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The FDA responds to fears of nationwide shortages following the closure of two medtech sterilisation plants

There are fears the closure of two medtech sterilisation plants could result in years of nationwide shortages for a number of surgical kits and implantable medical devices.

Recently a Sterigenics sterilisation facility in Illinois has been shut down, another Sterigenics facility in Georgia has been shut temporarily and there are talks of potentially closing down a Becton Dickinson (BD) sterilisation facility in Convington.

The types of surgical kits affected includes those used in emergency surgical procedures and knee and hip replacement surgeries. Additionally, the Food and Drug Administration (FDA) warns that feeding tube devices for neonatal care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices could be at risk.

The reason for the closures is because the Environmental Protection Agency (EPA) considers Ethylene Oxide (EO) to be a carcinogen. The EPA found the levels of EO at the facility in Illinois to be higher than acceptable, resulting in the closure of the facility. As a result of this closure there was a temporary shortage of paediatric breathing tubes.

Acting FDA commissioner Ned Sharpless commented: “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 EO to sterilise these devices.

“In short, this method is critical to our healthcare system and to the continued availability of safe, effective and high-quality medical devices.”

According to the FDA 50% of all devices which are sold within the United States (US) and require sterilisation, are sterilised using EO. EO is used due to its penetration properties and its ability to leave products undamaged during the process.

Sharpless added: “Because the number of EO contract sterilisation facilities in the US is limited, we are very concerned that additional facility closures could severely impact the supply of sterile medical devices to healthcare delivery organisations that depend on those devices to take care of patients.

“The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care.”

Although some large medtech companies are able to sterilise its own devices, many of the smaller medtech companies contract this service out. The potential impact is huge, and Sharpless mentioned how the FDA are committed to helping manufacturers look for alternative sterilisation methods.

The FDA offered the following advice:

  1. Keep an inventory of critical medical supplies that undergo contract terminal EO sterilisation
  2. Seek the agency’s help to identify a potential substitute for devices
  1. Do not hoard devices, but instead order larger quantities than normal
  2. Email the agency’s shortages mailbox in the case a shortage occurs or there are concerns about the adequacy of medical devices to meet patient needs. The email address is - deviceshortages@fda.hhs.gov

Suzanne Schwartz, acting director of the office of strategic partnerships and technology innovation at FDA’s centre for devices and radiological health added: “It’s kind of like a tipping point right now.

“If there were to be any more closures then the likelihood is we will not only see spot or local shortages, it will have a ripple effect nationally.” 

Additionally, AdvaMed president and CEO Scott Whitaker commented: “FDA is right to point out the serious consequences to US patients and the healthcare system should access to EO be further limited.

“Make no mistake: Without EO sterilisation, there will be a true healthcare crisis in this country as physicians and surgeons will not have access to critical medical devices. The importance of safe, sterilised medical devices to patient care must be emphasised as we continue to debate the true risk of this crucial sterilisation method."

The FDA is holding a public advisory committee meeting on Novermber 6th and 7th to talk about how to encourage innovation in medtech sterilisation. Additionally, the FDA are collaborating with the US EPA, who are responsible for reviewing and enforcing the Clean Air Act regulations for sterilisation facilities. The EPA attempt to ensure the public are protected from EO emissions from these facilities.

Sharpless concluded: “We want to be clear that we understand that there are very real consequences that medical device shortages have on patients, and we’re committed to doing everything in our authority to help mitigate the adverse patient impact these sterilisation facility closures are expected to have.

“We’re also calling on all stakeholders - manufacturers, contract sterilisers, government agencies and other public health advocates to join us and do your part to avert new device shortages and ensure patients have access to important and life-saving medical devices.”

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