GAITHERSBURG Md -- An FDA advisory panel recommended the agency critically evaluate sterility assurance levels for medical products in its efforts to reduce ethylene oxide EtO emissions The common sterilant is used to disinfect medical devices everything from wound dressings to endoscopes to surgical kits but is also a known carcinogenic In February a commercial sterilization facility in Illinois was ordered to close under a state order related to emissions of the gas In response the FDA issued a warning that such closures could lead to a shortage of medical devices In March another sterilization facility this time in Michigan announced it would close by the end of the year More than 50 of all sterilization in the US uses EtO As for switching to alternative methods for device sterilization Such a move would require significant amounts of time and investment as well as validation of each product with a new method experts said at the FDAs General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee In almost every case the device is dictating the sterilization method said panelist Stephen Li MD who heads a consulting firm in Palm Harbor Florida The panel met on Wednesday and Thursday with an agenda aimed at reducing emissions from EtO during device sterilization without compromising assurance of sterility or effective processing of medical devices and to determine whether alternative sterilization methods might be considered as a replacement EtO Scope of the Problem During public testimony Chaun Powell of the healthcare consultancy Premier said excess capacity of EtO sterilization across the US is nearly exhausted Yet in surveying 600 suppliers his group found that just 3 of respondents believed there was a legitimate risk of product disruption Following the Illinois and Michigan sterilization plants closures the countrys current excess capacity is about 520 million Powell explained The average facility sterilizes roughly 200 million units per year He noted as an example that the combined volume of Medline in Illinois and BD in Georgia is 550 million units -- both of these facilities are at risk of closure Simple math shows that if we close those two plants we exceed the current capacity across the entire US by 30 million units he said Two facilities of average size you name them thats all the capacity we have today To prevent or at least address this looming potential crisis Powell urged the FDA to create greater upstream visibility for stakeholders in order to reduce any potential disruptions to the supply of medical devices and products or prevent them entirely FDA should also seek to extend the authority it already has to deal with drug shortages to include device shortages as well Asked whether the dire predictions cast by Powell were accurate Suzanne Schwartz MD MBA of the FDAs Center for Devices Radiological Health CDRH said the numbers were consistent with the FDAs own research and analysis If even one additional facility shutdown we will start to see spot shortages Theres no question about that Schwartz told reporters In terms of a more catastrophic national impact with two facilities shutdown its almost a certainty The Environmental Protection Agency EPA also now has its sights on cutting EtO emissions after a new assessment showed the carcinogen to be 50 times more potent than was previously known In August 2018 the EPA identified 20 areas in the country where EtO is the main contributor to potential cancer risk On Thursday the EPA proposed cutting EtO emissions by 93 for industrial users of the chemical Medical device sterilizers are considered commercial users and fall outside of this proposal but plans were announced to review emissions standards for commercial sterilization operations as well Advice to the FDA Asked what the agency can do to help minimize the impact of closures on healthcare delivery organizations one panelist suggested framing the question in two time frames Any immediate action would fall not to the FDA but to the HHS Secretary said Robert Burr MD MSc an endocrinologist whose expertise includes occupational and environmental medicine The Secretary could declare a public health emergency and in doing that simply override the state and override the EPA and get their missing plants back online he said Burr said the technology around abatement reducing pollutants is extraordinarily good and he sees no reason why with investments in abatement technology sites would not be able to reach the proper emission standards relatively quickly and reassure people in the neighborhood that things are okay Schwartz agreed with the idea of separating the solutions into long- and short-term strategies The FDA recently issued two innovation challenges for stakeholders -- one focused on long-term strategies such as identifying new sterilization methods and the other on more near-term solutions ie cutting EtO emissions Submissions from stakeholders are currently under review by the agency However she noted that any abatement or structural changes to a facility would be subject to the EPAs authority and not the FDAs David Krause PhD deputy office director for CDRH noted that current standards for EtO sterilization are validated at about 10 -- meaning that the possibility that a single spore remains nonsterile is one in a million -- and asked whether 10 might suffice for some products Panelist Gary Socola CEO of HIGHPOWER Validation Testing Lab Services in Rochester New York suggested that the 10 validation makes sense for reusable devices but not for single-use items -- which were the focus of the discussion Industry representative Carol Pekar MBA a consultant in Massachusetts suggested that the FDA put out guidance or a communication explaining that these lower validation levels are acceptable She also suggested the agency issue sample validation protocols and that review could be accelerated for any related 510 k applications Going a step further gastroenterologist Ashley Faulx MD pointed out that many products are sterile without cause We use sterile water in the colon That makes no sense she said Michael Saubolle PhD of the University of Arizona College of Medicine Phoenix pointed out that while the idea conceptually makes sense it would be a non-starter for immuno-compromised patients Panel chair Frank Lewis Jr MD seemed confident that allowing new methods of validating EtO sterilization and potentially reducing the amount of sterilant would not impact patient safety or the efficacy of the products But he said increasing the patient risk profile for some devices such as endovascular devices would not be acceptable What we heard from industry was that the level can be reduced and still maintain the same assurance of sterility because the actual sterility that they achieved was several orders of magnitude greater than 10 said Lewis Are the standards higher than they need to be he said The answer to that has already been stated -- yes Alternatives to EtO Over 2 days the panel heard presentations from experts in sterilization with hydrogen peroxide nitrogen dioxide chlorine dioxide peracetic acid gamma rays x-ray e-beam and moist and dry heat Lewis concluded that while there were many ideas suggested as a path forward none could be completed in the short run Most of the gas sterilization methods cannot be used with cardboard or cellulose materials and many of the beam technologies and other processes like gamma rays could not be used for certain plastics without fear of damaging the device In addition these products would need to be re-validated before any switch was made For Class III devices FDA reviews sterilization validation as part of its manufacturing controls to assure the products safety and effectiveness But the panelists agreed with the idea of pursuing alternative sterilization methods for niche categories and one even suggested the FDA consider a new innovation challenge to determine which broad categories of devices could be sterilized by which methods Jason Dominitz MD a gastroenterologist for the Veterans Health Administration in Seattle suggested that the FDA do whatever is in its purview to fast-track additional sterilization approvals so that capacity for switching exists While experts testified that currently only 2 of medical devices have recorded another means of sterilization besides EtO the possibility exists that some device makers could use other methods and have not Schwartz told MedPage Today Defining the FDAs Role Asked by reporters between sessions whether the FDA would consider asking Department of Health and Human Services HHS Secretary Alex Azar to declare a public emergency and force facilities back into production Schwartz intimated that such a step was premature When were dealing with a national crisis thats certainly a lever she said noting that it had been used for Ebola and other types of infectious disease events But a decision regarding such an aggressive measure would require more discussion with HHS and the Assistant Secretary of Preparedness Response to determine its appropriateness Regarding the FDAs own authorities Schwartz told MedPage Today that the agency has proposed legislation around device shortages similar to those by the Center for Drug Evaluation and Research for its drug shortage program In a situation like the current one with the EtO sterilization facility closures or in the case of a natural disaster or all-hazards event CDRH can only request this kind of information but companies have no regulatory or legal requirement to comply she said The proposed request for additional authorities which was published in the FDAs 2020 Budget Request is intended to ensure the agency has timely and accurate information related to likely or confirmed national shortages of essential devices The request if made law would give the FDA the authority to require firms to notify FDA of an anticipated significant interruption in the supply of an essential device require all manufacturers of devices determined to be essential to periodically provide FDA with information about the manufacturing capacity of the essential device s they manufacture and authorize the temporary importation of devices whose risks presented when patients and healthcare providers lack access to critically important medical devices outweigh compliance with US regulatory standards The FDA is currently working on the statutory language and will be seeking out sponsors for the bill