NDLI: Materials vigilance and traceability.

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Surgical technique and indications of the induced membrane procedure in children.

Pathological fractures in children: Diagnosis and treatment options.

L5S1 spondylolisthesis in children and adolescents.

Brachial plexus birth palsy: Management during the first year of life.

High-energy injuries of the wrist.

Radial head replacement in adults with recent fractures.

Extensor tendon ruptures after total knee arthroplasty.

Surgical reconstruction of the medial patellofemoral ligament.

Amputation and prosthesis fitting in paediatric patients.

Lower limb length and offset in total hip arthroplasty.

Arthroscopic tibiotalar and subtalar joint arthrodesis.

Degenerative disease supra- and infra-jacent to fused lumbar and lumbo-sacral levels.

Partial tears of the anterior cruciate ligament.

Removal of well-fixed fixed femoral stems.

New modalities of pain treatment after outpatient orthopaedic surgery.

Osteosynthesis in sacral fracture and lumbosacral dislocation.

Materials vigilance and traceability.

Patient information in orthopedic and trauma surgery. Fundamental knowledge, legal aspects and practical recommendations.

Patient-specific risk factors for infection in arthroplasty procedure.

Complications and revision of reverse total shoulder arthroplasty.

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Materials vigilance and traceability.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Tracol, P.
Description	Author Affiliation: Tracol P ( Centre chirurgical Saint-Roch, BP 65, 84302 Cavaillon cedex, France. Electronic address: phtracol@orange.fr.)
Abstract	Patient safety requires speedy detection of any medical device malfunction; this is known as 'materials vigilance'. It entails the need to be able to trace back the life-long pathway of a device; this is 'traceability'. European regulations enact free circulation of medical devices throughout the European Union, with each member state being responsible for safety within its own territory. Medical devices are divided into 3 categories of increasing risk. CE marking mandatory for medical devices distributed within the EU, and count as market authorizations. They are delivered with 5-year validity by what is known as a 'notified body'. Health authorities are responsible for monitoring the market and any incidents. New regulations are presently being drawn up to improve efficiency and transparency. Materials vigilance is founded on mandatory declaration of medical device incidents. At local level, it comprises local reporters responsible for informing the National Health Products Safety Agency (Agence nationale de sécurité du médicament et des produits de santé [ANSM]) of any incidents and taking all necessary precautions. At national level, the ANSM assesses the safety, efficacy and quality of healthcare products; it centralizes and assesses materials vigilance reports and takes the requisite decisions. Materials vigilance is further organized at the European and international levels, to harmonize legislation regarding medical devices. Traceability is intended to rapidly identify medical device bearers in case of product recall. Each center is to organize the traceability of its devices; manufacturers' obligation of traceability ceases with the healthcare establishment or user. CE marking involves strict labeling rules to ensure safety of use. A change in the organization of traceability is presently underway, in the form of international Unique Device Identifiers, with harmonized label data, barcodes and standardized terminology. A European and later international database will be set up. The objective is to make Unique Device Identifiers mandatory within the EU by 2017.
File Format	HTM / HTML
Issue Number	1 Suppl
Volume Number	102
e-ISSN	18770568
Journal	Orthopaedics & Traumatology: Surgery & Research
Language	English
Publisher	Elsevier
Publisher Date	2016-02-01
Publisher Place	France
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Orthopedics Discipline General Surgery Discipline Traumatology Equipment Failure European Union Patient Safety Product Labeling Standards Prostheses And Implants Equipment And Supplies Classification Humans Reference Standards Journal Article Review
Content Type	Text
Resource Type	Article

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Eye hazards of laser 'pointers' in perspective.

Medical device specificities: opportunities for a dedicated product development methodology.

Prosthesis replacement in Mason III radial head fractures: A meta-analysis.

Cost effectiveness.

Device regulation in the European Union: response from MHRA.

Radial head replacement in adults with recent fractures.

Patient information in orthopedic and trauma surgery. Fundamental knowledge, legal aspects and practical recommendations.

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

Wrist osteoarthritis.

Materials vigilance and traceability.

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Cost effectiveness.

Device regulation in the European Union: response from MHRA.

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