Designing Alarms in medical Devices to Address the Hospital Concerns
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)