martedì 27 dicembre 2016

INTERNATIONAL MEDICAL DEVICE REGULATION FORUM (EX GHTF)


The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.
It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.
The IMDRF Management Committee, composed of regulatory officials, provides guidance on strategies, policies, directions, membership and activities of the Forum. Furthermore, the Management Committee oversees Working Groups, which draw upon expertise from various stakeholder groups such as industry, academia, healthcare professionals, consumer and patient groups.
The roles of IMDRF Chair and Secretariat rotate annually
The current members are:
Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore and the United States of America.
The World Health Organization (WHO) and the APEC LSIF Regulatory Harmonization Steering Committee are Official Observers. The Asian Harmonization Working Party (AHWP) and the Pan American Health Organization (PAHO) are IMDRF Affiliate Organizations.

SANTA CLAUS NEED DENTIST - САНТА-КЛАУС ИЗ ИГРЫ СТОМАТОЛОГ


Santa eat a lot of candyes this year and forgot to take care of his teeth. Now unfortunately he has some serious teeth problmes and he decided to pay a visit to the dentist who in this case is you. You have to analyze Santa Claus’ teeth and repair each one of them. You have to be very carefull and clean the ones you need, repair the one that can be saved and replace those which are to damaged to be repaired. You will have all the necessary medical tools in order to take care of Santa and his teeth and make his smile white and healthy again. 

martedì 20 dicembre 2016

PHARMACEUTICAL EXECUTIVES CHARGED IN RACKETEERING SCHEME

From


FDA (USA)web site


  U.S. Department of Justice - District of Massachusetts - Press Release


For Immediate Release
December 8, 2016


BOSTON – Several pharmaceutical executives and managers, formerly employed by Insys Therapeutics, Inc., were arrested today on charges that they led a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers.

The indictment alleges that Michael L. Babich, 40, of Scottsdale, Ariz., the former CEO and President of the company; Alec Burlakoff, 42, of Charlotte, N.C., former Vice President of Sales; Richard M. Simon, 46, of Seal Beach, Calif., former National Director of Sales; former Regional Sales Directors, Sunrise Lee, 36, of Bryant City, Mich. and Joseph A. Rowan, 43, of Panama City, Fla.; and former Vice President of Managed Markets, Michael J. Gurry, 53, of Scottsdale, Ariz., conspired to bribe practitioners in various states, many of whom operated pain clinics, in order to get them to prescribe a fentanyl-based pain medication.  The medication, called “Subsys,” is a powerful narcotic intended to treat cancer patients suffering intense episodes of breakthrough pain.  In exchange for bribes and kickbacks, the practitioners wrote large numbers of prescriptions for the patients, most of whom were not diagnosed with cancer. 


Причины конфликтов между стоматологом и зубным техником

From
web site

Autor:

Моисеева Татьяна Петровна - Соучредитель в cad cam центре "Sтахановец" (Киев);  Маркетолог в cad cam центре "Sтахановец" (Киев); Административный руководитель в cad cam центре "Sтахановец" (Киев).

Все согласятся, что доктор и зубной техник задействованы в одном, общем процессе - это изготовление какой-то конкретной работы для пациента. Часто в этом процессе задействованы еще и другие участники, например литейка, CAD/CAM центр и другие. Всех участников этого общего процесса я буду далее в статье называть партнерами. И чаще всего проблемы между этими партнерами возникают тогда, когда у них нет ЧЕТКИХ, понятных и выполняемых правил. Где нет правил – всегда был, есть и будет хаос.
Давайте посмотрим ближе на те факторы, которые портят отношения доктора с зубным техником и другими участниками общего процесса.

Отсутствие своих личных стандартов и правил работы. Или же нарушение этих правил.

Мало кто из стоматологов и зубных техников имеют очень четкую, понятную и главное известную другим позицию в отношении своей работы. По сути это определенные правила, по которым вы работаете.
Например такие: «Я работаю только со стоматологами своего города», «Я никогда не работаю без предоплаты», «На изготовление таких работ я беру минимум 6 дней, по-другому работу просто не принимаю», «Я не отдаю работу без полной оплаты», «При необходимости, я всегда бесплатно переделываю работу в течение такого-то времени после ее сдачи», «Я никогда не буду использовать дешевые расходные материалы сомнительного качества», «Я никогда не сотрудничаю с теми, кто нарушает договоренности и приносит проблемы, даже если они платят деньги» и так далее.
Каждый специалист сам устанавливает для себя такие правила, исходя из своих личных ценностей, а также из того с кем он хочет сотрудничать. По сути, вы и есть эти правила. Как специалист, вы состоите из таких вот правил. И именно они влияют на то, как вас воспринимают партнеры и коллеги.


AVVISI DI SICUREZZA - DISPOSITIVI MEDICI - Ministero della Salute

Aggiornamento al 16 dicembre 2016



lunedì 19 dicembre 2016

GOMMINI PER ZIRCONIA, DISILICATO DI LITIO, PORCELLANA

L'introduzione della zirconia e del disilicato di lito ha elevato i requisiti qualitativi che i gommini per lucidatura devono possedere.
Se per la porcellana o per i metalli duri erano necessari lucidanti con un alto livello abrasivo oggi si richiede che il gommino lucidante abbia maggiori qualità in termini di capacità abrasiva, durezza, durata e risultato finale.
Abbiamo provato i gommini di un’azienda italiana poco conosciuta, ha sempre fabbricato per altri marchi anche molto noti, che produce da tempo gommini lucidanti per zirconia, disilicato di litio, porcellana e altro.
I gommini sono fabbricati in gomma dura con diamante puro al 100%, non contengono altri abrasivi come ad esempio il corindone o il carburo di silicio ma solo diamante. La mescola è a saturazione, significa che la gomma è impregnata di polvere di diamante fino al suo interno, cosa quest'ultima estremamente importante in quanto il gommino può essere utilizzato fino al gambo.
La durezza permette di lavorare senza esercitare pressione sul pezzo, la saturazione permette di sfruttare il gommino fino alla fine. Questo si traduce in risparmio di tempo, risparmio di materiali e in un netto miglioramento del risultato finale.
L’azienda si chiama “Quasar Dental Equipment”, da poco presenta i gommini anche a suo marchio presentandoli in kit.
I Kit sono formati da tre frese (3 microfiamme per studio e tre fiamme per laboratorio) confezionate in un portafrese (base universale) in silicone autoclavabile con coperchio (coperchio non autoclavabile).


Per il laboratorio sono disponibili anche gomme lenticolari e ruote da montare su mandrino che viene fornito in omaggio.
La qualità è di altissimo livello ma provare questi gommini vale più di qualsiasi voce autorevole o proclama commerciale.
Coloro che desiderano gommini realmente efficaci e realmente Made in Italy, possono chiedere informazioni direttamente all’azienda, questo il recapito: 

venerdì 16 dicembre 2016

RAPEX - RAPID ALERT SYSTEM FOR DANGEROUS NON-FOOD PRODUCTS - SISTEMA EUROPEO DI ALLERTA RAPIDA PER I PRODOTTI DI CONSUMO PERICOLOSI

The Rapid Alert System for non-food dangerous products facilitates the rapid exchange of information between national authorities of 31 countries and the European Commission on dangerous products found on the market.


The Commission publishes a weekly overview of the alerts on products reported by the national authorities. They include information on the dangerous products found, the risks identified and the measures taken in the notifying country in order to prevent or restrict their marketing or use. Measures can be ordered by national authorities ("compulsory measures") or be taken directly by producers and distributors ("voluntary measures"). Each alert also includes information on the countries where the same product was found and further measures were taken.
Updated to / Aggiornamento al 
16/12/2016
Rapid Alert System – Weekly Notification reports

giovedì 15 dicembre 2016

БИОАКТИВНОЕ ПОКРЫТИЕ, УЛУЧШАЮЩЕЕ ПРИЖИВАЕМОСТЬ ЗУБНЫХ ИМПЛАНТАТОВ

From
Web site

Одна из причин неудачного протезирования в стоматологии – отторжение имплантата в результате иммунной реакции организма. Иммунные клетки воспринимают имплантат как чужеродное тело, вследствие чего начинается воспаление, приводящее к отторжению имплантата. Российские ученые разработали биоактивное покрытие для медицинских имплантатов, которое потенциально может изменять механизм иммунного ответа, способствуя восстановлению тканей вокруг имплантата.


domenica 11 dicembre 2016

RAPEX - RAPID ALERT SYSTEM FOR DANGEROUS NON-FOOD PRODUCTS - SISTEMA EUROPEO DI ALLERTA RAPIDA PER I PRODOTTI DI CONSUMO PERICOLOSI

The Rapid Alert System for non-food dangerous products facilitates the rapid exchange of information between national authorities of 31 countries and the European Commission on dangerous products found on the market.


The Commission publishes a weekly overview of the alerts on products reported by the national authorities. They include information on the dangerous products found, the risks identified and the measures taken in the notifying country in order to prevent or restrict their marketing or use. Measures can be ordered by national authorities ("compulsory measures") or be taken directly by producers and distributors ("voluntary measures"). Each alert also includes information on the countries where the same product was found and further measures were taken.
Updated to / Aggiornamento al 
09/12/2016
Rapid Alert System – Weekly Notification reports

giovedì 1 dicembre 2016

FURY OF PARENTS WHOSE ONE-YEAR-OLD GIRL DIED UNDER ANESTHESIA WHILE HER DENTIST FIXED 'SIX CAVITIES' - AS AN AUTOPSY NOW REVEALS SHE DID NOT NEED THE PROCEDURE

From
web site


  • Daisy Lynn Torres died in March after being brought to Austin Children's Dentistry to get six fillings
  • The 14-month-old was put under anesthesia, went into cardiac arrest and died 
  • Autopsy report in July concluded that there was 'no indication of dental disease or pathology'
  • Daisy's dentist, Dr Michael Melanson, was suspended indefinitely by the practice 
  • Lawyer for the dentist disputes the claim that her teeth were not decaying 
  • His attorney said Melanson was not at fault, and that Daisy's best interest 'was everyone's goal'

Betty Squier says she never thought her 14-month-old daughter, Daisy Lynn Torres, would die going to see dentist Dr. Michael Melanso
But that is what happened when the mother-of-two from Texas took the toddler to Austin Children's Dentistry to have a pair of cavities filled back in March. 
And now Squier says she is shocked and furious after her daughter's autopsy report published  last month revealed there was nothing wrong with Daisy's baby teeth and did not need any dental work.