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




U.S. Healthcare Homepage

NY DOH gives green light for HealthAlliance $93 million hospital expansion Will host new centers and a new imaging department

AMA issues recommendations for accountability of AI in healthcare Aid in advancing quadruple aim

Radiologist hit with $11.5 million malpractice verdict Found negligent for missing enlarged heart diagnosis in 2009

Bill aiming to reduce prior authorization delays for cancer treatment introduced in Congress Supporting timely access to care

Kansas cardiologist and practice pay $5.8 million to settle false billing claims Will also be excluded from federal health programs for three years

SEC probes Siemens, GE and Philips over business with China Lawsuit alleges OEMs worked together to fix prices on medical equipment

HealthTrust in deal to acquire ROi Will become sole national GPO for Mercy Catholic

Cancer mortality for men, women and children on the decline, says report Decreased by 1.8 percent in men and 1.4 percent in women

Enhancing the patient experience with Medicare Advantage plans that embrace coordinated care Aligning financial incentives in the name of better care

Observations after 20 years of single-use device reprocessing Insights on the ongoing battle to safely increase market competition

Device safety researchers to FDA: Release the hidden data

par Thomas Dworetzky , Contributing Reporter
The FDA should release the reports of injury and malfunction of medical devices buried in non-public databases, numerous medical device safety researchers have told Kaiser Health News.

“The FDA absolutely should be making all of this information available,” said Diana Zuckerman, president of the National Center for Health Research, who has testified to Congress and the FDA.

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 latest KHN reporting adds more fuel to the controversy stemming from its earlier expose in March on the scope of “exemptions” from the regular rules of public reporting for medical device injuries and failures.

The numbers of these “alternative summary reporting” (ASR) exemptions, Zuckerman added “takes my breath away," KHN has now reported.

In a recent interview with the news organization, FDA chief Dr. Scott Gottlieb, who is leaving his post April 5, confessed to the news agency that he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE [the FDA public-facing database of device safety reports].”

He added, however, that there are no “immediate plans” to make safety reports public – although there is a review going on to see if there are “ways to make ASR data received prior to 2017 more easily accessible.”

“I think that the imperative of the agency is to make as much of this information available to the public as possible,” Gottlieb said, adding, “I think these databases, by and large, should be searchable to the public.”

According to KHN, FDA data shows that there have been over 2 million such reports since 2014.

Other experts also weighed in on the KHN revelations. For Dr. Alan Shapiro, an associate professor at the New York University School of Medicine and a MAUDE user, this is the wrong approach to the data – more eyes on this type of material are bound to improve safety.

“The FDA isn’t so capable that they can afford to hide data,” he said, according to KHN.

The bottom line, added Alan Card, an assistant professor and patient-safety researcher at the University of California-San Diego School of Medicine, is that “there are a lot of people out there who are trying to make reasonable decisions on data that isn’t what it was purported to be.”

An agency spokeswoman told KHN that the FDA revoked most of the “alternative summary reporting” exemptions in mid-2017.

In 2018, the agency decided to permit filing of a summary report for malfunctions, meaning that makers of 5,600 devices now need no special exemption to file this way. A single public report is sent to the agency for a unique malfunction. After that, reports of like problems are sent to the FDA directly and are not readily available to the public.

The exemption issue involves hundreds – even thousands – of injury and malfunctioning events. For example, KHN had determined from FDA records that “some cardiac device makers have filed hundreds of death reports under the registry exemption. The FDA confirmed that nearly 12,000 litigation summary reports related to injuries associated with pelvic mesh were filed in 2017 alone.”

In its February industry guidance, “The Least Burdensome Provisions: Concept and Principles,” the agency noted that, “in some cases, FDA has allowed manufacturers to provide a summary MDR [medical device report] generated from a specific registry each quarter. These approaches can streamline the drafting and submission of MDRs for industry, and review of MDRs by the agency, while maintaining or enhancing the quality, utility, and clarity of MDRs through a more holistic view of reportable event trends.”

U.S. Healthcare 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.