Displaying all 2 publications

Abstract:
Sort:
  1. 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 Safety/standards
  2. Fulltext Safety of thoracic pedicle screw application using the funnel technique in Asians: a cadaveric evaluation
    Chan CY, Kwan MK, Saw LB
    Eur Spine J, 2010 Jan;19(1):78-84.
    PMID: 19763636 DOI: 10.1007/s00586-009-1157-8
    The objective of this cadaveric study is to determine the safety and outcome of thoracic pedicle screw placement in Asians using the funnel technique. Pedicle screws have superior biomechanical as well as clinical data when compared to other methods of instrumentation. However, misplacement in the thoracic spine can result in major neurological implications. There is great variability of the thoracic pedicle morphometry between the Western and the Asian population. The feasibility of thoracic pedicle screw insertion in Asians has not been fully elucidated yet. A pre-insertion radiograph was performed and surgeons were blinded to the morphometry of the thoracic pedicles. 240 pedicle screws were inserted in ten Asian cadavers from T1 to T12 using the funnel technique. 5.0 mm screws were used from T1 to T6 while 6.0 mm screws were used from T7 to T12. Perforations were detected by direct visualization via a wide laminectomy. The narrowest pedicles are found between T3 and T6. T5 pedicle width is smallest measuring 4.1 +/- 1.3 mm. There were 24 (10.0%) Grade 1 perforations and only 1 (0.4%) Grade 2 perforation. Grade 2 or worse perforation is considered significant perforation which would threaten the neural structures. There were twice as many lateral and inferior perforations compared to medial perforations. 48.0% of the perforations occurred at T1, T2 and T3 pedicles. Pedicle fracture occurred in 10.4% of pedicles. Intra-operatively, the absence of funnel was found in 24.5% of pedicles. In conclusion, thoracic pedicle screws using 5.0 mm at T1-T6 and 6.0 mm at T7-T12 can be inserted safely in Asian cadavers using the funnel technique despite having smaller thoracic pedicle morphometry.
    Matched MeSH terms: Equipment Safety/standards
Related Terms
    Try searching for something
Filters
Contact Us

Please provide feedback to Administrator (afdal@afpm.org.my)

External Links