Should medical simulation be regulated?

In short reply to the title of this post: No, not unless we plan to deprive learners of valuable educational opportunities.

At a recent simulation course that I attended, one session ended with a discussion about the need to regulate simulation. One of the instructors for the day was suggesting that simulation be conducted only by individuals well trained and experienced in medical simulation. He advocated for a need to implement regulation and accreditation for simulation activities. Furthermore he voiced about low fidelity simulation and just anybody out there thinking they can conduct a simulation scenario.

Do we need approval from a governing body to run a simulation scenario? In thinking we do may lead to unintended harms such as clinical errors that may have been prevented by simulation (while we wait for the appropriate regulation)

I approached him afterwards and listened a bit more to his perspective. He described concern about some technology that would facilitate a “lower” fidelity simulation scenario. In his opinion training in an environment  that isn’t identical to the actual work environment might lead to the participant acting inappropriately or being unable to manage in the real world since they may only become proficient using the machines available during simulation. In other words, if you teach people on one machine this may result in error if they’re faced with another machine in their actual work environment. He cited the Tenerife airport disaster as an example whereby simulation could be harmful. This devastating incident occurred when two jumbo jets collided on a runway in the Canary islands.

Despite the pilot being extremely experienced, he had just recently returned from a prolonged period where he had been instructing in the flight simulator. There’s some speculation that this may have contributed. Whether “too long” in the flight simulator and not enough real flight time played a role is difficult to determine. Is it possible that he picked up bad habits in the simulator and subsequently brought these back to his real work environment?

I agree that there is potential for harm in simulation. A recent report from Toronto described a critical event of an anaesthetic canister overheating (unintended) during a simulation scenario. There’s also reports of in-situ simulation equipment being accidentally brought into live use. Such events mandate safety for participants as paramount and that processes are in place to prevent mixing simulation-grade equipment into real life. However, to suggest that eager, enthusiastic clinicians who want to initiate simulation must pass tests or wait until policies are implemented or even receive some type of accreditation risks stifling valuable education. Holding the key to the simulation door in an ivory tower, available only to those who are pass the “test” is irresponsible and impractical.

We have implemented simulation into medicine as a means to improve care, practice critical events and work as a team. If we are to wait for accreditation and have only select individuals conduct simulation, then we are doing a disservice to our trainees and our patients. We should encourage teachers who wish to run scenarios to do so, even if they can’t use the latest most expensive high-fidelity manikin. To suggest that there’s considerable risk by training in a non-identical training environment is crazy. If you can’t train using high-fidelity, would it be better to just read about the procedure and practice on a real patient? Oh wait, this is what we’ve done for years and simulation was implemented to help reduce the harms of such an approach.

If accreditation or regulation will become part of simulation, the process should not inhibit the creativity of clinicians who have generated amazing learning opportunities (often with very little). Waiting for the “most appropriate” policy or procedure to be implemented will only expose our trainees and patients to further threats, errors and harms.

3 thoughts on “Should medical simulation be regulated?

  1. I agree with you, Andrew. While there is undoubtedly a case for people having the opportunity to pursue courses and formal qualifications for simulation teaching, restricting simulation teaching to those individuals is ludicrous. What would happen in practice is that a large number of people would lose access to simulation training and be left with ‘traditional’ medical teaching. Traditional medical teaching builds knowledge, but when things go wrong in an emergency however, it is (in my opinion) rarely a lack of knowledge that causes disasters. Instead, it is a lack of situational awareness, lack of awareness of human factors, poor communication, and poor decision-making under pressure that generate poor outcomes. These elements are notoriously difficult to teach in a traditional fashion.

    Provided a simulation scenario is run with clear learning objectives decided beforehand, is “medically accurate”, and the debrief acknowledges elements where the simulation differs from the real thing, it doesn’t really matter whether the person running the simulation has the right letters after their name.

    And it sure beats tackling a critical patient with no prior rehearsal!

  2. I most definitely concur with the comments above. First and foremost, the original speaker seems to be making an unvalidated assumption that those facilitating a simulation education session do not take steps to ensure that its quality and safety are maintained. He seems to have the perspective that we can only guarantee this through certification and accreditation processess. Although I do not disagree such processes have significant benefits, at this time I would welcome the evidence that proves eliminates or diminishes the risks associated with poor simulation delivery. Indeed, we seem to have a plethora of research suggesting simulation is making a positive difference, even without certified facilitators or program accreditation. Such measures do assure the trainee and the system at large that all possible steps are being taken to ensure a quality program, but they cannot ensure effective simulation. I’m sure we’ve all seen educator/facilitators with “formal” training in simulation that still run less than stellar sessions.

    The analogy of not having identical equipment generates high risk (the aircraft example) is also a point that I would challenge. In a flight simulator, the entire scenario is typically focused on the skills of operating the aircraft. One can assume that such ‘saturation” training may have an adverse effect on slowing response if controls, etc are not in the identical position when encountering an emergency situation as described. However, in most inter-disciplinary simulations, the equipment is frequently not much more than a prop to support the immersive reality. Although we do have to accept it may slow a participant’s response during the simulation (e.g. has to search for the charge button on a defibrillator) the key learning objectives here are not the operation of the defibrillator, but are more on the overall scenario management including teamwork, communications, resource allocation, etc. To assume that the limited use of the equipment will develop response memories that will carry back to the practice area is, in my opinion, a bit of a stretch. Indeed, one may even argue such simulations better prepare staff to manage just such situations. I would suggest that a significant majority of nurses have had to manage multiple variants of monitors, IV pumps, etc within a clinical practice area.

    Bottom line, yes, certify facilitators and accredit simulation programs, but do not argue that simulation education must be abandoned if such conditions don’t exist.

    • Dan, Thanks for that great post. I appreciate you addressing some of those key issues that were raised in the discussion about regulating simulation. Both you and Scott (in my opinion) present an insightful perspective about how we should approach simulation. I agree 100% with you about your comment regarding “formally trained” educators who can’t actually run a session! And you make an excellent point that as we’ve shown great benefits of simulation, it should be encouraged that if there’s evidence that “poorly” delivered simulation leading to negative outcomes, that it should be published! As of now, I haven’t seen any. I’m not sure if you’ve encountered much discussion in your region about regulating simulation but this was the first time I’d been exposed to it. It was an interesting, though somewhat concerning, conversation. I think your final sentence summarizes my position as well. We should continue to move forward with simulation as its benefits have been well documented and simultaneously if we can improve simulation through some accreditation process but this should not hinder our progress.

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