Detailed order process custom implant

Transcription

1 Detailed order process custom implant GS-157 A-V / 04

2 Consultation and data acquisition The surgeon makes the diagnosis and performs a chest scan (CT scan) on the patient On the back, arms along the body, CT scan of the entire thorax 1 to 2 mm thick DICOM standard format cuts Medical tomography, with a CT or Mediastinal filter to achieve good contrast. YES! NO! Sending patient data and the prescription The surgeon sends the scan CD as well as the prescription by mail to the sales administration department of Groupe Sebbin (to the attention of Ouiza Seba, 39 Parc d'activités des Quatre Vents Boissy l'aillerie - France). The prescription contains the following information: The prescriber's identification and contact information Date of the prescription Patient identification: name, sex, city of the patient concerned or identifying code given by the prescriber for traceability of the implant o Identifying code in the format AABBjjmmaaCC size (AA = 2 first letters of the patient's last name; BB = 2 first letters of the patient's first name; ddmmyy size = date of the prescription; CC = first 2 letters of the prescriber). Any technical particularities Sentence to write: "This custom-made medical device is intended for the patient, subject of this prescription ". Checking the scan data quality After data exchange between Groupe Sebbin and, the quality of the data sent and the project feasibility are validated. This validation triggers sending a quote by Groupe Sebbin. 1

3 Quote and opening the file The sales administration department of Groupe Sebbin : Formulates a quote to be signed by the surgeon with 50% deposit (hospital draft a purchase order) Sends the prescription and the descriptive sheet of the custom implant to the quality department of Groupe Sebbin that will open a dossier, Reminder: a custom device cannot have the CE marked as it is intended for a unique patient. However, it complies with the requirements of Directive 93/42 / EEC concerning medical devices On receipt of the signed quote and 50% down payment or the hospital's purchase order, The implant design process begins. 3D design of the implant and sending of specifications launches the 3D implant design sends a PDF file "3D_implant specifications" by to the surgeon including: o Implant characteristics: 3D images, size, volume, thickness... views with or without the implant, from the side, front and below, with hard and soft tissues... o Advice on the installation of the implant and points to note (and in addition, a video of the surgery) o At the end of the document, an approval form of the implant design If change requests are issued, a new specification document will be sent by the surgeon to for approval Validation of the implant design On receipt of the document "3D_implant specifications," the surgeon must: Study this document with the utmost attention to ensure that the design of the implant corresponds to the expectations If necessary, ask to make changes Return by to the final approval page signed () with a copy to the sales administration of Groupe Sebbin (serviceclients@laboratoires-sebbin.fr ). This will launch the production of the prototype. 2

4 Manufacture of the prototype Once the design of the implant is approved, launches production of a model in stereolithography (prototype). This prototype is sent to Sebbin Group to manufacture the customised silicone implant. It will also serve to perform the preoperative drawing before surgery. Patient name (coded), a directional arrow indicating the direction of the implant, measurement of the inter-clavicular distance to the distal apex and a central line (pectus) are indicated on the implant. Manufacture, sterilisation, delivery of the implant Upon receipt of the prototype, Groupe Sebbin prosthetist manufactures the mould and then the implant will be sterilised. This device has at this stage a specific sterilisation certificate. Upon receipt of the sterile implant, the quality department completes formating with the suitable documents and establishes the EC declaration of conformity (available on request). The device is ready to be delivered. The sales administration department delivers the sterile implant with its non-sterile prototype. Advice With over 10 years of collaboration with Toulouse University Hospital to develop these custom implants and optimise the surgical technique (over 400 cases), delivers to the surgeon guidance to place the implants in the document "3D_implant specifications" is available to surgeons for any matter relating to product design, surgical technique,and questions related to a particular case: 3

5 In summary: Approximately two months are required to receive the implant and the prototype, from the receipt of the signed quote and the deposit, subject to the validation of the prototype on time. Consultation / scan Send patient data / scan (CD) + prescription to Sebbin Data validation and feasibility Send the quote to the surgeon W W+1 W+2 W+3 W+4 W+5 W+7 W+8 Return the signed quote to Sebbin Start the CAD design, send the specifications to the surgeon Send the validation to Manufacture the prototype Manufacture the mould Manufacture by silicone injection / packaging of the implant Sterilise the implant Receive the prototype of the implant at the hospital Surgery Surgeon Sebbin 4