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, a Los 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 reporter Peter 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.
Manufacturers must file medical device reports within 30 days of all related deaths, serious injuries and malfunctions, and those reports are available online in a searchable database called MAUDE.
But most of these notifications only note which device was involved and roughly what happened. The FDA redacts critical details such as the state and hospital where the problem occurred, making it difficult to find doctors and patients involved in specific incidents.
It is safe to say these reports do not please Eisler.
“They’re awful,” he told panel attendees. “They are, like, one of the worst, most incomplete, useless pieces of information that you will ever see coming out of a government agency.”
To be fair, they do, at least, notify the public that a given medical device has had some sort of problem. Luckily, there are other places to look for more information.
The FDA inspects factories where devices are made, and when it finds serious problems, a special report, called a “Form 483” is issued. A searchable index of these forms is on the FDA website, but getting an actual report requires a public information request.
“They will give it to you, hopefully before you retire,” Eisler remarked wryly.
Press releases, enforcement reports, warning letters and safety communications bulletins are also available on the FDA website.
Asking deeper questions
When devices have problems, it can help to start thinking like someone who investigates this kind of thing for a living.
That is the mission of the ECRI Institute, a nonprofit organization that studies various aspects of the health care system from drugs to devices. It issues recommendations to member hospitals based on comparative effectiveness studies, and also dispatches investigators to help hospitals find the root causes of harmful incidents. The investigations are independent, but are not considered public information. The institute signs and follows confidentiality agreements that keep it from linking the problems it finds to specific hospitals, but it does publish general reports in its findings for member hospitals with identifying information removed.
Having conducted more than 100 such investigations during his career, Lucas said the first step is to get and read a device’s operating manual, which spells out how a device is designed to work and how it is supposed to be used.
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. Class III devices, for example, should have a paper trail of staff reports and minutes from advisory panel meetings that may mention any concerns discussed before the approval vote.
A reporter’s first question should always be “why?” Eisler said.
- Why is this device better than others already used to treat the same condition?
- How, precisely, does a patient benefit?
“A lot of the time, the advantage is not to the patient, it’s to the doctor or to the hospital,” Eisler said.
Training is another big issue. Doctors generally learn to use new devices from the company that made them, and sometimes that training is delivered by a sales representative, not a fellow physician.
“You can ask, how many procedures have you done, and how many were proctored by a more experienced surgeon?” Lucas said.