미국 FDA의 의료기기 리콜 : 동향과 영향 분석

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