venerdì 29 aprile 2016

FDA USA - RECENT MEDICAL DEVICE RECALLS updated 04 19 2016

From  

Web site

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. If you wish to find a Class II or Class III recall, you can search the CDRH Recalls Database.  
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.
Learn more about medical device recalls here.

mercoledì 27 aprile 2016

CHE COS'E' LA KINESIOGRAFIA


Il fabbricante italiano di kinesiografi ed elettromiografi BIOKET Srl (Sanbenedetto del Tronto) ha messo a disposizione una pubblicazione, scaricabile, gratuita, che spiega cos'è la kinesiografia.

La pubblicazione, ricca di foto, grafici, tabelle e spiegazioni, tratta i seguenti argomenti:

La kinesiografia
L’esame kinesiografico
Kinesiorafia in odontostomatologia
Kinesiografia nelle sindromi disfunzionali dell’ATM
Kinesiografia in ortodonzia
Kinesiografia in protesi
Kinesiografia in implantologia


lunedì 25 aprile 2016

IMPRESSION TRAY

Luca Martinelli

Basics on dental impression tray

Publication nr. 52 – 29th December 2014

Foreword
Take the impression of the patient’s mouth is not a trivial operation. To the doctor’s office, a wrong impression may represent a loss of time, extensions of the patient stey in the chair, waste of expensive materials, misunderstanding with the dental laboratory, new dates which are a damage to the patient and to the dentist, with a tarnished image itself of the dental office.

Over the years from dental impressions detected using wax, in the Seventeenth Century, we moved to the plaster and then to the gutta percha. Around 1925 we can find hydrocolloids, later alginates, curing silicons and polyether. From 1976 on we find addition silicon and many others will come.

Trays have remained essentially the same from their first invention up to now. Perhaps that’s the reason why they have always been considered the “Cinderella” of manual dental devices yet they are of fundamental importance to get a corretc impression. The kind of impression material and skill of operator are not the only requirements to get a correct dental impression.

With the use of new technologies such as laser light, particularly effective in the detection of impressions,  mentioning the traditional impression tray is a bit “anachronistic”. On the other hand, in the vast majority of dental offices around the world, is even massive the use of traditional tray and it is therefore still interesting an overview on them.

Prof. Enrico Gherlone about fingerprint says: "The fingerprint is an innovation that is revolutionizing the traditional dental impression methods because it allows you to transfer images to your computer the mouth through the use of a tiny camera ".

The impression
European statistical reports says that almost 50% of cases detected impressions are not accurate enough, so are unusable or otherwise that may cause incorrect work. In particular the impressions needed to build fixed prosthesis show a defect precisely at the expense of the preparation margins; not least the antagonist should be precise, even in this case has been detected a frequent shallowness in the accuracy of these.

In this publication we will go neither in clinical appearance, nor in the aspect of choosing the most suitable type of tray for each type of different impression but only in appearance constructive-normative. For in-depth knowledge we recommend the excellent book by Prof. own Gherlone "The impression denture" (Publisher ELSEVIER - MASSON), which in the updated version devotes ample space to the new technologies.

Signs on digital impression
The digital impression, detected by laser light scanner, it is particularly suitable for fixed prostheses. It is also used in orthodontics, at all stages of the treatment.

We recall that more than 6% of the “child” population is subjected to orthodontic treatment, it is therefore easily understood that the use of a not-invasively impression detection system, without that for this lost in precision, becomes a particularly pleasing from the doctor and the patient, too.

The instrument that allows the digital detection now represents the near future impression. It is substantially a scanner (oral Scanners - Fig. 1) that detects, captures and processes in 3D the image of the mouth, creating an accurate virtual reconstruction of it.


1
Scanner in the patient’s mouth



On the market we can find a remarkable variety in the photos below (Fig. 2, 3, 4, 5, 6) a few examples by way of example only.
         

            


Various types of impression trays
There are different types of impression tray, perforated, non-perforated, with border, without border, for edentulous, partially edentulous, for orthodontics, implantology, for reversible hydrocolloid. There are also a number of trays that actually should not be used for clinical technical reasons as the partial impression trays, the impression trays to take simultaneously arch, or upper and lower hemi arch, and also the impression tray for the control of the bite. The complete impression tray itself (upper and lower full arch) is already a loophole - understandable for costs reasons and time - to the individual impression tray that it is actually the only real “accurate” impression tray.

Construction materials

The impression trays can be built with different materials, depending on the use and the cost that these must have. Most of them are steel manufactured, but we find many also in aluminum, teflon coated aluminum, coated aluminum Rislan, nickel-plated or chrome-plated brass (although today the use of chrome stainless steel (usually steel of the AISI 304 series) is prohibited almost everywhere), polycarbonate, teflon and polypropylene sulphide, as regards the reusable impression trays. Polystyrene and in some cases aluminum (Ex. Impression tray for implantology) as regards instead the disposable impression trays.



Trays for edentulous type Schreinemakers

A impression trays coming out of the standard is to Josephus Schreinemakers. Usually made of steel, it has the edges with special millimetrature, drilled laterally and not only on the top (American patent of 1979 presented a few years before in Holland 1975).





                           
The classification of the impression tray
The trays are regulated by a standard, in this case it is an American standard, and more precisely the ANSI / ADA 1995 Specification 87  - raffirmed 2014.

Like all technical standards are voluntary adaptation, in this case it is not a European standard. However, as in all cases in which there is a national or European standard reference, these still represent state of the art.

This standard indicates:
-Classification
-Definitions
-Requirements such as biocompatibility
-Security Of form and surface finish
-Shapes and sizes
Operating instructions packaging and marking
-Functionality And water seal for PI for reversible hydrocolloids
-Corrosion and resistance
-Sampling for test methods
And more.

Let's see in detail at least the three main aspects
1-Classification;
2-Measurement and exposure to the user of the measures;
3-Labelling.

Classification
The impression trays are divided into:
Type 1: metal tray, perforated reusable;
Class 1: Cooled water;
Class 2: "Normal" is not water-cooled.
Type 2: metal impression tray, smooth reusable (non-perforated);
Class 1: Cooled water;
Class 2: "Normal" is not water-cooled.
Type 3: disposable impression tray perforated
Type 4: smooth disposable impression tray (not drilled).

Measures and outline measures
The measurement of the impression tray and the exposure to the catalog of its measures should take place as in figure 7.


Most of the time the catalogs of the various manufacturers only show the D1 and D2 extent, rarely the D3 even if it would be desirable, especially for the choice of the impression tray for orthodontics, that there are measures with major and minor edge, or impression tray which have necessarily the high board, to get them to take well the fornix area.

The right impression tray – very brief.
As we wrote in the introduction we won’t tell anything about the impression argument, that is, what is the way and the best way to keep an impression; However, we do a very brief including but not limited to some schools of thought just to give a general indication of the use of different impression tray.

Precise impression can not be separated from the use of a rigid metal tray.

The impression tray in plastic material does not have sufficient rigidity to ensure the accuracy of the impression material, particularly when using silicones dual-phase (to be relined), the finger pressure is enough to deform the impression trays and the same impression.

A slightly rigid impression trays makes impressions with dimensional changes that, especially for fixed prosthesis, are unacceptable.

The deformation of the plastic impression tray during impression taking implies, after its removal from the mouth, it returns to its original geometry consequently the models developed by this imprint will be affected from the actual sizes of the elements and the arch .

The use of a perforated impression tray rather than unperforated can, for example, cause dimensional alterations impression depending on the impression material used;
-If you use a polyether monophasic will be important to choose an impression tray without holes so that they may contain the material without it is extended and therefore allow for a sufficient build up of pressure against the walls of the impression tray which will retain positioned the same material;
-If You use an alginate or elastomer two-phase perforated impression tray allows a better retention of the impression material without major compromises.

Both may have a retentive edge, solid ones with the retentive board were equipped with mostly edge to their users using alginate.


It goes without saying that the impression tray for reversible hydrocolloid, as little used today, are solid (Fig. 14).



Conclusions
Still employed at full capacity the traditional impression trays are different in form, material of construction and prices.
The impression materials have undergone transformations over time for the composition, type of use and final precision.
It is not always clear the construction material, the classification, the type and the use of the impression tray. While remaining unchanged in time, it should in fact be the accessory that supports the most recent impression materials created.

The advent of new technologies, which allow greater precision, greater savings in time and money, is starting faster and faster to "retire" the traditional impression tray.




domenica 24 aprile 2016

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - TURKEY

Membership status

Candidate country

Background

In 1987, Turkey applied to join what was then the European Economic Community, and in 1997 it was declared eligible to join the EU.
Turkey's involvement with European integration dates back to 1959 and includes the Ankara Association Agreement (1963) for the progressive establishment of a Customs Union (ultimately set up in 1995).
Accession negotiations started in 2005, but until Turkey agrees to apply theAdditional Protocol of the Ankara Association Agreement to Cyprus, eight negotiation chapters will not be opened and no chapter will be provisionally closed.
Turkey is seeing an unprecedented and continuously increasing influx of people seeking refuge from Syria which has exceeded 2.2 million to date. Overall, Turkey is the country in the world hosting the highest number of refugees, and has already spent more than 7 billion EUR of its own resources on addressing this crisis. The Commission has engaged with Turkey to step up their cooperation on support of Syrians under temporary protection and migration management in a coordinated effort to address the crisis created by the situation in Syria. As a result a Joint EU-Turkey Action Plan was agreed in October and was activated at the EU-Turkey Summit on 29 November 2015. The Action Plan aims at bringing order in the migratory flows and stemming the influx of irregular migration.
On 24 November 2015 the Commission adopted a Commission Decision establishing a Turkey Refugee Facility which will pool 3 billion EUR additional resources. This represents a major additional support and the Facility will coordinate and streamline actions financed from the Union's budget and bilateral contributions from EU Member States in order to enhance the efficiency and complementarity of support provided to refugees and host communities in Turkey. 
Negotiation chapters
OpenProvisionally closed
Free Movement of Capital
Company Law
Intellectual Property Law
Information Society and Media
Food Safety, Veterinary & Phytosanitary Policy
Taxation
Statistics
Enterprise & Industrial Policy
Trans-European Networks
Environment
Consumer & Health Protection
Financial Control
Regional policy & coordination of structural instruments
Economic and Monetary Policy
Science and Research
The EU Delegation in Ankara provides more information on Turkey.

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - YUGOSLAV REPUBLIC OF MACEDONIA

Membership status

Candidate country

Background

The former Yugoslav Republic of Macedonia – along with other Western Balkans countries – was identified as a potential candidate for EU membership during the Thessaloniki European Council summit in 2003.
The former Yugoslav Republic of Macedonia applied for EU membership in March 2004. The Commission issued a favourable opinion in November 2005, and the Council decided in December 2005 to grant the country candidate status. In October 2009, the Commission recommended that accession negotiations be opened.

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - SERBIA

Membership status

Candidate country

Background

Serbia – along with 5 other Western Balkans countries – was identified as a potential candidate for EU membership during the Thessaloniki European Council summit in 2003. In 2008, a European partnership for Serbia was adopted, setting out priorities for the country's membership application, and in 2009 Serbia formally applied. In March 2012 Serbia was granted EU candidate status. In September 2013 a Stabilisation and Association Agreement between the EU and Serbia entered into force.
In line with the decision of the European Council in June 2013 to open accession negotiations with Serbia, the Council adopted in December 2013 the negotiating framework and agreed to hold the 1st Intergovernmental Conference with Serbia in January 2014.
On 21 January 2014, the 1st Intergovernmental Conference took place, signaling the formal start of Serbia's accession negotiations.

venerdì 22 aprile 2016

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - MONTENEGRO

Membership status

Candidate country

Background

In 2006 Montenegro's parliament declared independence from the State Union of Serbia and Montenegro. In 2008, the new country applied for EU membership.
In 2010, the Commission issued a favourable opinion on Montenegro's application, identifying 7 key priorities that would need to be addressed for negotiations to begin, and the Council granted it candidate status.
In December 2011, the Council launched the accession process with a view to opening negotiations in June 2012.
The accession negotiations with Montenegro started on 29 June 2012.

ON THE ROAD TO EU MEMBERSHIP - CANDIDATE COUNTRIES - ALBANIA

Albania

Membership status

Candidate country

Background

Albania – along with other Western Balkans countries – was identified as a potential candidate for EU membership during the Thessaloniki European Council summit in June 2003.
In 2009, Albania submitted its formal application for EU membership. In its Opinion on Albania's application (in 2010), the Commission assessed that before accession negotiations could be formally opened, Albania still had to achieve a necessary degree of compliance with the membership criteria and in particular to meet the 12 key priorities identified in the Opinion.
In October 2012, Commission recommended that Albania be granted EU candidate status, subject to completion of key measures in the areas of judicial and public administration reform and revision of the parliamentary rules of procedures.
In June 2014, Albania was awarded candidate status by the EU.

giovedì 21 aprile 2016

III° CONVEGNO NAZIONALE WPAI - CONDIZIONAMENTO DELLO STIMOLO ADATTATIVO SUI SISTEMI PSICHICO, BIOCHIMICO E STRUTTURALE

Venerdì 30 settembre e sabato 1 ottobre 2016, presso il Park Hotel Resort Paradiso del Garda a Peschiera del Garda, si terrà il III° Convegno WPAI



Il Congresso quest ʼanno si pone l ʼobiettivo di confrontare e collegare le scuole ed i professionisti che si occupano di riabilitazione posturale in relazione ai condizionamenti
adattativi psichici, biochimici e strutturali che inducono a variazioni dell ʼassetto posturale.

Per qualsiasi informazione o prenotazione:
Segreteria Organizzativa WPAI:
Sig. Sergio Zanfrini Tel. 348 2637890
Presidenza WPAI:
Dott. Tullio Toti Tel. 045 4649244
Email: wpaitalia@gmail.com



EU - MEDICAL DEVICES GUIDANCE

From

website

The European Commission provides a range of guidance documents to assist stakeholders in implementing directives related to medical devices.


Guidance MEDDEVEs


The MEDDEVs promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures.
  • The MEDDEVs are drafted by authorities charged with safeguarding public health in conjunction with all stakeholders; industry associations, health professionals associations, Notified Bodies and European Standardisation Organisations. This is in accordance with the relevant annexes of the directives
  • MEDDEVs are carefully drafted through a consultation process with all interested parties and are subject to a regular updating process
  • These documents have particular reference codes and are endorsed at the Medical Devices Expert Group (MDEG) plenary meetings
  • The guidelines are not legally binding. However, due to the participation of the aforementioned interested parties and the experts from competent authorities, it is expected that the guidelines be followed, ensuring the uniform application of relevant directive provisions.
Disclaimer: Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated into all MEDDEVs.

List of Guidance MEDDEVs

See below a complete list of all Guidance Meddevs, including links to further information:



Title
2.1 Scope, field of application, definition
MEDDEV 2.1/1 (18 kB) Definitions of 'medical devices', 'accessory' and 'manufacturer'
April 1994

MEDDEV 2.1/2 rev.2 (14 kB) Field of application of directive 'active implantable medical devices'
April 1994

MEDDEV 2.1/2.1 (12 kB) Treatment of computers used to program implantable pulse generators
February 1998

MEDDEV 2.1/3 rev.3 (183 kB) Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative
December 2009

MEDDEV 2.1/4 (21 kB) Interface with other directives – Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment
March 1994
For the relation between the MDD and Directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009 (28 kB)

MEDDEV 2.1/5 (10 kB) Medical devices with a measuring function
June 1998

MEDDEV 2.1/6 (514 kB) Qualification and classification of stand alone software
July 2016
2.2 Essential requirements
MEDDEV 2.2/1 rev.1 (16 kB) EMC requirements
February 1998

MEDDEV 2.2/3 rev.3 (17 kB) 'Use by'-date
June 1998

MEDDEV 2.2/4 (38 kB) Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products
January 2012
2.4 Classification of MD
MEDDEV 2.4/1 rev.9 (759 kB) Classification of medical devices
June 2010
2.5 Conformity assessment procedure
General rules

Quality assurance.
Regulatory auditing of quality systems of medical device manufacturers
(See document in the GHTF-global harmonization task force)

MEDDEV 2.5/3 rev.2 (8 kB) Subcontracting quality systems related
June 1998

MEDDEV 2.5/5 rev.3 (7 kB) Translation procedure
February 1998

MEDDEV 2.5/6 rev.1 (9 kB) Homogenous batches (verification of manufacturers' products)
February 1998

Conformity assessment for particular groups of products

MEDDEV 2.5/7 rev.1 (92 kB) Conformity assessment of breast implants
July 1998

MEDDEV 2.5/9 rev.1 (96 kB) Evaluation of medical devices incorporating products containing natural rubber latex
February 2004

MEDDEV 2.5/10 (80 kB) Guideline for authorised representatives
January 2012
2.7
Clinical investigation, clinical evaluation
MEDDEV 2.7/1 rev.4 (631 kB) Clinical evaluation: Guide for manufacturers and notified bodies
June 2016
Appendix 1: Clinical evaluation on coronary stents (100 kB)
December 2008

MEDDEV 2.7/2 rev. 2 (412 kB) Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 90/385/EEC and 93/42/EC
September 2015

MEDDEV 2.7/3 rev. 3 (383 kB) Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC - SAE reporting form (27 kB)
May 2015
The new SAE reporting form was taken in use by 1 September 2016.

MEDDEV 2.7/4 (183 kB) Guidelines on clinical investigations: a guide for manufacturers and notified bodies
December 2010
2.10 Notified bodies
The documents on designation of notified bodies under the new regulations are in the section above (MDCG documents)​

MEDDEV 2.10/2 rev.1 (105 kB) Designation and monitoring of notified bodies within the framework of EC directives on medical devices
annex 1 (119 kB), annex 2 (14 kB), annex 3 (16 kB), annex 4 (26 kB)
April 2001
2.12
Post-Market surveillance
MEDDEV 2.12/1 rev.8 (763 kB)
Guidelines on a medical devices vigilance system
January 2013
. MEDDEV 2.12/1 rev.8 – Latest Version Forms
MEDDEV 2.12 rev. 7 MIR and FSCA are still valid
Please note: Some browser plugins are not compatible with PDF forms. If you have problems opening these forms, please save them to your computer and open them from there.
Other forms and templates
Field safety notice template (195 kB)
FSN customer reply 
(108 kB)
FSN distributor/importer reply
 (103 kB)
FSN Q&A 
(152 kB)
Trend report (151 kB)
Periodic summary report (192 kB)
. Device specific vigilance guidance
DSVG Template (22 kB)
DSVG 00 (20 kB) Introduction to device specific vigilance guidance
DSVG 01 (24 kB) Cardiac ablation vigilance reporting guidance
DSVG 02 (26 kB) Coronary stents vigilance reporting guidance
DSVG 03 (250 kB) Cardiac implantable electronic devices (CIED)
DSVG 04 (219 kB) Breast implants
New MIR form* - as from January 2020
New manufacturer incident report (PDF form)
New manufacturer incident report for importing XML file* with Adobe Professional
The published MIR form is password-protected so it may be necessary to unlock it for specific purposes (e.g. translating the form, implementing it into in-house IT systems).
You can request the password for specific authorised uses, which are subject to terms and conditions.
New manufacturer incident report XSD file and XSL files (for implementation in manufacturer’ databases)
New manufacturer incident report help text
Changelog file
*If you're a manufacturer and have already adapted your IT system to version 7.1, you may use this version until the end of March 2020.

MEDDEV 2.12/2 rev.2 (228 kB) Post market clinical follow-up studies
January 2012
2.13 Transitional period
MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05)
August 1998

As regards the transitional regime of Directive 2007/47/EC see the interpretative document of the Commission's services of 5 June 2009 (35 kB)
2.14 IVD
MEDDEV 2.14/1 rev.2 (76 kB) Borderline and classification issues. A guide for manufacturers and notified bodies
January 2012

MEDDEV 2.14/2 rev.1 (64 kB) Research use only products
February 2004

MEDDEV 2.14/3 rev.1 (80 kB) Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices
January 2007


MEDDEV 2.14/4 (114 kB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP
January 2012

2.15
Other guidance
MEDDEV 2.15 rev.3 (32 kB) Committees/working groups contributing to the implementation of the medical device directives
December 2008