How to test medical devices as families? Dr. Sophie Michel Study Director Medical Devices Toxikon Europe
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1 How to test medical devices as families? Dr. Sophie Michel Study Director Medical Devices Toxikon Europe
2 Introduction
3 Category Body Contact Contact Contact duration Cytotoxicity Sensitivity/Sensitization Chemical characterization ISO (2017): Biocompatibility Evaluation Matrix Device Categories Initial Evaluation Supplemental Body Surface Contact Device/Surface Device Devices connecting the internal to the external/external communicating device Internally implanted devices/implant device Skin Mucous/Mucosal Membrane Breached/Compromised Surface Blood Vessels/Blood Path Indirect Tissue/Bone/Dentin Circulating Blood Tissue/Bone Blood Irritation/Intracutaneous Reactivity Systemic Toxicity (Acute) Pyrogenicity Sub acute and/or Sub chronic toxicity Genetic Toxicity/Genotoxicity less than 24 hours 24 hours to 30 days more than a 30 days less than 24 hours 24 hours to 30 days more than a 30 days less than 24 hours 24 hours to 30 days more than a 30 days less than 24 hours 24 hours to 30 days more than a 30 days less than 24 hours 24 hours to 30 days more than a 30 days less than 24 hours 24 hours to 30 days more than a 30 days less than 24 hours 24 hours to 30 days more than a 30 days less than 24 hours 24 hours to 30 days more than a 30 days Implantation Hemocompatibility Chronic Toxicity Carcinogenicity Reproductive/ Developmental Biodegradation/ Biodegradable = Evaluation required by ISO, FDA and MHLW = Evaluation required by ISO and FDA =Evaluation required by FDA =Evaluation required by ISO
4 ISO (2017): Risk Management Process GAP ANALYSIS
5 ISO (2017): Risk Management Process GAP ANALYSIS TOX ASSESSMENT
6 ISO (2017): Challenges for companies PAST
7 ISO (2017): Challenges for companies PAST FUTURE
8 ISO (2017): Challenges for companies
9 ISO (2017): Challenges for companies
10 Chemical characterisation What level is needed?
11 Analyses of the extracts VOC SVOC NVOC HS-GC/MS Screening GC/MS Screening UPLC/MS Screening ICP/OES IC Reflux
12 Analyses of the extracts Evaluation? VOC SVOC NVOC HS-GC/MS Screening GC/MS Screening UPLC/MS Screening ICP/OES IC Reflux AET
13 Analyses of the extracts Evaluation? VOC SVOC NVOC RL? HS-GC/MS Screening GC/MS Screening UPLC/MS Screening ICP/OES IC Reflux AET
14 Analyses of the extracts Evaluation? VOC SVOC NVOC RL? HS-GC/MS Screening GC/MS Screening UPLC/MS Screening ICP/OES IC Reflux AET
15 Analyses of the extracts Evaluation? VOC SVOC NVOC RL? HS-GC/MS Screening GC/MS Screening UPLC/MS Screening ICP/OES IC Reflux AET
16 ISO (2017): what level is needed? Analytical Evaluation Threshold
17 Calculation of the AET
18 Calculation of the AET: which guideline should be used?» TTC (Threshold of Toxicological Concern) for medical device: Potential guideline: ICH M7
19 Calculation of the AET: which guideline should be used?» TTC for medical device: Potential guideline: ICH M7
20 Calculation of the AET: which guideline should be used?» TTC for medical device: Potential guideline: PQRI: 5 µg/day
21 Calculation of the AET: which guideline should be used?» TTC for medical device: Potential guideline: PQRI: 5 µg/day Choose the most worst-case one!
22 Calculation of the AET: how many devices can be implanted in a day? 10 devices in a day 1 device in a day
23 Calculation of the AET: how many devices can be implanted in a day? 10 devices in a day 1 device in a day Permanent implant: TTC = 1.5 µg/day
24 Calculation of the AET: how many devices can be implanted in a day? 10 devices in a day 1 device in a day Permanent implant: TTC = 1.5 µg/day
25 Calculation of the AET Option 1: devices pooled at a ratio 1/1
26 Pooling ratio 1/1: impact on the AET Surface area: 10 cm² Surface area: 40 cm² 10 devices in a day 1 device in a day
27 Pooling ratio 1/1: impact on the AET Surface area: 10 cm² Surface area: 40 cm² 10 devices in a day 1 device in a day Maximum dose of the family : 10 devices in a day
28 Pooling ratio 1/1: impact on the AET Surface area: 10 cm² Surface area: 40 cm² TTC = 1.5 µg/day 10 devices in a day TTC = 0.15 µg/family Total surface area of the family: 50 cm² AET = µg/cm²
29 Calculation of the AET Option 2: devices pooled at a ratio based on the maximal dose in a day
30 Pooling ratio based on the maximal dose in a day: impact on the AET Surface area: 10 cm² Surface area: 40 cm² 10 devices in a day 1 device in a day
31 Pooling ratio based on the maximal dose in a day: impact on the AET Surface area: 10 cm² Surface area: 40 cm² 10 devices in a day 1 device in a day Family: = 11 devices Maximum dose of the family: 1 family in a day
32 Pooling ratio based on the maximal dose in a day: impact on the AET Surface area: 10 cm² Surface area: 40 cm² TTC = 1.5 µg/day 1 family in a day TTC = 1.5 µg/family Total surface area of the family: 140 cm² AET = µg/cm²
33 Pooling ratio based on the maximal dose in a day: impact on the AET Surface area: 10 cm² Surface area: 40 cm² TTC = 1.5 µg/day 1 family in a day TTC = 1.5 µg/family Ratio 1/1 AET = µg/cm² AET = µg/cm² Total surface area of the family: 140 cm²
34 Pooling strategy: impact on the sample requirement
35 Pooling ratio and sample requirements AET = µg/cm² AET = 9 µg/l Ratio 3 cm²/ml AET = µg/cm² AET = 30 µg/l Ratio 3 cm²/ml
36 Pooling ratio and sample requirements AET = µg/cm² AET = 9 µg/l Ratio 3 cm²/ml AET = µg/cm² AET = 30 µg/l Ratio 3 cm²/ml Standard detection limit for semi and non-volatiles: 500 µg/l
37 Pooling ratio and sample requirements AET = µg/cm² AET = 9 µg/l Ratio 3 cm²/ml AET = µg/cm² AET = 30 µg/l Ratio 3 cm²/ml Standard detection limit for semi and non-volatiles: 500 µg/l Concentration factor is needed to analyse up to 5 µg/l (lowest detection limit analytically feasible)
38 Pooling ratio and sample requirements AET = µg/cm² AET = 9 µg/l Ratio 3 cm²/ml AET = µg/cm² AET = 30 µg/l Ratio 3 cm²/ml 360 cm² needed 120 cm² needed
39 Pooling ratio and sample requirements AET = µg/cm² AET = 9 µg/l Ratio 3 cm²/ml AET = µg/cm² AET = 30 µg/l Ratio 3 cm²/ml 360 cm² needed 120 cm² needed 50 cm²/family 140 cm²/family 8 families 1 family
40 Pooling ratio and sample requirements AET = µg/cm² AET = 9 µg/l Ratio 3 cm²/ml AET = µg/cm² AET = 30 µg/l Ratio 3 cm²/ml 360 cm² needed 120 cm² needed 50 cm²/family 140 cm²/family 8 families 1 family
41 Design of the families Think about your CRO
42 Case study 1: size matters SENT TO TOXIKON TEST Unitary Surface Area (mm²) Quantity per extract Surface Area Per extract (mm²) , , Family TOTAL ,6
43 Case study 1: size matters SENT TO TOXIKON TEST Unitary Surface Area (mm²) Quantity per extract Surface Area Per extract (mm²) , , Family TOTAL ,6 Surface area of the family: 1721 cm²!
44 Case study 1: size matters Permanent implant: TTC = 1.5 µg/day 1 family in a day TTC = 1.5 µg/family Total surface area of the family: 1721 cm² AET = µg/cm² Ratio 3 cm²/ml AET = 2.4 µg/l
45 Case study 1: size matters Permanent implant: TTC = 1.5 µg/day 1 family in a day TTC = 1.5 µg/family Total surface area of the family: 1721 cm² AET = µg/cm² Ratio 3 cm²/ml AET = 2.4 µg/l Minimal detection limit for organic compounds: 5 µg/l after concentration
46 Case study 2: Laboratory constrains exist Total surface area of the family: 256 cm² 2 families per day AET = µg/cm² Ratio 3 cm²/ml AET = 6.0 µg/l
47 Case study 2: Laboratory constrains exist Limitations Shape & Thickness Shape device Shape extraction container
48 Case study 2: Laboratory constrains exist Total surface area of the family: 256 cm² 2 families per day AET = µg/cm² Final ratio used by the laboratory: 1.5 cm²/ml
49 Case study 2: Laboratory constrains exist Total surface area of the family: 256 cm² 2 families per day AET = µg/cm² Final ratio used by the laboratory: 1.5 cm²/ml AET = 3.0 µg/l
50 Understand how the data will be interpreted
51 Interpreting the data: differences matter
52 Interpreting the data: differences matter DEHP
53 Interpreting the data: differences matter 0 µg/device DEHP 6 µg/device
54 Interpreting the data: differences matter 0 µg/device DEHP 6 µg/device In the family: 6 µg
55 Interpreting the data: differences matter 0 µg/device DEHP 6 µg/device In the family: 6 µg Surface area: 40 cm² Surface area: 40 cm²
56 Interpreting the data: differences matter 0 µg/device DEHP 6 µg/device In the family: 6 µg Surface area: 40 cm² Surface area: 40 cm² 3 µg/device 3 µg/device
57 Interpreting the data: differences matter 0 µg/device DEHP 6 µg/device In the family: 6 µg Surface area: 40 cm² Surface area: 40 cm² 3 µg/device 3 µg/device
58 Interpreting the data: differences matter
59 Interpreting the data: differences matter 0 µg/device DEHP 6 µg/device In the family: 6 µg 6 µg/device 6 µg/device
60 CONCLUSION
61 Conclusion - Save money - Save time
62 Conclusion - Save money - More compounds reported - Difficulties are multiplied - Save time - Compounds detected impact the whole family
63 Questions For further questions, please contact:
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