Regulation, approval, and access of spinal implants in low-middle-income countries: a narrative review and case study

References

• Quene TM, Bust L, Louw J, et al. Global surgery is an essential component of global health. Surg J R Coll Surg Edinb Irel. 2022;20(1):9–15. doi: 10.1016/j.surge.2021.10.001
   PubMed Web of Science ®Google Scholar
• Griswold DP, Makoka MH, Gunn SWA, et al. Essential surgery as a key component of primary health care: reflections on the 40th anniversary of Alma-Ata. BMJ Glob Health. 2018;3(Suppl 3):e000705. doi: 10.1136/bmjgh-2017-000705
   PubMedGoogle Scholar
• Meara JG, Leather AJM, Hagander L, et al. Global surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015;386(9993):569–624. doi: 10.1016/S0140-6736(15)60160-X
   PubMed Web of Science ®Google Scholar
• Mock CN, Donkor P, Gawande A, et al. Essential surgery: key messages of this volume. Dis Control Priorities Third Ed Vol 1 Essent Surg [Internet]. The World Bank; 2015 [cited 2023 Jan 21]. p. 1–18. Available from: https://elibrary.worldbank.org/doi/10.1596/978-1-4648-0346-8_ch1
   Google Scholar
• Huys SEF, Markus AF, Mommaerts MY. Obstacles for accessing customised craniofacial implants in low- and middle-income countries. J Oral Biol Craniofacial Res. 2022;12(1):80–85. doi: 10.1016/j.jobcr.2021.10.011
   PubMedGoogle Scholar
• World Health Organization. INJURIES VIOLENCE THE FACTS [Internet]. World Health Organization; [cited 2023 Jan 21]. Available from: https://apps.who.int/iris/bitstream/handle/10665/149798/9789241508018_eng.pdf
   Google Scholar
• Jayakumar N, Munuswamy S, Kulshreshtha R, et al. Implant wastage in orthopaedic trauma: a UK experience. Ann R Coll Surg Engl. 2020;102(3):225–228. doi: 10.1308/rcsann.2019.0151
   PubMed Web of Science ®Google Scholar
• World Health Organization, World Bank Group, OECD. Delivering quality health services: a Global Imperative for Universal Health coverage [Internet]. Geneva: World Health Organization; 2018 [cited 2023 Jan 21]. Available from: http://hdl.handle.net/10986/29970
   Google Scholar
• World Health Organization. Landscape analysis of barriers to developing or adapting technologies for global health purposes [Internet]. World Health Organization. 2010 [cited 2023 Jan 21]. Report No.: WHO/HSS/EHT/DIM/10.13. Available from: https://apps.who.int/iris/handle/10665/70543
   Google Scholar
• De Maria C, Di Pietro L, Díaz Lantada A, et al. Safe innovation: on medical device legislation in Europe and Africa. Health Policy Technol. 2018;7(2):156–165. doi: 10.1016/j.hlpt.2018.01.012
   Web of Science ®Google Scholar
• Ndeleva BM. Regulation of orthopedic implants in Kenya. East Afr Orthop J. 2018;12:1–2.
   Google Scholar
• McAllister P, Jeswiet J. Medical device regulation for manufacturers. Proc Inst Mech Eng [H]. 2003;217(6):459–467. doi: 10.1243/09544110360729090
   PubMedGoogle Scholar
• Shah AR, Goyal RK. Current status of the regulation for medical devices. Indian J Pharm Sci. 2008;70(6):695–700. doi: 10.4103/0250-474X.49085
   PubMed Web of Science ®Google Scholar
• Lamph S. Regulation of medical devices outside the European Union. J R Soc Med. 2012;105(1_suppl):S12–S21. doi: 10.1258/jrsm.2012.120037
   PubMedGoogle Scholar
• Dusabe G. Regulation of medical devices in Europe and Africa [Doctoral Dissertation]. Malta: University of Malta; 2020 [cited 2022 Apr 22]. https://www.um.edu.mt/library/oar/handle/123456789/72649
   Google Scholar
• Bouchard M A qualitative case study of orthopaedic services in Uganda.
   Google Scholar
• Hubner S, Maloney C, Phillips SD, et al. The evolving Landscape of medical device regulation in East, central, and Southern Africa. Glob Health Sci Pract. 2021;9:136–148. doi: 10.9745/GHSP-D-20-00578
   PubMed Web of Science ®Google Scholar
• Shukla S, Gupta M, Pandit S, et al. Implementation of adverse event reporting for medical devices, India. Bull World Health Organ. 2020;98(3):206. doi: 10.2471/BLT.19.232785
   PubMed Web of Science ®Google Scholar
• Guo X, Liu B, Lu Z. Correlation between conditional approval and customized Bone implant devices. Orthop Surg. 2019;11(1):10–14. doi: 10.1111/os.12415
   PubMed Web of Science ®Google Scholar
• Wadhwa A, Talegaonkar S, Popli H. A regulatory overview of hip and knee Joint replacement devices. Appl Clin Res Clin trials regul aff discontin. App Clin Res Clin Trials Regul Aff. 2019;6(3):212–230. doi: 10.2174/2213476X06666190823142403
   Google Scholar
• Park KB, Iv V. Spinal implants in resource-limited settings: “keep It simple. World Neurosurg. 2016;86:36–38. doi: 10.1016/j.wneu.2015.09.101
   PubMed Web of Science ®Google Scholar
• Stewart BT, Gyedu A, Tansley G, et al. Orthopaedic trauma care capacity assessment and strategic planning in Ghana: mapping a way forward. J Bone Joint Surg Am. 2016;98(23):e104. doi: 10.2106/JBJS.15.01299
   PubMed Web of Science ®Google Scholar
• Kramer DB, Tan YT, Sato C, et al. Postmarket surveillance of medical devices: a comparison of strategies in the US, EU, Japan, and China. PLOS Med [Internet]. 2013; [cited 2023 Jan 21]; 10(9):e1001519. doi: 10.1371/journal.pmed.1001519
   PubMed Web of Science ®Google Scholar
• Harkins CS, McGarry A, Buis A. Provision of prosthetic and orthotic services in low-income countries: a review of the literature. Prosthet Orthot Int. 2013;37(5):353–361. doi: 10.1177/0309364612470963
   PubMed Web of Science ®Google Scholar
• Goemans B, McLaughlin R. Route to market Guide for inventors: medical devices. University of Cape Town; 2018. https://uct.ac.za/rci/articles/2019-01-14-route-2-market-guides-launched
   Google Scholar
• South African Health Product Regulatory Agency. South Africa - an overview of leading industry sectors [Internet]. [cited 2023 Jan 21]. Available from: https://www.trade.gov/country-commercial-guides/south-africa-overview-leading-industry-sectors
   Google Scholar
• Estelle. Medical devices and IVDs classification classification of medical devices and ivds.
   Google Scholar
• Developing affordable titanium implants in Africa | The AAS [Internet]. [cited 2023 Jan 21]. Available from: https://www.aasciences.africa/news/developing-affordable-titanium-implants-africa
   Google Scholar
• Abhishek BVM, Balamuralidhara V, Kumar MP Market authorisation approval pathway for medical devices in Brazil & Japan [Internet]. Available from: http://portal.an
   Google Scholar
• Wichlas F, Hofmann V, Strada G, et al. Off-label use of orthopedical trauma implants in a low-income country. Int Orthop. 2022;46(1):21–27. doi: 10.1007/s00264-021-04990-x
   PubMed Web of Science ®Google Scholar
• World Health Organization. WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices [Internet]. World Health Organization; 2017 [cited 2023 Jan 21]. Available from: https://apps.who.int/iris/handle/10665/255177.
   Google Scholar
• Medicines and related substances | Principal Legislation [Internet]. [cited 2023 Jan 21]. Available from: https://botswanalaws.com/alphabetical-list-of-statutes/medicines-and-related-substances
   Google Scholar
• South African Health Products Regulatory Authority. medicines and related substances act no. 101 of 1965 [Internet]. Government Gazzette; [cited 2023 Jan 21]. Available from: https://www.sahpra.org.za/wp-content/uploads/2020/02/Government_Gazette_Medicines_and_Devices_Act_Jun_2017-1.pdf
   Google Scholar
• World Health Organization. Guidance for post-market surveillance and market surveillance of medical devices, including in-vitro-diagnostics [Internet]. 2020 [cited 2023 Jan 21]. Available from: https://www.who.int/docs/default-source/essential-medicines/in-vitro-diagnostics/draft-public-pmsdevices.pdf?sfvrsn=f803f68a_2
   Google Scholar
• Global atlas of medical devices 2022 [Internet]. [cited 2023 Jan 21]. Available from: https://www.who.int/publications-detail-redirect/9789240062207
   Google Scholar
• Kenya - Healthcare - Medical Devices [Internet]. [cited 2023 Jan 21]. Available from: https://www.trade.gov/country-commercial-guides/kenya-healthcare-medical-devices
   Google Scholar
• Rugera SP, McNerney R, Poon AK, et al. Regulation of medical diagnostics and medical devices in the East African community partner states. BMC Health Serv Res. 2014 [[cited 2023 Jan 21]];14. InternetAvailable from: https://pubmed.ncbi.nlm.nih.gov/25366990/
   Web of Science ®Google Scholar
• Cheng M. Medical device regulations: global overview and guiding principles. Geneva: World Health Organization; 2003.
   Google Scholar
• India approval process for medical devices & IVDs [Internet]. Emergo UL. [cited 2023 Jan 21]. Available from: https://www.emergobyul.com/resources/india-approval-process-medical-devices-ivds
   Google Scholar
• Agbor VN, Ntusi NAB, Noubiap JJ. An overview of heart failure in low- and middle-income countries. 2020. [[cited 2023 Aug 14]]. InternetAvailable from Cardiovasc Diagn Ther. 10(2):244–251. doi: 10.21037/cdt.2019.08.03.
   PubMed Web of Science ®Google Scholar
• Waterkeyn F, Lohkamp L-N, Ikwuegbuenyi CA, et al. Current treatment management of aneurysmal subarachnoid hemorrhage with prevailing trends and results in Tanzania: a single-center experience at Muhimbili orthopedic and Neurosurgery Institute. World Neurosurg. 2022;S1878-8750(22):01543–1.
   Google Scholar
• GBD. Traumatic brain injury and spinal cord injury collaborators. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol. 2016;18:56–87. 2019.
   Google Scholar
• Kumar R, Lim J, Mekary RA, et al. Traumatic spinal injury: global epidemiology and worldwide volume. World Neurosurg. 2018;113:e345–e363. doi: 10.1016/j.wneu.2018.02.033
   PubMed Web of Science ®Google Scholar
• Lessing NL, Lazaro A, Zuckerman SL, et al. Nonoperative treatment of traumatic spinal injuries in Tanzania: who is not undergoing surgery and why? Spinal Cord. 2020;58(11):1197–1205. doi: 10.1038/s41393-020-0474-y
   PubMed Web of Science ®Google Scholar
• Lessing NL, Zuckerman SL, Lazaro A, et al. Cost-effectiveness of operating on traumatic spinal injuries in low-middle income countries: a preliminary report from a major East African referral center. Glob Spine J. 2022;12:15–23.
   PubMed Web of Science ®Google Scholar
• Nakandi BT, Muhimbise O, Djuhadi A, et al. Experiences of medical device innovators as they navigate the regulatory system in Uganda. Front Med Technol. 2023;InternetAvailable from. 5:[cited 2023 Aug 14]. doi: 10.3389/fmedt.2023.1162174
   PubMedGoogle Scholar
• Tzikas A, Gafoor S, Meerkin D, et al. Left atrial appendage occlusion with the amplatzer Amulet device: an expert consensus step-by-step approach. EuroIntervention. 2016;11(13):1512–1521. InternetAvailable from. [cited 2023 Aug 14]. doi: 10.4244/eijv11i13a292
   PubMed Web of Science ®Google Scholar
• Mpaata CN, Matovu B, Takuwa M, et al. Systems and processes for regulation of investigational medical devices in Uganda. Front Med Technol. 2023;InternetAvailable from. 4:[cited 2023 Aug 14]. doi: 10.3389/fmedt.2022.1054120
   PubMedGoogle Scholar