Handbook of Medical Device Design PDF
Preview Handbook of Medical Device Design
7700664488..ccaasseewwrraapp..iinndddd 11 77//3311//22000077 1100::4466::1199 AAMM Handbook oj Medical Device Design Handbook of Medical Device Design edited by Richard C. Fries Datex-Ohmeda, Inc. Madison, Wisconsin o ~~~F~~~~", BocaRaton London NewYork CRCPressisanimprintofthe Taylor&FrancisGroup,aninformabusiness ISBN:0-8247-0399-5 Thisbookisprintedonacid-freepaper. Headquarters MarcelDekker 270MadisonAvenue,NewYork,NY 10016 tel: 212-696-9000;fax: 212-685-4540 Thepublisheroffersdiscountsonthisbookwhenorderedinbulkquantities. Formoreinfor mation,writetoSpecialSalesfProfessionalMarketingattheheadquartersaddressabove. Copyright©2001 byMarcelDekker AllRightsReserved. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher. Currentprinting(lastdigit): 10 9 8 7 6 5 4 3 2 PRINTEDINTHEUNITEDSTATESOFAMERICA To Alexa Bayley Fries whose smile, laughter, and enthusiasmfor life makeyou a very specialyoung lady Preface v Preface Themedicaldevicefield isoneofrapidtechnologicalinnovation. The processofdesigningandproducingmedicaldeviceshasbecomeanincreasingly moredifficultone,asthenumberofstandardsandregulationsconstantly increases,thefunctionalityofdevicesbecomesmorecomplex, andthe expectationsofthe customerregardingprice,reliability, andlifecyclecosts becomesmoredemanding. Thishandbookhasbeenwrittento givethoseprofessionalsworkingin the developmentanduseofmedicaldevicespracticalknowledge about biomedicaltechnology, regulations,andtheirrelationshiptoqualityhealthcare. Thishandbookincludespracticaltechniqueswhichadeveloperand manufacturerofmedicaldevicesmayincorporateintheirprocessesto improve themethodologyofdesigning andmanufacturingmedicaldevices,butto improvethefunctionalityandreliabilityofthedeviceaswell. Thelayoutofthehandbookfollows atypicalproductdevelopment process. Section I addresses the determinationanddocumentationofdevice requirements. Thefirst actionisdeterminingcustomerneeds. Oncethesehave beendetermined,productandthendesignspecificationsmustbedevelopedand documented, includingdesigningformanufacturinganddesigningfor service. Thisisalsothetimetoestablishcertainreliabilityandqualitymetricsthatcanbe monitoredthroughouttheproductdevelopmentcycle. vi Preface Section2addresses the currentregulatoryandstandards issues. Of special interestto medicaldevice manufacturersare FDAregulations,the ISO 9000series, the Medical Device Directives. Inaddition, the sectiondiscusses currentstandardsandregulations fromcountriessuchasCanada, Japan, and Australia. Thesectionalsoaddress intellectualpropertyconsiderations, suchas patents, copyrights, andtrademarks. Section3discussesactualdesign issues, byspecialty, as wellas corollaryissuespertinentto completingawellconceived,wellcontrolleddesign. Currentdesigntopicsare discussed inthe areasofelectrical,mechanical, software, industrialdesign, andhumanfactors. Preparingandmaintainingthe necessaryprojectfiles isdiscussed withexamplesofwhatis includedineach. Otherimportantissues thatareaddressed inthissectioninclude biocompatibility, safety/riskanalysis, reliability, thirdpartycertification, technical documentation, translations, and lifecyclecosts. Section4addressesthe importanttopicsofverificationandvalidation. Oncethe design iscompleted, itmustbeverifiedthatitsfunctionalitymeetsthe requirements that wereoriginallydocumented. Inaddition, the designmustbe proventoberobustandreliableovertime. Anoverviewofverificationand validationisprovidedfollowedbyadetailedinvestigationofelectrical, mechanical, andsoftwareverificationandvalidation. Section5examinesthemanufacturingprocess, because evenifthe productisdesigned tomeetappropriatestandardsandtobeveryreliable, unless theproductismanufacturedtothesamehighstandards,theproductwillbe a failure. This sectiondiscusses the variousaspects ofthemanufacturingprocess, the validationofthe manufacturingprocess,theparticularrequirementsofthe QualitySystemRegulationthatapplyto manufacturing, andfinally, howto preparefor aqualitysystemaudit. Knowledge ofessentialdesign, productdevelopment, qualityassurance, andregulatoryrequirementsandtechniques isanessentialpartofeverymedical device developmentprocess. Itishopedthatthishandbookwillbe aninvaluable resource inhelpingmedical device manufacturersdevelopasafe, effective, and reliableproductdevelopmentprocess. Iamindebtedto theauthors, notonlyfortheircontributions,butfor adviceandsuggestionsthathelpedshapethistext. RichardC. Fries Contents Vll Contents Preface v Contributors xvii Section 1 Standards and Regulations•..••.•••.•••..•••••.••..••.•••••••••••1 Chapter 1 FDA Regulations 3 RichardC. Fries 1.1 History ofDevice Regulation .4 1.2 Device Classification .5 1.3 Registration and Listing 9 1.4 Good LaboratoryPractices (GLP) 10 1.5 Good Manufacturing Practices (GMP) IO 1.6 Human Factors 11 1.7 Design Control. 11 1.8 Software 12 1.9 The FDAInspection 14 1.10 Dealing with the FDA 15 References 16 Chapter2 Preparingan FDA Submission 21 RichardC. Fries 2.1 DeviceClassification 22 2.2 TheTraditionaI51O(k) 26
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