Georgia Sterilization Plant Hit with Hefty Fines for EtO Violation

An Atlanta, GA-based medical sterilization plant is learning an expensive lesson after missing a critical deadline related to ethylene oxide (EtO) pollution controls. Sterilization Services of Georgia received a permit on Nov. 7 to use EtO to sterilize medical devices, but the company was supposed to install filters to reduce the gas by Dec. 31. The filters were fully operational as of Jan. 18, according to a Jan. 20 letter, but the Georgia Environmental Protection Department (EPD) fined the company $3,000 for each day beyond the deadline that the filters were not connected. In the letter to the Georgia EPD, the company noted that the testing of these filters, which is required under its permit, is scheduled for March 10. EtO is a flammable, colorless gas used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment. In fact, about half of all sterilized medical devices undergo sterilization using this gas. Breathing air containing elevated EtO levels over many years has been linked to increased risk of some types of cancers, including cancers of the white blood cells (such as non-Hodgkin's lymphoma, myeloma, and lymphomatic leukemia). It also has been found to cause breast cancer in women. EtO sterilization became a hot topic in 2019 after at least two facilities that use EtO to sterilize medical devices shutdown, creating concerns of shortages in the indus...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Source Type: news

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Shutdowns earlier this year of two facilities that use ethylene oxide (EtO) to sterilize medical devices prompted FDA to monitor for supply shortages in the industry because EtO is such a popular sterilization method for medical devices. This week the agency revealed steps it will take to reduce medtech's reliance on EtO sterilization. EtO is a flammable, colorless gas used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment. In fact, about half of all sterilized medical devices undergo sterilization using this gas. Breathi...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Regulatory and Compliance Source Type: news
Conclusions: CAR T cell therapies have demonstrated the clinical benefits of harnessing our body's own defenses to combat tumor cells. Similar research is being conducted on lesser known modifications and gene-modified immune cells, which we highlight in this review. Introduction Chimeric antigen receptors and engineered T cell receptors (based on previously identified high affinity T cell receptors) function by redirecting T cells to a predefined tumor-specific (or tumor-associated) target. Most of these modifications use retroviral or lentiviral vectors to integrate the construct, and most of the receptors ...
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
Shutdowns of two facilities that use ethylene oxide to sterilize medical devices have raised concern about potential shortages in the medtech industry because this is such a popular sterilization method for medical devices. Ethylene oxide (EtO) is a flammable, colorless gas used to make a range of products. EtO also is used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment. In fact, about half of all sterilized medical devices undergo sterilization using this gas. According to the EPA, long-term exposure to EtO can irritate the eyes,...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Regulatory and Compliance Source Type: news
This study aimed to explore whether a correlation exists between the incidence and mortality of cancers and normalized internet search volumes on the big data platform, Baidu. We also assessed whether the distribution of people who searched for specific types of cancer differed by gender. Finally, we determined whether there were regional disparities among people who searched the Web for cancer-related information. Methods: Standard Boolean operators were used to choose search terms for each type of cancer. Spearman’s correlation analysis was used to explore correlations among monthly search index values for each can...
Source: Journal of Medical Internet Research - Category: General Medicine Authors: Source Type: research
Objective: To investigate the clinical features of 2nd hematological malignancies post to the initial cancer treatment.METHODS: A retrospective study was performed to analyze the available clinical data of 116 patients diagnosed with 2nd hematologic malignancies after treatment of various malignant tumors from June 1998 to June 2018 at Sun Yat-sen University cancer center.RESULTS: The characteristics of the 116 patients diagnosed with 2nd hematological cancer post to initial cancer treatment were indicated as following: 62 males and 54 females. The primary tumor category was grouped as (according to ICD-10 International Di...
Source: Blood - Category: Hematology Authors: Tags: 904. Outcomes Research-Malignant Conditions Source Type: research
Conclusion The favorable-risk cohort had better RFS and OS compared to the outcomes of patients in the intermediate- and adverse-risk cohorts; the RFS and OS did not differ between intermediate- and adverse-risk cohorts. The presence of AHD did not affect OS. Micro-Abstract The presence of antecedent hematologic disorders at diagnosis of therapy-related acute myeloid leukemia did not affect overall survival (OS). The favorable-risk cohort had better relapse-free survival (RFS) and OS compared to the outcomes of patients in the intermediate and adverse-risk cohorts; the RFS and OS did not differ between intermediate- and adverse-risk cohorts.
Source: Clinical Lymphoma Myeloma and Leukemia - Category: Cancer & Oncology Source Type: research
Publication date: Available online 10 August 2016 Source:Clinical Lymphoma Myeloma and Leukemia Author(s): Koji Sasaki, Elias Jabbour, Jorge Cortes, Tapan Kadia, Guillermo Garcia-Manero, Gautam Borthakur, Preetesh Jain, Sherry Pierce, Naval Daver, Koichi Takahashi, Susan O’Brien, Hagop Kantarjian, Farhad Ravandi We reviewed 301 patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) who presented from January 2000 to January 2014 (183, t-AML without antecedent hematologic disorders [AHD]; 118, t-AML with AHD). Overall, median follow-up was 44 months. The primary malignancy was non-Hodgkin lympho...
Source: Clinical Lymphoma Myeloma and Leukemia - Category: Cancer & Oncology Source Type: research
Using a time-dependent approach, we investigated all-site and site-specific cancer incidence in a large population stratified by diabetes status. The study analyzed a closed cohort comprised of Israelis aged 21–89 years, enrolled in a health fund, and followed from 2002 to 2012. Adjusting for age, ethnicity, and socioeconomic status, we calculated hazard ratios for cancer incidence using Cox regression separately for participants with prevalent and incident diabetes; the latter was further divided by time since diabetes diagnosis. Of the 2,186,196 individuals included in the analysis, 159,104 were classified as havin...
Source: American Journal of Epidemiology - Category: Epidemiology Authors: Tags: RESEARCH-ARTICLE Source Type: research
Abstract Using a time-dependent approach, we investigated all-site and site-specific cancer incidence in a large population stratified by diabetes status. The study analyzed a closed cohort comprised of Israelis aged 21-89 years, enrolled in a health fund, and followed from 2002 to 2012. Adjusting for age, ethnicity, and socioeconomic status, we calculated hazard ratios for cancer incidence using Cox regression separately for participants with prevalent and incident diabetes; the latter was further divided by time since diabetes diagnosis. Of the 2,186,196 individuals included in the analysis, 159,104 were classif...
Source: Am J Epidemiol - Category: Epidemiology Authors: Tags: Am J Epidemiol Source Type: research
aradağ O, Kasifoglu N, Arslantas D, Sahin F, Keser G, Yavuz S, Birlik M, Onat AM Abstract Systemic sclerosis (SSc) is an autoimmune connective tissue disease with multisystem involvement. An increased incidence of cancer in SSc patients compared with the general population has been reported in several reports. Our aims in this study were to determine the most common malignancies and to investigate the possible risk factors for the development of malignancy in patients with SSc. Three hundred forty SSc patients from 13 centers were included to the study. Data of the patients were obtained by evaluating their medic...
Source: Clinical Lymphoma and Myeloma - Category: Cancer & Oncology Authors: Tags: Clin Rheumatol Source Type: research
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