Acoustic outputs from clinical extracorporeal shock wave lithotripsy devices

Jong Min Kim; Oh Bin Kwon; Jin Sik Cho; Sung Joung Jeon; Ki Il Nam; Sung Yong Cho; Min Joo Choi

doi:10.7776/ASK.2023.42.5.469

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2023 Vol.42, Issue 5 Preview Page

Research Article

Acoustic outputs from clinical extracorporeal shock wave lithotripsy devices 임상에서 사용중인 체외충격파쇄석기의 음향 출력 분포

30 September 2023. pp. 469-490

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Abstract

Survey was carried out on the acoustic outputs from 12 shock wave fields produced by the 10 extracorporeal shock wave lithotriptors whose technical documents are available, among the 33 devices approved by the Ministry of Food & Drug Safety (MFDS).The results show that the acoustic outputs (P+, P-, efd, and E), critical to the therapeutic efficacy and the patient safety, are largely different between the devices. The maximum values of P+, P-, efd, and E vary up to 2.08, 3.72, 3.89, and 15.98 times, respectively. The acoustic output parameters are not thoroughly provided in the technical documents, and some of data (eg. efd) are suspected to be abnormal outside usual ranges. The large device to device differences in the shock wave outputs are likely to undermine equivalence between the ESWL devices approved for the same indication. To verify the reliability of the data in the technical documents of the approved devices and to confirm if the acoustic outputs from the devices in clinical use are the same as those in their technical documents, an authorized test laboratory should be available. A postapproval monitoring led by the regulatory agency is suggested to maintain the acoustic outputs from the ESWL devices that suffer from degrading in performance due to aging.

Keywords

Extracorporeal Shock Wave Lithotripsy (ESWL)

Focusing

Acoustic output

Technical documents

Equivalence

식약처에서 허가된 33개 체외 충격파 쇄석기 중 기술 문서가 공개된 10개(12개의 충격파 음장)에 대해 치료 효과 및 안전을 좌우하는 충격파의 음향 출력 분포를 조사했다. 조사 결과 핵심 충격파 음향 출력(P+, P-, efd, E)의 최대값은 제품별로(각각 최대 2.08배, 3.72배, 3.89배, 15.98배) 크게 차이가 나고 있다. 음향 출력 변수들의 값은 기술 문서에 충실하게 포함되지 않고 있으며, 일부 데이터는(예. efd) 통상적인 범위를 벗어나는 비정상적인 값을 가지는 것으로 나타났다. 제품 별로 큰 차이를 보이는 충격파 음향 출력은 동일한 적응증으로 허가 받은 ESWL 장비의 동등성을 훼손할 가능성이 높다는 것을 시사한다. 허가된 Extracorporeal Shock Wave Lithotripsy(ESWL) 제품의 기술 문서에 기재된 자료의 신뢰성을 검증하고, 임상에서 사용되는 제품의 성능이 기술 문서와 동일한지 확인하기 위해 공인된 시험 검사 기관의 확보가 필요하며, 노화로 인해 충격파 출력이 저하되는 ESWL 제품의 성능 유지 및 관리를 위한 규제 기관 주도의 사후 관리가 제안된다.

키워드

체외충격파쇄석술

집속

충격파 음향 출력

기술 문서

동등성

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Information

Publisher :The Acoustical Society of Korea
Publisher(Ko) :한국음향학회
Journal Title :The Journal of the Acoustical Society of Korea
Journal Title(Ko) :한국음향학회지
Volume : 42
No :5
Pages :469-490
Received Date : 2023-09-13
Accepted Date : 2023-09-18
DOI :https://doi.org/10.7776/ASK.2023.42.5.469

The Journal of the Acoustical Society of KoreaISSN:1225-4428(Print) 2287-3775(Online)한국음향학회

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