by Michael A. Olympio, MD
As a mid-level faculty member in the Department of Anesthesiology at Wake Forest University School of Medicine, I was invited by then member, and current APSF Newsletter editor, Dr. Bob Morell, to join the Committee on Technology (COT). Having assured me that it would not require more than 2-4 hours of effort per year, and a single annual meeting, he gladly informed Dr. E.S. Siker, then chair of the COT, of my willingness to board the patient safety train, particularly with the COT’s emphasis on technology.
Major efforts in 1999, however, were directed not on technology per se, but to the office-based-anesthesia (OBA) safety issue, and the manner in which the states regulated such practice. Ongoing initiatives included medication errors associated with labeling discrepancies; medical gas pipeline construction, quality, and safety; consideration of producing a technology guide of standards pertaining to OBA; standardization and hazards of new wireless communications; and publication of comparable data on anesthesia equipment that had already caught the attention of ECRI. In 1999, the COT team consisted of Drs. Siker, Andrews, Moss, Peterson, Foster, Goldman, Olympio, and Petty, and industry representatives Argentieri, Cross, and Evans.
By 2000, the group had expanded with the addition of Calkins and Narbone, and by 2001 there was internal frustration with the difficulty in getting ideas to materialize into safety products. A quarterly article entitled “From the Committee on Technology” was suggested by Chairman Siker, and would include such topics as equipment analysis, how things work, and problems/solutions with specific pieces of equipment. However, there was “the usual APSF policy” of avoiding naming specific products, which was perceived as a significant barrier to open discussions (let alone publication) of equipment limitations, and a barrier to the promotion of equipment safety. These ideas and obstacles created the foundation for inevitable change that was to begin in October 2002.
The first question from a provider that I had ever received through the COT came from a Dr. Forstot, who wanted to learn more about perceived “rebreathing” in his new Datex-Ohmeda Aestiva 3000 gas machine. I recall feeling how “wasteful” the discussion had been, even though a response was provided, because no other clinicians in the anesthesia community would learn from it without publication. At my first meeting as the new COT Chairman, I directed the group to adopt a new and specific set of goals for the Committee:
- To ensure that no person shall be harmed by anesthesia technology.
- To foster investigations that will provide a better understanding of preventable equipment-related injuries.
- To promote communications of information and ideas about the causes and prevention of equipment-related injuries.
Furthermore, realizing the provocative nature of this mission and the importance of sensitivities to special interest, the COT had the desire and the intent of working constructively together, to promote safety for our patients. The COT was deliberately constructed of a group of clinicians and industry representatives who chose to identify and/or to resolve equipment safety issues. At that meeting, which laid the foundation for all subsequent endeavors, I recall asking each member to describe how they might contribute to such a mission.
The 2002 membership slate included Siker, Olympio, Abramovich, Baumgart, Chamoun, Moss, Narbone, Wyman, Andrews, Argentieri, Calkins, Foster, Goldman, Peterson, and Cross, each of whom described a number of specific initiatives, with new emphasis upon investigation and communication of findings. This was an energetic and hard-working group of individuals determined to share their interests with the readership.
A plan rapidly took shape, as we described how “Modern Anesthesia Machines Offer New Safety Features” in the Summer 2003 APSF Newsletter, and placed a unique series of overlapping breathing circuit diagrams on the APSF website (www.apsf.org) for clinicians to understand new technologies in fresh gas decoupling. More importantly, the global plan for communications first recognized the accomplishments of ECRI through its “Hazard Alerts” and “Hazard Bulletins,” but wondered whether enough of the clinical anesthesia community was aware of those articles, or had the opportunity to gain the manufacturers’ perspectives.
Dear SIRS Conceived
The COT decided that its communications, “would involve input, participation, and feedback from the manufacturers,” and I, as chair, informed the Board of Directors in October 2002 that the COT would “work with industry to promulgate appropriate reports.” Although the Committee initially toyed with the concept of conducting independent and original device research, that idea was well ahead of its time, and would not come to fruition for another 4 years. By December 2002, the seeds for Dear SIRS had been planted in the minds of committee members, and as chair, I asked a seasoned Dr. Erv Moss what we should do with increasing numbers of clinicians’ questions being delivered to the committee’s doorstep. In my report to the January 2003 APSF Executive Committee, I asked for “advice and direction” in the manner of communicating with clinicians who encountered device safety concerns, reiterating the Committee’s desire to “communicate such concerns to industry, and when possible, to provide a joint statement about the concern in the Newsletter.”
At the May 2003 Executive Committee meeting, a systematic process was developed that would target specific representatives of industry for interactions with me, the COT chair, acting as intermediary for the question/answer process. Finally, the concept crystallized at the October 2003 meeting in San Francisco as I walked along Fisherman’s Wharf with Newsletter editor, Bob Morell, debating “Safety Issues Reporting System (SIRS)” versus “Safety Information Response System” (Dear SIRS). Only we know the exact details of that conversation! It was agreed that that column would be “pre-emptive” in nature and not deal with issues that had already caused harm to patients.
Membership and Representation Expand
The year 2003 brought the first wave of dramatic expansion in membership with the welcomed increase of CRNA representation to the COT, and new representation by the American Society of Anesthesia Technologists and Technicians (ASATT). Over the next several years, the committee would continue its growth, adding more physicians, industry representatives, and the chair of the Department of Anesthesia Sciences in Savannah, GA, a school for Anesthesiologist Assistants. Today, the ranks include some 25 members who voluntarily participate to varying degrees in the many projects of the COT.
Liaisons with Other Organizations
Frequently, the COT mission overlaps with the efforts of other organizations. Several members of COT have actively participated in the ASA Committee on Equipment and Facilities’ (ASA-CEF) “Statement on Machine Obsolescence,” under the meticulous leadership of Dr. Jerry Dorsch, which provides helpful guidelines for both clinicians and hospital administrators to determine whether or when an anesthesia machine should be replaced and/or eliminated from practice. Those guidelines were published in the September 2004 ASA Newsletter, and described both absolute and relative criteria. The absolute criteria were further divided under 1) lack of essential safety features, and 2) presence of unacceptable features. Such guidelines could herald stricter future requirements with regulatory agencies, as the desirability of new features, or dangers of older or missing features, become more apparent. In fact, elevating the significance of machine obsolescence was the most frequently cited topic for fut
ure efforts among COT members at the October 2006 annual meeting.
The COT has been further represented within the ASA-CEF by my leading the last 3 panel presentations at the ASA: “The New Generation of Intraoperative Mechanical Ventilation” (2004), “The New Generation of Anesthesia Ventilators—Why, How, and for Whom?” (2005), and “Hazards of the Modern Anesthesia Workstation” (2006). Participation by the COT is again expected in 2007 with the proposed resurrection of the ever-popular anesthesia machine workshop. This year promises to introduce the modern technologies in conjunction with the newly proposed Checkout Recommendations.
Several COT members participated in the revision of the 1993 FDA Anesthesia Apparatus Checkout Recommendations under Dr. Jeff Feldman, to accommodate the complexities of new designs and automated checkouts, which may or may not contain all of the steps previously expected in the FDA recommendations. That document is currently in submission to the ASA Board of Directors for their consideration. Along with that effort came the development of language by Dr. Don Martin, chair of the ASA-CEF, for the recently proposed Practice Alert on “Safe Operation of the Anesthesia Workstation.” Within that proposal are the recommendations that “anesthesia machines and workstations should be used to provide patient care only by qualified anesthesia providers who have satisfactorily completed an institutionally approved, machine-specific, training program and demonstrated competence in the use of that particular machine or workstation.” The COT was separately and actively pursuing efforts to improve technology training (discussed below), and considers this language to be one of the first steps in implementing mandates for technology training.
This discussion would not be complete without recognizing the contributions of the APSF to the advancement of health care simulation education. Two pioneers in simulation, David Gaba and Jeffrey Cooper, both sit on the APSF’s Executive Committee, while Matt Weinger and I joined their ranks to further promote the national effort. I formed and led the ASA Workgroup on Simulation Education until the ASA approved an official Committee on Simulation Education at the October 2006 House of Delegates meeting. The combined efforts of those individuals produced a White Paper on “ASA Approval of Simulation Education Programs,” (which would direct the establishment of high quality training programs), a website on simulation: http://www.asahq.org/SIM/, a needs-assessment survey of the ASA membership, and a Directory of Simulation Education Opportunities for anesthesia clinicians. I also conducted a roundtable discussion and produced a report on Simulation Center Credentialing at the 2007 International Meeting on Simulation in Healthcare.
Major Safety Initiatives Launched
Three major safety products of the Committee on Technology all came to light during the October 2003 annual meeting. First, the complexity of new anesthesia machine technologies was perceived as a barrier to patient safety if clinicians did not know how to operate or troubleshoot their equipment, and concurrent APSF efforts in High Reliability Organizations begged the question of whether clinicians should be certified to use such technologies. These initial discussions helped to launch the Technology Training Initiative described below, and fueled our interest in the ASA efforts for checkout and training statements, above.
The second safety product, so to speak, arose from a mandate by the APSF Executive Committee for the COT to publish a discussion on the use of audible alarms on physiological monitors and the use of an audible beep tone from the pulse oximeter during all anesthetics. Drs. Julian Goldman and Fred Robertson from the COT prepared a pro/con article on the January 2004 JCAHO Safety Goal #6, “to improve the effectiveness of clinical alarm systems,” and the APSF’s EC organized its Fall 2004 Board of Director’s Workshop to specifically consider the adoption of an ASA Standard of Care for clinicians to maintain the audible feature of the pulse oximeter and capnogram alarms. The Corporate Advisory Council of the APSF enthusiastically agreed that such discussions were not only warranted but strongly desired. Industry was looking for direction from the APSF regarding audible monitoring standards and default settings. Details of that effort are described below.
Third, and perhaps most dramatic, were a few circulating reports of spontaneous fires or explosions that had erupted within the gas machine absorber. A confluence of stories and individuals all in the right place, at the right time, created a flurry of intense activity that quickly resulted in a “Dear Health Care Professional” letter from Abbott Laboratories that sevoflurane in the presence of desiccated Baralyme® could result in the formation of intense heat, or fire in the absorber. The COT and the APSF worked with Abbott Laboratories, the FDA, and the ECRI to disseminate this critical information in the Winter 2003/2004 APSF Newsletter, article entitled “Canister Fires Become a Hot Safety Concern.” This preliminary investigation would later launch the Absorbent Safety Conference. Of particular significance to the COT, this article was the first to foster a new relationship with the AANA, as APSF granted permission for that organization to reprint this and other articles in the AANA News Bulletin. This soon led to the agreement with AANA that the APSF Newsletter would be mailed to their membership.
Dear SIRS Published
With the first publication of Dear SIRS in the Spring 2004 Newsletter, came the realization of a dream that industry and clinical anesthesia could openly discuss and publish device safety issues, with the intent of improving a product or improving the clinician’s understanding of a product. It should be noted how grateful the Anesthesia Patient Safety Foundation and its readership are to have major corporations willing to publish potentially embarrassing information about their products for the promotion of patient safety. It is truly a commendable accomplishment. That first commentary by James M. Berry, MD, and Steve Blanks, CRNA, with response by Michael Mitton, Director of Clinical Affairs at Datex-Ohmeda, then a part of GE Medical Systems, explained how a misplaced valve in the scavenger system could and did result in a potentially dangerous situation. The real value in the column, however, was the attention drawn to the mechanism of operation of a little-understood component of the anesthesia machine. Subsequent quarterly columns have enlightened our readership with the following titles:
- O2 Blender Causes Concern
- Common Gas Outlet Concern Leads to Corrective Action
- Clinician Recognizes Importance of Machine Checkout
- Cause of Ventilator Failure is Unclear
- Descending Bellows Drives Question
- Dear SIRS Making a Difference
- Absorbent Wrapper Design Questioned
- Channeling Causes Concern
- Line Isolation Still Important
- Is an In-line Oxygen Monitor Still Necessary?
- Reader Seeks Standards for Equipment Check
Audible Alarms Become a Standard of Care
As the above mentioned discussion of audible alarms appeared in the Summer 2004 Newsletter, the APSF’s EC was working behind the scenes to arrange a panel of expert presentations for October, while proposing a new standard of care for debate during the conference breakout sessions. Until that time, no other Standard for Basic Anesthetic Monitoring addressed audible tones and alarms except one, and that was the disconnection of the breathing circuit. After stunning testimony and debate within the roundtables, the APSF subsequently announced their recommendation: “When the pulse oximeter is utilized, the variable pitch pulse tone and the low threshold alarm must be audible. When capnography is
utilized, a capnography alarm for hypoventilation must give an audible signal.”
At the time, Dr. Bob Stoelting described this proposal as “low hanging fruit,” which was subsequently adopted in similar form effective October 25, 2005 (exact wording published in the Spring 2006 Newsletter), by the ASA House of Delegates and the American Association of Nurse Anesthetists. Stoelting commented that such a likely addition would probably not have been possible without the efforts of the APSF.
Absorbent Safety Issues Heat Up
Following the Winter 2003/2004 reports of fire in the breathing system, subsequent revelations of intense heat and agent destruction within desiccated, strong-base absorbents prompted Michael Mitton of GE Healthcare to request that the APSF moderate an industry-wide conference on absorbent safety. That conference was convened on April 27, 2005, with the intent to “develop a consensus statement on the use of carbon dioxide absorbents to reduce the risk of adverse interactions with volatile anesthetic drugs,” and was attended by representatives and experts of the scientific community, ASA, AANA, drug and equipment manufacturers, carbon dioxide absorbent manufacturers, ASATT, AHA, ECRI, AORN, JCAHO, AAAA, and The Doctors Company. A significant effort preceding the conference produced a comparative table of then-current carbon dioxide absorbents. The table was used during the presentation to keep the myriad of names, contents, and manufacturers straight, and was published in the Summer 2005 Newsletter as a lasting comparison of strong-base and catalyst contents. Comments by industry representatives explained the “soda lime cycle,” informed the audience that all of the companies were developing non-reactive absorbents, and explained potential methods for monitoring carbon monoxide, desiccation, and heat generation. Finally, and within a single day, a consensus statement was achieved:
The APSF recommends use of carbon dioxide absorbents whose composition is such that exposure to volatile anesthetics does not result in significant degradation of the volatile anesthetic.
The APSF further recommends that there should be institutional, hospital, and/or department policies regarding steps to prevent desiccation of the carbon dioxide absorbent should they choose conventional carbon dioxide absorbents that may degrade volatile anesthetics when absorbent desiccation occurs.
Conference attendees generally agreed on specific steps to promote safety, consistent with ECRI recommendations.
Mandated Technology Training Initiative Gains Momentum
Initial High Reliability Organization discussions in October 2003 (mentioned above) were followed by the concerns of the Corporate Advisory Council in October 2004. From the perspective of their field instructors, many clinicians were unreceptive or unable to receive meaningful training. Frustration and/or concern was voiced over the ignorance of checklists and even automated checkout procedures, responsibilities for providing training, most effective types of training, physician refusal to participate in training, credentialing use in simulators, complexity of new machines, and specific accountabilities in receiving training. The impetus for launching a significant effort came through Dr. Michael Cox’s question in the Dear SIRS column, Winter 2004/2005, when he commented, “I want to propose . . . that we really need to pay some organized, formal attention to increasing our facility with our machines.” Through the combined efforts and interest of Bonnie Reinke, then General Manager of Anesthesia Delivery at GE Healthcare, and Abe Abramovich, then Director of Anesthesia Systems Development at Datascope Corp., we developed an intent to mandate a new and extensive training program prior to the introduction of modern new machines at Wake Forest University Baptist Medical Center. Institutional buy-in was essential to accomplish the 4-step training program. It included preliminary web-based study, lecture, workshop and simulation, followed by written MCQ examination, and was implemented in the winter of 2005/2006. The unintended results demonstrated how a late failure to mandate training among faculty members (as compared to SRNAs, residents, and CRNAs) dramatically and progressively reduced participation levels (Fall 2006 Newsletter). Although operational performance outcomes were not measured, the implication was that a failure to receive training would hinder the safe and satisfying use of the new technology. The effort required to conduct this training program raised serious questions about the ability of any organization to successfully credential a large number of diversified clinicians on the use of an essential device, prior to installation. Rare testimony of successful mandates from another department chair, and from 2 other corporate installations suggested that it might be possible and beneficial. In a called conference during the October 2006 ASA meeting, GE Healthcare presented 2 examples of installations that either completely or only partially implemented the prescribed training program. The company was able to demonstrate a significant reduction in the consumption of resources (e.g., service calls) in the department that followed the prescribed plan. Meanwhile, the COT was developing the Technology Training Initiative (TTI) as a multi-institutional pilot study that would attempt to show the benefits, the capability, the difficulties, and the outcomes of a mandated technology training program. That study is currently under development and will be initiated by summer 2007.
The significance and need for such mandates and equipment credentialing is not lost on the APSF. The October 2007 Board of Directors’ Retreat will consider this topic in depth and may provide recommendations for device credentialing soon thereafter.
Q&A Column Responds to Readers’ Needs
With so many technology questions and answers relayed through COT (38 to date), it quickly became impossible or inappropriate to publish all of them in the Dear SIRS column. That column was originally intended to “expeditiously communicate technology-related safety concerns raised by our readers, with input and responses from manufacturers and industry representatives.” It is a forum for the APSF to intervene and moderate a discussion between clinical anesthesia providers and device manufacturers, specifically. However, it was apparent that the COT had to develop another column, “Q&A,” which could provide “. . . quickly answered questions . . . by knowledgeable committee members . . . whose responses would be of value to the general readership.” Now entering its fourth column, the “Q&A” has provided yet another service to the APSF readership.
The COT has been tremendously active, responsive, and visionary over the past 5 years, and has tackled some provocative technology safety issues. COT members thoroughly enjoy their opportunities to participate in the patient safety movement, and have repeatedly witnessed their efforts providing benefit to patients and clinicians. More exciting developments are in the works for the second 20 years, but none of this would be possible without the completely voluntary efforts of otherwise fully-employed, safety-conscious anesthesia professionals!
Michael Olympio, MD, is chair of the APSF Committee on Technology and co-founder of the Dear SIRS Initiative. He is also Professor of Anesthesia at Wake Forest University Medical Center, Winston-Salem, NC.