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Regulatory Intelligence on Medical Device Recalls – Ineffective Process Control, Defects in Design of Device, Software or Other Components are the Major Reasons for Recall
Summary
GBI Research report, “Regulatory Intelligence on Medical Device Recalls – Ineffective Process Control, Defects in Design of Device, Software or Other Components are the Major Reasons for Recall”, provides an in-depth analysis on medical device recalls in the US. The report analyzes the number of medical device recalls in the US by year, recall class, therapeutic area and root cause from 2005–2010. The report includes an in-depth analysis on medical device recalls by the top 10 recall firms, with the number of device recalls by year and by recall class. The report presents information on medical device regulatory systems, with emphasis on regulatory intelligence in the following seven countries: the US, the UK, Germany, France, Spain, Italy and Japan. The medical equipment approval process, device classification, conformity assessment process and post-market surveillance are explained in the report.
Medical devices play an important role in the healthcare industry. Many technological advances have revolutionized the medical equipment industry. Medical devices include a wide range of products that vary in complexity and application. They range from simple devices, such as tongue depressors and medical thermometers, to complex devices such as artificial hearts.
The medical devices industry is a large and rapidly growing field that is often complicated by legal technicalities. Therefore, it is important to maintain regulatory surveillance on medical devices in order to protect public health by evaluating the safety and effectiveness of medical devices. Center for Devices and Radiological Health (CDRH) uses its pre-market review and evaluation programs to ensure the safety and effectiveness of new, high risk and complex devices, and uses its post-market surveillance and assessment methods, scientific research, regulatory enforcement tools and educational programs to maintain the safety and effectiveness of medical devices following approval for use.
According to the US Food and Drug Administration (FDA), there were 4,343 medical device recalls from 2005–2010. The number of medical device recalls per annum increased from 578 in 2005 to 928 in 2010.The main reasons for these recalls were problems with device design and process control, which includes developing, conducting, controlling and monitoring production processes to ensure that a device conforms to its specifications; concerns with software design, component design and employee errors; the incorrect labeling of medical devices and the mistaken use of materials and components; as well as medical devices that pose a risk to patient health, devices that violate law, products with sterility failure and maintenance problems, and product repairs and contamination.
Scope
- The basic concepts of medical device recalls, such as device classification and the device recall process by the FDA.- Medical device recalls in the US by year, recall class, number of recalls in different therapeutic areas and root cause. – In-depth analysis of the top 10 recall firms in the US from 2005–2010, by year and by recall class. – The regulatory framework for medical devices in the following seven countries: the US, the UK, Germany, France, Spain, Italy and Japan.
Reasons to buy
- Analyze the number of recalls by year from 2005–2010.- Analyze the key reasons for recalls, along with the therapy areas and class of recalled devices, in order to strengthen the areas which may lead to quality defects in a company’s product portfolio. – Reinforce quality and manufacturing strategies so as to be complaint with the current regulation requirements. – Develop key strategic initiatives by understanding the key focus areas of the medical device recalls market.- Understand the regulatory frameworks for medical devices in the following countries: the US, the UK, Germany, France, Spain, Italy and Japan.1 Table of Contents1 Table of Contents 31.1 List of Tables 51.2 List of Figures 62 Regulatory Intelligence on Medical Device Recalls – Introduction 82.1 GBI Report Guidance 93 Regulatory Intelligence on Medical Device Recalls – Overview 103.1 FDA Medical Device Recall Process 114 Analysis of Medical Device Recalls from 2005–2010 124.1 Number of Recalls by Year 124.2 Number of Recalls by Class 134.3 Number of Recalls by Therapeutic Area 154.4 Number of Recalls by Root Cause 164.5 Number of Recalls by Top Ten Recall Firms 174.6 Analysis of Top 10 Recall Companies’ Medical Device Recalls 194.6.1 Stryker 194.6.2 Abbott 214.6.3 Medtronic 234.6.4 Siemens 254.6.5 GE 284.6.6 Philips 304.6.7 Boston Scientific 324.6.8 Baxter 364.6.9 Zimmer 384.6.10 Biomet 405 Global Harmonization Task Force 435.1 Scope of GHTF 435.2 Benefits of GHTF 436 Medical Device Safety 446.1 Medical Device Safety and Risk Management 446.1.1 Phases in the Life Span of a Medical Device 457 Regulatory Intelligence on Medical Devices – The US 477.1 Overview of the Medical Equipment Industry 477.2 Regulation System 477.2.1 Medical Equipment Approval Process 487.2.2 Device Classification 487.2.3 Medical Device Review Process 497.2.4 Post-market Approval Process 558 Regulatory Intelligence on Medical Devices- Top Five European Countries 568.1 Europe 568.1.1 Overview of the Medical Equipment Industry 568.1.2 Regulation System 568.2 UK 608.2.1 Regulation System 608.2.2 Post-market Surveillance 618.3 Germany 618.3.1 Regulation System 618.3.2 Post-market Surveillance 628.4 France 628.4.1 Regulation System 628.4.2 Post-market Surveillance 628.5 Spain 638.5.1 Regulation System 638.6 Italy 638.6.1 Regulation System 648.6.2 Post-market Surveillance 649 Regulatory Intelligence on Medical Devices – Japan 659.1 Overview of the Medical Equipment Industry 659.2 Regulation System 669.2.1 Medical Equipment Approval Process 669.2.2 Device Classification 669.2.3 Third Party Certification for Controlled Medical Devices 679.2.4 PMDA Approval for Highly Controlled Medical Devices 689.2.5 Post-market Surveillance 699.2.6 Labeling and Packaging 6910 Appendix 7110.1 Market Definitions 7110.2 Abbreviations 7110.3 Research Methodology 7210.3.1 Coverage 7210.3.2 Analysis of Medical Device Recalls in the US 7210.3.3 Regulatory Intelligence on Medical Devices in the US 7210.3.4 Regulatory Intelligence on Medical Devices in the Top Five European Countries 7210.3.5 Regulatory Intelligence on Medical Devices in Japan 7310.3.6 Expert Panels 7310.4 Contact Us 7310.5 Disclaimer 7310.6 Sources 73
1.1 List of Tables
Table 1: Regulatory Intelligence on Medical Device Recalls, Comparison of FDA Recall Classification and Device Classification, 2011 11Table 2: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls, 2005–2010 12Table 3: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls by Class, 2005–2010 14Table 4: Regulatory Intelligence on Medical Device Recalls, US, 10 Companies that Initiated the Most Device Recalls, 2005–2010 18Table 5: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Number of Medical Device Recalls, 2005–2010 20Table 6: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Number of Medical Device Recalls, 2005–2010 22Table 7: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Number of Medical Device Recalls, 2005–2010 25Table 8: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Number of Medical Device Recalls, 2005–2010 27Table 9: Regulatory Intelligence on Medical Device Recalls, US, GE, Number of Medical Device Recalls, 2005–2010 29Table 10: Regulatory Intelligence on Medical Device Recalls, US, Philips, Number of Medical Device Recalls, 2005–2010 32Table 11: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Number of Medical Device Recalls, 2005–2010 35Table 12: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Number of Medical Device Recalls, 2005–2010 37Table 13: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Number of Medical Device Recalls, 2005–2010 39Table 14: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Number of Medical Device Recalls, 2005–2010 41Table 15: Regulatory Intelligence on Medical Device Recalls, Classification of Medical Devices in the UK, 2010 57
1.2 List of Figures
Figure 1: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls, 2005–2010 12Figure 2: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Class (%), 2005–2010 13Figure 3: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls by Class, 2005–2010 14Figure 4: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Therapeutic Area (%), 2005–2010 15Figure 5: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Root Cause (%), 2008–2010 16Figure 6: Regulatory Intelligence on Medical Device Recalls, US, Recall Share of Top 10 Recall Companies (%), 2005–2010 17Figure 7: Regulatory Intelligence on Medical Device Recalls, US, 10 Companies that Initiated the Most Device Recalls, 2005–2010 18Figure 8: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Number of Medical Device Recalls by Year, 2005–2010 19Figure 9: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Medical Device Recalls by Recall Class (%), 2005–2010 20Figure 10: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Number of Medical Device Recalls by Year, 2005–2010 21Figure 11: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Medical Device Recalls by Recall Class (%), 2005–2010 22Figure 12: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Number of Medical Device Recalls by Year, 2005–2010 23Figure 13: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Medical Device Recalls by Recall Class (%), 2005–2010 24Figure 14: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Number of Medical Device Recalls by Year, 2005–2010 26Figure 15: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Medical Device Recalls by Recall Class (%), 2005–2010 27Figure 16: Regulatory Intelligence on Medical Device Recalls, US, GE, Number of Medical Device Recalls by Year, 2005–2010 28Figure 17: Regulatory Intelligence on Medical Device Recalls, US, GE, Medical Device Recalls by Recall Class (%), 2005–2010 29Figure 18: Regulatory Intelligence on Medical Device Recalls, US, Philips, Number of Medical Device Recalls by Year, 2005–2010 30Figure 19: Regulatory Intelligence on Medical Device Recalls, US, Philips, Medical Device Recalls by Recall Class (%), 2005–2010 31Figure 20: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Number of Medical Device Recalls by Year, 2005–2010 33Figure 21: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Medical Device Recalls by Recall Class (%), 2005–2010 34Figure 22: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Number of Medical Device Recalls by Year, 2005–2010 36Figure 23: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Medical Device Recalls by Recall Class (%), 2005–2010 37Figure 24: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Number of Medical Device Recalls by Year, 2005–2010 38Figure 25: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Medical Device Recalls by Recall Class (%), 2005–2010 39Figure 26: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Number of Medical Device Recalls by Year, 2005–2010 40Figure 27: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Medical Device Recalls by Recall Class (%), 2005–2010 41Figure 28: Regulatory Intelligence on Medical Device Recalls, Phases in the Life Span of a Medical Device, 2011 45Figure 29: Regulatory Intelligence on Medical Device Recalls, Medical Equipment Approval Process in the US, 2010 50Figure 30: Regulatory Intelligence on Medical Device Recalls, 510(k) Approval Process for Medical Devices in the US, 2010 51Figure 31: Regulatory Intelligence on Medical Device Recalls, PMA Approval Process in the US, 2010 54Figure 32: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class I Medical Devices, 2010 58Figure 33: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class IIa Medical Devices, 2010 59Figure 34: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class IIb Medical Devices, 2010 59Figure 35: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class III Medical, 2010 60Figure 36: Regulatory Intelligence on Medical Device Recalls, Medical Device Classification in Japan, 2010 67Figure 37: Regulatory Intelligence on Medical Device Recalls, Approval Process for Controlled Medical Devices in Japan, 2010 68Figure 38: Regulatory Intelligence on Medical Device Recalls, Approval Process for Highly Controlled Medical Devices in Japan, 2010 69
To order this report:Medical Devices Industry: Regulatory Intelligence on Medical Device Recalls – Ineffective Process Control, Defects in Design of Device, Software or Other Components are the Major Reasons for Recall
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