‘Failure in Standards and Regulations’ Leads to Disaster, Former Airline Pilot, Patient Safety Expert Warns

Posted April 30, 2019

When it comes to safety, the aviation industry’s organized approach to risk minimization, oversight, and investigation is generally held as the gold standard. However, recent crashes involving two Boeing 737 Max 8 aircraft that killed nearly 350 people show that catastrophic accidents can, and still do, occur.

During the opening keynote address at last week’s International Conference on Medical Devices Standards and Regulations, which was co-hosted by AAMI, the Food and Drug Administration, and BSI, anesthesiologist and former commercial airline pilot Michael Appel presented what he described as “perhaps the biggest failure in standards and regulations in the aviation industry in history” as a cautionary tale for medical device manufacturers and regulators.

Michael Appel
Michael Appel presents at the International Conference on Medical Device Standards and Regulations.

“I’m always telling stories about the successes of aviation, trying to compare to how successful we in healthcare could be by using the success stories in aviation. Today, I’m going to be telling a story about a huge failure, which is new,” said Appel, who is chief patient safety officer for Northeast Georgia Health System, Inc. in Gainesville, GA.

On Oct. 29, 2018, Lion Air Flight 610 crashed into the Java Sea shortly after takeoff from Jakarta, Indonesia, killing all 189 people on board. A few months later, on March 10, Ethiopian Airlines Flight 302 crashed minutes after taking off from Addis Ababa en route to Nairobi, Kenya, killing 157 people. Since then, the plane involved in both crashes, the 737 Max, has been grounded all over the world.

To find out what went wrong, you need to not only look at the design of the plane, but also the culture in which it was built, according to Appel, who is a member of the AAMI Board of Directors.

The 737 Max was a new model of Boeing’s flagship aircraft that was developed in response to Airbus’s A320neo. Both aircraft were not new designs, but were “re-engineered derivatives,” which means that current versions of the planes were re-engineered to accommodate larger engines with greater fuel efficiency, Appel explained during his presentation.

This was primarily a business decision, according to Appel; one that would run contrary to the basic tenets of aviation safety and could have been countered by effective regulatory oversight and applying the aviation industry’s “absolute standards for ‘acceptable risk.’”

“What possibly happened is that they invested in a bad [design] decision early on, and it became harder over time to rethink that decision, to the point that once they realized it was a bad decision―nobody wanted to admit it,” Appel said, so they came up with “workarounds,” such as the Maneuvering Characteristics Augmentation System, which has been cited as a possible factor in both crashes.

In hindsight, scrapping the planned engine modifications for the 737 would probably have been the right decision. “But what happens when we make the right decision in the world of safety? Nothing. A dynamic non-event. That’s the world of safety management,” Appel said. “There’s no reward for preventing an accident that you never knew was going to happen in the first place.”

The lesson, according to Appel, is that “maybe the stakes were too high for a good decision,” which is an issue that cuts across industries, including healthcare.

“This is an example of how vulnerable we are as humans to these types of problems that come with any high-stakes decision,” Appel said. That is why standards and regulations are so important—without them disasters literally can occur.