Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Tenwek Hospital, Bomet, Kenya.
JCO Glob Oncol. 2021 Jan;7:118-126. doi: 10.1200/GO.20.00318.
The eastern corridor of Africa is affected by a high burden of esophageal cancer (EC), with > 90% of patients presenting with advanced disease. Self-expanding metal stents (SEMS) have been previously reported as safe and effective for palliation of malignant dysphagia in resource-limited settings; however, access is limited throughout Eastern Africa.
In response to demand for palliative interventions for patients with dysphagia because of EC, the African Esophageal Cancer Consortium (AfrECC) partnered with the Clinton Health Access Initiative to improve access to SEMS in Eastern Africa. We undertook a stepwise implementation approach to (1) identify barriers to SEMS access, (2) conduct a market analysis, (3) select an industry partner, (4) establish regulatory and procurement processes, (5) develop endoscopic training resources, (6) create a medical device registry, and (7) establish principles of accountability.
Following an evaluation of market demand and potential SEMS manufacturers, Boston Scientific Corporation announced its commitment to launch an access program to provide esophageal SEMS to patients in Tanzania, Kenya, Malawi, and Zambia at a subsidized price. Parallel regulatory and procurement processes were established in each participating country. Endoscopy training courses were designed and conducted, using the Training-of-Trainers model. A device registry was created to centralize data for quality control and to monitor channels of SEMS distribution. Principles of accountability were developed to guide the sustainability of this endeavor.
The AfrECC Stent Access Initiative is an example of a multisector partnership formed to provide an innovative solution to align regional needs with a supply chain for a high-priority medical device.
非洲东部走廊地区食管癌负担沉重，超过 90%的患者就诊时已处于晚期。在资源有限的环境下，自膨式金属支架（SEMS）此前被报道可安全有效地缓解恶性吞咽困难。然而，整个东非地区的 SEMS 应用都受到限制。
为满足因食管癌而出现吞咽困难的患者对姑息治疗干预的需求，非洲食管癌联盟（AfrECC）与克林顿健康倡议组织合作，以改善东非地区 SEMS 的获取途径。我们采用逐步实施的方法：（1）确定 SEMS 获取途径的障碍，（2）进行市场分析，（3）选择行业合作伙伴，（4）建立监管和采购流程，（5）开发内镜培训资源，（6）建立医疗器械登记册，以及（7）制定问责原则。
在评估了市场需求和潜在 SEMS 制造商之后，波士顿科学公司宣布承诺启动一项准入计划，以优惠价格向坦桑尼亚、肯尼亚、马拉维和赞比亚的患者提供食管 SEMS。每个参与国都建立了平行的监管和采购流程。设计并开展了内镜培训课程，采用了培训师培训模式。建立了一个设备登记册，以集中数据进行质量控制，并监测 SEMS 分销渠道。制定了问责原则，以指导这项工作的可持续性。
AfrECC 支架准入倡议是一个多部门合作的范例，旨在提供一个创新的解决方案，使区域需求与高优先级医疗器械的供应链相匹配。
