M e d i c o I n d u s t r i e n

1. M e d i c o I n d u s t r i e n Meeting 20 August 2009

2. Andy Vaughan Environmental Consultant Eucomed andrew.vaughan@eucomed.be

3. Agenda • Discussion on: • Progress by CEN/CLC/TC3/WG1 "standard for phthalate labelling" : • Labelling requirements, minimum thresholds, • IFU information, deadline for implementation • The justification for use of phthalates for children, pregnant and nursing women • Interpretation of "intended use of such device includes treatment of children, pregnant and nursing women? • Is a precaution in the IFU for vulnerable groups always needed? • Interpretation of 'specific justification'? • Should there be measurements of phthalate exposure for all products containing phthalates? • Is it possible to justify a product containing phthalates, if a phthalate-free product exists for the same intended use? (and the same price?) • Measurements of phthalates. • Is a standard available? • Could the standard for measurement of food contact materials be applied? • Small Bore Connectors

4. prEN 15986 Requirements for labeling of medical devices containing phthalates (CEN/CLC/TC3/WG1 ) • Standard drafted • Just issued for comment (Comments to NSBs by 30 Nov 2009) • Proposes following symbols:

5. prEN 15986 Requirements for labelling of medical devices containing phthalates (CEN/CLC/TC3/WG1 ) • Standard still in development so may change (though unlikely) • May not be ready for 21 March 2010 • Symbol will need to be explained in IFU • Threshold for labelling: ‘part of the formulation’. • Why? • Plasticizer is a significant component of item (20-40%) • If threshold (eg 0.1%) how to demonstrate? (Eg testing, methodology)

6. REACH (1907/2006) • Article 33 • 1. Any supplier of an article containing a substance meeting the criteria in Article 57 [Annex XIV] and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance. • 2. On request by a consumer any supplier of an article containing a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) shall provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.The relevant information shall be provided, free of charge, within 45 days of receipt of the request.

7. The justification for use of phthalates for children, pregnant and nursing women

8. SCENIHR Report SCENIHR Report http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_014.pdf

9. Opinion of the UK MHRA 1/2 • The MHRA has reviewed the SCENIHR report and has concluded that: • there is no new evidence to suggest that medical devices plasticised with DEHP present an unacceptable health risk to humans. In particular, there is no proven effect of exposure to DEHP on male reproductive health – the adverse effect of concern in the SCENIHR report • medical devices containing DEHP-plasticised PVC have important clinical benefits • in view of the proven clinical benefits of PVC medical devices plasticised with DEHP it would be premature to recommend a change to other plasticisers. http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Technicalinformation/PhthalatesinPVCmedicaldevices/index.htm

10. Opinion of the UK MHRA 2/2 • Meanwhile, recognizing that the undesirable characteristics of DEHP-plasticised PVC represent only one facet of a complex risk-to-benefit equation, it appears at present that this material is essential in some medical devices used in critical circumstances. In some situations, coatings that lead to a significant reduction in DEHP-exposure can improve the total risk-to-benefit ratio. Where DEHP is not essential, the manufacturer’s risk assessment (required by the Medical Devices Directive) should lead to the conclusion that alternative materials that do not result in exposure to DEHP should be used. http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Technicalinformation/PhthalatesinPVCmedicaldevices/index.htm

11. EU Risk Assessment Reports European Union Risk Assessment Report DEHP http://ecb.jrc.ec.europa.eu/home.php?CONTENU=/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/

12. EN ISO 10993 Series Biological evaluation of medical devices • ISO 10993-1 Part 1: Evaluation and testing within a risk management process • ISO 10993-2:2006 Part 2: Animal welfare requirements • ISO/CD 10993-3 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity • ISO 10993-4:2002 Part 4: Selection of tests for interactions with blood • ISO 10993-5:2009 Part 5: Tests for in vitro cytotoxicity • ISO 10993-6:2007 Part 6: Tests for local effects after implantation • ISO 10993-7:2008 Part 7: Ethylene oxide sterilization residuals • ISO/FDIS 10993-9 Part 9: Framework for identification and quantification of potential degradation products • ISO/DIS 10993-10 Part 10: Tests for irritation and skin sensitization • ISO 10993-11:2006 Part 11: Tests for systemic toxicity • ISO/CD 10993-12 Part 12: Sample preparation and reference materials • ISO/DIS 10993-13 Part 13: Identification and quantification of degradation products from polymeric medical devices • ISO 10993-14:2001 Part 14: Identification and quantification of degradation products from ceramics • ISO 10993-15:2000 Part 15: Identification and quantification of degradation products from metals and alloys • ISO/DIS 10993-16 Part 16: Toxicokinetic study design for degradation products and leachables • ISO 10993-17:2002 Part 17: Establishment of allowable limits for leachable substances • ISO 10993-18:2005 Part 18: Chemical characterization of materials • ISO/TS 10993-19:2006 Part 19: Physico-chemical, morphological and topographical characterization of materials • ISO/TS 10993-20:2006 Part 20: Principles and methods for immunotoxicology testing of medical devices

13. Small Bore Connectors(Luer Connectors)

14. Small Bore Connectors • EN 13014: Connections for gas sampling tubes to anaesthetic and respiratory equipment. BSI appeal against ratification of Amendment and was successful Amendment nor ratified and Standard withdrawn (Danger of mis-connection)

15. Small Bore Connectors • EN 15546-1: 2008 Harmonised, but causing problems. From the ‘Introduction’: • FTG* recommended that the Luer connector should be restricted to devices intended to be connected to the vascular system or a hypodermic syringe. • No alternative for other applications at present. * Forum Task Group. Set up by CEN Healthcare Forum (CheF) steering group to consider mis-connection issues

16. Small Bore Connectors • UK National Patient Safety Agency proposing use of ‘safer’ (ie non luer) connectors by 31 March 2011 for neuraxial syringes and needles that will not connect with intravenous devices, to collect samples and administer medicines by neuraxial routes.

17. Small Bore Connectors • ISO TC/210 starting work on 80369 series of Standards: • Part 1: General Requirements (To replace EN 15546-1 ) • Draft out for comment • Part 2: Connectors for breathing systems and driving gases applications • Draft out for comment • Part 3: Connectors for enteral applications • Part 4: Connectors for urethral and urinary applications • Part 5: Connectors for limb cuff inflation applications • Part 6: Connectors for neuraxial applications • New Work Item Proposal

18. M e d i c o I n d u s t r i e n Meeting 20 August 2009