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美国FDA医疗设备回想：趋势与影响分析
市场调查报告书
商品编码
1408131

美国FDA医疗设备回想：趋势与影响分析

US FDA Medical Device Recalls: Trend and Impact Analysis
出版日期: | 出版商: Frost & Sullivan | 英文 45 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

产品创新减少医疗设备召回

病患死亡人数的增加引发了人们对医疗设备（尤其是第二类和第三类医疗设备）有效性的质疑。所有在美国市场商业化的医疗设备都必须符合 510(k) 合规性。美国食品药物管理局(FDA) 提供了有关最严重的医疗设备召回的资讯摘要。

本研究分析了美国FDA 在医疗设备市场的最新召回情况。这是透过检查 FDA 的资讯摘要来完成的。此清单包括在研究期间（2020-2028 年）因给患者带来某些风险而被召回的设备。

调查的设备类型（依美国FDA 分类）如下：

  • I 级回忆
  • II 级召回

召回列出了可能导致严重健康问题甚至患者死亡的设备。医疗设备召回通知反映的是政府清单上发布的日期，而不是召回的开始日期。

FDA I 级召回： FDA I 级是最重要的召回类型。使用 I 类医疗设备可能会导致严重伤害或死亡。

当暴露或使用不合规的医疗设备可能导致严重的不良健康问题或患者死亡时，就会发生这种召回。根据法定授权，FDA 可以请求、实施或下令 I 级召回。这种召回类型涉及 FDA 的要求，因此大多数公司自愿召回其设备。

FDA II 级召回：当医疗设备对患者造成重大健康和安全风险时，就会发生 FDA II 级召回。 Ⅱ 类医疗设备回收涵盖极有可能造成严重伤害或暂时的、医学上可逆的不良健康后果的器械。当使用医疗设备有非紧急死亡或严重伤害风险但风险仍然存在时，FDA 会发布 II 级召回。

目录

战略问题

  • 为什么成长如此困难？
  • The Strategic Imperative 8（TM）
  • 三大策略重点对防止医疗设备回想的影响
  • 成长机会推动Growth Pipeline Engine（TM）

成长机会分析

  • 美国FDA医疗设备回想
  • 医疗设备回收 - 细分
  • 生长促进因子
  • 成长抑制因素

美国FDA医疗设备召回（按年份、类型和公司）

  • FDA 迈向 510(k)核准
  • 美国FDA医疗设备回收 - 2018-2023
  • 美国FDA医疗设备召回－召回的主要原因
  • 美国FDA医疗设备召回 - 回收数量：依公司分类
  • FDA召回对进入医疗设备市场的参与企业的影响

FDA I 级召回

  • 召回 1 - Fresenius Medical Care 召回血液透析机
  • 召回 2 - 飞利浦伟康召回 V60 和 V60 Plus 呼吸机
  • 召回 3 - Draeger Carina 因气道存在污染物而召回亚急性护理呼吸机
  • 召回 4 - Covidien LLC (Medtronic) Palindrome 和 Mahurkar Hemodialysis 的导管召回 FDA I 类医疗器材召回摘要
  • FDA I 类医疗设备召回摘要

FDA II 级召回 - 内视镜和 AER

  • 内视镜设备产品召回*
  • AER 产品召回
  • FDA 关于病患内视镜检查和 AER 相关感染报告的沟通
  • 推动十二指肠镜从可重复使用和可再处理转变为一次性十二指肠镜的因素
  • 增加防止交叉污染风险的建议促进了灵活的一次性内视镜市场
  • 案例研究- 波士顿科学公司如何从医疗保险和医疗补助服务 (CMS) 获得 EXALT(TM) D 型一次性十二指肠镜的额外报销
  • 内视镜和 AER 召回及行动计划概述

成长机会宇宙

  • 成长机会 1：在医疗设备中使用创新化学品和材料
  • 成长机会2：一次性柔性内视镜、一次性鞘套等新技术创新
  • 图表列表
  • 免责声明
简介目录
Product Code: K98F-54

Product Innovation will Reduce Medical Device Recalls

Rising incidents of patient deaths are raising questions about medical device efficacy, specifically Class II and Class III medical devices. All medical devices commercialized in the US market must adhere to 510(k) compliance. The US Food and Drug Administration (FDA) posts summaries of information about the most serious medical device recalls.

This study analyzes the latest US FDA recalls in the medical device market. It does this by examining the FDA's information summaries. This list includes devices recalled during the study period (2020-2028) as they presented specific risks to patients.

The device types (according to US FDA classification) studied include:

  • Class I recalls
  • Class II recalls

In terms of recalls, devices that could cause serious health issues and even patient death are listed. Medical device recall notices reflect the date of posting on the government list and not the recall initiation date.

FDA Class I Recalls: The FDA Class I is the most crucial recall type. Using Class I medical devices may cause serious injuries or even death.

This recall occurs when a high probability exists that a violative medical device, through exposure or use, causes serious adverse health issues or patient death. Under statutory authority, the FDA can request, conduct, or order a Class I recall. As this recall type includes FDA requests, most companies voluntarily recall their device.

FDA Class II Recalls: An FDA Class II recall occurs when a medical device presents patients with a substantial health and safety hazard. Class II medical device recalls cover devices that have even a slight chance of causing serious injury or producing adverse health consequences, which may be temporary and medically reversible. The FDA issues a Class II recall where the risk of death or severe injury from the device usage is not immediate, but the danger remains.

Table of Contents

Strategic Imperatives

  • Why is it Increasingly Difficult to Grow?
  • The Strategic Imperative 8™
  • The Impact of the Top 3 Strategic Imperatives on the Prevention of Medical Device Recalls
  • Growth Opportunities Fuel the Growth Pipeline Engine™

Growth Opportunity Analysis

  • US FDA Medical Device Recalls
  • Medical Device Recalls-Segmentation
  • Growth Drivers
  • Growth Restraints

US FDA Medical Device Recalls, by Year, Type, and Company

  • FDA Steps for Working on 510(k) Approval
  • US FDA Medical Device Recalls-2018-2023
  • US FDA Medical Device Recalls-Major Recall Reasons
  • US FDA Medical Device Recalls-Number of Recalls by Companies
  • Impact of FDA Recalls on Medical Device Market Participants

FDA Class I Recalls

  • Recall 1-Fresenius Medical Care's Recall of Hemodialysis Machines
  • Recall 2-Philips Respironics's Recall of V60 and V60 Plus Ventilators
  • Recall 3-Draeger Carina's Recall of Sub-Acute Care Ventilators Because of Contaminants in Air Path
  • Recall 4-Covidien LLC (Medtronic) Palindrome and Mahurkar Hemodialysis's Recall of Catheters
  • Summary of FDA Class I Medical Device Recalls

FDA Class II Recalls-Endoscopes and AERs

  • Product Recalls of Endoscopic Devices*
  • AER Product Recalls
  • FDA Communications on Reported Patient Endoscope- and AER-related Infections
  • Factors Leading to the Transition from Reusable and Reprocessed Duodenoscopes to Disposable Duodenoscopes
  • Increased Recommendations to Prevent Cross-contamination Risks Boosting the Flexible Single-use Endoscope Market
  • Case Study-How Boston Scientific Received Additional Centers for Medicare & Medicaid Services (CMS) Reimbursement for the EXALT™ Model D Disposable Duodenoscope
  • Summary of Endoscope and AER Recalls and Action Plans

Growth Opportunity Universe

  • Growth Opportunity 1: Innovative Chemical and Material Usage in Medical Devices
  • Growth Opportunity 2: New Technology Innovation, such as Flexible Single-use Endoscopes and Disposable Sheaths
  • List of Exhibits
  • Legal Disclaimer