It is a problem that has long been in the making, stretching back before the Covid-19 pandemic. In the months before the virus was first identified, the US healthcare system was contending with device shortages due to a sharp fall in sterilisation capacity.
Used for more than half of the devices and equipment sterilised in the US annually (20 billion), according to trade body AdvaMed, ethylene oxide (EtO) has long been the go-to for reprocessing. However, with growing concerns about the safety risks associated with EtO production and its impact on local communities, a trio of incidents at plants producing the gas and liquid material in 2019 were met with state orders for the facilities to close.
It was a move that brought pressure to the supply chain, threatening the safety of patients and the healthcare system’s ability to treat the unwell. In October 2019, the FDA warned that the closure of plants in Georgia, Illinois and Michigan was having a detrimental impact; then the pandemic hit. Though it led to a notable decrease in surgeries, Covid-19 saw demand for single-use personal protective equipment (PPE), some of which can be sterilised with EtO, skyrocket.
EtO, however, is not just a tool for PPE sterilisation. It is, for now at least, used for an array of devices and other medical equipment – from surgical tools to syringes, ventilators to catheters, and more – and has been the mainstay of sterilisation for more than half a century. At the end of 2016, however, the US Environmental Protection Agency (EPA) announced it was classifying EtO as a human carcinogen, saying it had been shown to increase the risk of breast and white blood cell cancers among those working with it.
Find a balance
Although many had long argued the case, the news raised big questions for healthcare providers and regulators, and demonstrated the tricky task agencies like the EPA and FDA have in addressing issues while trying to complement each other. “Each federal agency has a different mission,” says Soumi Saha, a pharmacist and senior director of advocacy at Premier Inc, a US-based specialist healthcare services and advocacy provider. “The FDA is very patient-focused, while the EPA is environmental-focused,” she continues. “Their missions are complementary to one another but, at the same time, each has a different stakeholder they’re representing.”
It presents a conundrum for the medical device and healthcare communities, as the FDA’s Amanda Turney explains: “Although medical devices can be sterilised by several methods, the use of EtO is the most common … and is well established and scientifically proven for preventing harmful microorganisms from reproducing, and causing infections.”
She warns that, without adequate EtO sterilisation capacity, the agency anticipates a national shortage of devices, many of which are critical – such as feeding tubes used in neonatal intensive care units, drugeluting cardiac stents, catheters, shunts and other implants. When the Sterigenics plants in Illinois and Georgia, and the Viant plant in Michigan closed, the country’s excess capacity stood at 520 million units. The closure of a large plant in one of the same states – Medline in Illinois and BD in Georgia, for instance – would have left the country with a sterilisation deficit.
“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 EtO to sterilise these devices,” continues Turney. “In short, this method is critical to our healthcare system and to the continued availability of safe, effective, and high-quality medical devices.” The EPA is currently reviewing the impact of EtO production and use, both on those working at production plants and local communities. Along with the 2016 announcement that it was classifying EtO as a carcinogen, the agency suggested that it could tighten restrictions on the emissions associated with its production. However, it has received criticism from community and environmental groups, as well as state authorities, for taking too long to act on the matter and adhere to the 2016 Clean Air Act.
20bn
Devices in the US sterilised using EtO each year.
94%
US device manufacturers would face shortages if their primary sterilisation facility were to go offline.
FDA
Looking for guidance
While the work of the EPA continues, the medical device sector finds itself in a difficult position, says Saha. “The problem that we’ve been facing for the past two years or so is balancing sterilisation of medical products with public health, for those who live in close proximity to sterilisation facilities. What we see is a willingness to look at alternatives like gamma radiation. However, what’s been challenging is that FDA and EPA regulations have not been updated.”
She says that this has led to a hesitancy among sterilisers to move without knowing how both agencies will define what ‘good’ is. “Until we have clear direction, it’s unlikely we’ll see a true shift because people are hesitant to invest dollars in research and development, upgrades to the facilities that are required and the regulatory licensure – especially [as] the FDA and EPA [could] come out with guidance contrary to the changes that were made.”
Progress had already been painfully slow, but the pandemic has added to the delay, contributing further to the difficulties of the past year. The concern now, as with what happened in the three states that ordered the closure of some facilities before reopening them as pressure mounted, is that state authorities will take unilateral action. For Saha, this is not ideal: “What we really want to see is a holistic, cohesive national approach. The fear is that if you don’t have a national approach soon, we’ll continue to see states act. We don’t want to have a fragmented approach, where we have 50 different strategies for EtO sterilisation.”
Saha believes that the issue is leading some in the industry to consider whether sterilisation services should now be classified as critical infrastructure, bringing them under the control of the federal government. “If they’re part of critical infrastructure, they’re subject to national oversight only. If that were the case, at minimum, it would stop the whack-a-mole approach we’re seeing at the state level,” she adds. Turney too has concerns about states acting on the issue in isolation. Accepting there are questions surrounding the production and use of EtO, she warns that such measures could be damaging. “Concerns about EtO emissions have resulted in certain state actions against sterilisation facilities that are currently impacting manufacturers’ ability to use the EtO process to sterilise their medical devices,” she says.
What can OEMs do?
It is not fair to accuse both the FDA and EPA of inaction. The Covid-19 crisis has impacted almost every aspect of day-to-day life. Saha says that much of the focus has rightly been on the federal government’s response to the crisis. But, she adds, as the fog clears the hope is that attention can come back to this topic, perhaps as the year draws to a close and the election result becomes clear. For its part, the FDA has been highlighting the matter for over a year now. In mid-2019, it launched the Innovation Challenge and the Master File Pilot Programme. The aim was to address two key issues: identifying new or alternative sterilisation methods and techniques, and reducing EtO emissions at the source.
In November 2019, the agency held a public advisory committee in a bid to understand the concerns of stakeholders and discuss ways in which EtO emissions can be managed, while not impacting the supply and sterility of medical devices. “The FDA engages with all aspects of the supply chain to help facilitate adequate supply of medical devices,” Turney says. “We communicate with device manufacturers and sterilisation facilities to encourage efforts to mitigate device shortages. The FDA stands steadfast in our commitment to help reduce overreliance on EtO for medical device sterilisation.”
Rising pressure
Saha believes it is becoming increasingly important that federal agencies take a renewed look at the issue if the medical device and healthcare sectors are to avoid further capacity problems, with individual states showing an eagerness to act themselves. She says it is likely that change is needed, but that change needs to come in a collaborative, coordinated and systematic way, adding that the FDA and EPA need to define what good looks like and how to get there. “Once those definitions have been made, we also need to provide sufficient time and a sufficient runway for sterilisers, device manufacturers and others to implement those changes. You can’t expect them to be compliant overnight, they’re going to need time.”
She calls on both agencies to work collaboratively to “ensure that any future regulations protect both the patient and the environment, and work in harmony with one another”.
For Turney, one thing is for sure: “Medical devices that are sterilised to remove potentially harmful germs and other microorganisms prior to use are critical to our healthcare system. A shortage – especially of life-saving, life-sustaining or other critical devices – can be a detriment to public health.” For now, it seems there is little the medical device sector and its supply chain can do, other than to engage, advise and wait. The hope is that unilateral state action remains the ‘nuclear option’, a button that nobody actually presses – again.
Time to go paperless
At the FDA’s November 2019 Medical Devices Advisory Committee meeting on how best to advance innovations in medical device sterilisation, Phil Cogdill, senior director of quality, sterilisation and microbiology at Medtronic, recommended that device manufacturers cut their EtO requirements by reducing the amount of paper labels and instruction manuals included in sterile device packaging.
While EtO can be used to sterilise paper, much of it is actually absorbed in the process. As such, when the sterilisation load includes a large amount of paper, it hinders the EtO getting to the device and generally means that more EtO is required. Cogdill suggested that paper IFUs could be replaced with a 3D barcode that would allow users to obtain the same information electronically and cut the emissions associated with sterilisation. The FDA is now encouraging device manufacturers to move to electronic materials where feasible and safe for device users.
Source: FDA
The advantages of ethylene oxide: why is it so difficult to replace?
• EtO sterilisation happens at a lower temperature than dry heat and steam processes, which means it is less likely to degrade device materials.
• EtO is not just a surface sterilant. It can penetrate easily into complex medical devices, such as oxygenators and respiratory circuits, and can be used to sterilise complicated procedure kits.
• Because it is able to sterilise paper-based products, it can be used for equipment in its packaging, accelerating the whole process.
• EtO sterilisation can be done in a chamber of any size, meaning it can be used in large manufacturing processes producing over one million products per day.
Source: FDA
