What are the recommendations for managing Medical Device Data Systems (MDDS) in a clinical setting?

Managing Medical Device Data Systems (MDDS) in Clinical Settings

Medical Device Data Systems (MDDS) should be managed with proper alarm customization, data assessment, and interdisciplinary oversight to reduce alarm hazards and improve patient safety in clinical settings. 1

Definition and Importance of MDDS

• MDDS are systems that route alarms to care providers' wireless devices using alarm algorithms and can collect alarm data in multiple formats such as tables or graphs 1
• These systems can handle unlimited numbers of alarms, which can be sorted by frequency, duration, unit, bed, or time 1
• MDDS play a critical role in monitoring patients and ensuring timely response to clinically significant alarms 1

Key Recommendations for MDDS Management

Establish an Interdisciplinary Committee

• Form teams composed of nurses, physicians, clinical engineers, quality and safety experts, IT professionals, and senior hospital leadership 1
• Some teams should also include representatives from monitoring equipment manufacturers and families of patients 1
• This interdisciplinary approach is essential for addressing alarm management effectively 1

Implement Alarm Customization

• Customize monitor alarms based on individual patient needs to decrease nonactionable alarm signals 1
• Revise default alarm settings based on patient-specific requirements 1
• Focus on the most frequent, duplicative, and staff-perceived "nuisance" alarms to reduce high-priority alarm signals 1

Conduct Regular Alarm Data Assessment

• Collect alarm signal data to identify types of alarm conditions within the monitoring system 1
• Use MDDS with annotation, direct observation, or video recording to evaluate alarm patterns 1
• Assessment of alarm data is essential in evaluating the effect of alarm reduction interventions 1

Optimize Technical Aspects

• Ensure proper skin preparation before electrode placement to enhance conductivity of signals 1
• Clean the area and wipe with a dry washcloth; avoid alcohol as it dries the skin and diminishes electric flow 1
• Consider clipping excessive hair before electrode application to optimize signal acquisition 1

Addressing Alarm Fatigue and Response Issues

• False and nonactionable alarms can lead to desensitization and the "cry wolf" effect, causing staff to develop mistrust in the alarm system 1
• Response time to alarms increases incrementally as the number of nonactionable alarms increases 1
• If an alarm signal is perceived to be reliable 90% of the time, the response rate will be approximately 90%; conversely, if perceived to be 10% reliable, the response rate will be only about 10% 1

Monitor Watcher vs. MDDS Considerations

• Monitor watchers may be based on the unit, in a nearby ICU, or in a central remote location 1
• The number of waveforms a monitor watcher can effectively observe is limited; as patient loads increase, response times increase significantly 1
• Using voice badge technology can significantly shorten the time to first contact, completion time, and improve closed-loop communication 1

Regulatory Considerations

• Medical device software like MDDS may require FDA clearance due to potential risks when interconnected with medical devices 2
• Hospitals implement MDDS because the technology allows nursing staff to spend more time on direct patient care and reduces charting errors 2
• MDDS vendors should have appropriate quality and risk management procedures to ensure development of the safest products possible 2

Integration with Healthcare Standards

• To represent medical device observations in a format consumable by clinical software, standards like HL7v3 and ISO/IEEE 11073 should be used jointly 3
• Standardization enables data exchange and decision support across different systems 3
• This standardization allows for flexible inclusion of device models and generation of needed artifacts for secondary uses 3

Common Pitfalls and How to Avoid Them

• Excessive false alarms leading to alarm fatigue and desensitization 1
• Inadequate alarm response due to mistrust in the system 1
• Improper skin preparation leading to poor signal quality 1
• Lack of alarm customization resulting in unnecessary interruptions 1
• Insufficient interdisciplinary collaboration in alarm management 1

By implementing these recommendations, healthcare facilities can optimize their MDDS to improve patient safety, reduce alarm fatigue, and ensure timely response to clinically significant alarms.