Michael Barbella, Managing Editor05.06.23
After a quite a lengthy lull, the ethylene oxide (EtO) controversy is back in the spotlight. And MPO website loyalists are taking notice.
Sterigenics U.S. LLC's latest troubles drove the bulk of online traffic this past week, as the company garnered headlines for closing its medical sterilization facility in Southern California. The South Coast Air Quality Management District (South Coast AQMD) ordered the company to close its Ontario, Calif., plant due to elevated ethylene oxide readings near the facility. On April 12, April 15, and April 18, monitoring data showed EtO levels near the facility to be at 33.6 ppb, 24.3 ppb and 39.8 ppb respectively—well above the allowable 17.5 ppb threshold. Consequently, the facility must remain closed for at least three days and cannot resume full operations until EtO levels drop below the 17.5 ppb threshold.
The Interim threshold is in place until all other actions committed to in the plan are implemented including the construction of a Permanent Total Enclosure (PTE) to prevent emissions from escaping the buildings, and implementation of an enhanced leak detection and repair system. Upon completion of these other actions, EtO levels should be substantially lower. Sterigenics, a Sotera Health Company, has not commented on South Coast AQMD's shutdown order. The company in recent years has been caught in the crossfire of controversy over the potential health hazards of EtO, a colorless, odorless carcinogenic gas used to sterilize about half of all medical devices on the market. Sterigenics closed its facility in Willowbrook, Ill., in 2019 and paid $408 million to settle more than 870 lawsuits over emissions from that plant.
New product approvals, a personnel announcement, and acquisition also amassed significant pageviews this past week. Medtronic plc and Olympus scored FDA blessings for their leadless pacemakers and new endoscopy system, respectively. Medtronic's
Micra AV2 and Micra VR2 provide longer battery life and easier programming than prior Micra pacemakers, while Olympus' new EVIS X1 endoscopy system has two compatible gastrointestinal (GI) endoscopes: the GF-1100 GI videoscope and CF-HQ1100DL/I colonovideoscope. The GIF-1100 is used in the upper digestive tract (esophagus, stomach, and duodenum) and the CF-HQ1100DL/I is used in the lower digestive tract (anus, rectum, sigmoid colon, colon, and ileocecal valve).
Other items of interest to online visitors included Cortland Biomedicals new operations director, and DuPont's purchase of Spectrum Plastics Group from AEA Investors.
Sterigenics U.S. LLC's latest troubles drove the bulk of online traffic this past week, as the company garnered headlines for closing its medical sterilization facility in Southern California. The South Coast Air Quality Management District (South Coast AQMD) ordered the company to close its Ontario, Calif., plant due to elevated ethylene oxide readings near the facility. On April 12, April 15, and April 18, monitoring data showed EtO levels near the facility to be at 33.6 ppb, 24.3 ppb and 39.8 ppb respectively—well above the allowable 17.5 ppb threshold. Consequently, the facility must remain closed for at least three days and cannot resume full operations until EtO levels drop below the 17.5 ppb threshold.
The Interim threshold is in place until all other actions committed to in the plan are implemented including the construction of a Permanent Total Enclosure (PTE) to prevent emissions from escaping the buildings, and implementation of an enhanced leak detection and repair system. Upon completion of these other actions, EtO levels should be substantially lower. Sterigenics, a Sotera Health Company, has not commented on South Coast AQMD's shutdown order. The company in recent years has been caught in the crossfire of controversy over the potential health hazards of EtO, a colorless, odorless carcinogenic gas used to sterilize about half of all medical devices on the market. Sterigenics closed its facility in Willowbrook, Ill., in 2019 and paid $408 million to settle more than 870 lawsuits over emissions from that plant.
New product approvals, a personnel announcement, and acquisition also amassed significant pageviews this past week. Medtronic plc and Olympus scored FDA blessings for their leadless pacemakers and new endoscopy system, respectively. Medtronic's
Micra AV2 and Micra VR2 provide longer battery life and easier programming than prior Micra pacemakers, while Olympus' new EVIS X1 endoscopy system has two compatible gastrointestinal (GI) endoscopes: the GF-1100 GI videoscope and CF-HQ1100DL/I colonovideoscope. The GIF-1100 is used in the upper digestive tract (esophagus, stomach, and duodenum) and the CF-HQ1100DL/I is used in the lower digestive tract (anus, rectum, sigmoid colon, colon, and ileocecal valve).
Other items of interest to online visitors included Cortland Biomedicals new operations director, and DuPont's purchase of Spectrum Plastics Group from AEA Investors.
