The Shutdown of an IL Sterilization Plant Is Directly Impacting High-Risk Kids

Last month FDA warned of potential medical device shortages amid a shutdown of facilities that use a gas called ethylene oxide (EtO) to sterilize medical devices. The situation is already impacting children who use Smiths Medical's Bivona tracheostomy tubes. The devices were previously sent to Sterigenics' Willowbrook, IL facility for EtO sterilization, but the Illinois EPA recently issued a seal order at that facility after finding dangerously high levels of the gas in the air around the facility. Viant Medical, another contract sterilizer, also plans to close its EtO sterilization facility in Grand Rapids, MI after receiving attention from the Michigan Department of Environmental Quality for air quality issues. "Smiths Medical is experiencing a severe supply disruption on the Bivona tracheostomy tubes due to the [EPA] shutdown of the Sterigenics sterilization site in Willowbrook, IL," Central Ohio Specialty Care (COHSC), a home medical equipment provider, said in a Facebook post. "This shutdown will result in a nationwide shortage of all standard/stock Bivona tracheostomy tubes, and all sterile, custom Bivona tracheostomy tubes." COHSC said custom, non-sterile tubes should not be impacted. According to Smiths Medical, Bivona tubes can be cleaned and sanitized at home for up to 10 re-insertions for adult sizes or up to five times for neonatal and pediatric sizes. "Do not dispose ...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Source Type: news

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Conclusions: HMV is feasible for patients with neurological diseases and COPD in a developing country. The relatively high rate of complications indicates the need for more comprehensive clinical services for chronic ventilator-dependent patients in this setting.
Source: Lung India - Category: Respiratory Medicine Authors: Source Type: research
The aim of this study was to describe the endotracheal respiratory flora in a population of adults suffering from neuromuscular or neurological disorders requiring a long-term tracheostomy and to identify risk factors for colonization. We conducted a prospective and single-center observational study among patients with chronic tracheostomy admitted for planned respiratory assessment between February 2015 and December 2016. Data were collected from patient interview and medical charts with a standardized questionnaire.
Source: Respiratory Medicine - Category: Respiratory Medicine Authors: Source Type: research
ConclusionsThe results of our network meta-analysis show that all tracheostomy techniques are comparable with respect to associated procedure-related complications, but all three percutaneous techniques take far less procedure time compared to the surgical tracheostomy.
Source: Lung - Category: Respiratory Medicine Source Type: research
MONDAY, April 22, 2019 -- For people with amyotrophic lateral sclerosis (ALS), African-Americans have longer survival than Caucasians when death is the outcome, but not when the outcome is death or tracheostomy and invasive ventilation (TIV),...
Source: Drugs.com - Pharma News - Category: Pharmaceuticals Source Type: news
ConclusionOptimal management and correction of subglottic stenosis is possible via laryngotracheal reconstruction with cartilage graft. The reconstruction procedure, first utilized in the 1970’s, allows correction of severe (grades III and IV) subglottic stenosis. After healing is complete, the patient regains function of her own airway.
Source: International Journal of Surgery Case Reports - Category: Surgery Source Type: research
A clinically useful model to prognose onset of respiratory insufficiency in amyotrophic lateral sclerosis (ALS) would inform disease interventions, communication and clinical trial design. We aimed to derive and validate a clinical prognostic model for respiratory insufficiency within 6 months of presentation to an outpatient ALS clinic. We used multivariable logistic regression and internal cross-validation to derive a clinical prognostic model using a single-centre cohort of 765 ALS patients who presented between 2006 and 2015. External validation was performed using the multicentre Pooled Resource Open-Access ALS C...
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Respiratory clinical practice Original Articles: Respiratory clinical practice Source Type: research
Might early elective tracheostomy reduce the incidence of postoperative pneumonia and delirium in patients undergoing head and neck surgery?BMC Anesthesiology
Source: Medscape Critical Care Headlines - Category: Intensive Care Tags: Anesthesiology Journal Article Source Type: news
Conclusions In the span of a very short time—less than a decade—robotic head and neck surgery has transformed the management of the head and neck cancer, and it seems clear that the future of treatment for these cancers lies in a multimodal approach in which TORS is likely to play an important role. Nevertheless, it is important to keep in mind that the current indications for TORS are limited and long-term data on the safety and oncological outcomes are needed to better understand the true role of TORS in treatment of head and neck cancer. Nonetheless, the emergence of ever more advanced robotic instruments i...
Source: Frontiers in Oncology - Category: Cancer & Oncology Source Type: research
CONCLUSION: In our case we believe that liposomal amphotericin B was significantly removed by ECMO and was responsible for the failure of the ECMO circuit. We would suggest amphotericin B deoxycholate be used in such patients preferentially and that serum levels of the drug be assessed when possible. PMID: 30994894 [PubMed - as supplied by publisher]
Source: American Journal of Health-System Pharmacy : AJHP - Category: Drugs & Pharmacology Authors: Tags: Am J Health Syst Pharm Source Type: research
The closing of an ethylene oxide sterilization plant in Illinois has led to a temporary shortage of Bivona tracheostomy tubes manufactured by Smiths Medical.News Alerts
Source: Medscape Business of Medicine Headlines - Category: Pharmaceuticals Tags: Pediatrics News Alert Source Type: news
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