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

In his health care reform proposal to Congress and the nation revealed today, President Obama has included requirements for pharmaceutical and medical device companies to disclose payments to health care providers and hospitals. These ‘Sunshine provisions,’ modeled after a bill introduced in the Senate in 2007 by Senators Herb Kohl and Charles Grassley, have bipartisan, bicameral support, and were included in the health care reform bills passed by both the House and Senate this winter.

Here’s the language:

To prevent conflicts of interests and insure full transparency and information for patients, the Act requires all drug companies, device, and medical supply manufacturers to fully disclose and report any gifts they make or financial arrangements they have with doctors, a physician practice or group.

The proposal, released ahead of a much-awaited bipartisan health care reform summit at Blair House this week, reflects a growing national consensus about the need for robust transparency of the financial relationships between providers and the pharmaceutical and device industries, including recommendations by the Institute of Medicine and the Medicare Payment Advisory Commission.

The President’s health care reform proposal also requires pharmacy benefit managers to disclose information about negotations and drug pricing deals they make, a component of the original House bill passed in November.

President Obama’s proposal goes beyond the Senate bill on prescription drugs in two other important ways:  closing the Medicare Part-D ‘doughnut hole,’ and banning pay-for-delay settlements that keep drug costs artificially high.

By closing the doughnut hole, the President’s plan would save the 8 million seniors who exhaust their prescription drug benefits each year an average of $4,080 a year by 2020. Like today, seniors will still have a 25 percent co-insurance obligation until ‘catastrophic’ coverage kicks in, unless they qualify for low-income subsidized coverage.

The proposal also grants the Federal Trade Commission the authority to police drug company patent settlements for “collusion” to keep generics off the market. FTC estimated that such a reform would save $35 billion over the next decade, and Obama’s proposal would give FTC the authority to prevent these settlements unless proven to increase competition.

–Kate Petersen, PostScript blogger

Medical device maker Boston Scientific is under investigation for its payments to doctors — and for payments to charities with whom those doctors and their families are affiliated. The company reported in an SEC filing that it has received subpoenas for the information from the HHS Office of the Inspector General. The company is also being investigated by the Department of Defense and the Army “concerning sales and marketing interactions with physicians” at an Army medical center in Tacoma, WA.

Boston Scientific’s marketing practices have been under scrutiny before. Last year, it was one of three companies investigated by the U.S. Attorney for marketing of defibrillators and pacemakers. This week, the company paid $296 million and plead guilty to charges of two misdemeanors resulting from that case.

Interestingly, at an industry conference in Washington, D.C. this week, an employee of one device company explained that his company was being asked by doctors to direct payments to “third-party entities.” Would the Sunshine Act require disclosure of the ultimate recipient? Yes, he was told, it would.

Here’s the full post.  Hat tip to Pharmagossip.

–Kate Petersen, PostScript blogger