Device Safety & Innovation

FDA Announces Plans to Improve Medical Device Safety and Innovation The FDA recently proposed steps to improve the government's system for overseeing medical device safety and new product/device innovation. For years the FDA has been criticized for failing to catch problems with high risk implants and complex/difficult to clean medical instruments. This new plan is designed to address and correct these problems.¹ In announcing this new plan, FDA Commissioner Scott Gottlieb, M.D., said, “Last year, the FDA approved a record number of novel devices. This reflects an advancing pace of innovation that’s resulting in many more potentially lifesaving new medical products. This includes the first artificial pancreas and the first blood test to evaluate traumatic brain injury. My colleagues in the FDA’s Center for Devices and Radiological Health (CDRH), led by Dr. Jeffrey Shuren, have been advancing new policies to drive innovation in medical product development by taking novel approaches to regulation, including the use of real world evidence to support iterative improvements in device performance and establishing a balanced framework for digital health devices that improves the lives of patients. Although medical devices provide great benefits to patients, they also present risks. And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”² Over the past decade, the FDA has been frequently forced to issue safety alerts over problems with products/devices that only appeared years after they were approved for use in patients. Those safety alerts have included hip replacements that failed prematurely; faulty wiring in implanted defibrillators, surgical mesh and a surgical instrument that inadvertently spread uterine cancer. In order to better address the problem, Commissioner Gottlieb said "We want to have better tools for detecting issues that occur post-approval. But we also want to have better policies to quickly intervene and better inform patients and providers if we see adverse events happening. Under Dr. Shuren’s leadership, the FDA has undertaken several important initiatives to prioritize and enhance our approach to medical device safety. We’re considering what more we can do inside the FDA to better protect patients, while at the same time working closely with patients, providers, and device developers to better understand and address device risk and make sure that we’re appropriately balancing risk and benefit.”³ The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the goal of improving safeguards on pacemakers, artificial joints, complex surgical instruments and other devices. Commissioner Gottlieb went on to say that “Building on these substantial efforts, today the FDA is releasing the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. This new Action Plan outlines our vision for how the FDA can continue to enhance our programs and processes to assure the safety of medical devices. Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs.”⁴ The new plan focuses on five key areas:

1. Establish a robust medical device patient safety net in the U.S.
2. Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations.
3. Spur innovation towards safer medical devices.
4. Advance medical device cybersecurity.
5. Integrate CDRH’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.

In addition to the five major proposals, the FDA’s new plan will consider:

1. How to quickly identify the need for additional safety requirements for certain devices, including additional training for doctors/surgeons who work with the complex devices and/or additional training for SPD personnel who reprocess the complex devices.
2. Increased scrutiny of devices for women, following recent problems with vaginal mesh, a birth control implant and numerous surgical instruments/devices.
3. Innovative new ways to encourage device manufacturers to improve safety, including quicker approval for devices that appear safer than what's currently available.
4. Requiring manufacturers to provide cybersecurity features for electronic devices (i.e., implantable heart pacemakers and defibrillators, etc.).

Dr. Gottlieb concluded his presentation by stating that “Medical device safety is a key priority for the FDA. We’re committed to protecting American patients by minimizing avoidable risks and advancing device technologies that are delivering growing benefits.”⁵ Like the FDA, I’m sure that you and your facility are committed to protecting your patients from harm by minimizing avoidable risks. When it comes to reducing the risk of a surgical infection from a contaminated instrument, a simple, inexpensive step that you can take immediately is to seek out companies that have validated their Cleaning and Sterilization IFUs. If a company can’t, or won’t, provide you with a copy of their validated IFUs, then seek out a company that will.  Always remember that you and your facility are responsible for the quality and safety of the reusable medical devices that you use on your patients. 1. FDA Press Release April 17, 2018 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604672.htm 2. FDA Op. Cite. 3. FDA Op. Cite. 4. FDA Op. Cite.