Soapbox

Four Ways to Approach the Medical Device Sterilization Predicament in an Election Year

By Chaun Powell, Soumi Saha
January 15, 2020


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, Combination Products, Market Access, Soapbox

In an election year, healthcare tends to dominate the conversation—talk of insurance coverage, pharmaceutical prices and out-of-pocket spending will likely ramp up tenfold now that we’ve turned the calendar.

Amid candidate and voter conversations about the future of healthcare, one item that should not get overlooked is how recent events regarding medical device sterilization could compromise safe patient care.

One out of every two medical devices in the United States is sterilized using ethylene oxide (EtO). Environmental agencies, concerned about potentially carcinogenic emissions that can result from EtO sterilization, ordered the closure of multiple sterilization facilities in 2019, leaving the remaining 100 plants at dangerous capacities if more facilities were to shudder.

Patients and families need to be top of mind, meaning the industry’s charge is to find a path forward that addresses EtO concerns while carefully weighing the unintended negative consequences that plant closures have on patient care and caregivers. The FDA, EPA and industry must unite to define acceptable EtO emissions and sterilization techniques, and all parties should cohesively designate a reasonable timeframe for sterilization plants to achieve the mark; if change is warranted, it cannot occur overnight or absent clear guidance and expectations.

The federal EPA is poised to propose updates on permissible levels of EtO in March, so the industry will need to deliberate and determine its next steps quickly. Here, we lay out four key recommendations to mitigate potential shortages.

Defining the Real Issue

While the debate has centered around EtO, it’s important to point out that EtO itself is not the issue. Manufacturers have safely sterilized billions of products using EtO over the past 80 years, and its derivatives are common ingredients in household cleaners, personal care products and plastics.

Instead, the emissions that result from the process of EtO sterilization should be the focus of the debate. After the EPA’s National Air Toxics Assessment released a report in 2018 that noted certain geographies could have elevated cancer risks from long-term EtO exposure, some state environmental agencies became more active in monitoring plants in their regions that emit EtO.

One solution to address emissions is abatement, or reducing pollutants. Experts say the technology to abate emissions is effective, and EtO plants should continue to focus on abatement as a primary solution until the federal EPA shares their proposal for acceptable levels in March. Still, proper implementation of this solution would require investments in technology and time, and will not likely quell the community groundswell that is commanding more attention on this issue.

The Viewpoints

The FDA and the EPA are key stakeholders in this issue, in addition to the public, healthcare providers, suppliers, and sterilizers themselves. The FDA monitors and regulates the sterility of medical devices on the market, while the EPA enforces the Clean Air Act to ensure toxic emissions do not pose a significant risk to the public. Both agencies are in alignment to reduce EtO emissions, but their motives and jurisdiction to act are largely disconnected from one another—a polarity that gets even more complicated when looking beyond the federal level to the state agencies that operate independently.

At the same time, community groups are calling on their state representatives to act due to a perceived increase in the risk of cancer surrounding these plants. And, hospitals are watching from the fringes in case they need to procure sterilized devices differently—or invest in their own sterile processing functions.

Why the Solutions Aren’t So Easy

Of the 20 billion devices that are delivered to healthcare providers through EtO sterilization each year, only 2% are registered with the FDA to be sterilized through a secondary means, and our research shows that most third-party EtO sterilization facilities are running at about 90% capacity. Few companies in this space are willing to construct new plants or expand their current operations with so much ambiguity surrounding the FDA’s response and the EPA’s action.

The upcoming election will affect both state and national ideologies around this issue, and the lead-up period to November will amplify the private sector’s hesitation to adjust operations. Luckily, Republican and Democrat-led states are showing a united front on the goal to reduce EtO admissions. This was most notable in November when congressional representatives from Illinois and Georgia formed a bipartisan taskforce to pressure the EPA to place stricter limits on EtO emissions.

Approaches the Industry and Government Must Consider in 2020

The short-term action to close plants is not a viable solution—our research shows that closing plants will leave the healthcare industry exposed and jeopardize modern medicine as we know it –and the proposed long-term answers such as abatement will require time, so it appears that we may be at a stalemate. Luckily, we’re not sitting idly.

The industry is using this time to come up with disruption strategies and approaches to mitigate shortages.

1. Forcing visibility to upstream stakeholders in the supply chain. Upstream stakeholders include raw material suppliers as well as packagers and sterilization locations, and visibility into their sourcing will help us prevent, estimate the impact of, and mitigate disruptions of all kinds. Absent true visibility into our suppliers, packagers and sterilization locations, we cannot predict or proactively address any disruptions.
2. Collaborating across stakeholders including suppliers, manufacturers, distributors, group purchasing organizations and associations. This issue is bigger than any single patient population or any one public or private entity. Industry experts must collaborate to proactively identify the root causes of disruptions and prevent them. As an example, and under the leadership of the Health Industry Distributors Association, Premier has partnered with other GPOs, manufacturers and distributors to create a disruption notification template that could and should become standard industry process. When we streamline communication around disruptions, we can more quickly evaluate the impact to patient care and identify alternatives.
3.  Applying the drug shortages methodology. When device manufacturers identify and try to prevent a potential disruption, they only notify the industry once the disruption is confirmed—a point when it is too late to prevent downstream patient care implications. By comparison, when there is an identified potential disruption with pharmaceuticals, the FDA has enacted formal regulation around the notification period to allow the industry and providers to plan accordingly. Medical devices need similar regulations. The FDA is working on implementing similar regulation, which we applaud as a strong step forward in creating a sustainable solution.
4. Advocacy by healthcare providers and the community. Activism tends to reach an all-time high during election years, and the solution to this complex issue will only prevail if the public and private sectors partner to push for more effective means of disruption prediction, prevention and mitigation. As industry organizations work with suppliers on the approaches mentioned above, community members and healthcare providers should engage with their state hospital associations to discuss the risks to basic care delivery should more of these facilities close.

2020 should be a pivotal year in which the microcosm of medical devices moves out of the shadows and joins the mainstream healthcare conversation. Clearly, this will not be solved overnight, but if we use the next few months wisely and continue to elevate the importance of medical device sterility, our industry can join together to maintain access to sterile devices while instituting a long-term, sustainable solution.