialysis machines, compression devices and hospital beds, to name a few.

One of the major hazards in monitoring the condition of critically ill patients is called alarm fatigue. It is a clinical scenario that may occur when an alarm sounds so often that the responders become desensitized to it and may not respond quickly enough - or at all. Failure of alarm discriminability, the clinician's ability to distinguish one medical device alarm from another to respond correctly to the actual alarm, is another major hazard. Problems with alarm volume may occur when the alarm sound is not loud enough, can't be adjusted to be loud enough for the responder to hear, or when settings have been changed and not reassessed frequently enough. Issues with alarm activation thresholds also occur when the sensitivity levels for a given medical device alarm are adjusted based on a clinical situation or environment and are left at that setting and not readjusted for a new patient or new clinical situation.

There are numerous alarm-related hazards within medical devices used by patients, as well. Such devices include medication-dispensing systems, pocket phones, pagers and telephones alarm systems. Reducing alarm-related mishaps requires the utilization of risk management methods by device manufacturers in close association with hospital staff such as nurses, and other care givers. An ideal situation would be one in which hospitals and manufacturers would develop solutions together. The FDA is taking the first step by intensifying its pre-market review of medical devices. The Joint Commission, the national organization that accredits hospitals, is planning to survey hospitals and nursing homes and evaluate these devices.

Areas Covered in the Session:

Alarm related death reports

Alarm Fatigue and causes

Inconsistent use of alarms

Understand risk to patients due to lack of response/malfunction

Systems Approach to alarm design

Assemble a multidisciplinary team

Review recent events and near misses

Nurses and other staff about their concerns

Observe alarm coverage processes and ask

Human factors considerations

Identify the most important alarms to manage based

on their own internal situations

Noise considerations

Quality of signal considerations

Determining right boundaries for alarms

Requirements for actionable alarms

Avoiding false alarms

Distinguishing from service alarms

Selecting the alarm thresholds

Distinguishing an urgent or critical alarm from the others

Standardizing alarm strategy

Better technology to improve the safety

FDA Preventive Actions

Who Will Benefit:

R&D and Engineering Managers

Design and Development

Quality Engineers

Manufacturing Engineers

Quality Auditors

Product Safety Managers

Manufacturing Managers

Medical staff evaluating risk, safety or effectiveness

Quality or regulatory staff assigned to complaint, CAPA or MDR management

Marketing Managers

Training Personnel

General/corporate counsel

IT Managers

Device Customers (nursing staff)

Dev Raheja MS,CSP, author of Safer Hospital Care: Strategies for Continuous Innovation, is an international risk management, patient safety and quality assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering.

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinars@globalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1n6JwPf

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