mercoledì 30 luglio 2014

EUROPEAN MEDICAL DEVICES DIRECTIVE – SYNTHESIS OF THE PROCESSES


Directives
As a first step, you need to verify whether your product(s) fall(s) within the definition of a medical device in accordance with Article 1 paragraph 2a) of Directive 93/42/EEC. Second, you need to exclude that your product(s) falls within the definition of an active implantable medical device (Directive 90/385/EEC) or of an in vitro diagnostic medical device (Directive 98/79/EC). Finally, you must verify that no other exclusion clause contained in the first Article of Directive 93/42/EEC is applicable. If all these conditions are fulfilled, Directive 93/42/EEC applies.
For further information on Directive 93/42/EEC on Medical devices (MDD), please visit the DG SANCO webpage dedicated to this sector by following this link: http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm

Verify requirements
The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover, within their respective scope, all requirements for products from each of the aforementioned sectors.
However, it is possible that more than one New Approach Directive applies to the same product. Furthermore, other legislation (such as horizontal legislation on chemicals or environment) can apply.
Directive 93/42/EEC on Medical Devices (MDD) specifies general requirements that the product has to meet in order for the manufacturer to affix the CE marking. These are the so-called Essential Requirements that are listed in Annex I to the MDD. Compliance with the essential requirements must be demonstrated by a clinical evaluation in accordance with Annex X to Directive 93/42/EEC.

Need for notified body?
Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.
In the Directive on Medical Devices, the medical device is classified in accordance with the provisions of Annex IX of the MDD as class I (low risk), class IIa or IIb (medium risk) or class III (high risk). The involvement of a Notified Body is not necessary for medical devices of class I unless they have a measuring function or are placed on the market in a sterile condition.
A Notified Body verifies in most of the cases only the quality management of the manufacturer. For all medical devices belonging to class III, and for medical devices belonging to class IIa and IIb on a representative basis, the design of the medical device and its compliance with the Essential Requirements must be examined by a Notified Body. The Notified Body issues a certificate that indicates, by referring to one of the Annexes II to VI of the MDD, what has been verified.
To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive, country or by the Notified Body's number (indicated next to the CE marking) via the NANDO homepage.

Check conformity
Subject to the class of the medical device, the manufacturer has different options as to how to assess the conformity of the medical device. The stringency of the conformity assessment procedures depends on the class of the medical device. For each class, the manufacturer has the choice between two or more conformity assessment procedures. Each of the conformity assessment procedures consists of the application of one or more Annexes out of Annexes II to VII of the MDD. In both cases, the clinical evaluation must be part of the documents which the manufacturer submits to the Notified Body for assessment and the Notified Body issues (a) certificate(s) that indicate(s), by referring to one of the Annexes, what has been verified.
Whether the involvement of a Notified Body has been necessary or not, the manufacturer must draw up theDeclaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics of the product, if applicable the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation.

Technical documentation
Prior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.
The manufacturer or the authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of at least 5 years, in the case of implantable devices at least 15 years, after the last product has been placed on the market.

Affix CE marking
Once the necessary steps have been successfully completed, the CE marking must be affixed to the medical device. The CE marking has to be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:


The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.
When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.
If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.

domenica 20 luglio 2014

3 SELF-ASPIRATING DENTAL SYRINGE

Luca Martinelli

The self-aspirating dental syringe

Publication no. 3 - 31st October 2012

1. THE SELF-ASPIRATING SYRINGE
The self-aspirating syringe is so called because the aspiration takes place "automatically", without any need for retracting the plunger.

There are at least two types of self-aspirating syringes, a standard and a "disk" model.

1.1 Standard self-aspirating syringe


 
Pic. 1

1.2 Disk self-aspirating syringe
The structure is identical to the previous one, with the difference that the disk is integral with the vial-holder cylinder, but completely independent with respect of the plunger (It has a through hole that allows the plunger to slide inside it).


 Example of a type of self-aspirating syringe with disk.

Pic. 2

1.3 Loading
The loading is substantially identical to the side-loading syringes except that the vial holder cylinder is to be retracted in order to have the space necessary to insert the tubular vial.

Hold the syringe and retract the plunger;
Pic. 3

Insert the tubular vial into the barrel of the syringe;

Pic. 4

Pic. 5 

When the plunger is retracted, to allow the tubular vial to enter into the barrel, the vial holder cylinder is placed at a rearmost position with respect to the tubular vial, while the plunger is completely out of it (hidden in the handle of the syringe).

Finally, the plunger is released and with it, automatically, also the vial holder cylinder.

When the plunger of the syringe is released the vial holder cylinder (1-Pic. 6) touches the tubular vial (2-Pic. 6) holding it into the barrel.

Pic. 6

The plunger of the syringe (1-Pic. 7) move downwards, until contact with the rubber plunger of the tubular vial (2-Pic. 7).


Pic. 7

Please note that the vial holder cylinder (3-Pic. 7) can not be pushed beyond its natural travel when it is separated from the plunger of the syringe and has no reference points which allow its descent (pressure) in an independent and separate way.

Then insert the needle as usual.

1.4 Operating principle of both "Standard and Thumb-disk" syringes

1.4.1 Physical operating principle
The self-aspiration occurs by variation of tubular vial internal pressure; this takes place when the tubular vial, pushed by the plunger of the syringe or by the vial holder cylinder, opposes the self-aspirating tube located inside the barrel of the syringe.

2 OPERATION

When the diaphragm (2 - Pic. 8) of the tubular vial (5 - Pic. 8) opposes the tube of the syringe (3 - Pic. 8) it undergoes a bending (2 - Pig 8) inwards, this causes an increase in pressure inside the tubular vial (7 - Pic. 8); its release (9 - Pic. 8) causes a drop in pressure inside the tubular vial, and this creates simultaneously an aspiration towards its inside (9 - Pic 8).



Pic.8


Detail of tubular vial in contact with the tube 
Pic.9


The physical operating principle of the two types of self-aspirating syringes (standard and thumb disc) is identical, the difference is the possibility of using two different activation modes.

1.4.3 "Standard" self-aspirating syringe
In "standard" self-aspirating syringes the aspiration is only operated by the plunger of the syringe.
Take as a reference the illustrations in Fig. 8, when pushed, the plunger of the syringe also pushes the rubber plunger of the tubular vial, which in turn pushes the anaesthetic towards the needle, this operation pushes all the tubular vial towards the tube of the syringe.
The diaphragm of the tubular vial thus opposes the tube and undergoes a pressure inwards the tubular vials, increasing its inner pressure; when released, the plunger causes a drop in internal pressure that simultaneously originates an aspiration.

5 Disk self-aspirating syringe
The disc is used when an aspiration is required even before pushing the plunger of the anaesthetic.
The physical operating principle is the same, this is simply and accessory, different mode of activating the self-aspiration.
The vial holder cylinder is integral with the disk (Pic. 10), if the disk is pressed (Pic. 11), the perimeter of the vial holder presses on the perimeter of the tubular vial (Pic. 12) which will be pushed downwards, causing in turn a contrast between the diaphragm and the tube, resulting in the self-aspiration.

Disc/vial holder cylinder (one-piece instrument)
Pic. 10


Pic. 11

               Disc pulled upwards            Disc lowered on the 
                                                          tubular vial
Pic. 12

Finally, in the standard self-aspirating syringe is the plunger that, by pressing on the rubber plunger of the tubular vial, activates the self-aspirating mechanism; in the disk syringe the self-aspiration can also be activated by the disk that, being integral with the vial holder cylinder, presses on the glass edge of the tubular vial (so not on the rubber plunger of the tubular vial) thus pushing and activating the self-aspiration.


venerdì 18 luglio 2014

COME VEDERE TUTTI I DISPOSITIVI MEDICI, FABBRICANTI E MANDATARI REGISTRATI AL MINISTERO DELLA SALUTE

Luca Martinelli
Come vedere tutti i dispositivi medici, fabbricanti e mandatari registrati al Ministero della salute

Molto spesso ci troviamo in difficoltà nell’individuare un dispositivo medico, in particolar modo individuarne il suo numero progressivo di registrazione presso la banca dati del Ministero, il numero di CND (Classificazione Nazionale Dispositivi medici) e per coloro che hanno eseguito la registrazione volontaria al RDM (Repertorio dispositivimedici) il numero dì RDM, a volte serve anche individuarne la classe di rischio di appartenenza.

Per ottenere tutti questi dati non è necessario rivolgersi esclusivamente al fabbricante, che spesso per un infinità di ragioni non è in grado di fornire in tempo reale le informazioni, basta infatti collegarsi al sito del Ministero della Salute e verificare on line tutte le informazioni relative al dispositivo di interesse.

Un data base ad hoc, con aggiornamento settimanale, permette infatti di fare una ricerca per fabbricante/assemblatore, per Mandatario, per dispositivo medico/assemblato.

In pratica si possono ottenere, in quanto atti pubblici, tutte le informazioni relative ad un preciso dispositivo medico di un preciso fabbricante, si noti per altro che da un punto di vista legale sono proprio questi dati a fare fede e non tanto i dati dichiarati, magari errati in buona fede, dal fabbricante.

Questo strumento permette quindi di identificare il dispositivo anche in assenza di informazioni del fabbricante e di verificare se per caso ci siano discrepanze fra le dichiarazioni del fabbricante e i dati che invece egli ha registrato al Ministero della Salute.

Oltre a questa possibilità il Ministero mette a disposizione, in un open data, un file anch’esso aggiornato settimanalmente (dataset), scaricabile e fruibile su excel, e quindi gestibile con tutte le possibilità che offre excel, di tutti i fabbricanti e dispositivi medici registrati presso il ministero italiano.


Di seguito i link per verificare dispositivi, fabbricanti e mandatari.


venerdì 4 luglio 2014

martedì 1 luglio 2014

Little Glossary of European Medical Devices Directive

Accessory
means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;

Active implantable medical device
means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

Active medical device
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device.

Authorised representative
means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;

Clinical data
means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:
— clinical investigation(s) of the device concerned; or
— clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
— published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;

Custom-made device
means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.
Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

Device intended for clinical
investigation’ means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.
For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

Device subcategory
means a set of devices having common areas of intended use or common technology;

Generic device group
means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

In vitro diagnostic medical device
means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients,
or
— to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

 Intended purpose
means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials;

 Manufacturer
means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already
  
Medical device
means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or  metabolic means, but which may be assisted in its function by such means;

Notified Bodies (also called Designated Bodies in the Community directives and decrees transposing) 
are public or private, authorized by the competent authorities of each Member State to carry out, at the request of companies manufacturers, conformity assessment procedures and certification of medical devices provided by law in the field of medical devices.
The list of organizations authorized by the several States shall be notified to the European Commission and the other Member States of the European Union and published in a special Community Register.

Placing on the market
means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

Putting into service
means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose;

Single use device
means a device intended to be used once only for a single patient.