FDA Scrambles to Prevent Shortages Amid Sterilization Shutdowns

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, skin, nose, throat, and lungs, and harm the brain and nervous system (causing headaches, memory loss, and numbness). Studies show that breathing air containing elevated EtO levels over many years increases the 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. Sterilization of medical devices is critical to the healthcare system, and ethylene oxide sterilization helps ensure the safety of medical devices and helps deliver quality patient care, according to outgoing FDA Commissioner Scott Gottlieb. Devices sterilized with EtO range from wound dressings to stents, as well as kits used in routine hospital procedures or surgeries that include multiple components made of different materials, the commissioner noted. &...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Regulatory and Compliance Source Type: news

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Publication date: Available online 2 June 2020Source: Pathology - Research and PracticeAuthor(s): Hyeongjoo Kim, Taewan Kim, Gunn Jaygal, Jongsoo Woo, Chang-Jin Kim, Moo-Jun Baek, Dongjun Jeong
Source: Pathology Research and Practice - Category: Pathology Source Type: research
ABSTRACT Objective To assess the outcome of an educational nutritional intervention in the quality of diet of women with breast cancer in adjuvant treatment. Methods Women with breast cancer and admitted for surgical treatment were divided in an intervention group (n=18) and a comparison group (n=78), and participated in a nonrandomized clinical trial. Participants were assessed before and after the treatment and/or intervention. A food frequency questionnaire was applied and the quality of diet was calculated using the Brazilian Healthy Eating Index Revised. The educational nutritional intervention lasted 12 months and wa...
Source: Revista de Nutricao - Category: Nutrition Source Type: research
On the heels of studies showing hydroxychloroquine doesn't help patients in the hospital with Covid-19, a new study -- the first of its kind -- shows the drug doesn't work to prevent infection with the virus, either.
Source: CNN.com - Health - Category: Consumer Health News Source Type: news
The United States should have 100 million doses of one candidate coronavirus vaccine by the end of the year, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases and a member of the White House Coronavirus Task Force, said Tuesday.
Source: CNN.com - Health - Category: Consumer Health News Source Type: news
The Trump administration chose 5 companies as the most likely to produce a vaccine. The tally of new cases is rising in the U.S., partly because of expanded testing. Italy ends travel restrictions.
Source: NYT Health - Category: Consumer Health News Tags: Coronavirus (2019-nCoV) Source Type: news
Researchers say that a malaria drug President Donald Trump took to try to prevent COVID-19 proved ineffective for that in the first large, high-quality study to test it in health workers and others closely exposed to people with the disease
Source: ABC News: Health - Category: Consumer Health News Tags: Health Source Type: news
This study aimed to analyze clinical and laboratory parameters and their association with long-term outcomes in patients who underwent liver transplantation for hepatocellular carcinoma treatment, according to the etiology of the underlying chronic liver disease, in order to identify predictors of response to this therapeutic modality. METHODS: Demographic, clinical, and laboratory data from a cohort of 134 patients who underwent orthotopic liver transplantation for hepatocellular carcinoma treatment at a referral center in Brazil were retrospectively selected and compared according to the etiologic group of the underlying...
Source: Clinics - Category: General Medicine Source Type: research
The first carefully controlled trial of hydroxychloroquine given to people exposed to the coronavirus did not show any benefit.
Source: NYT Health - Category: Consumer Health News Authors: Tags: Clinical Trials Drugs (Pharmaceuticals) Hydroxychloroquine (Drug) Coronavirus (2019-nCoV) United States Politics and Government Tests (Medical) Food and Drug Administration New England Journal of Medicine your-feed-healthcare Source Type: news
U.S. President Donald Trump had no side effects from a two-week course of hydroxychloroquine, an anti-malaria drug that can cause heart problems, after using it as a preventive measure against the coronavirus, his White House physician said on Wednesday.
Source: Reuters: Health - Category: Consumer Health News Tags: healthNews Source Type: news
The Trump administration has selected five companies, including Moderna Inc, AstraZeneca Plc and Pfizer Inc, as the most likely candidates to produce a vaccine for the novel coronavirus, the New York Times reported on Wednesday, citing senior officials.
Source: Reuters: Health - Category: Consumer Health News Tags: healthNews Source Type: news
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