1. National Coalition to Promote the Continuous Monitoring of Patients on Opioids Marilyn Neder Flack AAMI Foundation IPI Conference April 21 and 22, 2016

2. Association for the Advancement of Medical Instrumentation (AAMI)  Non Profit – 50 years young  8000 individual members or 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

3. 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

4. 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

5. 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

6. 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."

7. 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 7

8. 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. 8

9. 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 – Arouse patients, spur breathing – Left unmonitored 96% of the time – Must show deterioration at precise moment – Detect respiratory depression when in progress

10. 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

11. Coalition Kick-Off: November 13- 14, 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” 11

12. Barriers to Implementation Return on Investment – Business Case Clinical Culture & Education Patient Education Workflow Interruptions

13. 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

14. 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 135 beats, Sp02 36 breaths/min)

15. 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

16. 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 improvements- including 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).

17. Endorsed by…. 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

18. Coalition’s Next Steps Opioid Compendium http://s3.amazonaws.com/rdcms- aami/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 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