One of the big growth areas in health care in the last 20 years has been in medical devices. We are putting more medical devices in our bodies than ever before, and now doctors are using robots to perform surgery.
The Food and Drug Administration monitors adverse events with regard to medical devices and use of medical products such as robotic surgery devices. It is a voluntary reporting system and dependent upon full and complete reporting by manufacturers or health care providers as to adverse events.
Reporting of adverse events and complications is essential to quality healthcare. How can anyone quarrel with that? As consumers, we are entitled to know about the good, the bad and the ugly with regard to health care products. Yet, if there is not adequate reporting, how can we ever know if there is a problem?
Recently, there has been much discussion about underreporting of adverse events regarding use of robots in surgery. The FDA issued a warning letter to Intuitive Surgical Systems, the manufacturer of the da Vinci robotic surgery system, after inspection by the FDA found that the company had not adequately reported adverse events and device corrections in some cases.
Safety monitoring is critical for medical devices because devices face far less rigorous testing before they are cleared for widespread marketing than drugs. Most devices are allowed to reach the market without human trials if they are substantially equivalent to other devices on the market. Doctors are almost entirely dependent on "post-market" studies for information about a medical device. Thus, if under-reporting of adverse events is going on, the doctors and their patients are operating in the dark.
Researchers at Johns Hopkins Medical School, a prestigious institution, published a study last year on under-reporting of robotic surgery complications. It was reported that "despite widespread adoption by hospitals of surgical robot technology over the past decade, a ‘slapdash’ system of reporting complications paints an unclear picture of its safety." The lead author of the study, Martin Markary, M.D., found that there were more than 1 million robotic surgeries performed between 2000 and 2012, but only 71 deaths and 241 complications were reported. He stated that "doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes."
Dr. Markary suggested that one solution may be to use a database like the one maintained by the American College of Surgeons in which independent nurses identify and track adverse events and complications of traditional operations. If they can track adverse events and complications in surgeries not performed with robots, it would be just as easy to track adverse events and complications with robotic surgeries.
The doctors at Johns Hopkins are not the only doctors upset with the current system. Rita Redberg, M.D., a cardiologist in California and the editor of a prestigious journal, JAMA Internal Medicine, has recently stated that that the only way we are finding out about a lot of the problems with medical devices is through lawyers. She said that we use far more medical devices than anyone else in the world and yet we can’t say what happened to these people.
The Institute of Medicine of the National Academy of Science, an independent nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public, has also undertaken a study of the monitoring and regulating of medical devices and found that "every link in the chain has a reason not to report."
The Institute of Medicine "recommends that the FDA develop and implement a program of continuous quality improvement to increase predictability, transparency, and consistency in all regulatory decisions for devices and to address emerging issues that affect decision making."
Apparently, the FDA is working on a four-step plan to improve its monitoring of devices, including enhanced registries for certain devices, and automated reporting of safety events. Last September, the FDA finalized rules requiring medical devices to have unique identification codes, which is a step toward accurate reporting of adverse events.
At a time when trust in government could not be any worse, it is time for action. Many people despise governmental regulation, but in this case, when our own health and safety is at stake, more regulation is better than less.
Bob Buckley is an attorney in Independence. Email him at firstname.lastname@example.org