[Reblog] Illnesses, injuries linked to medical devices a ripe area for investigation #ahcj15
Most medical devices marketed in the United States do not need formal approval from the U.S. Food and Drug Administration.
Members of a panel at Health Journalism 2015 on medical device coverage provided a variety of advice for reporters covering and of the implants, instruments and diagnostic tools common to the modern medical machine.
Moderator of the session was Chad Terhune, aLos Angeles Times reporter who recently found himself chasing an outbreak of carbapenem-resistant enterobacteriaceae (CRE) linked to dirty duodenoscopes. Contributing to the discussion were panelists USA Today investigative reporterPeter Eisler and Scott Lucas, associate director of accident and forensic investigation at the ECRI Institute.
A recent CRE outbreak at Ronald Reagan UCLA Medical Center illustrates the broader issues of medical device approval and oversight. The Olympus scopes used at the Los Angeles hospital, and at other facilities around the nation where the superbug infected patients, did not require any formal study or approval from the FDA before hitting the market because they were considered “substantially equivalent” to a previous models. Equivalency, Eisler explained, allows thousands of devices to move from labs to patients with little more than a short 510K statement that the manufacturer files with the FDA.
Only 10 percent of devices, such as those which “sustain or support life, are implanted, or present potential unreasonable risk of illness or injury” fall into the FDA’s “premarket approval’” category requiring a greater level of regulatory scrutiny, including safety and effectiveness studies, before sale.
Things are not much better once devices hit the market.
It is important to understand that medical devices seldom stand alone, he said. They are usually part of much broader systems used to deliver care safely to patients. When a patient dies after a ventilator fails, for example, it may be that alarms, communications networks or staffing protocols designed to quickly detect and report the failure did not work.
Thus, if reporters want to understand what went wrong in a specific incident, they should ask about more than the device itself. “The system approach to an investigation is key to finding the answer,” Lucas said.
Also be aware that hospitals are supposed to have detailed plans that tell employees what to do when there is a problem with a device. Sequestering machines that malfunction, and downloading data from them before it is purged, are examples of best-practice steps that reporters can ask about.
Handling the pitch
So what should a reporter do when he or she receives a glowing pitch from a local hospital about the latest device?
Terhune suggests starting with Medicare’s open payments database to see if the doctors involved have a financial interest in the device that’s being pitched. While a financial interest is not necessarily a deal breaker for coverage, it is something reporters should know about going in and make sure they can adequately address in their coverage.
Next, look at whatever FDA approval process was required for the device
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