As part of our commitment to safety, BD’s Environmental Health and Safety standards ensure that all BD facilities are designed and operated with a high level of process safety and environmental controls.
The facility in Tucson will employ state-of-the-art emission controls to minimize the amount of EtO
Ethylene oxide (EtO) is used to sterilize medical devices in order to protect patients from the risks of infectious diseases caused by bacteria, viruses, and fungi. EtO is the only sterilization option for a large number of medical devices due to material sensitivities and/or complexity of design such as urinary catheters, PICC lines, oncology ports, breast biopsy needles, vascular and ureteral stents, feeding tubes and more. The vast majority of EtO in our air comes from organic and industrial sources other than medical devic e sterilization facilities. EtO is a byproduct of combustion, meaning it is produced by campfires, grills, auto exhaust, lawn mowers and many other sources. EtO is found in rural areas where there are swamps and decaying debris. Even our own bodies produce EtO emissions. released to the atmosphere and will be one of the most sophisticated EtO sterilization facilities in the world at capturing EtO. These emission controls will reduce the amount of EtO released substantially below U.S. EPA’s acceptable human exposure risk level.
BD uses the best available emission control technology in the industry. EtO from the sterilization chambers and degassing cells are captured and treated using catalytic oxidation. This achieves >99.95% destruction of EtO, significantly greater than the 99% required under the Clean Air Act. BD verifies the effectiveness of emission destruction through stack testing (conducted by an independent third-party), in accordance with permit requirements. The testing methodology is reviewed and approved in advance of the testing by regulatory authorities.
BD uses independent, third-party companies to test the effectiveness of our emission control technology. This is to ensure the safety of our operations and compliance with local, state, and federal regulations, as well as a requirement in our air permit. In addition, we employ monitoring inside our facilities to ensure the safety of our employees and compliance with Occupational Safety and Health Administration (OSHA) regulations. Individual associate exposure studies will be conducted at least quarterly using standard industrial hygiene methods and laboratory analysis through an accredited lab.
Unlike some other sterilization facilities where employees are exposed to EtO during loading/unloading of sterilization chambers, this facility will be fully automated to move products through the process with minimal direct handling by employees.