scholarly journals Orthopaedic device manufacturers’ perspective on MDR compliance

ABOUTOPEN ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. 34
Author(s):  
Peter Fennema ◽  
Hassan Achakri
Keyword(s):  
Orthopaedic Device

scholarly journals Molecular diagnosis of orthopaedic device infection direct from sonication fluid by metagenomic sequencing

2017 ◽  
Author(s):  
Teresa L. Street ◽  
Nicholas D. Sanderson ◽  
Bridget L. Atkins ◽  
Andrew J. Brent ◽  
Kevin Cole ◽  
...  
Keyword(s):  
Diagnostic Information ◽  
Species Level ◽  
Metagenomic Sequencing ◽  
Tissue Samples ◽  
Bacterial Dna ◽  
Dna Contamination ◽  
Prosthetic Joint ◽  
Device Infection ◽  
Fluid Culture ◽  
Orthopaedic Device

AbstractCulture of multiple periprosthetic tissue samples is the current gold-standard for microbiological diagnosis of prosthetic joint infections (PJI). Additional diagnostic information may be obtained through sonication fluid culture of explants. However, current techniques can have relatively low sensitivity, with prior antimicrobial therapy and infection by fastidious organisms influencing results. We assessed if metagenomic sequencing of complete bacterial DNA extracts obtained direct from sonication fluid can provide an alternative rapid and sensitive tool for diagnosis of PJI.We compared metagenomic sequencing with standard aerobic and anaerobic culture in 97 sonication fluid samples from prosthetic joint and other orthopaedic device infections. Reads from Illumina MiSeq sequencing were taxonomically classified using Kraken. Using 50 samples (derivation set), we determined optimal thresholds for the number and proportion of bacterial reads required to identify an infection and validated our findings in 47 independent samples.Compared to sonication fluid culture, the species-level sensitivity of metagenomic sequencing was 61/69(88%,95%CI 77-94%) (derivation samples 35/38[92%,79-98%]; validation 26/31[84%,66-95%]), and genus-level sensitivity was 64/69(93%,84-98%). Species-level specificity, adjusting for plausible fastidious causes of infection, species found in concurrently obtained tissue samples, and prior antibiotics, was 85/97(88%,79-93%) (derivation 43/50[86%,73-94%], validation 42/47[89%,77-96%]). High levels of human DNA contamination were seen despite use of laboratory methods to remove it. Rigorous laboratory good practice was required to prevent bacterial DNA contamination.We demonstrate metagenomic sequencing can provide accurate diagnostic information in PJI. Our findings combined with increasing availability of portable, random-access sequencing technology offers the potential to translate metagenomic sequencing into a rapid diagnostic tool in PJI.

scholarly journals Orthopaedic device innovation in South Africa: A study of patenting activity

2021 ◽  
Vol 117 (5/6) ◽  
Author(s):  
Faatiema Salie ◽  
Kylie de Jager ◽  
Tania S. Douglas
Keyword(s):  
South Africa ◽  
Innovation System ◽  
Knowledge Development ◽  
Healthcare Sector ◽  
Small Contribution ◽  
Collaboration Networks ◽  
Research Organisations ◽  
Network Metrics ◽  
Patenting Activity ◽  
Orthopaedic Device

We assessed knowledge development and exchange among actors who patent orthopaedic devices in South Africa over the period 2000–2015. A social network analysis was performed on bibliometric data using co-inventorship on patents as an indicator of collaboration between different organisations, with a focus on the spatial and sectoral contexts. Network metrics and innovation system indices are used to describe knowledge development and exchange. The results show that university, healthcare and industry organisations have primarily been responsible for increased patenting over time. The key actors were a set of industry actors – a national actor and its US partner – who have patented many devices jointly. National universities were found to make a small contribution, and science councils were found to be absent, despite the efforts in the changing innovation landscape to encourage publicly financed research organisations to protect their intellectual property. The collaboration networks were found to be sparse and disjointed, with many actors – largely from the private healthcare sector – patenting in isolation.

Bioceramics for Orthopaedic Device Applications: Hydroxyapatite

2016 ◽  
pp. 49-77 ◽  
Author(s):  
Qiaomu Tian ◽  
Laura Rivera-Castaneda ◽  
Zachary S. Dunn ◽  
Huinan Liu
Keyword(s):  
Device Applications ◽  
Orthopaedic Device

scholarly journals Getting your devices ready for MDR compliance – a clinical approach and orthopaedic device manufacturers’ perspective

ABOUTOPEN ◽  
2019 ◽  
Vol 6 (1) ◽  
pp. 70-75
Author(s):  
Peter Fennema ◽  
Hassan Achakri
Keyword(s):  
Clinical Evaluation ◽  
Medical Devices ◽  
Market Access ◽  
Transition Period ◽  
Current Medical ◽  
Clinical Approach ◽  
The Impact ◽  
Orthopaedic Device

On 26 May 2017, the Medical Devices Regulation (MDR 2017/745) was published, with the aim of replacing the current Medical Devices Directive (MDD 93/43/EC). Following a transition period of 3 years, this regulation will be applied in full from 26 May 2020. This article describes and discusses the impact of MDR on the clinical evaluation and gives advice to manufacturers on the preparation, planning and implementation of processes to support compliance with the new regulation. (HTA & Market Access)

scholarly journals Bacteriophage therapy as a treatment strategy for orthopaedic-device-related infections: where do we stand?

2020 ◽  
Vol 39 ◽  
pp. 193-210 ◽  
Author(s):  
J Onsea ◽  
◽  
J Wagemans ◽  
JP Pirnay ◽  
M Di Luca ◽  
...  
Keyword(s):  
Treatment Strategy ◽  
Bacteriophage Therapy ◽  
Orthopaedic Device

The Influence of Surface Microgeometry on Fibroblast Colonization of Synthetic Surfaces

1991 ◽  
Vol 252 ◽  
Author(s):  
J. L. Ricci ◽  
H. Alexander ◽  
C. Howard
Keyword(s):  
Connective Tissue ◽  
Surface Chemistry ◽  
Dental Implant ◽  
Tissue Response ◽  
Mineralized Tissue ◽  
Implant Material ◽  
Surface Microgeometry ◽  
Orthopaedic Device

Tissue response to any synthetic implant—whether vascular device, dental implant, orthopaedic device, or any other implant that is in contact with soft connective tissue or mineralized tissue—has been found to correlate with the composition, surface chemistry, and surface microgeometry of the implant material.

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