Regulations Hurt Instead of Protect

Just when I thought we had reached the limits of regulatory madness, they go deeper into la-la-land. Healthcare rules are now stopping patient safety measures!

Several years ago, intensive care units in the State of Michigan banded together to reduce infections that occur when central IV (intravenous) lines are placed in hospitalized patients. The solution was nothing more complex than a checklist before inserting a line, similar to a pilot’s pre-flight checklist before taking off. Results were impressive: average infection rate fell almost to zero; over 1500 lives were saved over 18 months; and nearly $200 million in costs were avoided.

What was their reward for this great achievement? The Office for Human Research Protections (OHRP) in Bethesda shut down the program because, get this, they did not follow the Office’s rules and regulations.

In essence, OHRP said that healthcare research is all the same, regardless of whether you are trying a new, untested drug or operation that might kill the patient; or a checklist before starting an IV. No difference. All should follow the same regulations.

The general public has no sense of the incredibly complex, time-consuming, sometimes contradictory, and obscenely expensive regulatory system set up ostensibly to protect patients as the subjects of research. David Dilts counted 87 separate steps or committee hearings before a research project could be started at Vanderbilt. While some process is necessary to protect patients, protections should be proportional to the risk and produce value commensurate with their cost.

At present, our regulatory system that is supposed to protect us is actually hurting us. We need to inject – as painfully and as quickly as possible – some balance, reality and purpose clarity into the regulatory machinery that governs healthcare.

Ref: http://www.nytimes.com/2007/12/30/opinion/30gawande.html?ex= 1200200400&en=32b83b2befa63ff0&ei=5070&emc=eta1.

The System MD

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