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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

Published By :

GBI Research

Published Date : Apr 2012

Category :

Software

No. of Pages : 73 Pages


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 20052010. 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 20052010. 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 20052010, 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 20052010.
  • 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 companys 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.
Table of Contents

1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6

2 Regulatory Intelligence on Medical Device Recalls - Introduction 8
2.1 GBI Report Guidance 9

3 Regulatory Intelligence on Medical Device Recalls - Overview 10
3.1 FDA Medical Device Recall Process 11

4 Analysis of Medical Device Recalls from 2005–2010 12
4.1 Number of Recalls by Year 12
4.2 Number of Recalls by Class 13
4.3 Number of Recalls by Therapeutic Area 15
4.4 Number of Recalls by Root Cause 16
4.5 Number of Recalls by Top Ten Recall Firms 17
4.6 Analysis of Top 10 Recall Companies’ Medical Device Recalls 19
4.6.1 Stryker 19
4.6.2 Abbott 21
4.6.3 Medtronic 23
4.6.4 Siemens 25
4.6.5 GE 28
4.6.6 Philips 30
4.6.7 Boston Scientific 32
4.6.8 Baxter 36
4.6.9 Zimmer 38
4.6.10 Biomet 40

5 Global Harmonization Task Force 43
5.1 Scope of GHTF 43
5.2 Benefits of GHTF 43

6 Medical Device Safety 44
6.1 Medical Device Safety and Risk Management 44
6.1.1 Phases in the Life Span of a Medical Device 45

7 Regulatory Intelligence on Medical Devices - The US 47
7.1 Overview of the Medical Equipment Industry 47
7.2 Regulation System 47
7.2.1 Medical Equipment Approval Process 48
7.2.2 Device Classification 48
7.2.3 Medical Device Review Process 49
7.2.4 Post-market Approval Process 55

8 Regulatory Intelligence on Medical Devices- Top Five European Countries 56
8.1 Europe 56
8.1.1 Overview of the Medical Equipment Industry 56
8.1.2 Regulation System 56
8.2 UK 60
8.2.1 Regulation System 60
8.2.2 Post-market Surveillance 61
8.3 Germany 61
8.3.1 Regulation System 61
8.3.2 Post-market Surveillance 62
8.4 France 62
8.4.1 Regulation System 62
8.4.2 Post-market Surveillance 62
8.5 Spain 63
8.5.1 Regulation System 63
8.6 Italy 63
8.6.1 Regulation System 64
8.6.2 Post-market Surveillance 64

9 Regulatory Intelligence on Medical Devices - Japan 65
9.1 Overview of the Medical Equipment Industry 65
9.2 Regulation System 66
9.2.1 Medical Equipment Approval Process 66
9.2.2 Device Classification 66
9.2.3 Third Party Certification for Controlled Medical Devices 67
9.2.4 PMDA Approval for Highly Controlled Medical Devices 68
9.2.5 Post-market Surveillance 69
9.2.6 Labeling and Packaging 69

10 Appendix 71
10.1 Market Definitions 71
10.2 Abbreviations 71
10.3 Research Methodology 72
10.3.1 Coverage 72
10.3.2 Analysis of Medical Device Recalls in the US 72
10.3.3 Regulatory Intelligence on Medical Devices in the US 72
10.3.4 Regulatory Intelligence on Medical Devices in the Top Five European Countries 72
10.3.5 Regulatory Intelligence on Medical Devices in Japan 73
10.3.6 Expert Panels 73
10.4 Contact Us 73
10.5 Disclaimer 73
10.6 Sources 73

List of Table


Table 1: Regulatory Intelligence on Medical Device Recalls, Comparison of FDA Recall Classification and Device Classification, 2011 11
Table 2: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls, 20052010 12
Table 3: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls by Class, 20052010 14
Table 4: Regulatory Intelligence on Medical Device Recalls, US, 10 Companies that Initiated the Most Device Recalls, 20052010 18
Table 5: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Number of Medical Device Recalls, 20052010 20
Table 6: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Number of Medical Device Recalls, 20052010 22
Table 7: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Number of Medical Device Recalls, 20052010 25
Table 8: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Number of Medical Device Recalls, 20052010 27
Table 9: Regulatory Intelligence on Medical Device Recalls, US, GE, Number of Medical Device Recalls, 20052010 29
Table 10: Regulatory Intelligence on Medical Device Recalls, US, Philips, Number of Medical Device Recalls, 20052010 32
Table 11: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Number of Medical Device Recalls, 20052010 35
Table 12: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Number of Medical Device Recalls, 20052010 37
Table 13: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Number of Medical Device Recalls, 20052010 39
Table 14: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Number of Medical Device Recalls, 20052010 41
Table 15: Regulatory Intelligence on Medical Device Recalls, Classification of Medical Devices in the UK, 2010 57

List of Chart


Figure 1: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls, 20052010 12
Figure 2: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Class (%), 20052010 13
Figure 3: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls by Class, 20052010 14
Figure 4: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Therapeutic Area (%), 20052010 15
Figure 5: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Root Cause (%), 20082010 16
Figure 6: Regulatory Intelligence on Medical Device Recalls, US, Recall Share of Top 10 Recall Companies (%), 20052010 17
Figure 7: Regulatory Intelligence on Medical Device Recalls, US, 10 Companies that Initiated the Most Device Recalls, 20052010 18
Figure 8: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Number of Medical Device Recalls by Year, 20052010 19
Figure 9: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Medical Device Recalls by Recall Class (%), 20052010 20
Figure 10: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Number of Medical Device Recalls by Year, 20052010 21
Figure 11: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Medical Device Recalls by Recall Class (%), 20052010 22
Figure 12: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Number of Medical Device Recalls by Year, 20052010 23
Figure 13: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Medical Device Recalls by Recall Class (%), 20052010 24
Figure 14: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Number of Medical Device Recalls by Year, 20052010 26
Figure 15: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Medical Device Recalls by Recall Class (%), 20052010 27
Figure 16: Regulatory Intelligence on Medical Device Recalls, US, GE, Number of Medical Device Recalls by Year, 20052010 28
Figure 17: Regulatory Intelligence on Medical Device Recalls, US, GE, Medical Device Recalls by Recall Class (%), 20052010 29
Figure 18: Regulatory Intelligence on Medical Device Recalls, US, Philips, Number of Medical Device Recalls by Year, 20052010 30
Figure 19: Regulatory Intelligence on Medical Device Recalls, US, Philips, Medical Device Recalls by Recall Class (%), 20052010 31
Figure 20: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Number of Medical Device Recalls by Year, 20052010 33
Figure 21: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Medical Device Recalls by Recall Class (%), 20052010 34
Figure 22: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Number of Medical Device Recalls by Year, 20052010 36
Figure 23: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Medical Device Recalls by Recall Class (%), 20052010 37
Figure 24: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Number of Medical Device Recalls by Year, 20052010 38
Figure 25: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Medical Device Recalls by Recall Class (%), 20052010 39
Figure 26: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Number of Medical Device Recalls by Year, 20052010 40
Figure 27: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Medical Device Recalls by Recall Class (%), 20052010 41
Figure 28: Regulatory Intelligence on Medical Device Recalls, Phases in the Life Span of a Medical Device, 2011 45
Figure 29: Regulatory Intelligence on Medical Device Recalls, Medical Equipment Approval Process in the US, 2010 50
Figure 30: Regulatory Intelligence on Medical Device Recalls, 510(k) Approval Process for Medical Devices in the US, 2010 51
Figure 31: Regulatory Intelligence on Medical Device Recalls, PMA Approval Process in the US, 2010 54
Figure 32: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class I Medical Devices, 2010 58
Figure 33: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class IIa Medical Devices, 2010 59
Figure 34: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class IIb Medical Devices, 2010 59
Figure 35: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class III Medical, 2010 60
Figure 36: Regulatory Intelligence on Medical Device Recalls, Medical Device Classification in Japan, 2010 67
Figure 37: Regulatory Intelligence on Medical Device Recalls, Approval Process for Controlled Medical Devices in Japan, 2010 68
Figure 38: Regulatory Intelligence on Medical Device Recalls, Approval Process for Highly Controlled Medical Devices in Japan, 2010 69

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