RAPID Response to questions from readers

(formerly Dear SIRS)

Reader Seeks Standards for Equipment Check

I am a retired member of the ASA. I am involved in Q/A in the Department of Anesthesia of Lenoir Memorial Hospital in Kinston, NC.

We have found that there are no specific current standards for checking of equipment prior to the start of an anesthetic. We do have departmental safety requirements that are met.

Are there guidelines or standards of which we are not aware? Please advise me of any current standards. The last standards are 1993 and hence those are out of date. As part of our Q/A we meet JCAHO requirements, hospital policies, and departmental rules and regulations. However, as previously stated, we are looking for national standards regarding equipment check.

Robert J. Dean, MD
Kinston, North Carolina

In Response:

While it is common sense and good practice to check equipment prior to using it, there are a few specific guidelines and standards that address this topic, which I have summarized below. The anesthesia literature reminds us that the incidence of pure anesthesia equipment failure is rare, while human error is much more frequent, with a failure to check being most likely.1-4 Therefore, the real question becomes not Sshould we check?” but rather “What, how, and how often should we check, and who should perform the check?”

Operator Manuals from both Draeger Medical, Inc. and Datex-Ohmeda/GE Healthcare contain instructions for preoperative checklists. For example, the Datex-Ohmeda Aestiva has one for “Everyday before the first patient,” “Every time a different clinician uses the system,” and “Before every patient.” The Draeger Fabius Tiro has “Daily” and “Pre-use” checkout forms. Ideally, each anesthesia provider should follow the guidelines and frequency specified in the Operator Manual, but, realistically, this is not the common practice.5

The active standard for anesthesia machines/ workstations in the United States is ASTM F1850-00 (2005): Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components. The specification states that each anesthesia workstation shall have a checklist(s) from the manufacturer to be performed prior to each use. This is in agreement with IEC 60601-2-13:2003, the international standard for anesthesia machines. Both documents state that attention should be paid to any additional checklists established by regional or national medical associations, or government agencies.

The ASA 2004 Guidelines for Office-Based Anesthesia, Monitoring, and Equipment state that, “All equipment should be maintained, tested and inspected according to the manufacturer’s specifications.” These guidelines, however, do not specifically address non-office-based locations, but do reiterate the suggestion to follow the manufacturer’s recommendations.

The AANA 2002 Scope and Standards for Nurse Anesthesia Practice states in Standard VIII: “Adhere to appropriate safety precautions, as established within the institution, to minimize risks of fire, explosion, electrical shock and equipment malfunction. Document on the patient’s medical record that the anesthesia machine and equipment were checked.” The interpretation of Standard VIII states, “Prior to use, the CRNA shall inspect the anesthesia machine and monitors according to established guidelines. The CRNA shall check the readiness, availability, cleanliness and working condition of all equipment to be utilized in the administration of the anesthesia care….”

JCAHO Standard EC.6.10 states, “The hospital manages medical equipment risks,” with the rationale that, “Medical equipment is a significant contributor to the quality of care…. It is essential that the equipment is appropriate for the intended use; that staff, including licensed independent practitioners, be trained to use the equipment safely and effectively, and it is essential that the equipment is maintained appropriately by qualified individuals.”

In summary, studies show that “failure to check” equipment is causative in many adverse events; the ASTM standard says manufacturers shall include a pre-anesthesia checklist as part of their labeling; the ASA says we should test equipment as per the manufacturer’s specifications in office based anesthesia; the AANA says the CRNA shall check all equipment prior to use; and JCAHO says it is the hospital’s role to ensure that staff be trained to use equipment safely and effectively. One hopes that, upon publication of the new FDA pre-anesthesia checkout (discussed below) and adoption by both ASA and AANA, this lack of a uniformly accepted practice standard will be addressed. The bottom line is that anesthesia providers should follow the recommendations of their professional organizations and the institutional policy regarding the pre-anesthesia checkout of their equipment. This is the safest practice in my opinion.

Sincerely,
Carolyn G. Holland, CRNA, MSN Representative of AANA, ASA Task Force on the Pre-Anesthesia Checkout Recommendation
Visiting Assistant Professor
University of Cincinnati College of Nursing
Cincinnati, OH

In Response:

Dr. Dean is correct that there are no current standards for checking anesthesia equipment prior to use. The 1993 document entitled “Anesthesia Apparatus Checkout Recommendations” is only a “recommendation” and was promoted officially by the FDA not by the ASA or AANA. Although the 1993 FDA Recommendations are aging, the steps outlined in that document still apply to much of the equipment currently in use. They are, however, obsolete for the newer designs that have changed the architecture of the system and/or rely upon automated checkout procedures. For that reason, the ASA Committee on Equipment and Facilities formed a task force in 2003 to formulate an approach to pre-anesthesia checkout procedures that is relevant for modern equipment and practice.5

I believe that the precedent of the 1993 FDA Recommendations establishes a continuing responsibility to check. Other than brief mentions in the Guidelines for Office-Based Anesthesia, and the 2005 ASA Manual for Anesthesia Department Organization and Management (MADOM, http://www.asawebapps.org/ docs/2005MADOM.pdf, page 109), which states that appropriate checklists “should be” available in a department’s manual, the ASA website does not have anything else in the practice parameters, standards, or guidelines sections.

The task force on revising the pre-anesthesia checkout procedures is in the process of finalizing what we hope will be accepted as a new approach to the pre-anesthesia checkout. Guidelines for designing the checkout have been developed that apply to modern anesthesia delivery systems as well as older, more traditional, equipment. Lessons learned regarding patient safety have been incorporated into the guidelines including an emphasis on checking backup ventilation equipment, ensuring that alarms are functional, and creating redundant checks for critical items to minimize the potential for human error. An important aspect of the new recommendation is to encourage utilizing technicians for some checkout procedures when feasible to reduce the burden on the provider and hopefully improve compliance.

The FDA is once again interested in evaluating and possibly endorsing the new recommendation. Documents will also be submitted to ASA, AANA, and ASATT leadership for consideration and adoption as appropriate into society guidelines or standards. We have learned over the years that failure to check equipment can threaten patient safety. I believe there is little question that appropriate checkout procedures are an important aspect of safe practice. The new pre-anesthesia checkout recommendations will likely be published in the upcoming year. Whether these recommendations are ultimately accepted as practice standards or not, it is incumbent on each individual practitioner to take the responsibility of the pre-anesthesia checkout seriously. The new design guidelines will hopefully become a useful resource to support that goal.

Sincerely,
Jeffrey M. Feldman, MD
Chair, ASA Task Force on the Pre-Anesthesia Checkout Recommendation
Division Chief, General Anesthesia
Dept of Anesthesiology and Critical Care Medicine
Children’s Hospital of Philadelphia
University of Pennsylvania School of Medicine

In Response:

Several changes have occurred since the last widely accepted Anesthesia Apparatus Checkout Recommendations were published by the FDA 13 years ago. Anesthesia machines and workstations have become more flexible, user friendly, and now include more design safety features and often so-called “automated” checkout procedures. However, they have also become more complex, with significant differences in design among manufacturers and even among machine models. At the same time, the anesthetic environment has also evolved, to include a larger number of ambulatory and office-based procedures with a higher volume of rapid cases and demands for efficiency.

Both of these developments have decreased the use of the 1993 checklist, and indeed any pre-use check. Lampotang and colleagues, in 2005, found that only 38% of the anesthesia providers they surveyed rated their competence in performing the 1993 FDA checklist as “good” or “excellent,” and less than 25% still perform a pre-use machine check before each procedure.5 The most frequent reasons cited for not performing a check include, “The checklist takes too long to perform,” “I do not know how to perform a proper pre-use check,” and “My anesthesia machine has an automated pre-use check and does it for me.”

However, the need for a pre-use check is greater than ever. Therefore, the ASA Committee on Standards and Practice Parameters, and the Committee on Equipment and Facilities are drafting a “Practice Alert.” This alert will emphasize the necessity of 1) adequate training and demonstrated competence in the use of each model of machine a practitioner uses to deliver anesthetics to patients, and 2) a routine pre-use machine check, performed according to institutionally-established standards, prior to each anesthetic. We would expect the submission of this Practice Alert to ASA for approval this year.

Sincerely,
Donald E. Martin, MD
Chair, ASA Committee on Equipment and Facilities
Professor of Anesthesiology
Vice-Chair for Academic and Faculty Development
Department of Anesthesiology
Penn State University College of Medicine
Hershey, PA

Co-Editor’s Note:

Dr. Robert J. Dean of Kinston, NC, has asked a very timely question. There are 2 issues that concurrently developed and merged into the proposed Practice Alert, described by Dr. Martin above. One issue was published in the previous edition of the Newsletter,6 and described the challenges and success of a pilot study on mandated anesthesia machine training. Since that publication, the APSF leadership has described a new Initiative to investigate a widespread implementation of mandated machine training programs. You can read about that Initiative on the APSF Website at https://www.apsf.org/initiatives/technology_training.mspx. The second issue, of course, was the effort by Dr. Feldman and his Taskforce to re-engineer the checkout recommendations as described above. Thus, it is hoped these concurrent and related safety efforts will soon lead to some version of a Practice Alert, encouraging anesthesiologists to not only check their machine, but also to learn how to operate and understand it thoroughly. As the benefits and feasibility of implementing such training programs are described, one could hope for an emerging Standard of Care.

Dr. Michael A. Olympio
Chair, APSF Committee on Technology

References

  1. Caplan RA, Visteca MF, Posner KL, Cheney FW. Anesthesiology 1997;87:741-8.
  2. Cooper JB, Newbower RS, Long CD, McPeek B. Anesthesiology 1978;49:399-406.
  3. Cooper JB, Newbower RS, Kitz RJ. Anesthesiology 1984;60:34-42.
  4. Williamson JA, Webb RK, Sellen A, et al. Anaesth Intensive Care 1993;21:678-83.
  5. Lampotang S, Moon S, Lidzas DE, Feldman JM, Zhang RV. Anesthesiology 2005;A1195.
  6. Olympio MA, Reinke B, Abramovich A. APSF Newsletter 2006;21:43-48.

The information in this column is provided for safety-related educational purposes only, and does not constitute medical or legal advice. Individual or group responses are only commentary, provided for purposes of education or discussion, and are neither statements of advice nor the opinions of APSF. It is not the intention of APSF to provide specific medical or legal advice or to endorse any specific views or recommendations in response to the inquiries posted. In no event shall APSF be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the reliance on any such information.