Integrated safety and risk assessment for medical devices and combination products / Shayne C. Gad.

Format:

Book

Author/Creator:

Gad, Shayne C., 1948- author.

Language:

English

Subjects (All):

Medical instruments and apparatus--Safety measures.

Medical instruments and apparatus.

Medical instruments and apparatus--Testing.

Pharmacology.

Physical Description:

xiii, 490 pages : some illustrations ; 25 cm

Place of Publication:

Cham : Springer, [2019]

Summary:

While the safety assessment ("biocompatibility") of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials - largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also co nservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. · Identify and verify the most appropriate available data. · As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. · As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. · As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. · Incorporating assessments for special populations such as neonates. · Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. · Performance and presentation of integrative assessments cov er ing all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.

Contents:

1. Introduction

History and Where We are Headed

2. Regulatory Guidance

3. Sample Preparation and Biocompatibility Testing

4. Testing for Leachables and Extractables

5. Where the Data is

And What is It?

6. Bridging Issues of Route

7. Risk Assessments for Medical Devices

8. (Q)SAR

9. Histopathology in Medical Device Studies

10. Assessment of Nanomaterial Devices

11. Integrated Safety Assessments for Devices

12. Toxicity of Common Extractables and Leachables.

Notes:

Includes bibliographical references and index.

Other Format:

e-book version

ISBN:

9783030352400

3030352404

OCLC:

1147756776

Publisher Number:

9783030352400