Descriptive analysis of postmarket surveillance data for hip implants

Pane, Josep; Verhamme, Katia; Rebollo, Irene; Sturkenboom, Miriam

doi:10.1002/pds.4971

Cited by 4 publications

(8 citation statements)

References 7 publications

(6 reference statements)

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“…The identification of the root cause of the adverse event is crucial for a robust PMS system. In order to identify the root cause, the evaluation of the medical device sample is key to isolate the failure mode associated with the event, and is often lacking [4].…”

Section: Medical Device Traceabilitymentioning

confidence: 99%

“…To execute regulatory actions related to safety, it is required to quickly identify the location of all the medical devices in the market, which requires a Unique Device Identifier (UDI) [4].…”

Section: Regulatory Actionsmentioning

confidence: 99%

“…The data collection cover large populations and their processing is centralized normally in a repository or database where they are available for assessment [15,16,17,18,19]. Nevertheless, SRS suffer from different limitations including: lack of harmonized global standard data set for reporting which makes integration of data from different databases challenging [3,20], difficulty to determine root causes for individual events conclusively due to limited information and no access to the actual device, with a large part of investigation results being inconclusive [4], missing and incomplete data that impact the evaluation of the case, underreporting and over-reporting where medical devices with well-known adverse event/product problems are more likely to be reported than other medical devices based on influence from social network, or media coverage [21]. -Medical Device Registries: A medical device registry is defined as an 'organized system with a primary aim to increase the knowledge on medical devices contributing to improve the quality of patient care that continuously collects relevant data, evaluates meaningful outcomes and comprehensively covers the population defined by exposure to particular device(s) at a reasonably generalizable scale (e.g.…”

Section: Standardizationmentioning

confidence: 99%

“…The global adoption of UDI [4], and blockchain technology could improve the efficiency of the regulatory action coordination process by tracking all the medical devices that are on the market to ensure fast and efficient removal from the market. Through its ability to track all transactions, blockchain technology is able to monitor every stage of the medical device supply chain.…”

Section: Regulatory Actions and Counterfeitmentioning

confidence: 99%

“…This has led many of the stakeholders involved in the process of safety evaluation of medical devices to explore solutions to address some of the challenges associated with this changing regulatory environment. Furthermore, they understand the need to respond to some of the gaps associated with this process [3,4]. As in any other field of the medical device industry, the stakeholders have started working on artificial intelligence (AI) solutions that could help change the current reactive medical device PMS system.…”

Section: Introductionmentioning

confidence: 99%

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Blockchain technology applications to postmarket surveillance of medical devices

Pane

Verhamme

Shrum³

et al. 2020

Expert Review of Medical Devices

Self Cite

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Introduction: The amount of mandatory data that needs to be analyzed as part of a medical device postmarket surveillance (PMS) system has grown exponentially in recent times. This is a consequence of increasingly demanding and complex regulatory requirements from Health Authorities, aimed at a better understanding of the medical device safety evaluation. Proactive approaches to PMS processes are becoming more necessary as regulators increase the scrutiny of device safety. New technologies have been explored to address some of the challenges associated with this changing regulatory environment. Areas covered: This paper focuses on the different technical aspects of blockchain and how this new technology has the potential to support the ongoing efforts to improve the PMS system for medical devices. Expert opinion: To address these challenges, we suggest to generate a private PMS data permissioned blockchain with a proof-of-authority consensus mechanism, to which only a restricted number of designated and audited participants have authorization to validate transactions and add them to the PMS data blockchain ledger. Blockchain has the potential to support a more efficient approach, which could offer many advantages to the different stakeholders involved in the PMS process, such as supporting with new regulatory initiatives.

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Section: Medical Device Traceabilitymentioning

confidence: 99%

Section: Regulatory Actionsmentioning

confidence: 99%

Section: Standardizationmentioning

confidence: 99%

Section: Regulatory Actions and Counterfeitmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Blockchain technology applications to postmarket surveillance of medical devices

Pane

Verhamme

Shrum³

et al. 2020

Expert Review of Medical Devices

Self Cite

View full text Add to dashboard Cite

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Bioactivation of New Harmonic Titanium Alloy to Improve and Control Cellular Response and Differentiation

Rangel

Lam

Hocini

et al. 2023

IRBM

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Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

Li,

Feng,

Gong

et al. 2024

J Patient Saf

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Objective This article aims to assess the reproducibility of Manufacturer and User Facility Device Experience (MAUDE) data-driven studies by analyzing the data queries used in their research processes. Methods Studies using MAUDE data were sourced from PubMed by searching for “MAUDE” or “Manufacturer and User Facility Device Experience” in titles or abstracts. We manually chose articles with executable queries. The reproducibility of each query was assessed by replicating it in the MAUDE Application Programming Interface. The reproducibility of a query is determined by a reproducibility coefficient that ranges from 0.95 to 1.05. This coefficient is calculated by comparing the number of medical device reports (MDRs) returned by the reproduced queries to the number of reported MDRs in the original studies. We also computed the reproducibility ratio, which is the fraction of reproducible queries in subgroups divided by the query complexity, the device category, and the presence of a data processing flow. Results As of August 8, 2022, we identified 523 articles from which 336 contained queries, and 60 of these were executable. Among these, 14 queries were reproducible. Queries using a single field like product code, product class, or brand name showed higher reproducibility (50%, 33.3%, 31.3%) compared with other fields (8.3%, P = 0.037). Single-category device queries exhibited a higher reproducibility ratio than multicategory ones, but without statistical significance (27.1% versus 8.3%, P = 0.321). Studies including a data processing flow had a higher reproducibility ratio than those without, although this difference was not statistically significant (42.9% versus 17.4%, P = 0.107). Conclusions Our findings indicate that the reproducibility of queries in MAUDE data-driven studies is limited. Enhancing this requires the development of more effective MAUDE data query strategies and improved application programming interfaces.

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Descriptive analysis of postmarket surveillance data for hip implants

Cited by 4 publications

References 7 publications

Blockchain technology applications to postmarket surveillance of medical devices

Blockchain technology applications to postmarket surveillance of medical devices

Bioactivation of New Harmonic Titanium Alloy to Improve and Control Cellular Response and Differentiation

Assessing the Reproducibility of Research Based on the Food and Drug Administration Manufacturer and User Facility Device Experience Data

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