by Elizabeth Hofheinz, M.P.H., M.Ed., January 13, 2020
“There is an elephant—a growing elephant—in the room,” says Chaun Powell, MBA. “And it is the impending shortage of life-saving sterile medical devices.”
Medical device sterilization and shortages are a hot topic right now—the elephant in the room, if you will—as 2019 saw the shutdown of multiple plants that sterilize everyday medical devices. Powell is Group Vice President of Strategic Supplier Engagement for Periop and Interventional, Nursing, and Disaster Response at Premier, a healthcare improvement company. He and the supply chain team at Premier, which unites an alliance of more than 4,000 hospitals and health systems and 175,000 other healthcare providers, conducted primary research to detect what kind of impact these shutdowns could have on the industry-wide supply chain.
“We found that the threat to supply chain disruptions—and the downstream impact to patient harm as a result of continued sterilization facility closures—is real,” Powell says. “We identified that most third-party EtO sterilization facilities are operating currently at 90 percent capacity, meaning there is little excess capacity left if more facilities close. Luckily, we also identified solutions that the industry and national agencies should consider in order to help prevent and mitigate device disruptions.”
Powell laid out five things to know about this topic and how it may affect orthopedic devices.
- Environmental and political factors affect medical device manufacturing and the continued availability of devices used in everyday patient care.
“We have learned much from the 2018 maelstrom of tariffs, concerns about bringing items in from China, discussions about a potential border shutdown with Mexico, and recent hurricanes that particularly affected Puerto Rico,” Powell says. “Collectively, those situations resulted in a roughly 36% increase in product disruptions last year.”
- Ethylene oxide (EtO), a form of medical device sterilization, is under scrutiny and this may trickle down to affect orthopedics.
“Ethylene oxide (EtO) is a form of sterilization not typically used for orthopedic implants, but it is used to sterilize ancillary items used in orthopedic surgeries including custom procedure trays for hips and knees. As manufacturers and distributors seek alternative means of sterilization for these ancillary devices, all forms of sterilization are taking on additional burden, which may lead to further disruption.”
- The national EPA and FDA are both stakeholders in this topic, but their priorities are slightly offset.
“The EPA is poised to propose permissible levels of EtO in March and Powell says he expects more industry attention to this matter given the closure of several sterilization facilities. He notes that the FDA and the EPA are looking at this issue from different perspectives. The EPA is viewing this as an environmental emissions issue, whereas the FDA has a vested interest in the availability of the medical devices that are sterilized in the plants responsible for those emissions. They are both working to protect the stakeholders in their jurisdiction, and are now partnering more closely to ensure that there aren’t unintended consequences to patient care, should additional plants face closure.”
- The solutions to preventing medical device disruptions may mimic the solutions that have been put in place for drug shortages.
“We know that poor demand planning accounts for roughly 68% of disruptions across all industries,” Powell explains. “Premier’s supply chain team is actively working to increase visibility of the device supply chain in concert with the FDA, and we are working in collaboration with trade associations to proactively predict and prevent disruptions in device delivery.”
“As it stands now, pharmaceutical manufacturers are legislatively required to report potential shortages. The medical device industry lags behind, however, as there is no such requirement for them to report their shortages – meaning once a shortage is recognized and communicated to providers, they’re already behind the ball.”
- Preventing medical device disruptions is possible if the industry has better insight into raw material suppliers, packagers and sterilization locations.
“Our overarching goal is upstream visibility,” says Powell. “At present, one half of all medical devices are sterilized using EtO. Because of the plant closures, Premier has been working with trade associations and the FDA to identify specific actions to prevent disruptions. Premier is advocating for the FDA to put a regulation into place so that medical device manufacturers have the obligation to report potential shortages – doing so helps create a level playing field.”
Knowing who the third-party upstream contributors are to the supply chain – raw materials providers, sterilizers, packagers – will be imperative. “As an example, Hurricane Maria was heading toward Puerto Rico in 2017, we worked with nearly 100 manufacturers, many of which are household names in orthopedics, to accelerate the shipment of orders to prevent damage to idle inventory due to the storm,” Powell says. “Having legislation regarding all possible upstream stakeholders in these types of instances would result in a more streamlined and successful delivery of products.”