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National Coalition to Promote
the Continuous Monitoring of
Patients on Opioids
Marilyn Neder Flack
AAMI Foundation
IPI Conference
April 21 and 22, 2016
Association for the
Advancement of Medical
Instrumentation (AAMI)
 Non Profit – 50 years young
 8000 individual members or
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representatives of:
– hospital, industry, government,
– R&D, QA/RA professionals, engineers,
– doctors, nurses, technicians, students,
– academic and government researchers,
– and consultant experts
 Over 300 corporate and institutional members
 FDA is “sustaining” member
Non-profit organization dedicated to:
Working with stakeholders to achieve safe adoption and
safe use of medical technology, resulting in improved
patient outcomes.
The Foundation engages the healthcare community in
solving healthcare technology issues that are:
• complex
• multidisciplinary
• require a systems approach
Current Initiatives
• National Coalition for Alarm-Management Safety (Launched April
2014)
• National Coalition to Promote Continuous Monitoring of Patients
on Opioids (Launched November 2014)
– The National Coalition for Infusion-Therapy Safety (Launched
March, 2015)
• Home Health Project- (Launched June 2015)
• NEW-launching in November 2016: Helping Hospitals Improve
How Clinicians are Prepared to Use Complex Technology
National Coalition to
Promote Continuous Monitoring of
Patients on Opioids
• Why this Coalition?.....The Background Story!
– Unintended consequence of opioids
• Affect part of brain that controls breathing
• Insufficient oxygen may lead to fatal respiratory depression and
cardiac arrest
– Increase in opioid-related adverse events
• More aggressive pain management standards tied to patient
satisfaction & reimbursement
• Increase use of PCA pumps (“PCA by proxy”)
• More complex patient population
Past Efforts to Monitor Patients on Opioids
On March 14, 2014, CMS issued guidance "Requirements for Hospital
Medication Administration, Particularly Intravenous (IV) Medications and
Post-Operative Care of Patients Receiving IV Opioids."
Problems Continue….
• Opioids are involved in almost half of all deaths
attributed to medication errors.
• Approximately one-third of code blue arrests in
hospitals are from respiratory depression, and about
0.3% of postoperative patients receive naloxone
rescue, accounting for up to 20,000 patients annually.
9/25/2013
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Problems Continue…
Approximately 350,000 to 750,000 in-hospital cardiac
arrests occur annually.
– Patients suffering unrecognized opioid-induced respiratory arrest on the
general care floor may make up a significant proportion of these deaths.
– Odds of survival for in-hospital arrest-- only one in five will survive to
hospital discharge.
– Patients in “unmonitored” beds—twice as likely as those in monitored
beds to receive delayed treatment.
– Patients arresting at night -only a 15% chance of survival until discharge.
Economic costs high:
one study of 40 M hospitalized patients – costs
associated with post-op respiratory failure totaled 2 billion dollars.
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Issues with Current
Standard of Care
1. Unrecognized Risk Factors
– Risk-prediction models are insufficient
– People with no known risk factors have died
– 75% of people with sleep apnea are undiagnosed
2. “Spot Checks” every 2-4 hours
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Arouse patients, spur breathing
Left unmonitored 96% of the time
Must show deterioration at precise moment
Detect respiratory depression when in progress
Why Continuous
Electronic Monitoring?
• Adverse events are typically preceded by 6-8
hours of physiologic instability
• Identifies subtle changes in respiratory
• Detects trends, analyzes, interprets
• Provides clinicians with actionable information
Coalition Kick-Off: November 1314, 2014 – Chicago
• Hospitals, patient advocates, representatives from 50+
national associations & societies, and industry-partners
joined together to:
– Present data
– Present best practices and strategies to overcome barriers
to adopting continuous monitoring
– Describe lessons learned
– Disseminate the conference proceedings freely & publicly
to the nation to ensure all hospitals have critical information
around “continuous monitoring leading practices”
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Barriers to
Implementation
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Return on Investment – Business Case
Clinical Culture & Education
Patient Education
Workflow Interruptions
Strategies to Overcome
Barriers
• ROI Data:
– Collect baseline data
• Measure rescue and transfer calls
– Report outcomes
• Financial and clinical metrics
– Cite payment models/reimbursement changes
Strategies to
Overcome Barriers
• Clinical Culture & Education:
– Resolve concerns
• Connectivity
• Ergonomic impact
• Perceived unreliability of systems
– Educate multi-disciplinary teams
• Interpreting data
• Assessing sedation levels
• Manage alarm limits (ex. Heart rate < 45 beats or >135 beats,
Sp02 < 85%, respiratory rates <6 or >36 breaths/min)
Strategies to Overcome
Barriers (cont.)
• Patient Education:
– Meet resistance to wearing monitoring devices by
providing visual education tools
– Explain alarms (i.e. false positives)
– Focus on empowerment
• Workflow Interruptions:
– Clarify policies
• Develop a technical support model, governance plans, data
retention, etc.
– Analytic or decision support tools
– Targeted messaging and feedback loop
Coalition’s Vision
Statement
We recommend improving the safety for in-patients receiving parenteral opioids
by supplementing ongoing assessments of sedation level and respiratory status
with continuous electronic monitoring and opioid sparing strategies (i.e..
multimodal analgesia) for timely detection of respiratory decompensation.
Experience from early adopters demonstrates that continuous respiratory
monitoring combined with education, culture change, and process improvementsincluding effective management of clinical alarms, increases the quality of patient
care in a financially sustainable manner.
– Staging the approach: Hospitals may implement this vision by using a staged
approach to address the necessary components, cited above, that are key to success,
and by implementing continuous electronic monitoring for patients included under
The Joint Commission’s Sentinel Event #49
(http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf).
Endorsed by….
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American College of Clinical Engineering (ACCE)
American Association of Nurse Anesthetists (AANA)
American Association for Respiratory Care (AARC)
American Society for Pain Management Nursing
(ASPMN)
Anesthesia Patient Safety Foundation (APSF)
A Promise to Amanda
Consumers Advancing Patient Safety (CAPS)
Hospital Quality Institute (HQI)
Infusion Nurses Society (INS)
Institute for Safe Medication Practices (ISMP)
Leah’s Legacy
Mothers Against Medical Error
Physician-Patient Alliance for Health & Safety
(PPAHS)
Premier Safety Institute
CHI Health–St. Francis
San Diego Patient Safety Council
Coalition’s Next Steps
Opioid Compendium
http://s3.amazonaws.com/rdcmsaami/files/production/public/FileDownloads/Foundation/Reports/2015_Op
ioid_Compendium.pdf
Patient Safety Seminars http://www.aami.org/PatientSafety/content.aspx?ItemNumber=2933&navIt
emNumber=3086
Safety Innovation Papers –
http://www.aami.org/patientsafety/content.aspx?ItemNumber=3116&navIt
emNumber=3168
Regional Events – Chicago: September 27 and 28, 2016