How We Got Our Start
In May 2010, the U.S. Food and Drug Administration (FDA) held a two-day public workshop on infusion pumps that outlined the challenges and long-standing problems that the FDA and the healthcare community were encountering with these devices. According to the FDA, over 56,000 adverse incidents had occurred in the last five years from infusion devices. Many questions were raised during the workshop about design, human factors, and data collection but it was clear that more input from designers, users, clinicians, regulators, manufacturers, patient advocates, and others was needed in order to reduce incidents. As a result, AAMI and the FDA entered into a partnership to hold a Summit designed to facilitate extensive discussion among and between key stakeholders in order to set a clear direction for improving infusion pump safety.
The Summit received public and open support from:
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In October 2010, a remarkable group of thoughtful, committed, and diverse experts came together at the AAMI/FDA Infusion Device Summit. The Summit opened with this quote from Margaret Mead: “Never doubt that a group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has.
The spark for hosting this unprecedented, groundbreaking event was the result of listening well. The FDA listened well to the barrage of data it received about too many adverse incidents involving infusion devices. The academic and industry co-chairs of AAMI’s Infusion Device Standards Committee listened well to their gut: the international standard up for revision needed more work than simply an up or down vote. AAMI as an organization listened well to the need for a neutral convener to bring the right people together from across the entire healthcare community. Industry listened well by answering the call to actively engage in the event. The clinician, clinical engineering, and expert consultant community listened well by giving two days of their time, expertise, and passion for patient safety for the “good of the order.” The time was right, and from listening well the event was conceived and took shape.
The spark for what happened during the event also was the result of listening well by the 330 people in the room. Attendees from hospitals, medical device and pharmaceutical manufacturers, the FDA, academia, and many others heard challenges presented by speakers and amplified by audience discussion. The attendees heard questions, audience comments, suggestions, frustrations, and opinions. Participants together fulfilled the challenging assignment of developing a list of priorities that all agreed must be addressed.
What made the event even more remarkable was the overwhelming commitment of attendees that, as a community, they would continue to work together on implementing action plans based on the agreed-upon priorities.
At the conclusion of the Summit, Pat Baird (co-chair, AAMI Infusion Device Standards Committee) and Mary Logan (AAMI President) proposed the creation of a council dedicated to making infusion devices safer and to serve as “….the body that coordinates implementation of the action plans that result from the Summit.” Roles and responsibilities of this council include the development of working groups and/or cooperative arrangements with other organizations to implement action plans, to serve as a central discussion forum for all stakeholders, and to maintain an ongoing line of communication among all Summit participants.
Over ninety (90) Summit participants indicated their interest in working on specific priority issues identified at the Summit and their commitment to participating on the proposed “safety council." It was this commitment to making infusion devices safer through a safety council, that inspired the creation of the Medical Device Safety Council (MDSC), since renamed as the Healthcare Technology Safety Institute (HTSI).
Thus, the HTSI was launched in mid 2010 as part of the AAMI Foundation, a 501c3 charitable arm of AAMI, allowing agility and the freedom to tackle openly the sensitive issues of medical technology safety. Its first priority was to do just that for infusion devices with the goal of zero incidents.
The work of improving patient safety through the use, manufacture, and design of devices and systems is by no means done. Equipment and systems still at times fail and, also, basic preventable human errors still do sometimes occur. The HTSI continues to work hard both on established tenets and new safety principles.
The HTSI persists in pursuit of zero tolerance for injury to patients. It serves as a model for the pioneering collaboration and commitment of the entire constellation of healthcare professions to the common goal of patient safety.