  WHO/PSM/PAR/2008.1 Interagency List of Essential Medical Devices for Reproductive Health World Health Organization John Snow Inc. PATH Population Action International United Nations Population Fund World Bank In collaboration with the United Nations Children's Fund   © World Health Organization 2008 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: bookorders@who.int ). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: permissions@who.int). 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In no event shall the World Health Organization be liable for damages arising from its use.  i Contents  Acknowledgements iii Background 1 ObjectiveoftheInteragencyListofEssentialMedicalDevicesforReproductiveHealth 2 Process 2 Productsnomenclature 2 Productsclassification 2 Productstechnicalspecifications 4 Nextsteps:requestforcommentsandsuggestions 4 Additionalreferences 4 InteragencyListofEssentialMedicalDevicesforReproductiveHealth 7 Structureofthelist 7 Annex1:IntegratedManagementofPregnancyandChildbirth(IMPAC) 19 Annex2:Specialnotes 23 Specialnoteforunitsandbiomaterialsusedformedicaldevices 24 Units 24 Glossaryofbiomaterialsusedformedicaldevicesmaterials 27 Specialnoteonpackagingandlabelling 29 Packaging 29 Labelling 30 Expirationofmedicaldeviceswithlimitedshelf‐life 30 Specialnoteoninjectionsafety 32 References 32 Specialnoteonhealth‐carewastemanagement 33 Health‐carewastemanagementincludesthefollowingsteps: 33 Wastezone 34 References 34 Specialnoteonsurgicalsutures 35 Typeofthread 35 Sizeofthread 35 Threadwithneedle 35 Typeofneedle 36 Specialnoteonstandardprecautionsforhealthworkers 37 Specialnoteonwearingprotectiveequipment 38 References 39 Specialnoteontextilesusedforlinenandclothing 40 Single‐usenon‐woventextiles 40 Reusablewoventextiles 40 Specialnoteonsterilizationofmedicaldevices 42 Classificationofreusablemedicaldevice 42 Steamsterilizatonmethod 42 Highleveldisinfection 43 Methodsthatarenotrecommended 43 References 43 Specialnoteonsurgicalinstruments,stainlesssteel 44 Familiesofproducts 44  ii iii Acknowledgements The following persons and organizations are thanked for their contributions to the revision of the InteragencyListofEssentialMedicalDevicesforReproductiveHealth.  Stéphanie Arsac‐Janvier (ICRC), Kay Bond (WHO),Yves Chartier (WHO), Meena Cherian (WHO),VincianeCruyt(MSF),NadineCornier(UNHCR),AnneSophieCoutin(MSF),Nick Dodd (UNFPA), Wilma Doedens (UNFPA), Lindsay Edouard (UNFPA), Marthe Everard (WHO),BjörnFahlgren(WHO),RobinGray(WHO),LisaHedman(PATH),PeterHeimann (WHO), Myriam Henkens (MSF), Hans V. Hogerzeil (WHO), Jane Hutchings (PATH), Kathleen Hurst (WHO), Monir Islam (WHO), Andrei Issakov (WHO), Ann Janssens (UNFPA), Shalini Jayasekar‐Zurn (WHO), Rita Kabra (WHO), Selma Khamassi (WHO), TrevorLessey(UNFPA),SophieLogez(WHO),MathewsMathai(WHO),JulesMillogo(John Snow,Inc.), Paula Nersesian(JohnSnow, Inc.),Clive Ondari(WHO),Hanne BakPedersen (UNICEF), Monique Renevier (WHO), Murtada Sesay (UNICEF), David Smith (UNFPA), Monique Supiot (UNICEF), Susanadela Torre (John Snow, Inc.), Jagdish Upadhyay (UNFPA),MargaretUsher‐Patel(WHO),PaulVanLook(WHO),GodfreyWalker(UNFPA). iv  1 Background Medicaldevicesare essential to theprovisionofqualityreproductive health (RH)services. Rationalselectionofmedicaldevicesisacrucialcomponentinensuringimprovedaccessto reproductive health commodities, followed by efficient procurement, logistical systems, rationaluseanddemandwhichareequallyimportant.  AreviewofexistingUnitedNations(UN)listsofessentialmedicinesandmedicaldevices, including (1) The draft UNFPA/WHO Essential Drugs and Other Commodities for Reproductive HealthServices List (2003)and(2)The Interagency  UNFPA/UNAIDS/WHO Reproductive Health Medicines and Commodities ListreportedalackofconsensusamongvariousUNagencieson essential medicinesand medical devices forRH. Lack of consistent advice to countries on selection of RH medicines and medical devices may hamper access to them. Thus, this review was the catalyst towards the development of one interagency list of essential medicinesforRHandoneinteragencylistforessentialmedicaldevicesforRH.  In2005,theInteragency List ofEssential Medicines for ReproductiveHealthdevelopedbyWHO in collaboration with partners was endorsed by major international organizations and agencies. In addition, the interagency working group for the selection of essential commoditiesforreproductivehealthagreedtoworktowardsaharmonizedlistofessential medicaldevicesforRH.  As defined by the Global Harmonization Task Force (GHTF), medical device  means any instrument,apparatus,implement,machine,appliance,implant,invitroreagentorcalibrator, software,materialorothersimilarorrelatedarticle:  a) Intended by the manufacturer to be used, alone or in combination, for human beingsforoneormoreofthespecificpurpose(s)of:  • diagnosis,prevention,monitoring,treatmentoralleviationofdisease • diagnosis,monitoring,treatment,alleviationoforcompensationforaninjury • investigation,replacement,modification,orsupportoftheanatomyorofa physiologicalprocess • supportingorsustaininglife • controlofconception • disinfectionofmedicaldevices • providinginformationformedicalordiagnosticpurposesbymeansofinvitro • examinationofspecimensderivedfromthehumanbody,and; b) Whichdoes notachieve its primaryintended action inor onthe human body by pharmacological, immunological or metabolic means, but which may be assisted in its intendedfunctionbysuchmeans. 2 Objective of the Interagency List of Essential Medical Devices for Reproductive Health This interagency list is a tool to support planning for the selection, quality assurance and procurement of medical devices to implementthe Maternal and Newborn Health (MNH)  interventions,whicharedefinedasthe“Essentialcaretowomenandtheirnewbornduring pregnancy,childbirthandpostnatalperiod:uptosixweeksafterdelivery.”Theobjectiveof thislististoproposeaninternationalconsensusonarationalselectionofessentialmedical devices for reproductive health according to their public health relevance on the basis of evidenceregarding,efficacy,safetyandcosteffectiveness. Process TheInteragencyListofEssentialMedicalDevicesforReproductiveHealthwasdevelopedby WHO in collaboration with UNICEF and UNFPA and major international and nongovernmentalorganizationsactiveinthefieldofreproductivehealth.In2004and2005, severalinteragencymeetingswereheldtodiscussthediscrepancymedicaldevicesexisting among the vario us lists. During these consultations, the decision was taken to develop a commonlistofdevicespercategoryofproductsandnotperrangeofclinicalinterventions, toavoidredundancy.AgreementswerereachedregardingtherangeofMNHinte rventions tobeconsidered,theproductsnomenclature,theproductsclassificatio ntobeusedandthe additionoftechnicalspecificationsperproductlisted. Thecriterionfora devicetobeinc ludedintheinteragencylististobeidentifiedasessential to maternal and newborn health interventions according to procedures described in the WHOstandardtreatmentguidelines.(SeeAnnex1foralistofinterventions). Medicaldevicesrequestedforlaboratory(includingdiagnostictests)andbloodtransfusion servicesarenotincludedinthelist. Products nomenclature The nomenclature for the Interagency List of Essential Medical Devices for Reproductive HealthisbasedontheexistingUnitedNationsCommonCodingSystem(UNCCS)andthe UNICEFproductsdatabasefortheclassificationofproductsgroups.  Allproductsfromthislistareidentifiedwithageneric,shortdescriptionwithamaximumof 50characters,exceptforthesutures.Thecompletetechnicalspecificationsoftheproductsare basedontheUNICEFstandardproducts. Note: this nomenclature was used for the elaboration of the interagency guideline: “EmergencyReliefItems‐Volume2(July1999)”,relatedtomedicaldevices,medicinesand emergencyhealthkits. Products classification Thelistofproductsisdividedintothreemajorcategoriesandeachcategory canbedivided intosub‐groups:  3 Categories Sub‐groups MedicalDevices‐ Renewable/Consumables  • Renewableplasticgoods • Injectiondevices • Dressingsupplies • Surgicalsutures • Clothingandaccessories • Medicalstationery MedicalDevices‐Equipment  • Anthropometricequipment • Medicaldiagnosticequipment • Medicalutensils • Sterilizationequipment • Hospitalequipment • Anaesthesia/resuscitationequipment • Surgicalinstrumentssets(UNFPAand UNICEFsurgicalinstrumentssets) MedicalDevices‐MedicalKits  • Thelistiscomposedofthemedicalkits developedbyUNICEFandtheInter‐ AgencyReproductiveHealthKits.  This products classification system facilitates rapid research about the needed medical devices.Itisalsoaguaranteeofmaintainingcoherenceinthewholelistandobtainingaclear overviewofwhatisneededtosetupareproductivehealthservice.  The listof productsis specifiedby twolevels of care:the firstlevel ofMNH care and the referrallevel.ThefirstlevelofcareforMNHincludesnormalcarethatshouldbeofferedto all women, including pregnant women, and babies, and the initial management of complications. The secondary level of care is the referral level where complications are managed(e.g.thedistricthospital).  Ten special notes have been added as Annex 2 to the list to complement technical informationandimproveuseofthelist.Notesweredevelopedinthefollowingareas:  • Unitsmeasureandbiomaterialsusedformedicaldevices • Packagingandlabelling • Injectionsafety • Health‐carewastemanagement • Surgicalsutures • Standardprecautionforhealthworkers • Wearingprotectiveequipment • Textilesusedforlinenandclothing • Sterilizationofmedicaldevices • Stainlesssteelforsurgicalinstruments. 4 Products technical specifications Technicalspecifications pergenericproductweredevelopedincollaborationwithUNICEF and UNFPA. Each product specification is a set of technical characteristics describing the  device. The aim is to support procurement officers, pharmacists, project managers in selecting,pre‐qualifyingandprocuringthesemedicaldevices.  Theseproductspecificationsareavailableonthewebsiteat: http://www.supply.unicef.dk/catalogue/medical.htm  Thequantificationofmedicaldevicesneededperinterventionwillbebasedonassessments atnationallevelandwillsystematicallytakeintoconsiderationthefollowingcriteria:  • Thehealthsystem:policiesandprotocols. • Thehealthfacility:capacity,activitiesandorganization. • Theexistingreplenishment/inventorysystemfor medicaldevices: renewable/consumableandequipment. Next steps: request for comments and suggestions The WHO Department of Essential Medicines and Pharmaceutical Policy, along with the other organizations involved, plans to update the Interagency List of Essential Medical DevicesforReproductiveHealtheverytwoyears.Meanwhile,anycommentsorsuggestions regarding the list can be addressed to the Department of Essential Medicines and PharmaceuticalPolicy,WorldHealthOrganization,20AvenueAppia,CH‐1211Geneva27, Switzerland,oremail:par@who.int  Additional references • UNICEF.Supplycatalogue.Availableat:http://www.supply.unicef.dk/catalogue • WHO.Medicaldeviceregulations.Globaloverviewandguidingprinciples.2003.Availableat: http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf  • WHO.Aide‐memoirefornationalmedicaldevicesadministrations.Availableat: http://www.who.int/medical_devices/publications/en/AM_Devices_EN.pdf  • Interagencylistofessentialmedicinesforreproductivehealth,2006.Documentno. WHO/PSM/PAR/2006.1–WHO/RHR/2006.1.Availableat: http://www.who.int/medicines/publications/essentialmedicines/WHO‐PSM‐PAR‐ 2006%20I_Rev.pdf • WHO.Managingnewbornproblems:aguidefordoctors,nurses,andmidwives(IMPAC). Availableat:http://www.who.int/reproductive‐health/publications/mnp/index.html  • WHOReproductiveHealthLibrary.Availableat:http://www.who.int/reproductive‐ health/rhl/index.html • WHO.Firstglobalstrategyonreproductivehealth.Availableat: http://www.who.int/reproductive‐health/strategy.htm/  [...]... http://www.who.int/diagnostics_laboratory/en/index.html  • WHO. Integrated management for emergency and essential surgical care (IMEESC) toolkit.  Based on the WHO manual Surgical care at the district hospital. Available at:  http://www.who.int/surgery/en/    5    6  Interagency List of Essential Medical Devices for Reproductive Health Structure of the list Medical Devices - Renewable/Consumables 1    2    3    4    5    6 ... Other anaesthesia equipment  Medical Devices - Equipment: surgical instruments sets 7  Surgical instruments sets  7.1  UNICEF surgical instruments sets  7.2  UNFPA surgical instruments sets  Medical Devices - Medical kits 1  2  UNICEF Kits  Inter‐Agency Reproductive Health Kits for crisis situations      8    Medical Devices - Renewable/Consumables   "Special note" on units measure and biomaterials used for medical devices. .. childbirth; regular monitoring for detection of complication and recording (including use of partograph); prevention and control of infection; and active management of third stage of labour 15.a Detection of prolonged and obstructed labour 16.a Diagnosis of pre-labour rupture of membrane (PROM) 17.a Detection of bleeding 18.a Identification of newborn breathing problems Endemic areas Care of the mother from 1-2... Special note on textiles used for linen and clothing  Special note on sterilization of medical devices Special note on surgical instruments, stainless steel  23  Special note for units and biomaterials used for medical devices Units The different units (symbols) used to express external diameter in medical devices are listed  below:  Charrière = Ch, CH Synonym:  Definition:     Field of use:     French gauge ... extraction; forceps; c-section (10-15% of all birthing women) 16.c Management of prelabour rupture of membranes (PROM) (5-7%) 17.c Management of severe bleeding (5%) 18.c Management of respiratory distress (2-4%) 19.c Management of severe hypothermia (2%) 20.c PMTCT including administering of ARV 21.b Initial management of anaemia (40% of all women during pregnancy, birth and postpartum) 21.c Management of. .. hypertensive 2.b Initial management of predisorders of pregnancy (part of ANC) eclampsia and eclampsia 3.a Prevention (iron supplementation) and screening for anaemia (part of ANC) 3.b Treatment of mild to moderate anaemia (Hb:7-11g/dl) 4.a Diagnosis of bleeding during pregnancy (part of ANC) 4.b MVA for threatened or incomplete abortion (10-15%) and first line management of bleeding during pregnancy (e.g.,... Management of correctable congenital malformations 38.c Treatment of malaria (1%) 39.c Management of postpartum depression (2%) 40.c Management of severe anaemia, including blood transfusion (4% of p,b,p) 41.c Management of severe puerperal sepsis 3% 42.c Sterilization (1-5%) 43.c Treatment of complicated malaria ( . development of one interagency list of essential medicines for RHandone interagency list for essential medical devices for RH.  In2005,the Interagency List of Essential Medicines for Reproductive Health developedbyWHO in. Nextsteps:request for commentsandsuggestions 4 Additionalreferences 4 Interagency List of Essential Medical Devices for Reproductive Health 7 Structure of the list 7 Annex1:IntegratedManagement of PregnancyandChildbirth(IMPAC). its intendedfunctionbysuchmeans. 2 Objective of the Interagency List of Essential Medical Devices for Reproductive Health This interagency list is a tool to support planning for the selection, quality