Regulatory Intelligence on Medical Device Recalls - Ineffective Process Control, Defects in Design of Device, Software or Other Components are the Major Reasons for Recall

GBI Research, April 2012, Pages: 73

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.

1.1 List of Tables
1.2 List of Figures

2 Regulatory Intelligence on Medical Device Recalls - Introduction
2.1 GBI Report Guidance
3 Regulatory Intelligence on Medical Device Recalls - Overview

3.1 FDA Medical Device Recall Process

4 Analysis of Medical Device Recalls from 2005–2010
4.1 Number of Recalls by Year
4.2 Number of Recalls by Class
4.3 Number of Recalls by Therapeutic Area
4.4 Number of Recalls by Root Cause
4.5 Number of Recalls by Top Ten Recall Firms
4.6 Analysis of Top 10 Recall Companies’ Medical Device Recalls
4.6.1 Stryker
4.6.2 Abbott
4.6.3 Medtronic
4.6.4 Siemens
4.6.5 GE
4.6.6 Philips
4.6.7 Boston Scientific
4.6.8 Baxter
4.6.9 Zimmer
4.6.10 Biomet

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

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

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

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

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

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

1.1 List of Tables
Table 1: Regulatory Intelligence on Medical Device Recalls, Comparison of FDA Recall Classification and Device Classification, 2011
Table 2: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls, 2005–2010
Table 3: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls by Class, 2005–2010
Table 4: Regulatory Intelligence on Medical Device Recalls, US, 10 Companies that Initiated the Most Device Recalls, 2005–2010
Table 5: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Number of Medical Device Recalls, 2005–2010
Table 6: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Number of Medical Device Recalls, 2005–2010
Table 7: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Number of Medical Device Recalls, 2005–2010
Table 8: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Number of Medical Device Recalls, 2005–2010
Table 9: Regulatory Intelligence on Medical Device Recalls, US, GE, Number of Medical Device Recalls, 2005–2010
Table 10: Regulatory Intelligence on Medical Device Recalls, US, Philips, Number of Medical Device Recalls, 2005–2010
Table 11: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Number of Medical Device Recalls, 2005–2010
Table 12: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Number of Medical Device Recalls, 2005–2010
Table 13: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Number of Medical Device Recalls, 2005–2010
Table 14: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Number of Medical Device Recalls, 2005–2010
Table 15: Regulatory Intelligence on Medical Device Recalls, Classification of Medical Devices in the UK, 2010

1.2 List of Figures
Figure 1: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls, 2005–2010
Figure 2: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Class (%), 2005–2010
Figure 3: Regulatory Intelligence on Medical Device Recalls, US, Number of Medical Device Recalls by Class, 2005–2010
Figure 4: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Therapeutic Area (%), 2005–2010
Figure 5: Regulatory Intelligence on Medical Device Recalls, US, Medical Device Recalls by Root Cause (%), 2008–2010
Figure 6: Regulatory Intelligence on Medical Device Recalls, US, Recall Share of Top 10 Recall Companies (%), 2005–2010
Figure 7: Regulatory Intelligence on Medical Device Recalls, US, 10 Companies that Initiated the Most Device Recalls, 2005–2010
Figure 8: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Number of Medical Device Recalls by Year, 2005–2010
Figure 9: Regulatory Intelligence on Medical Device Recalls, US, Stryker, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 10: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Number of Medical Device Recalls by Year, 2005–2010
Figure 11: Regulatory Intelligence on Medical Device Recalls, US, Abbott, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 12: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Number of Medical Device Recalls by Year, 2005–2010
Figure 13: Regulatory Intelligence on Medical Device Recalls, US, Medtronic, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 14: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Number of Medical Device Recalls by Year, 2005–2010
Figure 15: Regulatory Intelligence on Medical Device Recalls, US, Siemens, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 16: Regulatory Intelligence on Medical Device Recalls, US, GE, Number of Medical Device Recalls by Year, 2005–2010
Figure 17: Regulatory Intelligence on Medical Device Recalls, US, GE, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 18: Regulatory Intelligence on Medical Device Recalls, US, Philips, Number of Medical Device Recalls by Year, 2005–2010
Figure 19: Regulatory Intelligence on Medical Device Recalls, US, Philips, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 20: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Number of Medical Device Recalls by Year, 2005–2010
Figure 21: Regulatory Intelligence on Medical Device Recalls, US, Boston Scientific, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 22: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Number of Medical Device Recalls by Year, 2005–2010
Figure 23: Regulatory Intelligence on Medical Device Recalls, US, Baxter, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 24: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Number of Medical Device Recalls by Year, 2005–2010
Figure 25: Regulatory Intelligence on Medical Device Recalls, US, Zimmer, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 26: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Number of Medical Device Recalls by Year, 2005–2010
Figure 27: Regulatory Intelligence on Medical Device Recalls, US, Biomet, Medical Device Recalls by Recall Class (%), 2005–2010
Figure 28: Regulatory Intelligence on Medical Device Recalls, Phases in the Life Span of a Medical Device, 2011
Figure 29: Regulatory Intelligence on Medical Device Recalls, Medical Equipment Approval Process in the US, 2010
Figure 30: Regulatory Intelligence on Medical Device Recalls, 510(k) Approval Process for Medical Devices in the US, 2010
Figure 31: Regulatory Intelligence on Medical Device Recalls, PMA Approval Process in the US, 2010
Figure 32: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class I Medical Devices, 2010
Figure 33: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class IIa Medical Devices, 2010
Figure 34: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class IIb Medical Devices, 2010
Figure 35: Regulatory Intelligence on Medical Device Recalls, EU, Conformity Assessment of Class III Medical, 2010
Figure 36: Regulatory Intelligence on Medical Device Recalls, Medical Device Classification in Japan, 2010
Figure 37: Regulatory Intelligence on Medical Device Recalls, Approval Process for Controlled Medical Devices in Japan, 2010
Figure 38: Regulatory Intelligence on Medical Device Recalls, Approval Process for Highly Controlled Medical Devices in Japan, 2010

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