What is the Outlook for Medical Device Shortages in 2020?

​Concerns over medical device shortages are again at the forefront for providers and for health professionals. Though there are always worries over the availability of certain types of medical technology,  the current, looming crisis began with state environmental protection agencies issuing orders for sterilization facilities to stop using ethylene oxide (EtO) in their processes.  

Ethyl Oxide Shortages Raise Concerns

In February 2019, the Illinois Environmental Protection Agency issued a Seal Order to Sterigenics in Willowbrook to stop sterilization cycles using EtO to prevent emissions, “which present an imminent and substantial endangerment to residents and off-site workers in the Willowbrook community.” In August, a Sterigenics facility in Atlanta closed for construction to reduce EtO emissions, and the Willowbrook facility announced in October it would not reopen. 

In an FDA statement from Normal Sharpless MD, he says, “In light of the possibility of continued ethylene oxide sterilization facility closures, we are again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages.” 

Using ethylene oxide has been a common method of sterilizing devices made from plastic, resin, metal, or glass or devices that have multiple layers or deep crevices. One of the reasons it’s preferred is its ability to sterilize without damaging products. EtO sterilization is used on more than 20 billion devices — about half of all devices that require sterilization — each year in the US. The FDA states products commonly sterilized with ethylene oxide, include:

• Surgical kits for emergency room procedures, cardiac surgery, or hip or knee replacements
• Feeding tube devices used in neonatal intensive care
• Drug-eluting cardiac stents
• Catheters
• Shunt

The FDA statement continues, “Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices.”

Sharpless adds, “It’s important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective, and high-quality medical devices.”
​
The FDA advises medical device manufacturers to assess their supply chains for the impact sterilization facility closures will have on product availability. 

Other Factors Impacting Medical Device Shortages

Sterilization facility closures are just one type of disruption to the supply chain. Numerous additional factors can lead to medical device shortages, including:
​

• Demand Planning
  Demand for medical devices is unpredictable compared to providing products for other industries. Healthcare organizations often don’t enter into contracts with suppliers that include guaranteed demand over a specific timeframe, so it’s more difficult for manufacturers to forecast and have adequate inventory available when it’s needed. 
  
  
• Product Recalls
  Voluntary or FDA-mandated medical device recalls may result in shortages. The FDA guidance on recalls recommends that manufacturers develop a strategy that takes continued availability into account for essential products. 
  
  
• Environmental Disasters 
  Hurricanes or other natural disasters can disrupt medical devices manufacturing, packaging and processing, or delivery. For example, in 2018, Hurricane Michael, which made landfall on the Florida Panhandle, impacted 11 medical device manufacturers. And in 2017, Hurricane Maria impacted more than 50 medical device manufacturing facilities in Puerto Rico, which produced more than 1,000 medical devices. 
  
  
• M&A Activity
  MedTech mergers and acquisitions can reduce the number of manufacturing facilities, which can lead to inventory shortages and supply chain bottlenecks. 
  
  
• Regulatory & Industry Changes
  Medical device manufacturers must comply with continually evolving regulations, tech disruption, and care standards. A warehouse filled with inventory is useless if it doesn’t comply with regulations. 
  
  
• Political Tensions
  The US-China trade war has impacted the industry, with the US imposing tariffs on approximately $2 billion worth of medical devices and parts made in China. MedTech manufacturers are dealing with product availability and increased costs to produce assets and devices such as MRIs, electrocardiographs, diagnostic monitors, and laboratory equipment. 

Is there a Way to Minimize Medical Device Shortages in the Future?

Forecasting demand will continue to challenge Medtech manufacturers, due to uncertainty in the industry, contract variability, and incomplete data. New solutions that leverage advanced analytics, additional data sources, and machine learning may help manufacturers forecast more accurately. 

As for the current risk of medical device shortages due to sterilization plant closures, the FDA is monitoring supplies of critical devices and encouraging manufacturers and healthcare providers to provide supply data voluntarily. The FDA has also announced innovation challenges in an attempt to identify alternative sterilization methods to EtO and find ways to reduce EtO emissions during sterilization procedures.   

Subscribe to the Carevoyance Blog

About the Author

Carevoyance contributor Bernadette Wilson of B Wilson Marketing Communications is an experienced journalist, writer, editor, and B2B marketer, specializing in content for technology companies.