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Публикация No 12 - 09 ноября 2012 г.
Blog di Servizio / Service Blog - Senza scopo di lucro - Copyright © Luca Martinelli
martedì 30 settembre 2014
lunedì 29 settembre 2014
venerdì 26 settembre 2014
martedì 23 settembre 2014
FDA USA - MEDICAL DEVICE REPORTING (MDR)
MDR Overview
Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
Mandatory Medical Device Reporting Requirements:
The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Device User Facilities: A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office. User facilities must report a suspected medical device-related death to both the FDA and the manufacturer. User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.
A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under FDA’s Safety Information and Adverse Event Reporting Program. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. See "Medical Device Reporting for User Facilities", a guidance document issued by FDA.
Please visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes.
Voluntary Medical Device Reporting:
The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program or through the MedWatcher mobile app.
How to Report a Medical Device Problem:
Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).
Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):
Find information and instructions for mandatory device reporting at:
- Reporting Medical Device Adverse Events for Manufacturers, Importers and Device User Facilities
- Instructions for Completing Form FDA 3500A
- eMDR- Electronic Medical Device Reporting
- Draft Guidance for Industry and Food and Drug Administration Staff: Medical Device Reporting for Manufacturers
- FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB)
For Questions about Medical Device Reporting, including interpretation of MDR policy:
- Call: (301) 796-6670
- Email: MDRPolicy@fda.hhs.gov
- Or write to:
Food and Drug Administration
Center for Devices and Radiological Health
MDR Policy Branch
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002
Center for Devices and Radiological Health
MDR Policy Branch
10903 New Hampshire Avenue
WO Bldg. 66, Room 3217
Silver Spring, MD 20993-0002
Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):
Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Submit reports to FDA through the MedWatch program in one of the following ways:
- Using the MedWatcher mobile app that allows individuals to submit voluntary reports of serious medical device problems to the FDA using a smart phone or tablet.
Download the MedWatcher Mobile App
- Complete the MedWatch Online Reporting Form
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
To Report an Emergency
If you have identified a public health emergency, you may use the following contact information to alert the FDA:
FDA Office of Crisis Management, Emergency Operations Center
- Voice (24hr/day) phone: 866-300-4374 or 301-796-8240
- FAX: 301-847-8543
Searching Medical Device Reports
The Manufacturer and User Facility Device Experience (MAUDE) database contains mandatory reports filed by manufacturers and importers from August 1996 to present, all mandatory user facility reports from 1991 to present, and voluntary reports filed after June 1993. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA's several important postmarket surveillance data sources.
Individuals are also able to request information related to Medical Device Reports by submitting a Freedom of Information Act (FOIA) request either in writing or online.
Contact
For general questions, please contact the Division of Industry and Consumer Education (DICE) by telephone at (301) 796-7100, or by email at DICE@fda.hhs.gov.
lunedì 22 settembre 2014
PASSED 401.000 VISITS
Dear readers: colleagues, students, professors, professionals, companies and public bodies, you all that follow this blog, even through Google plus.
The number of visits received means the success of all of us. While reading, chatting, asking and also criticizing, we all could create technical documents, statistics, news on products safety, norms and laws which are useful both for study and work.
This is a spontaneously born free space, not only mine but even yours. We will improve it in order to benefit the best for everyone but also for the pleasure to share our knowledge.
Thank you so much to all those people who belong to the project and follow it with passion. I remain at your disposal and invite all the ones that would like to join us to write me at martinellimartinelli@live.com
Luca Martinelli
domenica 21 settembre 2014
THE VIRTUAL FACEBOW: A DIGITAL COMPANION TO IMPLANTOLOGY
Very interesting!
Photograph: Dr. Less Kalman (University of Western Ontario, ON N6A 5C1 London, Canada)
Photo from Dental Tribune International
"The
Virtual Facebow has been developed as an open-source tablet app that provides an
alternative to the conventional facebow for the mounting of casts to an
articulator."
TO BE CONTINUED Link to> Dental Tribune International
venerdì 19 settembre 2014
Prolonged hypotensive and bradycardic effects of passive mandibular extension: evidence in normal volunteers.
Various procedures involving stimulations of facial regions are known to induce so-
called trigemino-cardiac reflexes that entail a decrease of heart rate and blood pressure.
Persistent effects after trigeminal nerve proprioceptive stimulation by mandibular extension on rat blood pressure, heart rate and pial microcirculation.
The trigemino-cardiac reflex is a brainstem reflex known to lead to a decrement in heart rate and blood pressure, whereas few data have been collected about its effects on the cerebral hemodynamic.
Device for cyclical extension of the jaw
WO 2011107875 A8
Inventors - Daniele Tonlorenzi - MARCELLO BRUNELLI
A device (1) for treating or preventing cerebral diseases, arterial hypertension, cerebral stroke, neurodegenerative diseases, provides a means for causing a mouth hyperextension and activating the proprioceptive sensations of the mandibular muscles. The means for causing a mouth hyperextension comprise a central portion (30) including a "U"- folded metal lamina of about 1-2 mm of thickness, for example 1.2 mm. At the end (31.32) of the central portion (30) are provided two curved laminar portions (10.20) that are arranged to be located, in use, at the upper wall (41) and at the lower wall (42) of the oral cavity of a patient (50). More in detail, the curved laminar portions (10.20) can be connected to the central portion (30) through a respective stair portion (11.21). This allows the central portion (30) to go beyond the dental arches (51, 52) of the patient (50), in order to arrange the laminar portions (10.20) adjacent to the palate and to the space between the tongue and the lower dental arch of the patient, or directly on the tongue itself. The metal of the device (1) has such a hardness that allows, in use, to stretch the mandibular elevator muscles.
NEW DENTAL PROCEDURE COULD REPLACE ROOT CANAL TREATMENT
Researchers at the University of Liverpool are currently testing a new
procedure to treat infected pulp.
Revascularisation can be performed in just two visits and could spare
patients from undergoing the long and much disliked root canal treatment.
giovedì 18 settembre 2014
lunedì 15 settembre 2014
domenica 14 settembre 2014
FDA USA - RECENT MEDICAL DEVICE RECALLS - updated 09/05/14
FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.
Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products.
Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice.
mercoledì 10 settembre 2014
50 - PHYSICAL RECOVERY IN SPORT PERFORMANCE WITH MANDIBULAR STRETCHING (summary information)
Daniele Tonlorenzi – Luca Martinelli
PHYSICAL
RECOVERY IN SPORT PERFORMANCE WITH
MANDIBULAR
STRETCHING
(summary
information)
Publication nr. 50 – 07th August 2014
19.02.2016 BIOGRAFY UPDATE
19.02.2016 BIOGRAFY UPDATE
1.FOREWORD
During a race or workout the athlete is
subdued to a psycho-physical stress, which
encreases
-
Heartbeat pulsation;
-
Blood pressure;
-
Muscle tone;
-
Mental effort.
Only
at the end of performance (race or workout) the heart and pressure parameters
bring back to pre-stress values; this is possible thanks to recovery.
When
the recovery is not optimal, the fatigue remains; the athlete feels an agility
and reflex reduction, could have muscle contractures with possible
muscle-tendon complications (Ex. Pubalgie) and/or osseous complications (Ex.
Microfratture), performance capacity reduction as well.
In those
conditions the subject exposes himself to a high risk of sport accident.
2 TO
INCREASE THE PERFORMANCES
In order to enhance the performances,
every sport has got its own training method, its own lenght of time, places.
Surely all the sports have in common one thing: the need for relaxation to
obtain the best refreshment.
To
encrease the performance, therefore, a path to take with the confidence to have
good results is surely to obtain a heartbeat pulsation, blood pressure, muscle
tone and mental effort recovery as much as possible.
Studies and tests have dimonstrated that
the mandibular stretching activity, never used up to now in sport, takes
advantages as actual as unexpected.
If with our mind we recollect many sport
images, we could immediately remember how the athlets, in the maximum of their
performance, grit their teeth: they close them in a spasmodic way.
This is not only a personal attitude:
gritting the teeth for one minute permits the body to reinforce the stress mechanisms
and to encrease the medium arteria blood pressure of 5,5 mm hg. (http://www.ncbi.nlm.nih.gov/pubmed/277577).
This fact gives the athlet to express at
his best the sport performance.
The open mouth pleasant yawn image is likewise
clear and as much as the tightened mouth is associated to the stress, the open
mouth which yawns is associated to relax concept.
This study has been presented into the
sperimental thesis work of COPPI, ERIKA Study of trigeminal-cardiac reflex in the arteria
blood pressure and hearthbeat pulsation control (http://etd.adm.unipi.it/t/etd-04072010-114646/)
This has been done with sperimental prototype
of medical device called Spring device
and has been published (http://www.ncbi.nlm.nih.gov/pubmed/23479456)
Watching this image is perceived that
the mandibular stretching is an action mechanism that can already found in
nature without either realizing.
3 THE
INSTRUMENTS TO ENCREASE THE PERFORMANCES
For the mandibular
stretching studies and tests has been used the ”Spring Device” (Image 1 and 2), a device that permits to do a mandibular
extention in association with masticatory movements, in practice a mandibular
stretching activity. Tests have demonstrated that the use of this device,
otherwise the mandibulary stretching activity, permits a heartbeat pulsation
and blood pressure decrease (in the human being) and that it ecreases the
quantity of blood that flows into the brain (in the vertebrate). It is
afterwards conceivable that this activiy can even favour the mental recovery
work, which is fundamentally important in the sport performance.
Foto 1
Foto 2
Medical device “Spring Device” The “Spring Device” into
the tester mouth
4
CONCLUSIONS
Latest studies have
proved that the use of dinamic mandibular stretching permits the body the
quickly recovery of the physiological parameters that the athlet has got before
performance.
The use of medical
device “Spring Device” permits to do the mandibular stretching and so permits
the athlets to recovery quickly.
The “Spring Device”
acts through totally natural mechanisms, therefore it is not considered sport
doping in any way.
5 MANDIBULAR STRETCHING BIBLIOGRAPHY
1
Journal of the American Dental Association 1978 Jul;97(1):54-7.
Preliminary study of changes in
blood pressure associated with clenching in normotensive and
hypertensive subjects.
2
Archivies Italiennes the Biologie 2012
Dec;150(4):231-7. doi: 10.4449/aib.v150i4.1420.
Prolonged hypotensive and bradycardic effects of passive mandibular
extension: evidence in normal volunteers.
3
COPPI, ERIKA Studio
del riflesso trigemino-cardiaco nel controllo della pressione arteriosa e della
frequenza cardiaca Tesi di Laurea Specialistica - Universita’ di
Pisa – URN etd-04072010-114646 – 2010 AA 2008/2009
4
Se l’atleta è più rilassato
migliorano le performance? Si può rispondere misurando? – Tonlorenzi D, D’angelo M, Ravera F,
Traina G, Brunelli M - http://www.danieletonlorenzi.it/category/sport/ oppure http://www.slideshare.net/DanieleTonlorenzi/sport-35154369?ref=http://www.danieletonlorenzi.it/category/sport/
5
Analisi delle modificazioni prestazionali indotte
dall’uso dello Spring Device su ciclisti di alto livello. Un esperimento – Ravera F
http://www.danieletonlorenzi.it/category/sport/ oppure http://www.slideshare.net/DanieleTonlorenzi/sport-35154369?ref=http://www.danieletonlorenzi.it/category/sport/
6
Archivies Italiennes the Biologie 2013
Mar;151(1):11-23. doi: 10.4449/aib.v151i1.1470.
Persistent effects after trigeminal nerve proprioceptive stimulation
by mandibular extension on rat blood pressure, heart rate and pial
microcirculation.
7
MARIO D’ANGELO Influenza dello stretching mandibolare in
atleti sottoposti ad allenamento
ad alta intensita’ Tesi di Laurea Specialistica – Università degli studi di Perugia AA 2012/2013
ad alta intensita’ Tesi di Laurea Specialistica – Università degli studi di Perugia AA 2012/2013
8
MASSIMO CONTI Effetti dell’attivazione propriocettiva del nervo trigemino
sul microcircolo piale del ratto Tesi di Laurea – Università degli studi di Pisa AA 2009/2010.
sul microcircolo piale del ratto Tesi di Laurea – Università degli studi di Pisa AA 2009/2010.
9
Convegno nazionale Montecatini Terme - Italy - 4-5 Ottobre 2013 - (6
Crediti Formativi ECM)
EVIDENZE SCIENTIFICHE SULLA
STIMOLAZIONE TRIGEMINALE
CORRELAZIONI CON LA CLINICA ODONTOIATRICA, LO SPORT E IL BENESSERE
CORRELAZIONI CON LA CLINICA ODONTOIATRICA, LO SPORT E IL BENESSERE
-Prof. M. BRUNELLI Fisiologia del sistema trigeminale: Vie trigeminali (propriocettiva e via
esterocettiva) Controllo della postura mandibolare. Memoria e apparato
stomatognatico concetti pratici;
-Prof. U. BONUCCELLI Il dolore
facciale “tipico e atipico”;
-Prof. U. COVANI Anatomia dell’articolazione
temporomandibolare;
-Prof. M. D’ATTILIO Malocclusione disordine temporomandibolare. Linee guida, diagnosi, management;
-Sig. S. ZANFRINI Misuriamo
ciò che facciamo in odontoiatria;
-Dott. D. TONLORENZI La dimensione verticale e la gestione dello
stress;
-Dott. S. GHIONE Effetti dello stretching mandibolare nel
controllo dei parametri cardiaci nell’uomo;
-Dott.ssa R. SCURI Effetti della stimolazione propriocettiva del
nervo trigemino attraverso estensione mandibolare sul
microcircolo piale del ratto;
-Dott. D. TONLORENZI Il riflesso trigeminocardiaco: un grave pericolo
o un prezioso alleato per il dentista?;
-Dott. D.
TONLORENZI Come “costruire” un bite in
allungamento muscolare;
-Prof. G. GALANTI Ruolo del controllo nervoso autonomo nell’attività
sportiva;
-Prof. M. BRUNELLI Fisiologia della postura e del movimento;
-Prof. U. BONUCCELLI Patologia del movimento;
-S. ZANFRINI Sistemi di misurazione posturale;
-Prof. M. MARELLA Ruolo del movimento nella prevenzione
vascolare.
10
XXVII Congresso nazionale Società italiana
dell’ipertensione arteriosa – Lega italiana cpontro l’ipertensione arteriosa –
Roma – 30 Settembre – 3 Ottobre 2010 – Atti, pp. 122 – 122. Giornale della
Società Italiana dell’Ipertensione Arteriosa, 2010.
Effetto ipotensivo e bradicardizzante prolungato dello stiramento
mandibolare: evidenza nel soggetto volontario.
S. Ghione, C. Del Seppia, E. Coppo, D.
Tonlorenzi, M. Brunelli, R. Scuri (Pisa).
11
PlosOne Published: December 31,
2014. DOI: 10.1371/journal.pone.0115767
Trigeminocardiac Reflex by Mandibular Extension on Rat Pial
Microcirculation: Role of Nitric Oxide
Dominga Lapi, Giuseppe Federighi, M. Paola Fantozzi,
Cristina del Seppia, Sergio Ghione, Antonio Colantuoni, Rossana Scuri.
RELATED BIBLIOGRAPHY
12
Scand
J Med Sci Sports 1998; 8: 65-67.
Passive properties of human skeletal muscle during stretch
maneuvers. A review.
Magnusson
SP.
13
Arch
Phys Med Rehabil 1994,75:976-981.
Stretching exercises: effect on passive extensibility and
stiffness in short hamstrings of healthy subjects (see comments).
Halbertsma
JP, Goeken LN.
14
Arch Phys Med Rehabil 1984; 65: 452-456.
Myofascial pain: relief by post-isometric
relaxation.
Lewit K, Simons DG.
15
Physical
Therapy March 2010 vol. 90 no. 3 438-44.
Increasing Muscle Extensibility: A Matter of
Increasing Length or Modifying Sensation?
C. Holzman
Weppler, S. P. Magnusson
16
Scand J
Med Sci Sports. 1996 Dec;6(6):323-8.
Viscoelastic stress relaxation during static stretch
in human skeletal muscle in the absence of EMG activity;
17
J Dent Res. 2010
Nov;89(11):1259-63. doi: 10.1177/0022034510378424. Epub 2010 Aug 25.
Randomized clinical trial of treatment for TMJ disc
displacement.
18
J Oral Rehabil. 2009 Jan;36(1):71-8.
doi: 10.1111/j.1365-2842.2008.01887.x. Epub 2008 Oct 22.
Orthodontic treatment and management of limited mouth
opening and oral lesions in a patient with congenital insensitivity to pain:
case report.
Paduano S, Iodice G, Farella M, Silva R, Michelotti A.
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