國立高雄大學圖資館 |

Language: English

Back

Integrated safety and risk assessmen...

Gad, Shayne C.

Integrated safety and risk assessment for medical devices and combination products

Record Type:	Electronic resources : Monograph/item
Title/Author:	Integrated safety and risk assessment for medical devices and combination productsby Shayne C. Gad.
Author:	Gad, Shayne C.
Published:	Cham :Springer International Publishing :2019.
Description:	xiii, 490 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
Subject:	Medical instruments and apparatusSafety measures.
Online resource:	https://doi.org/10.1007/978-3-030-35241-7
ISBN:	9783030352417$q(electronic bk.)

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

Integrated safety and risk assessment for medical devices and combination products[electronic resource] /by Shayne C. Gad. - Cham :Springer International Publishing :2019. - xiii, 490 p. :ill., digital ;24 cm.

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.

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 conservative) 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 covering 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.

ISBN: 9783030352417$q(electronic bk.)

Standard No.: 10.1007/978-3-030-35241-7doiSubjects--Topical Terms:

485265
Medical instruments and apparatus
--Safety measures.

LC Class. No.: R856.6 / .G33 2019

Dewey Class. No.: 681.7610289

Integrated safety and risk assessment for medical devices and combination products
LDR:03737nmm a2200325 a 4500 001 569215
003 DE-He213
005 20200428173220.0
006 m d
007 cr nn 008maaau
008 200723s2019 sz s 0 eng d
020 $a 9783030352417$q(electronic bk.)
020 $a 9783030352400$q(paper)
024 7 $a 10.1007/978-3-030-35241-7 $2 doi
035 $a 978-3-030-35241-7
040 $a GP $c GP
041 0 $a eng
050 4 $a R856.6 $b .G33 2019
072 7 $a MMG $2 bicssc
072 7 $a MED071000 $2 bisacsh
072 7 $a MKG $2 thema
082 0 4 $a 681.7610289 $2 23
090 $a R856.6 $b .G123 2019
100 1 $a Gad, Shayne C. $3 509153
245 1 0 $a Integrated safety and risk assessment for medical devices and combination products $h [electronic resource] / $c by Shayne C. Gad.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2019.
300 $a xiii, 490 p. : $b ill., digital ; $c 24 cm.
505 0 $a 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.
520 $a 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 conservative) 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 covering 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.
650 0 $a Medical instruments and apparatus $x Safety measures. $3 485265
650 0 $a Medical instruments and apparatus $x Testing. $3 648945
650 1 4 $a Pharmacology/Toxicology. $3 273652
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer eBooks
856 4 0 $u https://doi.org/10.1007/978-3-030-35241-7
950 $a Biomedical and Life Sciences (Springer-11642)