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[Asian Harmonization Working Party (AHWP) report]

Takahashi S

Nihon Hoshasen Gijutsu Gakkai Zasshi, 2014 Apr;70(4):416-7.
PMID: 24759223
Matched MeSH terms: Equipment and Supplies/standards*
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/standards
Fulltext Prebiopsy localisation of impalpable breast lesions

Hisham AN, Harjit K, Fatimah O, Yun SI

Med J Malaysia, 2004 Aug;59(3):402-5.
PMID: 15727388

Prebiopsy localization of impalpable breast lesions (IBL) assures removal of suspicious mammographically detected lesions. Specimen radiograph of the excised specimen is mandatory to confirm complete excision. The aim of this study was to audit our series of percutaneous hookwire localization and to determine the positive biopsy rate of the mammographically detected impalpable breast lesion in our center. Thirty-eight patients with suspicious IBL underwent excision biopsy under mammographic localization in our unit from late February 1998 to May 2003. The excised specimen is immobilized and compressed within the Transpec device. This device incorporates a reference grid visible in the specimen radiograph. Hence, the target lesion marked in the reference grid of the specimen radiograph will allow precise examination and exact localization of the suspicious lesion by the pathologist. The positive biopsy rate for malignant lesion was 26.3%, the majority fall in the range of 40-59 age group. Thirty-two (84.2%) of the patients had clustered micro-calcifications, 4 (10.5%) had impalpable mass lesions and in 2 (5.3%) spiculated lesions were seen on the preoperative mammogram. Mammographic feature of clustered micro-calcification accounts for all the malignant lesions in our series. Utilization of Transpec device has shown to be practical, reliable and cost effective in the management of IBL. Nonetheless, it should be emphasized that optimal specimen radiography and pathological correlation requires close cooperation between radiologist, surgeon and pathologist.

Matched MeSH terms: Equipment and Supplies/standards*
The fundamentals of tissue engineering: new scaffolds

Di Silvio L, Gurav N, Sambrook R

Med J Malaysia, 2004 May;59 Suppl B:89-90.
PMID: 15468832

The ability to regenerate new bone for skeletal use is a major clinical need. In this study, two novel porous calcium phosphate materials pure HA and biphasic HA/beta-Tricalcium phosphate (HA/beta -TCP) were evaluated as potential scaffolds for cell-seeded bone substitutes using human osteoblast-like cells (HOS) and primary human mesenchymal stem cells (hMSCs). A high rate of proliferation was observed on both scaffolds. A greater increase in alkaline phosphatase (ALP- an indicator of osteoblast differentiation) was observed on HA/beta -TCP compared to HA. This observation indicates that HA/TCP may play a role in inducing osteoblastic differentiation. Although further evaluation is required both materials show potential as innovative synthetic substitutes for tissue engineered scaffolds.

Matched MeSH terms: Equipment and Supplies/standards
Testing the agreement of medical instruments: overestimation of bias in the Bland-Altman analysis

Zaki R, Bulgiba A, Ismail NA

Prev Med, 2013;57 Suppl:S80-2.
PMID: 23313586 DOI: 10.1016/j.ypmed.2013.01.003

The Bland-Altman method is the most popular method used to assess the agreement of medical instruments. The main concern about this method is the presence of proportional bias. The slope of the regression line fitted to the Bland-Altman plot should be tested to exclude proportional bias. The aim of this study was to determine whether the overestimation of bias in the Bland-Altman analysis is still present even when the proportional bias has been excluded.

Matched MeSH terms: Equipment and Supplies/standards*