As a report this week in the New York Times illustrated, patient harm caused by misconnection of tubes–such as feeding tubes inserted into veins—has been a recognized source of medical error for decades.
In April 2006, the Joint Commission issued a Sentinel Event Alert indicating that misconnection errors were an important and under-reported problem in health care organizations. Sentinel events are errors that are required to be reported to the Joint Commission Sentinel Event Database. That year, only nine cases had been reported–eight deaths and one permanent loss of function. Yet USP (United States Pharmacopeia) databases listed over 300 cases for the same time period.
The fact is that any number of cases over zero is unacceptable when such errors are entirely avoidable. Unfortunately, in health care, the way safety is approached is nineteenth century: Tell people to work harder to avoid making the mistake. No other industry would tolerate this antiquated approach for a second.
In 1961, Shigeo Shingo was an industrial engineer at Toyota Motor Corp; he came up with the concept of Poka-Yoke. If you want to prevent an error, design the product or system to be error or mistake-proof. Poka-Yoke is a process that:
• Makes wrong actions more difficult
• Makes it possible to reverse actions — to “undo” them — or make it harder to do what cannot be reversed
• Makes it easier to discover the errors that occur
• Makes incorrect actions correct
That process is why you cannot take the keys out of your ignition if the car is not in park and why the dryer goes off when you open the door. Robin Rogers, a woman in the Times story who died with her unborn child after a feeding tube was inserted into her vein, did not die because the nurse connected the wrong tube or because the FDA was lax. Roger’s unnecessary death was because we have not insisted on the same industry standards that we demand for our air or car travel.
U.S. health care is a complex industry of multiple “free-enterprise” zones, many of which have little or no accountability. We have multiple regulatory agencies: the Joint Commission to oversee facilities, the Medical and Nursing Boards to make certain doctors and nurses are meeting standards of care, the FDA to regulate devices and pharmaceuticals. But each has limited authority and none guides the combination of events that result in a nurse in an understaffed hospital at the end of a double 10-hour shift connecting a tube that is carrying food for the stomach that has the same connection as the line to the intravenous route.
Car manufacturers have put in ABS into their car brake systems (another “fail-safe” system that prevents you skidding if you stomp on the brakes) because it has given them a competitive advantage. The competitive advantage occurs because the public understands car safety. There was a Congressional hearing when stuck accelerators caused a highway patrolman to crash, killing him and his family. Where are the Congressional hearings for the deaths of people who are even more vulnerable, having put their trust in the system that cares for their health?
FDA oversight ultimately depends on statutory authority as well as public will. We should pursue legislative solutions that require tubing manufacturers to make tubing used for different purposes (intravenous, oxygen delivery, drainage tubes, feeding) totally incompatible with one another, including inability to connect them to standard Luer locks. But the likelihood of accomplishing meaningful change given the current adversarial political climate is slim.
The other approach is a change in how we look at medical liability. Currently, we tend to hold accountable the last person to touch a system error: in these cases, the person who connected the two tubes. This is despite the fact that we know that if error can occur, it will occur.
It is time to demand that the accountability fall to the manufacturers of medical tubing – just as it falls to the manufacturers of planes and automobiles. We are past the “buyer beware” phase of medical devices. Isn’t it time we demand that the designers of medical tubing produce products that are not just safe, but error-proof?
–Lynn Parry, M.D.
Chair, Colorado Prescription Project