AAMI President Mary Logan’s March quarterly update to the AAMI community describes precisely the essence—and challenge—of safety management: Risk, not outcomes, is what determines safety.
A shared challenge among medical device companies, as well as other industries whose focus is safety, is that a low tolerance for risk is confounded by the difficulty of identifying risk which is not yet known. However, just because a risk has not been detected, or its probability has been severely underestimated, does not mean it goes away. In fact, risks can remain latent for a long time, cloaking them even deeper in a disguise of “normal” until tragedy strikes. This month’s Germanwings’ air disaster is a case in point.
In the aftermath of the Sept. 11, 2001 terrorist attacks, the global air transport industry addressed a single, newly visible (but long-present) risk: the invasion of a cockpit for the purpose of seizing control of the airliner and using it as a weapon of mass murder. That risk was mitigated by modifying cockpit doors to ensure that the risk of a repeat takeover scenario was as low as reasonably practicable. That made us safe, right? This safety myth was further reinforced by 14 years of commercial flight without another 9/11-type attack. But to establish this “safety,” a new risk was immediately created: somebody with legitimate access to the cockpit (but with nefarious goals) could use this safety measure—cockpit doors that are much harder to penetrate from the outside—to again use a jet as a weapon of mass murder. That’s exactly what happened in the crash of Germanwings flight, according to authorities who say the co-pilot locked out the pilot and deliberately slammed the plane into the French Alps.
As that event tells us, this risk—latent for 14 years and probably considered as far-fetched as the pre-9/11 perceived likelihood that anyone would ever commandeer an airliner and crash it into a skyscraper—was there for every flight since 9/11. Once again, it became painfully clear that the absence of bad outcomes does not equal safety.
Thus, the ultimate challenge of risk management—for whatever its purpose—is to properly identify all risks because it’s the least visible ones that seem to come out of nowhere with each new catastrophe.
AAMI member Michael Appel, MD, is the chief patient safety officer with Northeast Georgia Health System, Inc.