Sunday, August 22, 2010

Yet another case for reforming the medical device industry

The New York Times just published a heartbreaking exposé about medical tubing and deaths that can result from nurses and doctors inserting the incorrect tubes into patients’ veins and bodies – ie inserting a feeding tube into a vein. http://www.nytimes.com/2010/08/21/health/policy/21tubes.html?_r=1&ref=health

Patients, hospitals, and many in the industry advocate making different kinds of tubing for different functions that are incompatible with one another so that this kind of mistake could not be made.  However, this initiative has run into major regulatory hurdles as the FDA has been slow to insist that this kind of tubing be put into use and industry advocates have challenged the necessity. 

The article is disheartening for a number of reasons.  The FDA is largely considered the most successful US regulatory agency (http://www.newyorker.com/talk/financial/2010/06/14/100614ta_talk_surowiecki ), yet even it has major systematic process errors like the ones described in the article that allow it to approve devices closely resembling those that have been recalled.  It also, like many government agencies, is not a fast-moving body.  The tube issue is clearly one it clearly must correct, yet the response has been incredibly slow.  The article also brings to light the flaws of a system that gives too much voice to industry concerns.  This is a case in which a simple adjustment of design would prevent a simple mistake from killing a patient; clearly, it’s a time when the public interest needs to outweigh the demands of a business.  However, industry lobbying has slowed the process and allowed for more deaths to occur. 
However, in some ways  be seen as inspiring.  The issues with tubing can be easily solved once hurdles are cleared.  There are many cases in medicine where simple changes can begin to eliminate unnecessary loss of life.  Coordinating such changes will be a massive challenge, but such changes are possible.  Standardizing medical devices so that doctors will not waste time figuring out how to use a new machine, setting up operating trays in the same way, implementing electronic record-keeping, and many other examples will help prevent mistakes from being made when they are eventually implemented.  There are so many clear paths forward in improving medical care and preventing medical errors; the challenge will be in sticking with these plans and following through on implementation. Key to this will be reforming the medical device industry -- forcing companies to standardize designs and adhere to safety-maximizing standards will be a huge, but not insurmountable challenge. 

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