An FDA panel on April 11 advised the federal watchdog agency to take another look at its emergency risk mitigation strategies, particularly in regard to how events like extreme weather and natural or nuclear disasters may threaten medical devices.
Current quality systems are likely sufficient, the panel noted, but lessons learned during some of the last decade’s catastrophes, including Hurricane Katrina and the Japanese earthquake and tsunami, should spur new efforts to minimize challenges that arise in emergencies.
Catastrophes such as Super Storm Sandy, the Icelandic volcano eruption and others created a number of problems that affected the quality of medical devices on the market, the panel said.
Such problems included power interruptions and outages; wireless network interruptions; extreme changes in temperature and humidity; fires, flooding, and inability to access clean water; contamination of water, devices, or packaging; and transport interruptions, FDA noted.
“Hospitals, manufacturers, everybody needs to accept a mindset that there have been more and more of these type of disasters,” said panel spokesperson Terry Schuenmeyer, an RN at Houston’s Methodist Hospital Research Institute. “It’s something that’s not going to go away and it’s not going to lessen.”
Learning from the past
Manufacturers both large and small should be “required to anticipate that something could at some time happen, depending on their geographical locale,” she continued. “If you’re on the Gulf Coast or in Florida or South Carolina, you should anticipate that you will at some time have a hurricane. If you are in tornado alley, then you might want to anticipate that sometime you may be hit by a tornado. If you’re in California, your process may be disrupted by an earthquake.”
After Hurricane Katrina, contact lens solutions became contaminated and dialysis services throughout the Gulf Coast were interrupted, FDA said. Power outages affected critical devices requiring electricity in hospitals and homes such as ventilators, insulin pumps, glucose meters and apnea monitors. These problems were intensified by out-of-date battery supplies and flooded back-up emergency power systems.
Super Storm Sandy caused flooding and damage to 266 regulated products facilities, including 54 device firms, the federal watchdog reported. FDA added that device packaging may not withstand flooding, or extreme humidity or temperature.
Transportation interruptions due to Sandy further caused delays in restocking supplies for hospitals, clinics and home use equipment, shipping of medical devices and their components and raw materials, and failures to meet environmental controls.
Room for improvement
The FDA’s Device Good Manufacturing Practices Advisory Committee on Thursday discussed how the agency and the medical device industry can minimize future challenges in times of emergency.
Current FDA quality system regulation for medical devices addresses product design and labeling, testing and procurement of materials, manufacturing processes, packaging, sterility, shipping and storage of devices, complaint handling, and corrective and preventive actions. Although the regulation sets expectations for the framework of a quality system, companies have the flexibility to develop procedures and documentation tailored to their particular devices, business size, and facilities, FDA said.
Panelists generally agreed that while no major changes are needed in the Quality System regulation for medical devices, FDA and industry should work together to update guidance to help facilitate emergency preparedness.
Panel industry representative Cecelia Kimberlin noted that the large company she worked for had a crisis management team in place to address what to do when catastrophic events occurred. Rather than re-inventing the wheel, companies should share information for how best to handle a crisis, she said.
“Whether you’re a large company or a small company, I don’t know that that matters,” spokesperson Schuenmeyer said. “Small companies may have an advantage. If you have 10-20 employees, you can get them in one room and discuss this altogether and say, look what if we have an earthquake? What are we going to do? Do we need to have drills? How will we review our processes, how will we get back on line?”
“[For larger companies] that could involve 100 people in different locations and multiple meetings and a lot more of their time and resources,” she continued. “It sounds like they have processes in place. Perhaps the regs are fine, but the management control needs to have even 1 statement that says that management must consider that you, at some time as a manufacturer, may experience an extreme weather event and you must plan for it and prepare for it.”
Breakdowns in communication
The larger problem, the panel agreed, is a breakdown in communication with medical device users during an emergency, which can result in improper use of products that have been contaminated or that are no longer functioning optimally, stock shortages to due shipping problems, or a breakdown of devices that rely on electricity.
In addition to establishing better communication with hospitals and patients prior to and during an emergency, the panel suggested that industry build emergency preparedness into their devices at the design and packaging phase.
For example, packaging for temperature sensitive products could be updated to include heat indicators that alert users as to whether it is still safe to use a device that may have undergone delays or extreme temperatures during shipment. To help resolve power outage problems, industry should be encouraged to adopt universal batteries or universal power supplies, the panel agreed.
“The QSR by itself is fine, but as we think about revising guidance documents, it’s not just the extreme weather events you might consider revising against," said the panel’s government representative, David Cranmer, of the National Institute of Standards & Technology. "It’s any disruption of operations, like the airplane that falls out of the sky, the toxic chemical spill that might force an evacuation. And any of those potential risk factors need to be included,”
Cranmer further recommended that the FDA create a simulation course, module or video based on the experiences of those who have been through extreme weather events, in order to share those lessons with others.
New communication channels are important, some panelists noted, but patient sensitivities about privacy and tracking may become a factor as well, Cranmer said.
In thinking about protocols for smart, durable equipment, “You’re going to put sensors and communication devices in,” he said. “I can think of lots of benefits to the manufacturers to have that information, and lots of benefits to a potential patient to have those. But the protocols about when that communication is activated, and by whom, reminded me that there are people who don’t want to be tracked. So that just needs to be part of the communications protocol as to how that gets dealt with. Who owns the device, who owns the information that comes from it?"