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美國FDA醫療設備回想：趨勢與影響分析
市場調查報告書
商品編碼
1408131

美國FDA醫療設備回想：趨勢與影響分析

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個工作天內

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簡介目錄

產品創新減少醫療設備召回

病患死亡人數的增加引發了人們對醫療設備（尤其是第二類和第三類醫療設備）有效性的質疑。所有在美國市場商業化的醫療設備都必須符合 510(k) 合規性。美國食品藥物管理局(FDA) 提供了有關最嚴重的醫療設備召回的資訊摘要。

本研究分析了美國FDA 在醫療設備市場的最新召回情況。這是透過檢查 FDA 的資訊摘要來完成的。此清單包括在研究期間（2020-2028 年）因給患者帶來某些風險而被召回的設備。

調查的設備類型（依美國FDA 分類）如下：

  • I 級回憶
  • II 級召回

召回列出了可能導致嚴重健康問題甚至患者死亡的設備。醫療設備召回通知反映的是政府清單上發布的日期，而不是召回的開始日期。

FDA I 級召回： FDA I 級是最重要的召回類型。使用 I 類醫療設備可能會導致嚴重傷害或死亡。

當暴露或使用不合規的醫療設備可能導致嚴重的不良健康問題或患者死亡時，就會發生這種召回。根據法定授權，FDA 可以請求、實施或下令 I 級召回。這種召回類型涉及 FDA 的要求，因此大多數公司自願召回其設備。

FDA II 級召回：當醫療設備對患者造成重大健康和安全風險時，就會發生 FDA II 級召回。 Ⅱ 類醫療設備回收涵蓋極有可能造成嚴重傷害或暫時的、醫學上可逆的不良健康後果的器械。當使用醫療設備有非緊急死亡或嚴重傷害風險但風險仍然存在時，FDA 會發布 II 級召回。

目錄

戰略問題

  • 為什麼成長如此困難？
  • The Strategic Imperative 8（TM）
  • 三大策略重點對防止醫療設備回想的影響
  • 成長機會推動Growth Pipeline Engine（TM）

成長機會分析

  • 美國FDA醫療設備回想
  • 醫療設備回收 - 細分
  • 生長促進因子
  • 成長抑制因素

美國FDA醫療設備召回（按年份、類型和公司）

  • FDA 邁向 510(k)核准
  • 美國FDA醫療設備回收 - 2018-2023
  • 美國FDA醫療設備召回－召回的主要原因
  • 美國FDA醫療設備召回 - 回收數量：依公司分類
  • FDA召回對進入醫療設備市場的參與企業的影響

FDA I 級召回

  • 召回 1 - Fresenius Medical Care 召回血液透析機
  • 召回 2 - 飛利浦偉康召回 V60 和 V60 Plus 呼吸機
  • 召回 3 - Draeger Carina 因氣道存在污染物而召回亞急性護理呼吸機
  • 召回 4 - Covidien LLC (Medtronic) Palindrome 和 Mahurkar Hemodialysis 的導管召回 FDA I 類醫療器材召回摘要
  • FDA I 類醫療設備召回摘要

FDA II 級召回 - 內視鏡和 AER

  • 內視鏡設備產品召回*
  • AER 產品召回
  • FDA 關於病患內視鏡檢查和 AER 相關感染報告的溝通
  • 推動十二指腸鏡從可重複使用和可再處理轉變為一次性十二指腸鏡的因素
  • 增加防止交叉污染風險的建議促進了靈活的一次性內視鏡市場
  • 案例研究- 波士頓科學公司如何從醫療保險和醫療補助服務 (CMS) 獲得 EXALT(TM) D 型一次性十二指腸鏡的額外報銷
  • 內視鏡和 AER 召回及行動計劃概述

成長機會宇宙

  • 成長機會 1：在醫療設備中使用創新化學品和材料
  • 成長機會2：一次性軟性內視鏡、一次性鞘套等新技術創新
  • 圖表列表
  • 免責聲明
簡介目錄
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