FDA Takes Action to Reduce EtO Use

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. 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. In July, FDA challenged medtech innovators to identify new sterilization methods and technologies that could be used as alternatives to EtO. The agency also challenged the industry to identify strategies or technologies that can significantly reduce the amount of EtO used to sterilize medical devices. The agency reported that 46 companies responded to the challenge and from these FDA selected 12 applicants that it will work with to accelerate the development and review of innovative technologies for sterilization processes. The selected ideas include such things as&Acir...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Regulatory and Compliance Source Type: news

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Authors: Maples KT, Joseph NS, Harvey RD Abstract INTRODUCTION: Therapy for patients with multiple myeloma has improved dramatically over the past decade following the introduction of novel agents and combinations across the disease spectrum. When relapse or refractory disease develops, non-cross-resistant drugs, most often used in multidrug regimens, have provided significant improvements in patient outcomes. Despite these advances, myeloma remains incurable and additional therapeutic approaches, based on emerging molecular and cellular biology, are moving rapidly through development phases. Approaches new to myel...
Source: Expert Review of Anticancer Therapy - Category: Cancer & Oncology Tags: Expert Rev Anticancer Ther Source Type: research
CONCLUSION: Optic nerve infiltration in systemic metastatic retinal lymphoma may have initial occult signs but with profound visual loss. Ocular infections like CMV retinitis and tuberculosis may mask and delay the diagnosis in immunocompromised patients. PMID: 32967510 [PubMed - as supplied by publisher]
Source: Ocular Immunology and Inflammation - Category: Allergy & Immunology Tags: Ocul Immunol Inflamm Source Type: research
Selective estrogen receptor modulators (SERMs) are an increasingly important therapeutic modality that are used by clinicians on a daily basis. Unfortunately, clinicians have a limited understanding regarding the underlying mechanism(s) of how SERMs function and their increasingly useful role in the treatment of estrogen-responsive target tissues such as the breast, bone, vagina, uterine endometrium, and brain. This review will provide a basic understanding of our current knowledge of SERM pharmacodynamics and will highlight the clinical applications of Food and Drug Administration–approved SERMs in the treatment of ...
Source: Menopause - Category: OBGYN Tags: Clinical Corner: Invited Review Source Type: research
This study aimed to assess the symptom burden in the last 6 months of life in a real-world cohort. METHODS: Patients diagnosed with metastatic gynaecologic malignancies from 2016 to 2019 who completed the revised Edmonton Symptom Assessment System (ESASr) questionnaire within 6 months of death in a large Canadian province were identified. Patient-reported symptom scores were categorized as none to mild (0-3) and moderate to severe (4-10). Individual symptoms were subsequently grouped into physical, psychological, and total subscores. The severity of symptoms was further analyzed for any associations with age, time to d...
Source: Journal of Obstetrics and Gynaecology Canada : JOGC - Category: OBGYN Tags: J Obstet Gynaecol Can Source Type: research
Publication date: Available online 24 September 2020Source: British Journal of Oral and Maxillofacial SurgeryAuthor(s): Patrick Magennis, Anne Begley, Frank Hölzle, Hans-Peter Ulrich, Peter A. Brennan, Iain Hutchison
Source: British Journal of Oral and Maxillofacial Surgery - Category: ENT & OMF Source Type: research
Publication date: Available online 24 September 2020Source: British Journal of Oral and Maxillofacial SurgeryAuthor(s): Rucira Ooi, Setthasorn Zhi Yang Ooi, Trust Chitokomere
Source: British Journal of Oral and Maxillofacial Surgery - Category: ENT & OMF Source Type: research
Publication date: Available online 24 September 2020Source: British Journal of Oral and Maxillofacial SurgeryAuthor(s): Patrick Magennis, Anne Begley, Daljit W. Dhariwal, Peter A. Brennan, Iain Hutchison
Source: British Journal of Oral and Maxillofacial Surgery - Category: ENT & OMF Source Type: research
Publication date: Available online 24 September 2020Source: Pharmacology &TherapeuticsAuthor(s): Kristen Fousek, Lucas A. Horn, Claudia Palena
Source: Pharmacology and Therapeutics - Category: Drugs & Pharmacology Source Type: research
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
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
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