A Modular Approach to Combine Postmarket Clinical Follow-Up Studies and Postmarket Surveillance Studies

2021 ◽  
Author(s):  
Andreas Ziegler ◽  
Kristin Forßmann ◽  
Sabine Konopka ◽  
Katja Krockenberger
Keyword(s):  
Medical Devices ◽  
Clinical Investigation ◽  
Good Clinical Practice ◽  
Modular Approach ◽  
Legal Requirements ◽  
Surveillance Studies ◽  
Modular Concept ◽  
Follow Up Studies ◽  
Medical Device Regulation

Abstract Background The European Medical Device Regulation 2017/745 (MDR) has its date of application in May 2021. This new legislation has refined and expanded the need of manufacturers to have a postmarket surveillance (PMS) system. According to this legislation, a postmarket clinical follow-up (PMCF) plan is also required. Manufacturers of high-risk medical devices are obliged to conduct both PMCF and PMS studies. There is thus the need to generate evidence from clinical data. Objectives The conduct of several studies for PMS and PMCF can be cumbersome. We therefore aim to present a modular approach to combine PMS and PMCF studies into a single study. Materials and Methods We extracted the topics listed in the MDR, especially Annex XV, Section 3, the Good Clinical Practice for medical devices (EN 14155:2020, Annex A). In addition, we added topics according to the SPIRIT and the SPIRIT-PRO statement and created a draft clinical investigation plan (CIP). Results The CIP template is provided as part of the manuscript. The modular concept has passed the required regulatory and legal requirements for one specific study. Conclusion A modular approach for combining PMCF and PMS studies in a single CIP has been developed and implemented, and it is ready for use. The provided CIP template should enable other researchers and groups to adopt this concept according to their needs.

A UK medical devices regulator’s perspective on registries

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
John Wilkinson ◽  
Andy Crosbie
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Sources Of Information ◽  
Implantable Medical Devices ◽  
Post Market ◽  
Adverse Incident ◽  
And Performance ◽  
The Uk ◽  
Medical Device Regulation

AbstractRegistries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer’s individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator – the Medicines and Healthcare Products Regulatory Agency (MHRA) – of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

What graduate follow-up studies can tell us

2000 ◽  
Vol 34 (12) ◽  
pp. 976-977 ◽  
Author(s):  
Linda H Distlehorst
Keyword(s):  
Follow Up Studies

Beurteilung der Adriamycin-Kardiotoxizität mittels der Äquilibrium-Radionuklid-Ventrikulographie

1987 ◽  
Vol 26 (05) ◽  
pp. 206-211 ◽  
Author(s):  
P. Knesewitsch ◽  
N. H. Göldel ◽  
S. Fritsch ◽  
E. Moser
Keyword(s):  
Left Ventricular ◽  
Peak Filling Rate ◽  
Base System ◽  
Filling Rate ◽  
Time To Peak ◽  
Ejection Rate ◽  
Follow Up Studies ◽  
Pathologic Findings ◽  
Peak Ejection Rate

Results of 606 equilibrium radionuclide ventriculographies (ERNV) performed in 348 non-selected patients receiving Adriamycin (ADM) therapy were stored in a data base system. The aim of the study was to assess the influence of a potential cardiotoxic therapy on left ventricular pump function. Increasing ADM doses yielded a significant (p <0.05) decrease of the resting ejection fraction (R-gEF), the peak ejection rate and the peak filling rate. Enddiastolic and endsystolic volumes increased significantly. Stroke volume, heart rate and time to peak filling rate did not change significantly. 368 follow-up studies were performed in 128 patients: 65/128 patients presented a decrease of R-gEF, but only in 45 of these patients R-gEF values fell into the pathologic range. In 44 of these follow-ups, R-gEF remained unchanged. In 19 patients, a R-gEF increase was observed. At the beginning of ADM therapy 14% of the patients had subnormal R-gEF values. With increasing ADM doses pathologic findings increased to 86% in patients with ADM doses higher than 500 mg/m2.

Synthesis and Biological Evaluation of the Antimicrobial Natural Product Lipoxazolidinone A

2018 ◽  
Author(s):  
Jonathan J. Mills ◽  
Kaylib R. Robinson ◽  
Troy E. Zehnder ◽  
Joshua G. Pierce
Keyword(s):  
Natural Products ◽  
Natural Product ◽  
Mechanism Of Action ◽  
Marine Natural Products ◽  
Biological Evaluation ◽  
Lead Compounds ◽  
Follow Up Studies ◽  
Initial Resistance ◽  
Synthesis And Biological Evaluation

The lipoxazolidinone family of marine natural products, with an unusual 4-oxazolidinone heterocycle at their core, represents a new scaffold for antimicrobial discovery; however, questions regarding their mechanism of action and high lipophilicity have likely slowed follow-up studies. Herein, we report the first synthesis of lipoxazolidinone A, 15 structural analogs to explore its active pharmacophore, and initial resistance and mechanism of action studies. These results suggest that 4-oxazolidinones are valuable scaffolds for antimicrobial development and reveal simplified lead compounds for further optimization.

Stereotactic radiation treatment planning and follow-up studies involving fused multimodality imaging

2004 ◽  
Vol 101 (Supplement3) ◽  
pp. 326-333 ◽  
Author(s):  
Klaus D. Hamm ◽  
Gunnar Surber ◽  
Michael Schmücking ◽  
Reinhard E. Wurm ◽  
Rene Aschenbach ◽  
...  
Keyword(s):  
Image Fusion ◽  
Treatment Planning ◽  
Radiation Treatment ◽  
Data Sets ◽  
Slice Thickness ◽  
Radiation Treatment Planning ◽  
Content Type ◽  
Follow Up Studies ◽  
Fine Print

Object. Innovative new software solutions may enable image fusion to produce the desired data superposition for precise target definition and follow-up studies in radiosurgery/stereotactic radiotherapy in patients with intracranial lesions. The aim is to integrate the anatomical and functional information completely into the radiation treatment planning and to achieve an exact comparison for follow-up examinations. Special conditions and advantages of BrainLAB's fully automatic image fusion system are evaluated and described for this purpose. Methods. In 458 patients, the radiation treatment planning and some follow-up studies were performed using an automatic image fusion technique involving the use of different imaging modalities. Each fusion was visually checked and corrected as necessary. The computerized tomography (CT) scans for radiation treatment planning (slice thickness 1.25 mm), as well as stereotactic angiography for arteriovenous malformations, were acquired using head fixation with stereotactic arc or, in the case of stereotactic radiotherapy, with a relocatable stereotactic mask. Different magnetic resonance (MR) imaging sequences (T1, T2, and fluid-attenuated inversion-recovery images) and positron emission tomography (PET) scans were obtained without head fixation. Fusion results and the effects on radiation treatment planning and follow-up studies were analyzed. The precision level of the results of the automatic fusion depended primarily on the image quality, especially the slice thickness and the field homogeneity when using MR images, as well as on patient movement during data acquisition. Fully automated image fusion of different MR, CT, and PET studies was performed for each patient. Only in a few cases was it necessary to correct the fusion manually after visual evaluation. These corrections were minor and did not materially affect treatment planning. High-quality fusion of thin slices of a region of interest with a complete head data set could be performed easily. The target volume for radiation treatment planning could be accurately delineated using multimodal information provided by CT, MR, angiography, and PET studies. The fusion of follow-up image data sets yielded results that could be successfully compared and quantitatively evaluated. Conclusions. Depending on the quality of the originally acquired image, automated image fusion can be a very valuable tool, allowing for fast (∼ 1–2 minute) and precise fusion of all relevant data sets. Fused multimodality imaging improves the target volume definition for radiation treatment planning. High-quality follow-up image data sets should be acquired for image fusion to provide exactly comparable slices and volumetric results that will contribute to quality contol.

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