한국음향학회지 (The Journal of the Acoustical Society of Korea)

  • 제39권4호
  • /
  • Pages.303-317
  • /
  • 2020
  • /
  • 1225-4428(pISSN)
  • /
  • 2287-3775(eISSN)
한국음향학회 (The Acoustical Society of Korea)
권호 표지
DOI QR코드

DOI QR Code

식약처에서 허가된 집속형 ESWT 치료기의 음향 출력 분석

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

  • 최민주 (제주대학교 의학전문대학원 의학과) ;
  • 전성중 (제주대학교 의공학협동과정) ;
  • 권오빈 (제주대학교 의공학협동과정) ;
  • 이민영 ((주)에이치엔티메디칼) ;
  • 조진식 (한국화학융합시험연구원) ;
  • 김한수 (한국화학융합시험연구원) ;
  • 맹은호 (한국화학융합시험연구원)
  • 투고 : 2020.05.07
  • 심사 : 2020.06.09
  • 발행 : 2020.07.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

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/㎟ ~ 35 mJ/㎟, 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.

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/㎟ to 35 mJ/㎟, 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.

키워드

참고문헌

  1. C. Chaussy, E. Schmiedt, V. Walther, W. Brendel, B. Forssmann, and W. Hepp, "Extracorporeal Shock Wave Lithotripsy New Aspects in the Treatment of Kidney Stone Disease," in Karger, edited by C. Chaussy (InTech, Available from: https://www.karger.com/Book/Home/220362, 1982).
  2. Food and Drug Administraion, "Guidance for the content of premarket notifications (510(k)s) for extracorporeal shock wave lithotripters indicated for the fragmentation of kidney and ureteral calculi," U.S. Department of Health and Human Services, Guidance for Industry and FDA Reviewers, 2000.
  3. C. Chaussy, "The history of shockwave lithotripsy," in The History of Technologic Advancements in Handbook of Urology, edited by S. Patel, M. Moran, and S. Nakada (Springer, Cham, 2018).
  4. F. Ioppolo, M. Tattoli, L. D. Sante, C. Attanasi, T. Venditto, M. Servidio, A. Cacchio, and V. Santilli, "Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels," Physical Therapy, 92, 1376-1385 (2012). https://doi.org/10.2522/ptj.20110252
  5. F. Sebastian, S. Florian, M. Patrick, G. Alexandra, P. Gert, and S. A. Manuel, "Extracorporeal shockwave therapy in calcifying tendinitis of the shoulder," Knee Surg. Sports Traumatol. Arthrosc. 19, 2085-2089 (2011). https://doi.org/10.1007/s00167-011-1479-z
  6. E. Rebuzzi, N. Coletti, S. Schiavetti, and F. Giusto, "Arthroscopy surgery versus shock wave therapy for chronic calcifying tendinitis of the shoulder," J. Orthop. Traumatol. 9, 179-185 (2008). https://doi.org/10.1007/s10195-008-0024-4
  7. The International Society for Medical Shockwave Treatment (ISMST), https://www.shockwavetherapy.org/, (Last viewed Mar 30, 2020).
  8. D. Erroi, M. Sigona, T. Suarez, D. Trischitta, A. Pavan, M. C. Vulpiani, and M. Vetrano, "Conservative treatment for Insertional Achilles Tendinopathy: platelet-rich plasma and focused shock waves. A retrospective study," Muscles, Ligaments Tendons J. 7, 98-106 (2017). https://doi.org/10.11138/mltj/2017.7.1.098
  9. H. Radinmehr, N. N. Ansari, S. Naghdi, G. Olyaei, and A. Tabatabaei, "Effects of one session radial extracorporeal shockwave therapy on post-stroke plantarflexor spasticity: a single-blind clinical trial," Disability and Rehabilitation, 39, 483-490 (2016). https://doi.org/10.3109/09638288.2016.1148785
  10. W. Y. Chou, C. J. Wang, K. T. Wu, Y. J. Yang, J. H. Cheng, and S. W. Wang, "Comparative outcomes of extracorporeal shockwave therapy for shoulder tendinitis or partial tears of the rotator cuff in athletes and non-athletes: Retrospective study," Int. J. Surgery, 51, 184-190 (2018). https://doi.org/10.1016/j.ijsu.2018.01.036
  11. G. Yang, C. Luo, X. Yan, L. Cheng, and Y. Chai, "Extracorporeal shock wave treatment improves incisional wound healing in diabetic rats," Tohoku J. Exp. Med. 225, 285-292 (2011). https://doi.org/10.1620/tjem.225.285
  12. A. Bechara, A. Casabe, W. D. Bonis, and P. G. Ciciclia, "Twelve-month efficacy and safety of low-intensity shockwave therapy for erectile dysfunction in patients who do not respond to phosphodiesterase type 5 inhibitors," Sexual Medicine, 4, e225-e232 (2016). https://doi.org/10.1016/j.esxm.2016.06.001
  13. E. Chung and R. Cartmill, "Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial," BJU international, 115, 4649 (2015).
  14. Ministry of Food and Drug Safety, "Guidelines for preparing technical documents for in extracorporeal shock wave therapy," Guide-0580-01, 2015.
  15. IEC 60601-2-36, Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy; Edition 2.0, 2014.
  16. IEC 61846, Ultrasonics - Pressure pulse lithotripters - Characteristics of fields; First Edition, 1998.
  17. Ministry of Food and Drug Safety, "Safety and performance evaluation test method guide for in extracorporeal shock wave lithotripte," Guide-0784-01, 2017.
  18. C. Perez, H. Chen, T. J. Matula, M. Karzova, and V. A. Khokhlova, "Acoustic field characterization of the Duolith: Measurements and modeling of a clinical shock wave therapy device," J. Acoust. Soc. Am. 134, 1663-1674 (2013). https://doi.org/10.1121/1.4812885
  19. K. S. Chang, "Development of ESWT performance evaluation guideline," Ministry of Food and Drug Safety, Tech. Rep., 2008.
  20. R. Schultheiss and M. Doerffel, "Standards for lithotripter performance," AIP Conference Proceedings. 1049, 226-237 (2008).
  21. M. J. Choi, S. C. Cho, D. G. Paeng, and K. I. Lee, "Extracorporeal shock wave therapy: Its acoustical aspects," J. Acoust. Soc. Kr. 29(3E), 119-130 (2010).
  22. M. J. Choi, G. Kang, and J. S. Huh, "Geometrical characterization of the cavitation bubble clouds produced by a clinical shock wave device," BMEL. 7, 143-151 (2017).
  23. C. J. Lee, J. Y. Kim, S. H. Choi, and M. J. Kim, "A study on developing a new evaluation method and a testing guideline for extracorporeal shockwave using cavitation visualization," Regulatory Research on Food, Drug and Cosmetic, 13:2, 113-124 (2018).
  24. L. E. Kinsler, A. R. Frey, A. B. Coppens, and J. V. Sanders, Fundamentals of Acoustics. In the 4thed. (John Wiley & Sons, USA, 2000), pp. 113-143.
  25. Food and Drug Administraion, "Summary of safety and effectiveness: Health Tronics $OSssaTron^{TM}$" U.S. Department of Health and Human Services, 2000.
  26. Food and Drug Administraion, "Summary of safety and effectiveness: SONOCUR Basic," U.S. Department of Health and Human Services, 2002.