The Anesthesia Patient Safety Foundation (dev2.apsf.org) believes that anesthesia professionals should be competent to use advanced medical technology to provide safe patient care. The APSF includes practicing anesthesia professionals, representatives from the medical device industry and other relevant stakeholders. The APSF, through its Committee on Technology (COT), has been considering the current state of medical device training for anesthesia professionals for many years and developed recommendations for Advanced Medical Technology Training. This document provides a framework for learning, assessment, and documenting of competency in the use of advanced medical technology (see Appendix for definition and examples).
Anesthesia professionals have not generally been required to demonstrate their competence to use anesthesia technology to care for patients. In contrast, mandatory user training and/or demonstration of competence are currently required for clinicians who use some devices including lasers, radiation emitting devices (e.g., fluoroscopy), some technology-based surgical procedures (e.g., carotid stents), and point-of-care laboratory devices. Demonstrating competency to use medical devices is consistent with safe patient care, and the requirements for anesthesia professionals should be consistent with other similarly complex and risky medical devices.
Industry members of the APSF COT reported a consistently low rate (as low as 20%) of anesthesia professional participation in training programs associated with the introduction of new technology into clinical practice. A number of obstacles to participation have been articulated:
- Absence of recommendations from an anesthesia professional organization to demonstrate competence before using a device to care for a patient.
- Limited time in an already busy workday to attend and complete technology training.
- A general lack of training programs that are easily accessible and can be completed in a realistic time frame.
- Regulations that prohibit offering CME/CEU credits when industry representatives deliver the training content despite the manufacturer’s expertise and incentives to provide quality training.
- Those who enter a practice or facility after a new technology has been introduced typically do not have ready access to a formal training program.
Anesthesia professionals widely agree that they should be able to safely use advanced medical technology to care for their patients. The APSF recognizes that the diversity of clinical practice models precludes a single framework for accomplishing this goal. Nevertheless, the APSF encourages relevant health care organizations to develop policies and procedures that promote adequate training and confirm continuing competence of anesthesia professionals to use advanced medical technology safely. It is anticipated that educational programs will be tailored to the unique needs of the organization and be compatible with available resources.
The following considerations are intended to guide anesthesia professionals, anesthesia technicians, health care organizations and technology manufacturers as they develop educational programs to train and confirm anesthesia professionals’ continued competence to use advanced medical technology. These educational programs may be developed in conjunction with anesthesia professionals, anesthesia departments, the medical device industry, health care institutions and other patient safety organizations.
Considerations for Anesthesia Professionals
Anesthesia professionals should participate in an educational program to become competent to use advanced medical technology before using that equipment to care for a patient. A quality educational program will not only include training, but also a means to assess and document competence.
Competence to use advanced medical technology includes the following skills:
- Understand the setup, function, operation, and information necessary to provide safe and effective patient care when using the device.
- Consistently use the device safely and effectively.
- Consistently use a device’s safety features and take appropriate measures to avoid known potential for patient harm.
- Identify when each device is not functioning as intended and be able to perform basic troubleshooting and respond appropriately to maintain the highest level of patient safety.
- Have competence assessed by various mechanisms, including but not limited to, written or oral examinations, demonstrating safe use to a skilled observer, and using the device in simulations of relevant clinical situations.
Considerations for Health Care Institutions
- Require appropriate advanced medical technology training and demonstrated competence before an anesthesia professional is permitted to use a (new or existing) device to care for patients unless a person with demonstrated competence is present throughout the procedure.
- Provide formal advanced medical technology training programs for every anesthesia professional including a mechanism to ensure that anesthesia professionals who are new to the institution receive this training before they begin delivering patient care.
- Document an individual’s participation in technology training, education, and assessment.
Create a mechanism to ensure that the advanced medical technology training program is meeting its goals.
- Establish a schedule for periodic reassessment of anesthesia professionals’ continued competence.
- Allocate time for training and assessment within the regular workday.
Consideration for the Technology Manufacturer
- Utilize a rigorous, user-centered, human factors design process to create devices that are easy to learn to use, easy to use, easy to remember how to use, and that fail safely and gracefully.
- Develop effective training materials and instructions for use (IFU) using the same rigorous engineering processes applied to other aspects of the device.
- Create standardized user training and recommended competency assessment materials, based on user-centered design and validation methods, which can be used by institutions to comply with these recommendations.
- Assist customers in the implementation of user training and competency assessment materials and procedures.
Disclaimer (Approved by APSF Executive Committee on October 16, 2009)
Recommendations developed and promulgated by APSF are intended to assist professionals who are responsible for making health care decisions. APSF’s mission is to assure that no patient is harmed by anesthesia care. Thus, our recommendations focus on minimizing the risk to individual patients for rare adverse events rather than necessarily on practices that balance all aspects of population health quality and cost. APSF does not intend for these recommendations to be standards, guidelines, practice parameters, or clinical requirements, nor does application of these recommendations guarantee any specific outcome. Furthermore, these recommendations may be adopted, modified, or rejected according to clinical needs and restraints. APSF recognizes that these recommendations are subject to revision as warranted by the evolution of medical knowledge, technology, and practice.
Definition and Examples of Advanced Medical Technology
We define Advanced Medical Technology as medical devices and software systems that are complex, provide critical patient data, or that directly implement pharmacologic or life-support processes whereby inadvertent misuse or use error could present a known probability of patient harm.
AMT for which these recommendations could apply include, but are not limited to, the following examples:
- Anesthesia workstations (traditionally known as “anesthesia machines”) and mechanical ventilators
- Patient monitoring systems that could include cardiovascular, respiratory, neuromuscular, and electrophysiological monitoring
- Complex diagnostic imaging systems including doppler velocity and ultrasonic imaging
- Medication delivery systems including infusion pumps
- Energy delivery systems including defibrillators and pacemakers
- Cardiovascular support devices including intraaortic balloon pumps
- Point-of-care diagnostic/laboratory devices
- Anesthesia and other health care documentation or informatics systems if they include medication ordering, clinical decision support, or diagnostic components on which an acute life-affecting diagnosis or therapy will be based.
Dr. William Paulsen is chair of the Committee on Technology for the APSF and is AA-C, Chair, Hamden, CT. For a full list of the committee members, please refer to Page 59 of this issue.