DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Pediatrics
Endroit courant :
> This Story

Ouverture ou Registre to rate this News Story
Forward Printable StoryPrint Comment




Molecular Imaging Homepage

US suppliers to join the Mo-99 market, high-energy materials gaining traction Radiopharmaceutical supply chain update

Navigating the molecular imaging market Purchasing insights from the experts at MD Buyline

Assessing the state of Alzheimer’s imaging The battle against neuro-degenerative disease wages on

Absolute Imaging Solutions acquires Northeast Electronics Facilitates push into East Coast market

Eden Radioisotopes scores funding for isotope reactor production Will primarily produce Mo-99

SHINE secures rights to new method for Lutetium-177 production Generate Lu-177 at greater speed and scale

FDA gives green light to new United Imaging PET/MR scanner The uPMR 790 HD TOF performs total-body scans within 20 minutes

Generating higher quality PET images 100x faster at MSK 'No one has done PET imaging in this way before'

Louisiana getting $14 million Center for Molecular Imaging and Therapy Increasing research opportunities, collaboration and radiopharmaceuticals

PET uncovers abnormal tau deposits associated with CTE in live subjects May enable diagnosis of CTE in living people one day

FDA reminder for properly eluting rubidium 82 generators prompted by 'recent incidents'

par Thomas Dworetzky , Contributing Reporter
Advising that there have been “recent incidents” in which incorrect solutions were used to elute rubidium 82 generators for PET scans, the FDA has issued a reminder and is requiring language changes and Boxed Warnings on the labels of the generators.

These incidents caused “excess radiation exposure to patients, due to user error with certain systems used to produce rubidium Rb 82 injection for use with Positron Emission Tomography (PET) myocardial perfusion imaging scans,” the agency said in its announcement. The safety label changes will “remind users to use the correct solution to elute the generator and carefully follow safety procedures for the system,” it stated.

Story Continues Below Advertisement

Servicing GE Nuclear Medicine equipment with OEM trained engineers

We offer full service contracts, PM contracts, rapid response, time and material,camera relocation. Nuclear medicine equipment service provider since 1975. Click or call now for more information 800 96 NUMED

The two systems used for the scans — CardioGen-82 and Ruby-Fill — both need additive-free 0.9 percent Sodium Chloride Injection USP.

There have been reported incidents in which the wrong solution was used, such as calcium-containing lactated Ringer's. This is bad, because the calcium “interacts with radioactive strontium 82 and strontium 85 in the generator’s structure,” leading to a strontium “breakthrough” into the rubidium injection-given patients.

This “can deposit high levels of radioactivity in organs including the bone, which can lead to suppressed bone marrow function and suppression of the immune system. Additional long-term risks could include radiation-induced cancers,” warned the agency.

The FDA has stressed the issue to facilities to ensure proper training for use of CardioGen-82 and Ruby-Fill systems and “strictly adhere to the mandatory eluate testing protocol,” as a solution mistake can cause such serious adverse consequences.

Beyond that, if the wrong solution is used, the FDA stated that the infusion should be immediately stopped and the patient evaluated regarding absorbed radiation dose, and monitored for radiation to critical organs “such as the bone marrow,” it advised.

The agency is working with manufacturers CardioGen-82's Bracco Diagnostics and Ruby-Fill’s Jubilant DraxImage, which sent out letters to users about the issue.

Molecular Imaging Homepage

You Must Be Logged In To Post A Comment

La publicité d'email
Développez la notoriété de votre marque
Enchères + Ventes Privées
Obtenir le meilleur prix
Acheter des équipement / pièces
Trouver le meilleur prix
Infos du jour
Lire Les dernières nouvelles
Consulter tous les utilisateurs DOTmed
Éthique concernant DOTmed
Voir notre programme d'éthique
L'or partie le programme de fournisseur
Recevoir des demandes PH
Programme de marchand de service d'or
Recevoir des demandes
Fournisseurs de soins de santé
Voir tous les outils des HCP (abréviation pour les professionnels de la santé)
Trouver / combler un poste
Parts Hunter +EasyPay
Obtenir des devis de pièces
Voir les utilisateurs récemment certifiés
Voir les utilisateurs récemment certifiés
Récemment évalué sur DOTmed
Voir les utilisateurs récemment certifiés
Central de location
Louer de l’équipement à moindre prix
Vendre des équipements / pièces
Obtenir le maximum d'argent
Service Technicians Forum
Trouver de l'aide et des conseils
Simple demande de propositions
Obtenir des devis pour des appareils
Expo Virtuelle
Trouver des services d'appareils
L'Access et l'utilisation de cet emplacement est sujet aux modalités et aux conditions du notre de nos MENTIONS LEGALES & DONNEES PERSONELLES
Propriété de et classe des propriétaires DOTmedà .com, inc. Copyright ©2001-2019, Inc.