Facing Challenges of Extreme Weather Events
Editor's Note: With this article, we introduce a new quarterly feature to AAMI News: Compliance Science. In these articles, experts with the Office of Compliance within the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) share their views on emerging science and technology as it applies to the manufacturing and marketing of medical devices. This installment was written by Jennifer Y. Kelly, commissioner's fellow at the FDA, and Scott G. McNamee, special assistant to the director, Office of Compliance.
We are interested in all stages of the medical
device manufacturing chain, which, in today's
marketplace, circles the globe. Changes in that
globe, and their impacts on the medical device
supply chain, is where we begin.
On April 11, 2013, the Device Good Manufacturing Practice Advisory Committee met, bringing together CDRH's Office of Compliance with the medical device industry and other stakeholders. The topic of discussion was how extreme weather events and natural disasters can interfere with the manufacturing, shipping, storage, or use of marketed devices, possibly compromising their safety or effectiveness. The FDA asked the committee to identify steps that industry and other stakeholders can take to minimize such risks to public health. The FDA also asked the committee how to optimize the use of the current regulatory framework to address risks and vulnerabilities throughout the manufacturing chain resulting from extreme weather conditions.
Extreme weather events and natural disasters can lead to a variety of challenges. Hurricanes, floods, thunderstorms, earthquakes, or fires can result in power and network outages, extreme temperatures and levels of humidity, and other widespread damage. Interruptions in land, sea, and air transportation can last for several days or even longer. Recent extreme weather events and natural disasters resulted in unforeseen conditions for communities and industries, as well as high levels of widespread damage, putting public health at risk.
Consider the following three weather events, each of which underscores how storms could easily have an impact on the manufacturing chain and ultimately interfere with the safety and quality of medical devices.
First, recall Hurricane Katrina, the August 2005 storm that left 3 million people in and around New Orleans without electricity for several weeks. The affected area covered 90,000 square miles. Breached levees resulted in extensive flooding. Pathogens contaminated floodwaters, and extreme heat and humidity challenged public health. The most costly storm to date left a large area in need of rebuilding. In March 2011, Japan experienced a magnitude 9.0 earthquake and devastating tsunami. Waves as high as 133 feet caused fires, structural damage, a collapsed dam, and widespread contamination. The earthquake knocked out power to a nuclear power plant, crippled its cooling system, and threatened a nuclear emergency.
Finally, in 2012, Hurricane Sandy caused widespread damage to 14 states in the northeastern United States, leaving millions without power for days to weeks. This superstorm ranks as the second-costliest hurricane in U.S. history behind Katrina. Its unprecedented storm surge on Oct. 29, 2012 hit New York City, flooding streets, tunnels, and subway lines, as well as cutting power in and around the city. Four hospitals had to evacuate during the storm. The city cancelled flights, stopped train services, and shut down subway systems. Many roads were damaged as well.
These types of extreme weather events can affect the safety and quality of medical devices in many ways. The FDA identified three primary scenarios: medical devices used during or in the aftermath of an extreme weather event; medical devices and component materials being stored or shipped in the path of extreme weather; and manufacturing processes and facilities caught in the path of an extreme weather event or natural disaster.
Hurricane Katrina starkly illustrated the importance of access to fresh water. In the aftermath of the hurricane, many public water supplies were contaminated. Dialysis machines require fresh, potable water to operate. A healthy patient may require 14 liters/week, while patients requiring dialysis treatment may need between 350 to 500 liters/week. Hurricane Katrina interrupted the dialysis function in communities, homes, and clinics. Intravenous pumps also require fresh water to function, a huge challenge in the aftermath of Hurricane Katrina. Water decontamination steps that do not address new, unidentified microbes can cause infections.
The lengthy power outages after the storm also pointed out vulnerabilities in patient care. Home-use and hospital-based devices requiring electricity could not operate if battery backups were unavailable or out of date. Emergency power generators also proved vulnerable to flooding, and when they did work, they were subject to power fluctuations that challenged safe and proper device function. As the power returned, many programmable medical devices reverted to default settings that may have compromised patient safety. The loss of electrical power also prevented some environmental controls. The resulting heat and humidity in warehouses and treatment centers may have affected the components and packaging of certain medical devices.
The Japan earthquake, tsunami, and associated nuclear emergency resulted in conditions that elevated concerns about medical products. The FDA was concerned about possible radioactive contamination of medical devices, water damage to electrical components, compromised sterility, and product shortages. Raw materials and components within the fallout zone required testing for radioactive contamination.
Hurricane Sandy caused widespread damage that left 266 regulated companies, including 52 medical device makers and facilities, affected by flooding and damage. Four hospitals had to evacuate during the storm due to faulty or flooded emergency power generators. Cardiac patients, premature babies, and others were evacuated through dark stairwells. Many patients required continuous treatment, including medical device support, throughout their transport. Sandy also interrupted clinical trials. Although the Office of Compliance focuses primarily on postmarket issues, one can see how such an extreme storm can cause a wide range of both pre- and postmarket challenges.
Unforeseen conditions, such as those we describe here, may require new practices, safety standards, and methods of risk assessment. This challenging and dynamic area is interdisciplinary in nature, requiring input from scientists, engineers, clinicians, nurses, doctors, project managers, quality assurance experts, and risk managers. The Office of Compliance is committed to protecting and promoting public health by evaluating, enhancing, and ensuring compliance with medical device laws. Readers are encouraged to engage with the FDA, medical device industry, and other stakeholders to continue to improve successful practices, awareness, and risk mitigation.
AAMI News: June 2013, Vol. 48, No. 6