한국임상수의학회지 (Journal of Veterinary Clinics)

  • 제39권1호
  • /
  • Pages.9-15
  • /
  • 2022
  • /
  • 1598-298X(pISSN)
  • /
  • 2384-0749(eISSN)
한국임상수의학회 (The Korean Society of Veterinary Clinics)
권호 표지
DOI QR코드

DOI QR Code

Side Effects of Orthopedic Products in Veterinary Medicine in South Korea

  • Yun, Taesik (Laboratory of Veterinary Internal Medicine, College of Veterinary Medicine, Chungbuk National University) ;
  • Jung, Soo Yeon (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Kang, Kyongmook (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Yun, Seon-Jong (Veterinary Pharmaceutical Management Division, Animal and Plant Quarantine Agency) ;
  • Koo, Yoonhoi (Laboratory of Veterinary Internal Medicine, College of Veterinary Medicine, Chungbuk National University) ;
  • Park, Jooyoung (Laboratory of Veterinary Internal Medicine, College of Veterinary Medicine, Chungbuk National University) ;
  • Kim, Ill-Hwa (Laboratory of Veterinary Obstetrics, College of Veterinary Medicine, Chungbuk National University) ;
  • Kang, Hyun-Gu (Laboratory of Veterinary Obstetrics, College of Veterinary Medicine, Chungbuk National University)
  • 투고 : 2021.10.19
  • 심사 : 2021.11.29
  • 발행 : 2022.02.28
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

As more veterinary clinics become specialized with the growth of the companion animal market, an increasing number of veterinary clinics perform orthopedic surgery and use orthopedic products, some of which are defective and have side effects. Thus, the present study aimed to prepare fundamental data for the revision and development of manufacturing standards for these products in order to prevent their side effects. We conducted a survey targeting veterinary clinics as consumers and medical device companies as suppliers. Veterinary clinics were surveyed via offline and online methods; 320 clinics that offered orthopedic surgery and approximately 4,000 veterinary clinics that were registered in the Korean Veterinary Medical Association were targeted, and 153 veterinary clinics responded to the survey. The survey for medical device companies, was performed online, targeting 29 companies; 14 companies responded. The number of side effects of orthopedic products was higher in animal orthopedic products than in those for human use. Many consumers tended to suspect that side effects were caused by product defects. To resolve side effects after using orthopedic products, consumers mostly underwent reoperation. Meanwhile, some severe cases proceeded to legal disputes. Similarly, medical device companies, or the suppliers, responded that most side effects occurred in veterinary orthopedic products and that product defects and mistakes in use were the causes. As for most of the follow-up actions for side effects, these companies either reported the issue to those in charge or analyzed and resolved the issues themselves. Therefore, to develop quality products, suppliers should be provided with clear standards for the production, and information disclosure and a report system for side effects should be particularly established to gain consumers' trust regarding the safety of these products.

키워드

과제정보

This study was carried out by the grant of research funding of the Animal and Plant Quarantine Agency technology development project in 2020 (Improvement of Standard and Specification, and Reevaluation on Orthopedic Materials for Veterinary Use; Z-1543072-2020-21-0101).

참고문헌

  1. An HJ, Kim CH, Yoon HJ, Wee SH, Moon JS. Performance evaluation of registration and sales of veterinary medical devices in Korea. J Vet Clin 2015; 32: 85-90. https://doi.org/10.17555/jvc.2014.02.32.1.85
  2. Animal and Plant Quarantine Agency Web site. Animals medical device: safety information and side effects casebook. Available at: https://www.qia.go.kr/downloadwebQiaCom.do?id=30658. Accessed Mar 2, 2017.
  3. Chang JH, Paik MJ, Chang DW. Survey on utilization of ultra-sonographic machine in small animal clinics in South Korea. J Vet Clin 2011; 28: 408-411.
  4. European Medicines Agency Web site. EU VICH adverse event report implementation guide. Available at: https://www.ema.europa.eu/documents/regulatory-procedural-guideline/eu-vich-adverse-event-report-implementation-guide_en.pdf. Accessed Jun 4, 2021.
  5. Fine EJ, Herbst L, Jelicks LA, Koba W, Theele D. Small-animal research imaging devices. Semin Nucl Med 2014; 44: 57-65. https://doi.org/10.1053/j.semnuclmed.2013.08.006
  6. Green MV, Seidel J, Vaquero JJ, Jagoda E, Lee I, Eckelman WC. High resolution PET, SPECT and projection imaging in small animals. Comput Med Imaging Graph 2001; 25: 79-86. https://doi.org/10.1016/S0895-6111(00)00057-4
  7. Koba W, Kim K, Lipton ML, Jelicks L, Das B, Herbst L, et al. Imaging devices for use in small animals. Semin Nucl Med 2011; 41: 151-165. https://doi.org/10.1053/j.semnuclmed.2010.12.003
  8. U.S. Food & Drug Administration Web site. CPG Sec. 607.100. Adequate directions for use (species designation). Animal drugs and veterinary devices. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-607100-adequate-directions-use-species-designation-animal-drugs-and-veterinary-devices. Accessed Mar, 1995.
  9. U.S. Food & Drug Administration Web site. How FDA regulates animal devices. Available at: https://www.fda.gov/animal-veterinary/animal-health-literacy/how-fda-regulates-animal-devices. Accessed Jun 29, 2021.