The Journal of the Acoustical Society of Korea (한국음향학회지)

The Acoustical Society of Korea (한국음향학회)
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Acoustic outputs from clinical ballistic extracorporeal shock wave therapeutic devices

임상에서 사용중인 탄도형 체외충격파 치료기의 음향 출력

  • 조진식 (제주대학교 의공학협동과정) ;
  • 권오빈 (제주대학교 의공학협동과정) ;
  • 전성중 (제주대학교 의공학협동과정) ;
  • 이민영 (한국화학융합시험연구원) ;
  • 김종민 (제주대학교 의공학협동과정) ;
  • 최민주 (제주대학교 의공학협동과정)
  • Received : 2022.08.12
  • Accepted : 2022.09.15
  • Published : 2022.09.30
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Abstract

We scrutinized the acoustic outputs from the 70 shock wave generators of the 15 product models whose technical documents were available, among the 46 ballistic extracorporeal shock wave therapeutic devices of 11 domestic and 6 foreign manufacturers, approved by the Minster of Food & Drug Safety (Rep. Korea). We found that the acoustic Energy Flux Density (EFD), the most popular exposure parameter, was different by up to 563.64 times among shock wave generators at their minimum output settings and by up to 74.62 times at their maximum settings. In the same product model, the EFD was shown to vary depending on shock wave transmitters by up to 81.82 times at its minimum output setting and by up to 46.15 times at its maximum setting. The lowest EFD 0.013 mJ/mm2 at the maximum output settings was much lower (2.1 %) than the maximum value 0.62 mJ/mm2 at the minimum settings. The Large acoustic output differences (tens to hundreds of times)from the therapeutic devices approved for the same clinical indications imply that their therapeutic efficacy & safety may not be assured. The findings suggest the regulatory authority to revise her guideline to give clearer criteria for clinical approval and equality in performance, and recommend the authority to initiate a post-approval surveillance as well as a test in conformance between the data in technical documents and the real acoustic outputs clinically used.

식약처에서 허가된 국내 11개 및 국외 6개 제조사의 46개 탄도형 체외 충격파 치료기 중 기술 문서가 공개된 15개 제품 70개의 충격파 발생 장치에 대해 충격파 음향 출력을 조사했다. 조사 결과, 임상에서 가장 보편적인 피폭 변수로 사용되는 에너지 속 밀도(Energy Flux Density, EFD)는 치료기의 충격파 발생 장치에 따라 최소 출력 설정에서 최대 563.64배, 최대 출력 설정에서 최대 74.62배까지 차이가 나고 있다. 동일 모델 제품에서 충격파 변환자의 선택으로 EFD의 값은 최소 설정에서 최대 81.82배, 최대 설정에서 최대 46.15배 차이를 보이고 있다. 최대 출력 설정에서 EFD의 최저값 0.013 mJ/mm2이 최소 출력 설정에서 EFD의 최대값 0.62 mJ/mm2보다 훨씬 낮은 것(2.1 %)으로 나타났다. 동일한 적응증으로 허가 받은 탄도형 체외 충격파 치료기의 음향 출력이 수십~수백 배 차이가 난다는 것은 치료기의 치료 효과 및 안전성을 보증하기 어렵다는 것을 시사한다. 본 연구의 결과는 치료기의 허가 및 성능의 동등성에 대한 명확한 기준을 포함하는 식약처의 가이드라인 개정 및 사용 중인 치료기의 음향 출력과 기술 문서와의 일치성 확인을 포함하는 치료기의 성능에 대한 규제 기관의 사후 관리의 필요성을 제기한다.

Keywords

Acknowledgement

본 연구는 정부(과학기술정보통신부, 산업통상자원부, 보건복지부, 식품의약품안전처)의 재원으로 범부처전주기의료기기연구개발사업단(과제고유번호: KD0000103G0003057)과 한국연구재단(과제고유번호: 2017R1A2B3007907)의 지원을 받아 수행된 연구임.

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