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2020 Vol.39, Issue 4 Preview Page

Research Article

Inspection on the acoustic output of the focused extracorporeal focused shock wave therapeutic devices approved by MFDS

식약처에서 허가된 집속형 ESWT 치료기의 음향 출력 분석

Min Joo Choi12∗
,
Sung Joung Jeon23
,
Oh Bin Kwon2
,
Min Young Lee3
,
Jin Sik Cho4
,
Han Soo Kim4
,
Eun Ho Maeng4
최 민주12∗
,
전 성중23
,
권 오빈2
,
이 민영3
,
조 진식4
,
김 한수4
,
맹 은호4
1제주대학교 의학전문대학원 의학과
2제주대학교 의공학협동과정
3(주)에이치엔티메디칼
4한국화학융합시험연구원
∗Corresponding Author
31 July 2020. pp. 303-317
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Abstract

Extracorporeal Shock Wave Therapy (ESWT) is an innovative treatment in chronic musculoskeletal pain management and cardiovascular diseases. In this study, we surveyed the acoustic shock wave outputs from the domestically used focal type ESWT devices. The survey data were collected through 30 technical documents registered to the Ministry of Food and Drug Safety (MFDS), Rep. Korea. The results show that the focusing geometry varies largely, 5 mm to 65 mm in the focal length, 3 mm to 30 mm in focal width, and 4 mm to 108 mm in focal depth. The maximum positive pressure (P+) ranges from 7 MPa to 280 MPa, the focal Energy Flux Density (EFD) from 0.0035 mJ/mm2 to 35 mJ/mm2, and the energy per pulse (E) from 0.737 mJ to 80.86 mJ. All domestic PE-type (five) and one EM-type domestic devices included in the analysis of the correlation between P+ and EFD are shown to be far beyond the usual ranges and do not comply with expected correlation so that the reliability of their data was suspected. For the suspected, post-performance tests are required by a recognized testing agency. MFDS guidelines need to be revised so that the pass criteria for the shock wave acoustic outputs can be based on the clinical tests for indications.

Keywords
Extracorporeal Shock Wave Therapy (ESWT)
Shock wave pulse
Acoustic output
Peak pressure
Energy flux density

체외충격파치료술(Extracorporeal Shock Wave Therapy, ESWT)은 보존적인 치료가 어려운 근골격계 난치성 통증 치료 뿐 아니라 심혈관계 질환까지 적용 분야가 확대되고 있는 혁신적인 치료술이다. 본 연구에서는 국내에서 사용되는 집속형 ESWT 치료기의 성능을 결정하는 충격파 음향 출력의 분포를 조사했다. 분석에 사용된 데이터는 식약처에 등록된 30개 기술 문서를 통해 수집했다. 조사 결과, ESWT 치료기 충격파의 집속 특성은, 초점 거리가 5 mm ~ 65 mm, 초점 폭이 3 mm ~ 30 mm, 초점 깊이가 4 mm ~ 108 mm 범위에서 변화하고 있다. 충격파의 최대 양압(P+)는 7 MPa ~ 280 MPa, 초점에서 에너지 밀도 Energy Flux Density(EFD)는 0.0035 mJ/mm2 ~ 35 mJ/mm2, 펄스당 에너지(E)는 0.737 mJ ~ 80.86 mJ로 매우 넓은 범위에서 분포하고 있다. P+ 및 EFD 상관성 분석에 포함된 모든 국내산 PE 방식 제품(5개) 및 1개의 EM 방식 국산 치료기는 P+ 및 EFD가 통상적인 범위를 크게 벗어나고 있으며, 예상되는 상관성을 따르지 않고 있어, 데이터의 신뢰성을 인정하기 어려운 상태이다. 음향 출력의 값에 신뢰성을 부여하기 어려운 경우, 식약처에서 인정하는 시험 검사 기관을 통해 사후 시험 검사 및 관리가 요구된다. 충격파 음향 출력에 대한 통과 기준이 치료기의 적응증에 대한 임상 시험 결과를 근거로 설정될 수 있도록 식약처의 규정 및 가이드라인 개선이 필요하다.

키워드
체외충격파치료술
충격파 펄스
음향출력
최대 양의 압력
에너지밀도
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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 : 39
  • No :4
  • Pages :303-317
  • Received Date : 2020-05-07
  • Accepted Date : 2020-06-09
  • DOI :https://doi.org/10.7776/ASK.2020.39.4.303
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