Annual Report 20

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AAMI Foundation Board of DirectorsChair Eamonn Hoxey E.V. Hoxey Ltd

Vice-Chair Phil Cogdill Medtronic

Treasurer Steve Yelton Cincinnati State Tech & Comm College

Secretary Robert Jensen AAMI President

Directors Sue Schade StarBridge Advisors

Ben Bulkley Trellis Rx

Michael Scholla Dupont

Patricia Shrader Medtronic

Matt Weinger, MD Vanderbilt University

Frank Overdyk, MD Independent Consultant

Leah Binder Leapfrog Group

Ronald Wyatt, MD Hamad Hospitals, Qatar

Gerald Castro The Joint Commission

Foundation LeadershipMarilyn Flack, Executive Director

Marilyn Flack is the senior vice president for patient safety initiatives and executive director of the AAMI Foundation. She leads the Foundation’s efforts to strengthen the development, management, and use of medical technology for improved patient outcomes, develops technology-related safety metrics, leads research efforts, and oversees all Foundation initiatives.

Prior to joining AAMI in 2013, Flack was director of the Division of Patient Safety Partnerships at the FDA’s Office of Surveillance and Biometrics in the Center for Devices and Radiological Health, where she worked with the nation’s thought leaders to solve problems with the use of medical devices, and participated in technology-related research. Previously, Flack was a director for clinical research and regulatory affairs for a medical device company, a premarket reviewer for the FDA, and worked in a variety of patient settings as an audiologist.

Jim Piepenbrink, Deputy Executive Director

Jim Piepenbrink is the deputy executive director of the AAMI Foundation. He coordinates the various coalition team activities to produce the deliverables, manages the social media aspects of the Foundation and collaborates with external partner organizations. Prior to joining the AAMI Foundation in 2016, Piepenbrink was the Director of Clinical Engineering at Boston Medical Center for 30 years. He has published more than 20 articles, participated in national

webinars and has presented on his research on the local, national and international level. Piepenbrink has served as an editorial board member for AAMI’s BI&T journal, as well as the Journal of Clinical Engineering and is currently a reviewer for the Journal of Critical Care Medicine.

Piepenbrink has a deep interest in patient safety. While at Boston Medical Center, his team was named a finalist three times by the ECRI Institute for a Health Devices Achievement Award, recipient of two $25,000 safety grants by the Boston Medical Center’s Patient Safety Foundation and was the recipient of the Gage Quality Award from America’s Essential Hospitals for their work on alarm management. In June of 2016, he was the recipient of the AAMI Foundation Clinical Solutions Award at the AAMI Annual Conference.

Dear Friends and Partners of the AAMI Foundation,

What a tremendous honor it is serving as the chair of the AAMI Foundation Board. Together, we accomplished an incredible amount of work to improve patient safety with healthcare technology.

I would like to thank our distinguished AAMI Foundation Board of Directors. Our Board is made up of the healthcare technology community’s very best. They volunteer their time and offer insight and energy to guide the Foundation’s most innovative and important work.

I also want to say a big thank you to our energetic Foundation Executive Director, Marilyn Flack and our Deputy Executive Director Jim Piepenbrink. The extraordinary team at AAMI Foundation has positioned the organization to succeed well beyond the Board’s expectations. Through collaboration with diverse stakeholders, they have generated new ideas and created high-impact initiatives to meet the needs of the healthcare community.

This year we have gained signifi cant traction in the areas of managing clinical alarms and promoting the continuous monitoring of patients on opioids, for which we won the American Society of Healthcare Executives (ASAE) 2016 Power of A Gold Award. Each year, the Power of A Awards recognize a select number of organizations that distinguish themselves with innovative, effective, and broad-reaching programs and activities that positively impact America and the world.

These achievements are a testament to the hard work of our passionate volunteers who are committed to ensuring the safety of all patients. These volunteers have shared their time, knowledge, leadership and talents—and it is because of them that we are able to evolve, engage and meet the needs of the healthcare community.

The AAMI Foundation is the only nonprofi t focused exclusively on solving technology-related patient safety issues and, as such, we have a robust plan for 2017 and beyond. With your support, the Foundation will drive continued success in the areas of clinical alarm management, reducing medication errors by focusing on infusion therapy safety, and preventing patient death from opioid-induced respiratory depression. In addition, we are launching a new effort to work with national stakeholders to improve how clinicians are trained to use complex healthcare technology.

Sincerely,

Eamonn HoxeyAAMI Foundation Board Chair

Letter to Our Friends

Together, we accomplished an incredible amount of work to improve patient safety with

I would like to thank our distinguished AAMI Foundation Board of Directors. Our Board is made up of the healthcare technology community’s very best. They volunteer their time and

I also want to say a big thank you to our energetic Foundation Executive Director, Marilyn

Healthcare technology is important to everyone’s well-being, especially when you or a loved one is in need of medical care. Healthcare technology has multiplied and advanced at an incredible pace, and plays a critical role in the quality of care patients receive. The benefi ts of advanced technology have contributed to a generation of healthier patients who live longer lives. However, the rapid advancement of technology necessitates a robust commitment to technology management across diverse stakeholder groups to ensure patients are receiving proper care.

The AAMI Foundation is a public charity 501(c)(3) with a mission to serve the public welfare and improve patient safety by promoting the safe adoption and safe use of healthcare technology. The AAMI Foundation collaborates with clinicians, professional societies, healthcare technology professionals, patient advocates, regulators, accreditors, industry, and other important stakeholder groups to identify and address issues that arise from today’s complex medical environment which have potential to threaten positive patient outcomes.

Priorities & Activities

To support the pursuit of patient safety nationwide, the Foundation has implemented several multiyear initiatives such as:

The National Coalition for Alarm Management Safety (April 2014 to December 2018) Hospitals no longer need to suffer from alarm fatigue (a situation where clinicians become desensitized to alarm signals in response to excessive frequency of nonactionable alarms), which can result in patient harm. The incredible body of work produced by the coalition members (papers, webinars, compendium, etc.) demonstrating best practices to reduce nonactionable alarms provides help to all hospitals regardless of where they are in their alarm management journey.

Additionally, three research projects are ongoing. First, development continues of a cloud-based database to house data from hospitals, researchers, and industry. Use of this “big data” set will lead to improved algorithms for detecting declining patient conditions. Second, research continues to make changes to the types of sounds made by alarms—changing from tones without meaning to alarms that have meaning and context so clinicians can easily understand what the sounds mean and know what type of problem the patient is

Tackling Urgent Issues in Healthcare Technology

experiencing. This is groundbreaking work and will be incorporated into international medical device standards. Third, development continues on a database designed to collect alarm parameter settings from the nation’s hospitals so all may compare settings and drive toward reducing nonactionable alarms. A second phase kicked off in July 2016. This phase is focused on moving beyond the basics of improving alarm management to developing and promoting more sophisticated methods to improve alarm management. Teams are working on the following projects: • Creating a mentorship program where the

more sophisticated hospitals will help other hospitals in the country improve alarm management

• Adding ventilator alarms to the work of the coalition and developing recommendations for methods to improve management of those alarms

• Creating alarm defaults for particular profiles of patients (e.g., pediatric)• Creating “rules” for improving alarm notification to reduce alarm

fatigue• Providing information to hospitals to move them to use of appropriate

monitoring of patients on telemetry• Developing training on alarm management for nurses

The National Coalition to Promote Continuous Monitoring of Patients on Opioids (November 2014 to December 2017)It is estimated that 3,000 to 5,000 patients per year die in the hospital from opioid-induced respiratory depression. This is totally preventable if the patient’s decline is detected and treated early. Some patients may deteriorate slowly over a period of hours, and some may rapidly decompensate. There is only one way to ensure all patients on opioids are safe from undetected respiratory failure—continuous electronic monitoring. During 2016, this coalition continued to engage with healthcare provider professional societies to raise their awareness of the need for clinicians to do this type of monitoring and to produce webinars and papers on this subject.

“The AAMI Foundation is a valued partner. Because of the incredible work of the AAMI Foundation, clinical nurse specialists have had opportunities to engage in inter-professional discussions on the safe utilization of healthcare technology to improve patient care, benefited from continuing education opportunities and built professional relationships that assist them in their day-to-day work. We look forward to working together, seeing how technology continues to shape the role of clinical nurse specialists in healthcare for years to come.”— National Association of Clinical Nurse Specialists

Executive Director Melinda Mercer Ray, MSN

National Coalition for Infusion Therapy Safety (March 2015 to December 2017)Medication errors are the number one reason for adverse events in hospitals. Throughout 2016, the AAMI Foundation continued to publish material for healthcare delivery systems showing ways to reduce medication errors associated with the use of infusion pumps. These various methods were offered via webinars, papers published in AAMI’s peer-reviewed journal, and “Quick Guides” for hospital senior leadership about the critical elements that must be in place to have an enterprise-level safe and robust infusion therapy program, and for bed-side nurses about how to reduce errors when multiple-lines are required for a patient’s infusions.

Home-Health Infusion InitiativeNew patient risks emerge as healthcare delivery moves from the hospital into the home and other nonmedical settings. Infusion therapy is one of the most common medical procedures migrating from the hospital to the home. The AAMI Foundation convened a national multidisciplinary team to provide a gap analysis comparing and contrasting the current state of how patients are transitioned from the hospital into the home with infusion therapy with the ideal state, and to offer strategies and recommendations to close the gaps. The work of the committee is completed and the report will be published in 2017, along with strategies and recommendations to mitigate risk and improve patient outcomes.

Each of these important programs is helping to advance patient safety and the safe adoption and use of healthcare technology. In addition to these initiatives, the Foundation is working

on other strategic objectives: continuously updating research agendas, developing projects for important patient safety topics such as The Joint Commission patient safety goals, conducting focus groups to determine emerging issues or reactions to new technologies, and many more.

“In an ever-changing and complex healthcare environment, where we strive to achieve positive patient outcomes, the AAMI Foundation has risen to the challenge. The Foundation embraces an interprofessional approach appreciating the clinical expertise and wisdom needed to address patient care issues associated with today’s advanced technologies. INS values the partnership we’ve established with the AAMI Foundation to identify evidence-based solutions that impact clinical practice and patient safety.”

— Mary Alexander, MA, RN, CRNI, CAE, FAANChief Executive Offi cer Infusion Nurses Society

National Coalition for Infusion Therapy Safety (March 2015 to December 2017)Medication errors are the number one reason for adverse events in hospitals. Throughout 2016, the AAMI Foundation continued to publish material for healthcare delivery systems showing ways to reduce medication errors associated with the use of infusion pumps. These various methods were offered via webinars, papers published in AAMI’s peer-reviewed journal, and “Quick Guides” for hospital senior leadership about the critical elements that must be in place to have an enterprise-level safe and robust infusion therapy program, and for bed-side nurses about how to reduce errors when multiple-lines are required for a patient’s infusions.

“In an ever-changing and complex healthcare environment, where we strive to achieve positive patient outcomes, the AAMI Foundation has risen to the challenge. The Foundation embraces an interprofessional

Patient Safety Seminars and Papers

This year the Foundation produced 12 complimentary patient safety seminars: two focusing on alarm management, five about monitoring patients on opioids, and five case studies on improving infusion therapy safety. Four papers were produced: two from our alarm coalition members, and two from our opioid coalition members. They were published in BI&T, AAMI’s peer-reviewed journal. Regional Events

The 2016 regional event was held in Chicago where 18 speakers covering topics from our three coalition efforts presented their strategies, lessons learned, and best practices to improve patient safety. The audience was comprised of clinicians, biomedical engineers, representatives from patient safety/healthcare organizations, pharmacists, respiratory therapists, and industry partners.

“Effective use of clinical technology has become essential to ensure patient safety and achieve optimal care outcomes. As a valued and respected catalyst, the AAMI Foundation seeks to create a collaborative environment where the right participants can have the right conversations. Critical-care nurses continue to benefit from this work, as do the patients and families for whom we provide care.” — Connie Barden, RN, MSN,

CCRN-K, CCNSChief Clinical Officer

American Association of Critical-Care Nurses

AAMI 2017 Foundation Goals Infusion Coalition

The primary goal of the coalition is to reduce medication errors related to infusion therapy. The Foundation will issue two remaining guides to help hospitals improve compliance with smart-pump drug libraries and to reduce pump alarms and create a body of knowledge to be promoted in 2018. Additionally, the Foundation will work closely with key stakeholders at the American Society of Healthcare Pharmacists to develop a research request for guidelines for when to use a large volume infusion pump versus a syringe pump on pediatric patients. The Foundation will seek funding from the FDA Center for Drug Evaluation and Research. Opioid Coalition

The Foundation will continue to work to prevent opioid-induced respiratory depression (OIRD). Through the creation of a nationwide campaign, we will inform patients and their loved ones about the risks and prevention measures of OIRD. The AAMI Foundation will engage

“The AAMI Foundation has been able to bring the appropriate interdisciplinary thought leaders together to address issues with technology to improve patient safety. Without these groups and all of the subsequent webinars and reference materials, the individual hospitals and health systems would be trying to address these items by themselves and more patients would be put at risk. It is my opinion that lives have been saved by addressing the issues together and having the reference material that has been available to clinicians around the country.”

— Nancy Blake, PhD, RN, CCRN, NEA-BC, FAANDirector, PCS Critical Care Services Children’s Hospital of Los Angeles

nursing organizations to develop a survey that the American Society for Healthcare Risk Management will send to its members to ascertain the current adoption of continuous monitoring of patients on opioids in hospitals and will publish the results.

The Foundation is committed to engaging fi ve hospitals in the evaluation of their pre and post continuous electronic monitoring patient outcome data to determine if the data is similar enough to be pooled and will publish the data in 2018.

Alarm Coalition

By guiding the nation to reduce nonactionable alarms, we will reduce alarm fatigue. The Foundation’s eight teams will create innovative deliverables. Leadership will ensure they stay in scope, on time, and have developed outcome measures to evaluate success of the team’s projects.

“The AAMI Foundation is a great source of knowledge for improving patient safety and quality. Within our own patient safety collaborative, we have leveraged speakers and materials from the Foundation’s Patient Safety Initiatives, including getting updates on the initiatives at our annual conference. This year, we again added the AAMI Foundation to the annual conference agenda because a member hospital wanted to hear the latest on the continuous monitoring of patients on opioids.”

— Rich ZinkManaging Director, Operations

Purdue University

Promoting the Safe Use of Complex Healthcare Technology Coalition

In order to ensure success of this Coalition, the AAMI Foundation hosted a kick-off meeting April 12 and 13 to set the agenda for the next two years. Teams established at the conference will work to develop scope, timeline, deliverable, and outcome measures that will be

used to determine success of the following projects:• Best practices for selecting and purchasing complex technology• Best practices for educating and training clinicians on

the use of complex technology• Best practices for establishing minimal levels of

profi ciency and for assessing that profi ciency• Building the business case for allocating fi nancial

resources to improve how clinicians are prepared for the safe use of complex technology

• Best practice for designing medical devices to improve usability Produce Regional Event

The AAMI Foundation will host a regional event in San Diego to raise awareness about the work of the Foundation and to multiply the safety messages. There will be approximately 20 presenters at a two-day event.

“What we are trying to do is use our collective resources to better triangulate our understanding of patient safety issues. The AAMI Foundation gives us the opportunity to share what we know—or don’t know—about new or emerging patient safety issues, helping us to direct future efforts.”

— Gerald M. Castro, PhDProject Director of Patient Safety Initiatives

The Joint Commission

Promoting the Safe Use of Complex Healthcare Technology Coalition

In order to ensure success of this Coalition, the AAMI Foundation hosted a kick-off meeting April 12 and 13 to set the agenda for the next two years. Teams established at the conference will work to develop scope, timeline, deliverable, and outcome measures that will be

“What we are trying to do is use our collective resources to better triangulate our understanding of patient safety issues. The AAMI Foundation gives us the opportunity to share what we know—or don’t know—about new or emerging patient safety issues, helping us to direct future efforts.”

2016 AAMI Foundation Award and Scholarship WinnersLaufman-Greatbatch Award

Roger G. Mark, MD, PhD (L); Ary L. Goldberger, MD; and George Moody—founders of PhysioNet—were selected to receive this award for their work over the past 20 years to collect and provide access to “big data” through the creation of PhysioNet. It is a free collection of recorded physiologic signals and related open-source software intended to stimulate current research and new investigations

The AAMI Foundation & ACCE’s Robert L. Morris Humanitarian Award

Roy Morris was the recipient of this award for his eight years of service around the world. Morris has helped design and construct healthcare facilities, train technical staff, organize equipment donations, and install and repair equipment in countries such as Ukraine, Honduras, Ecuador, and Iraq. He also was part of a 2010 earthquake disaster team in Haiti and organized a 2013 typhoon biomed response in the Philippines for Project HOPE, an international healthcare organization

The AAMI Foundation & Institute for Technology in Health Care Clinical Solution Award

James Piepenbrink was recognized for his commitment to combatting clinical alarm fatigue. At Boston Medical Center, Piepenbrink succeeded in reducing audible alarms from roughly 88,000 to 10,000 by creating a multidisciplinary team and prioritizing the problem across the organization.

Scholarship winnersJay McKinney

Sarah Brockway

Victor Makwinja

Conrad Robinson

2016 AAMI Foundation Award

Roger G. Mark, MD, PhD (L); Ary L. Goldberger, MD; and George Moody—founders of PhysioNet—were selected to receive this award for their work over the past 20 years to collect and provide access to “big data” through the creation of PhysioNet. It is a free collection of recorded physiologic signals and related open-source software intended to

Meaningful Partnerships The AAMI Foundation raises awareness about healthcare technology issues and develops solutions by working with co-convening organizations, such as The Joint Commission, the Food and Drug Administration, professional societies, healthcare technology groups, industry partners and like-minded patient safety organizations. Working together, we have the capacity to reach more than 1 million healthcare professionals.

American Association of Critical-Care Nurses (AACN)

American Nursing Association (ANA)

American Organization of Nurse Executives (AONE)

Infusion Nurses Society (INS)

National Association of Clinical Nurse Specialists (NACNS)

American Hospital Association (AHA)

American Association for Respiratory Care (AARC)

The Joint Commission (TJC)

Department of Veterans Affairs - National Center for Patient Safety

Food and Drug Administration (FDA)

National Patient Safety Foundation (NPSF)

ECRI Institute

Institute for Safe Medication Practices (ISMP)

American College of Clinical Engineering (ACCE)

American Society for Healthcare Risk Management (ASHRM)

Anesthesia Patient Safety Foundation (APSF)

Consumers Advancing Patient Safety (CAPS)

Healthcare Technology Foundation (HTF)

International Society for Rapid Response Systems (ISRRS)

Leah’s Legacy

Mothers Against Medical Error

Patient Safety Movement

Physician-Patient Alliance for Health and Safety (PPAHS)

Premier Safety Institute

REMEDI, Purdue University

2016 Financial Activities AAMI FOUNDATION, INC.STATEMENT OF ACTIVITIES AND CHANGES IN NET ASSETSFor the year ending December 31, 2016

SUPPORT AND REVENUE

$3,059,962 Board Designated*

$1,036,447 Unrestricted

$987,224 Temporarily Restricted

Operating and Supporting Expenses

$541,390 Education & Research

$114,110 Communication & Outread

$58,630 Awards & Grants

$114,209 Management & General

$49,978 Fundraising

SUPPORT AND REVENUE Board Designated*

Unrestricted Temporarily Restricted

Permanently Restricted

Total

Contributions and grants $3,006,799 $908,646 $259,273 $- $4,174,718

In-Kind contributions 402,197 - - 402,197

Other income 4,275 - - 4,275

Net assets released from restrictions - 383,700 (383,700) - -

Total Support and Revenue Before Investment Income

3,006,799 1,698,818 (124,427) - 4,581,190

Investment income (net) 53,163 2,141 49,851 - 105,155

Total Support and Revenue 3,059,962 1,700,959 (74,576) - 4,686,345

OPERATING AND SUPPORTING EXPENSES

Patient Safety InitiativesEducation and research 541,390 - - 541,390

Communication and outreach 114,110 - - 114,110

Awards and grants 58,630 - - 58,630

Supporting Services

Management and general 114,209 - - 114,209

Fundraising 49,978 - - 49,978

Total Operating and Supporting Expenses - 878,317 - - 878,317

Change in Net Assets 3,059,962 822,642 (74,576) - 3,808,028

Net Assets at Beginning of Year - 213,805 1,061,800 35,000 1,310,605

Net Assets at End of Year $3,059,962 $1,036,447 $987,224 $35,000 $5,118,632

* Board Designated: Gift from AAMI; AAMI Foundation designated that only earned income from the principal may be used to provide an $80,000 grant annually, beginning in 2017.

Platinum

Baxter B. Braun GE Healthcare Ivenix Malinckrodt Nihon Kohden PhilipsSmiths Medical Sotera

Gold

Bernoulli Cerner Crothall Draeger EarlySense MindraySpacelabs Vocera

Bronze

Fresenius Kabi Safen Medical Products VitalSims ZynoMedical

Industry Partners

Diamond

Stay ConnectedAccess the AAMI Foundation’s website to learn more about our programs and to obtain all of the Foundation’s complimentary deliverables that will help you improve patient safety: www.aami.org/thefoundation.

Follow us on Facebook, Twitter and LinkedIn!

www.facebook.com/aamiconnect @aami_connect AAMI’s LinkedIn group — AAMI Community

Share Your Thoughts and Share Your Stories!

The Foundation staff wants to hear about which products you fi nd the most useful and how you are using them to improve patient outcomes.

Have you conducted a quality improvement project to advance alarm management, infusion therapy, opioid safety, or how your clinicians are prepared to use complex technology? Please share those stories with us! We would love to share your lessons learned with the rest of the nation so all patients can enjoy positive outcomes.

Donate to the AAMI Foundation: http://my.aami.org/store/donation.aspx.

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