FDA-Sponsored Stakeholder Meeting on Surgical Fire Prevention
On October 22, 2010, the Food and Drug Administration held a workshop to discuss FDA regulated products implicated in surgical fires and challenges in eliminating fires. The workshop was organized by the Center for Drug Evaluation and Research’s Safe Use Initiative team and the Center for Devices and Radiological Health Division of Patient Safety Partnerships.
Surgical fires are rare events but can result in serious morbidity and death. Based on the best available data from ECRI Institute, a not-for-profit organization with a 30-year history of investigating operating room fires, approximately 550 to 650 occur in the United States each year1. Surgical fires occur during handling of one or more of the elements of the fire triad—the ignition source (e.g. electrocautery devices and lasers), the fuel source (drapes, alcohol based, surgical skin preparation products), and the oxidizer (e.g. oxygen, room air)—all components present in the surgical suite.
Surgical fires are "never events"—so called because they are serious events that should never occur. They are 100% preventable.2 In 2003, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a sentinel event alert bulletin to ambulatory surgical sites and some hospitals. The bulletin was related to fires that occur during operative and invasive procedures and served to raise the level of awareness of the dangers of surgical fires. The Joint Commission recommended that health care organizations prevent surgical fires by providing education and training for perioperative practitioners. The approach to developing policies and procedures to reduce fire risk should be multidisciplinary and involve all professions who provide patient care. Facilities were encouraged to report surgical fires to JCAHO, ECRI, and the US Food and Drug Administration (FDA). 3, 4
Despite the fact that the root causes of surgical fires are well understood, and various healthcare organizations developed education and outreach efforts, surgical fires still occur.
Purpose of FDA Stakeholder Meeting
To bring together stakeholders from a variety of healthcare organizations to:
- Identify opportunities to work together to improve safe use of medical devices, skin preparation agents, and oxygen to reduce surgical fires.
- Learn about barriers to implementing safe use of these products as it relates to surgical fire prevention and to learn about ways to overcome such barriers.
- Develop a joint focus and timeline for implementing surgical fire interventions.
- With stakeholders, to develop and implement interventions aimed at eliminating operating room fires.
Speakers presented perspectives on surgical fires and how to encourage hospitals to adopt known best practices. Participants were involved in question and answer sessions on such topics as the use of oxygen, education, and patient safety goals.
- Karen Weiss/Marilyn Neder Flack: Objective and goals
- Priscilla Callahan-Lyon: Flammability issues with Alcohol-Based Antiseptics
- Stephanie Joseph: Center for Devices and Radiological Health Surgical Fire Perspectives
- John Fishbeck/Margaret VanAmringe (JAHCO): How to Encourage Hospitals to Adopt Known best practices
- Sherry Markwell: MEDSUN Hospital Physician – Sharing Policies on Oxygen Reduction and Surgical Fire Prevention
- David Dockweiler: MEDSUN Hospital Physician – Sharing Experience with a surgical fire and subsequent fire prevention policy changes
- Jahan Azizi/Shawn Murphy: MEDSUN Hospital Physician – Sharing Test results of oxygen dissipation studies
The moderated afternoon session posed questions for participants to consider:
- What are the barriers to clinical practice change as it relates to surgical fire prevention?
- How can we work collaboratively to overcome these barriers?
- How should we prioritize these efforts? What should we do first?
- Outcome measures—how will we measure the success of collaborative initiatives?
Key points identified in the discussion:
- Address supplemental oxygen as the preeminent factor in fire causation.
- Educational efforts must be accompanied by efforts to determine whether people are learning what is being taught.
- Seek ways to involve all the key players and to convey messages; obtain support from the top levels within an organization.
- FDA can play a lead role in developing messages about safe and appropriate use of supplemental Oxygen.
- Support technological innovations that can reduce fire risks.
This stakeholder meeting was an initial step in identifying barriers to safe practices in the operating room. FDA personnel suggested a need for continued dialogue. FDA staff will consider the suggestions made during the discussion period, develop action items, and explore ways to continue the momentum from the meeting. The goal is to develop specific, tangible interventions to reduce surgical fires.
1 ECRI Institute, Preventing Surgical Fires: Important Recommendations Released (10/22/2009). Also available at https://www.ecri.org/Press/Pages/Preventing_Surgical_Fires.aspx
2 AORN Position Statement on Fire Prevention
3 Joint Commission on Accreditation of Healthcare Organizations, “Preventing surgical fires,” Sentinel Event Alert 29 (June 24, 2003). Also available at http://www.jointcommission.org/sentinel_event_alert_issue_29_preventing_surgical_fires/
4 “A clinician’s guide to surgical fires. How they occur, how to prevent them, how to put them out” Health Devices 32 (January 2003) 5-24