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Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.
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Medical Device Usability: Polly Shelton presents at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint.

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Polly Shelton, Human Sciences Consultant at PDD, presented this 20 minute talk at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint event on Medical Device …

Polly Shelton, Human Sciences Consultant at PDD, presented this 20 minute talk at UK UPA (Usability Professional’s Association) and London Ergonomics Group (LEG) joint event on Medical Device Usability on the 26th January 2012.

Polly discusses the human centred design process as it applies to medical devices. She outlines the process, regulatory requirements in Europe and the US and talks through some case studies, finishing with some top tips for conducting and analysing usability tests of medical devices.

Published in: Design, Technology, Business
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  • 1. UKUPA and LEG, January 2012 Medical Device Usability | Polly Shelton | Human Factors ConsultantPage 1 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 2. pdd Consumer v Industrial Design Medical FMCG ServicesPage 2 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 3. History Computer Aided Design & Manufacture Industrial Design & Prototyping Engineering & Analysis 1980 1990Page 3 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 4. Innovation planning Human factors Design Insight 2000 2010Page 4 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 5. Medical devices group Radiation Medical does meter oxygen Urine meter Needle safe catheter IV Pump Wireless Inhaler dose stethoscope counter Heart-rate monitor Auto injector device Pen injectorPage 5 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 6. What is a medical device? A product used to diagnose, treat or monitor a medical condition Device classes (FDA) • Class I – general controls • Class II – general controls w/ special controls • Class III – general controls & premarket approval • & Combination products. These products should all undergo a usability engineering approach Depending on the class, more or less HFE required Class depends on complexity, use characteristics, risk to patient & amount of regulatory control neededPage 6 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 7. Human Factors and Usability International/EU FDA (USA) ISO/IEC 62366 ANSI/AAMI HE:75 Ensuring that products are developed for safe and effective use and that potential use-errors have been mitigated.Page 7 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 8. History International FDA (USA) ISO/IEC 62366 ANSI/AAMI HE:75 Usability engineering process Medical device manufacturers must demonstrate that all International (EU & FDA) potential use-related hazards in 6 pages (+80page annex) their devices have been identified, tested, and mitigated Helps “design in” usability and “design out” use error The device must be shown to be Used with ISO 14971 usable by the target population in the intended environment.Page 8 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 9. History International FDA (USA) ISO/IEC 62366 ANSI/AAMI HE:75 A virtual encyclopaedia that Provides design principles provides human factors and practical guidelines engineering design guidance, 25 chapters, 465 pages case studies, and checklists Officially recognised by FDA in October 2010 FDA draft guidance document June 2011Page 9 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 10. History Human factors engineering guidelines and preferred 1988 AAMI HE: practices for the design of medical devices Human factors engineering guidelines and preferred practices 1993 AAMI HE:48 for the design of medical devices 1999 Institute of Medicine Report : to Err is Human 2001 ANSI/AAMI HE:74 Human factors design process for medical devices FDA Medical devices – Application of usability engineering March 2007 ISO/IEC 62366 to medical devices 2010, EU Human factors design process for medical devices 2009 ANSI/AAMI HE:74 (reaffirmed) FDA November 2009 ANSI/AAMI HE:75 Human factors engineering – Design of medical devices 2010, FDAPage 10 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 11. Process flowchart: IEC/ISO 62366Page 11 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 12. Page 12 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 13. Usability & Risk management How do they interact? ISO 62366 has a complex flowchart showing how.Page 13 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 14. Usability engineering process Insight Iteration ValidationPage 14 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 15. Expert interviews Task analysis Iteration Validation Insight Desk research Ethnographic Contextual research enquiryPage 15 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 16. Concept Anthropometry & refinement biomechanics Insight Validation Iteration Interaction design Formative Use error risk & prototyping usability testing analysisPage 16 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 17. Usability goals and Residual riskacceptance criteria Insight Iteration Validation Summative usability testing Regulatory submissionPage 17 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 18. Usability engineering process Expert Formative usability interviews testing Anthropometry & biomechanics Usability goals and Ethnographic acceptance criteria Residual risk research Task analysis Concept refinement Insight Iteration Validation Regulatory Summative submission usability testing Desk research Contextual Use error enquiry Interaction design risk analysis & prototypingPage 18 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 19. Ethnographic research Observation, shadowing, journaling, contextual enquiry, journey mapping • Gain a holistic view of your users, the task and the context of use • Identify opportunities and pain points • Deep-dive into users needs and experiences • Create personas, scenarios, journey/experience mapsPage 19 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 20. Desk research User and task characteristics, human factors design guidelines • Understand your stakeholders and the problem • Review similar products • Gather anthropometric and strength data • Source best practice design guidelinesPage 20 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 21. Development & refinement Prototyping, cognitive walkthrough, heuristic review, formative usability tests • Involve users early and often • Test concepts • Identify design problems early • Understand mental models and user interactions • Involve designers and clients where possible • Inform the designPage 21 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 22. Task analysis and user FMEA Cognitive walkthrough, use scenarios, journey and task mapping • Understand the task • Identify physical, sensory and cognitive challenges • Identify and understand potential risks and foreseeable use error • Control and mitigate use error risk through designPage 22 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 23. Validation & residual risk Formal summative testing against quantitative usability goals • Identify critical task scenarios • Validate risk mitigation effectiveness through testing with users • Error analysis • Root cause analysis • Residual risk analysis and mitigation • Follow-up testing • Regulatory submissionPage 23 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 24. Medical device user testing • Why do usability testing? • Formative vs. summative • Recruiting participants • Legal and ethical considerations • Task selection • Setting usability goals • Test environment • Set-up and pilot • Moderating sessions • Providing assistance • Providing training • Testing instructions • Data collection and error logging • Error analysis and classificationPage 24 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 25. Why do usability testing? Increase device sales, Meet device customer loyalty, regulators’ reduce customer expectations support Improve ease-of-use, Improve safety and ease of learning and reduce medical user experience device use errorsPage 25 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 26. For medical devices, poor usability is literally a matter of life or deathPage 26 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 27. Some stats 100 medical device alerts “One third of medical device reports issued each year involve use-error and human (MHRA,2010) factors are inherent in virtually all and 403 device-related incidents.” FDA Manufacturer’s 10,280 Field Safety Corrective adverse Actions incident Deaths and undertaken reports in UK serious injuries 2010 (MHRA) involving 301 medical devices An estimated15- fatalities up 29% 20% of all errors last year 2,383 due to mechanical serious failure; 60-80% injuries human error*Page 27 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk *Institute of Medicine Report 2000, & Perrow 1984)
  • 28. Formative vs. summative tests What’s the difference? Formative Summative • Part of the iterative design process • Determines if a finished device is vulnerable to • Prototypes of any fidelity potential harmful use errors • More explorative, informing the design • Production equivalent devices • Identifies an evolving device’s strengths • Tasks must include primary operating functions and weaknesses and all safety-related tasks • Extensive discussion of likes and dislikes • Actual or simulated use environments • Preliminary usability objectives • Focus is on use-safety • Small samples (5-8 users per group) • Effectiveness, efficiency, user satisfaction & ease • User research and marketing questions of user learning also evaluated can easily be incorporated • Usability goals and acceptance criteria • Modest size report including design • Record use errors, close calls and root causes recommendations • Can be large sample sizes (25+ per user group) • 30-90 minute sessions • Training and final IFU may be included • 90 minute + sessionsPage 28 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 29. Recruiting participants • Reflect the actual user population • Define inclusion and exclusion criteria within each user group • Include users with physical, cognitive and sensory impairments • Consider co-morbidities • Use a medical specialist agency with BHBIA/EPhMRA • Allow at least 4-6 weeks for recruitment • Over-recruit by 10% • Be prepared for difficult recruits and arranging in-home testing where necessary • Beware of “professional” participants ‐ ask for ID / registration numbers where possible ‐ patients to bring current medication/ a recent prescription • Pilot your recruitment materials • Test in different marketsPage 29 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 30. Legal and ethical considerations • Ethics committee / IRB approval • BHBIA and EPhMRA codes of conduct • Data protection act, 1998 • ABPI code of conduct • Adverse events and pharmacovigilance • Country-specific requirements • Video recording, streaming and transfer • Incentives (BMA guidance): ‐ minimum level ‐ proportionate to time involved ‐ appropriate to respondent type and task nature ‐ air market value of the services provided ‐ vouchers and not cash for children • Testing with childrenPage 30 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 31. Task selection • If possible, test every user task! • If not, prioritize by: ‐ Safety Critical tasks, and ‐ Frequent tasks • Address worst case scenarios where possible • Link tasks to risk managementPage 31 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 32. Usability goals • Derived from: ‐ Risk analysis ‐ Primary operating functions ‐ User interface requirements ‐ Worst case scenarios • Define acceptance criteria by criticality and risk level But…. • Don’t base the success of your test on the achievement of usability goals against quantitative acceptance criteria! • Always conduct: ‐ root cause analysis ‐ follow-up risk analysisPage 32 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 33. Test environment • Simulate the real context of use where possible – Lighting levels – Thermal environment – Noise – Furniture – Other equipment – Potential hazards – Working space – Multi-tasking and distractions • Consider testing devices in-field – In the home – In clinical environments (e.g. ICU) • For high risk products (e.g. infusion pumps) consider validation with clinical evaluation.Page 33 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 34. Set-up and pilot • Test logistics, protocol and timings • Equipment checklist • Video recording ‐ Define work area ‐ If possible, use two cameras to capture detailed interactions and scene-view ‐ Make sure the audio is ON! ‐ Remote control • Live streaming • Seating arrangements: ‐ Sit behind / next to participant ‐ Observer out of field of view • Consider recruiting “real” pilot participant • Pilot data collection materials and analysisPage 34 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 35. Moderating sessions • Protect participants’ rights • Be professional and build trust • Create rapport; but stay in charge • Ask open questions • Don’t be a robot! – remember the script is a guide • Be unbiased • Be consistent • Let the participant speak • Take care with “think-aloud” • Give participants time • Let participants struggle… but keep them safe • Watch non-verbal cues • Probe where appropriate to understand root causes • Good seminar from UIE and Beth Loring http://www.uie.com/events/virtual_seminars/good_moderating/Page 35 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 36. Providing assistance • An assisted task is a task failure • Observing participants struggle, commit use errors or near misses provides insight • Only assist as a last resort - safety risk - repeated pattern of unproductive behaviour - task abandonment - after pre-established time-limit - in order to continue • Provide appropriate levels of assistance • Pre-establish prompts for consistency • All interventions should be reportedPage 36 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 37. Training • Simulate the real-life training scenario • Consider including a retention interval • Simulate the worst case scenario where appropriate • Consider including some untrained users Do not… • Deliver better than normal training! • Ask trainees to study for their test!Page 37 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 38. Testing instructions • Simulate the anticipated situation-of-use • Ask users to behave naturally - refer to IFU/ quick guide as they would at home • Follow-up to address IFU in detail - test all risk mitigations and warnings • Evaluate and rate specific attributes e.g. ‐ Clarity of text ‐ Terminology ‐ Pictograms ‐ Structure & flow ‐ Text size and legibility ‐ Ease of use ‐ Ease of finding information ‐ Completeness ‐ Density of informationPage 38 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 39. Data collection and error logging • Collect data concurrently • If possible, have 2 people taking notes • Debrief and align data post-session • Review video where required Task log and Excel spread sheet Data: • Success rate • Use errors, close calls, operational difficulties and their root causes • Assistance provided • Verbatim comments • Other observations and behaviours • Responses to questions and ratingsPage 39 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 40. Error analysis & classification • FDA are interested in understanding the root causes of errors • Probe to understand observed errors • ISO 62366 includes a taxonomy (adapted from James Reason) • Close calls and operational difficulties should also be recordedPage 40 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 41. Case Study: IV infusion set • Pre-summative test Changes • 22 participants recommend • 3 hour sessions to design & • 13 primary usability goals instructions • 40 secondary usability goals Training needs 11 primary & identified 14 secondary usability goals 10 15 Contextual unmet major use additional insights errors risks gathered observed identified to FMEAPage 41 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 42. Case Study: easypod device Improved ease-of-use, ease-of-dosing, comfort, confidence & safety Ethnographic fieldwork ROI: drug identified sales rose Full User need Centred 7.5% in the Design first year to approach €58m User requirements specificationPage 42 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 43. Further reading Some good resources to get startedPage 43 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk
  • 44. Get in contact and keep updated via …Page 44 COMMERCIAL IN CONFIDENCE | PDD Group Ltd 2011 ISO 9001 & ISD 134BS registered | www.pdd.co.uk

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