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Fulltext The application study of harmonization code in medical device adverse event reporting

Choi SJ, Choi S, Park S, Nam KC, Jang HJ, Kim JK, et al.

BMC Health Serv Res, 2024 Nov 14;24(1):1402.
PMID: 39543640 DOI: 10.1186/s12913-024-11885-1

BACKGROUND: The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events.
METHODS: An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.
RESULTS: All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders.
CONCLUSIONS: We identified the diversification in terminology and code selection for reporting MDAEs.

Matched MeSH terms: Equipment and Supplies/adverse effects
Fulltext Streptomyces sp.-A Treasure Trove of Weapons to Combat Methicillin-Resistant Staphylococcus aureus Biofilm Associated with Biomedical Devices

Pusparajah P, Letchumanan V, Law JW, Ab Mutalib NS, Ong YS, Goh BH, et al.

Int J Mol Sci, 2021 Aug 28;22(17).
PMID: 34502269 DOI: 10.3390/ijms22179360

Biofilms formed by methicillin-resistant S. aureus (MRSA) are among the most frequent causes of biomedical device-related infection, which are difficult to treat and are often persistent and recurrent. Thus, new and effective antibiofilm agents are urgently needed. In this article, we review the most relevant literature of the recent years reporting on promising anti-MRSA biofilm agents derived from the genus Streptomyces bacteria, and discuss the potential contribution of these newly reported antibiofilm compounds to the current strategies in preventing biofilm formation and eradicating pre-existing biofilms of the clinically important pathogen MRSA. Many efforts are evidenced to address biofilm-related infections, and some novel strategies have been developed and demonstrated encouraging results in preclinical studies. Nevertheless, more in vivo studies with appropriate biofilm models and well-designed multicenter clinical trials are needed to assess the prospects of these strategies.

Matched MeSH terms: Equipment and Supplies/adverse effects*

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