First published 2/1/8/11 on Gooz News.
Joel Makower, a venture capitalist who invests in start-up medical device companies, and Ralph Hall, a University of Minnesota law professor who represents device companies in his legal practice, testified on Capitol Hill yesterday that the industry had an exemplary record in insuring the safety of devices allowed on the market under the 510(k) process, which does not require stringent clinical trial testing. Their key statistic: 99.6 percent of devices are never recalled.
Here’s another way to look at that number: Four out of every 1,000 devices are recalled. Put another way, for every million people who get those devices, 4,000 people are subjected to a faulty product whose failure could put their health at risk.
Now let’s compare that to the “Six Sigma” quality standards used by manufacturers of cell phones and flat-screen televisions. Six-sigma, for those not familiar with the concept, was adopted by Motorola in 1986 so it could compete with its Japanese competitors. Such firms aim to make products 99.99966 percent defect free. That’s 3.4 defective products per million made.
Here’s a real world example, drawn from Dr. Rita Redberg’s testimony yesterday, about what can happen when an industry has quality standards that are somewhere between Chinese toy manufacturer and a first world maker of sophisticated electronics:
The Bard Recovery and inferior vena cava (IVC) filter device, and a related device called the G2, were approved by the FDA pursuant to the 510k process. A filter is an umbrella-like device opened into one of the largest veins of the heart in order to trap clots. This device was investigated by surgeons, including Dr. William Nicholson and colleagues in Pennsylvania, who had noted that several patients at their hospital who had received Bard Recovery filters had returned with chest pain and shortness of breath. The physicians discovered that these devices had fractured apart. Pieces of the devices had traveled and punctured the lining of the heart, causing life-threatening complications of cardiac puncture. These doctors astutely decided to call back all of their patients who had received the Bard Recovery and G2 over the last 5 years to check on their condition. They were shocked to find that in fully a quarter of one type of device, and an eighth of the other type of device, these filters had fractured inside their patient’s bodies. Their research led them to notify the FDA of their findings, which were published in the Archives of Internal Medicine.
In my own research, I was alarmed to discover that these IVC filters, which were clearly implantable and could cause great harm to these patients, had been approved for use under the 510k mechanism without any clinical trial data. The day that we published Dr. Nicholson’s article (August 9, 2010), the FDA issued a warning that they had received 921 adverse event reports about IVC filters since 2005 and reminding doctors that these were approved as “retrievable” devices, and that doctors should be retrieving them. In actual fact, only 7% of all retrievable IVC filters are ever retrieved. On obvious question arising from this incident is why it took five years and 921 adverse events for the FDA to issue its warning. The reason, I learned, is that until reviewing the Archives article the FDA had no idea that there were so many serious adverse events associated with IVC filters.
If the House Energy and Commerce Committee, which held yesterday’s hearing, wanted to do something useful, it would require that every medical device be bar coded so its use can be tracked, and every patient who receives an implantable device have that code and their experience with the device entered into a registry that can be accessed by the FDA and outside researchers. If the industry and Congress are truly interested in promoting innovation in the medical device industry, the first step is to track the safety and outcomes performance of products that purport to be innovative.