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.