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 ObjectiveoftheInteragencyListofEssentialMedicalDevicesforReproductiveHealth 2 Process 2 Productsnomenclature 2 Productsclassification 2 Productstechnicalspecifications 4 Nextsteps:requestforcommentsandsuggestions 4 Additionalreferences 4 InteragencyListofEssentialMedicalDevicesforReproductiveHealth 7 Structureofthelist 7 Annex1:IntegratedManagementofPregnancyandChildbirth(IMPAC) 19 Annex2:Specialnotes 23 Specialnoteforunitsandbiomaterialsusedformedicaldevices 24 Units 24 Glossaryofbiomaterialsusedformedicaldevicesmaterials 27 Specialnoteonpackagingandlabelling 29 Packaging 29 Labelling 30 Expirationofmedicaldeviceswithlimitedshelf‐life 30 Specialnoteoninjectionsafety 32 References 32 Specialnoteonhealth‐carewastemanagement 33 Health‐carewastemanagementincludesthefollowingsteps: 33 Wastezone 34 References 34 Specialnoteonsurgicalsutures 35 Typeofthread 35 Sizeofthread 35 Threadwithneedle 35 Typeofneedle 36 Specialnoteonstandardprecautionsforhealthworkers 37 Specialnoteonwearingprotectiveequipment 38 References 39 Specialnoteontextilesusedforlinenandclothing 40 Single‐usenon‐woventextiles 40 Reusablewoventextiles 40 Specialnoteonsterilizationofmedicaldevices 42 Classificationofreusablemedicaldevice 42 Steamsterilizatonmethod 42 Highleveldisinfection 43 Methodsthatarenotrecommended 43 References 43 Specialnoteonsurgicalinstruments,stainlesssteel 44 Familiesofproducts 44 ii iii Acknowledgements The following persons and organizations are thanked for their contributions to the revision of the InteragencyListofEssentialMedicalDevicesforReproductiveHealth. Stéphanie Arsac‐Janvier (ICRC), Kay Bond (WHO),Yves Chartier (WHO), Meena Cherian (WHO),VincianeCruyt(MSF),NadineCornier(UNHCR),AnneSophieCoutin(MSF),Nick Dodd (UNFPA), Wilma Doedens (UNFPA), Lindsay Edouard (UNFPA), Marthe Everard (WHO),BjörnFahlgren(WHO),RobinGray(WHO),LisaHedman(PATH),PeterHeimann (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), TrevorLessey(UNFPA),SophieLogez(WHO),MathewsMathai(WHO),JulesMillogo(John Snow,Inc.), Paula Nersesian(JohnSnow, Inc.),Clive Ondari(WHO),Hanne BakPedersen (UNICEF), Monique Renevier (WHO), Murtada Sesay (UNICEF), David Smith (UNFPA), Monique Supiot (UNICEF), Susanadela Torre (John Snow, Inc.), Jagdish Upadhyay (UNFPA),MargaretUsher‐Patel(WHO),PaulVanLook(WHO),GodfreyWalker(UNFPA). iv 1 Background Medicaldevicesare essential to theprovisionofqualityreproductive health (RH)services. Rationalselectionofmedicaldevicesisacrucialcomponentinensuringimprovedaccessto reproductive health commodities, followed by efficient procurement, logistical systems, rationaluseanddemandwhichareequallyimportant. AreviewofexistingUnitedNations(UN)listsofessentialmedicinesandmedicaldevices, including (1) The draft UNFPA/WHO Essential Drugs and Other Commodities for Reproductive HealthServices List (2003)and(2)The Interagency UNFPA/UNAIDS/WHO Reproductive Health Medicines and Commodities ListreportedalackofconsensusamongvariousUNagencieson essential medicinesand medical devices forRH. 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 medicinesforRHandoneinteragencylistforessentialmedicaldevicesforRH. In2005,theInteragency List ofEssential Medicines for ReproductiveHealthdevelopedbyWHO in collaboration with partners was endorsed by major international organizations and agencies. In addition, the interagency working group for the selection of essential commoditiesforreproductivehealthagreedtoworktowardsaharmonizedlistofessential medicaldevicesforRH. As defined by the Global Harmonization Task Force (GHTF), medical device means any instrument,apparatus,implement,machine,appliance,implant,invitroreagentorcalibrator, software,materialorothersimilarorrelatedarticle: a) Intended by the manufacturer to be used, alone or in combination, for human beingsforoneormoreofthespecificpurpose(s)of: • diagnosis,prevention,monitoring,treatmentoralleviationofdisease • diagnosis,monitoring,treatment,alleviationoforcompensationforaninjury • investigation,replacement,modification,orsupportoftheanatomyorofa physiologicalprocess • supportingorsustaininglife • controlofconception • disinfectionofmedicaldevices • providinginformationformedicalordiagnosticpurposesbymeansofinvitro • examinationofspecimensderivedfromthehumanbody,and; b) Whichdoes notachieve its primaryintended action inor onthe human body by pharmacological, immunological or metabolic means, but which may be assisted in its intendedfunctionbysuchmeans. 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 implementthe Maternal and Newborn Health (MNH) interventions,whicharedefinedasthe“Essentialcaretowomenandtheirnewbornduring pregnancy,childbirthandpostnatalperiod:uptosixweeksafterdelivery.”Theobjectiveof thislististoproposeaninternationalconsensusonarationalselectionofessentialmedical devices for reproductive health according to their public health relevance on the basis of evidenceregarding,efficacy,safetyandcosteffectiveness. Process TheInteragencyListofEssentialMedicalDevicesforReproductiveHealthwasdevelopedby WHO in collaboration with UNICEF and UNFPA and major international and nongovernmentalorganizationsactiveinthefieldofreproductivehealth.In2004and2005, severalinteragencymeetingswereheldtodiscussthediscrepancymedicaldevicesexisting among the vario us lists. During these consultations, the decision was taken to develop a commonlistofdevicespercategoryofproductsandnotperrangeofclinicalinterventions, toavoidredundancy.AgreementswerereachedregardingtherangeofMNHinte rventions tobeconsidered,theproductsnomenclature,theproductsclassificatio ntobeusedandthe additionoftechnicalspecificationsperproductlisted. Thecriterionfora devicetobeinc ludedintheinteragencylististobeidentifiedasessential to maternal and newborn health interventions according to procedures described in the WHOstandardtreatmentguidelines.(SeeAnnex1foralistofinterventions). Medicaldevicesrequestedforlaboratory(includingdiagnostictests)andbloodtransfusion servicesarenotincludedinthelist. Products nomenclature The nomenclature for the Interagency List of Essential Medical Devices for Reproductive HealthisbasedontheexistingUnitedNationsCommonCodingSystem(UNCCS)andthe UNICEFproductsdatabasefortheclassificationofproductsgroups. Allproductsfromthislistareidentifiedwithageneric,shortdescriptionwithamaximumof 50characters,exceptforthesutures.Thecompletetechnicalspecificationsoftheproductsare basedontheUNICEFstandardproducts. Note: this nomenclature was used for the elaboration of the interagency guideline: “EmergencyReliefItems‐Volume2(July1999)”,relatedtomedicaldevices,medicinesand emergencyhealthkits. Products classification Thelistofproductsisdividedintothreemajorcategoriesandeachcategory canbedivided intosub‐groups: 3 Categories Sub‐groups MedicalDevices‐ Renewable/Consumables • Renewableplasticgoods • Injectiondevices • Dressingsupplies • Surgicalsutures • Clothingandaccessories • Medicalstationery MedicalDevices‐Equipment • Anthropometricequipment • Medicaldiagnosticequipment • Medicalutensils • Sterilizationequipment • Hospitalequipment • Anaesthesia/resuscitationequipment • Surgicalinstrumentssets(UNFPAand UNICEFsurgicalinstrumentssets) MedicalDevices‐MedicalKits • Thelistiscomposedofthemedicalkits developedbyUNICEFandtheInter‐ AgencyReproductiveHealthKits. This products classification system facilitates rapid research about the needed medical devices.Itisalsoaguaranteeofmaintainingcoherenceinthewholelistandobtainingaclear overviewofwhatisneededtosetupareproductivehealthservice. The listof productsis specifiedby twolevels of care:the firstlevel ofMNH care and the referrallevel.ThefirstlevelofcareforMNHincludesnormalcarethatshouldbeofferedto 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.thedistricthospital). Ten special notes have been added as Annex 2 to the list to complement technical informationandimproveuseofthelist.Notesweredevelopedinthefollowingareas: • Unitsmeasureandbiomaterialsusedformedicaldevices • Packagingandlabelling • Injectionsafety • Health‐carewastemanagement • Surgicalsutures • Standardprecautionforhealthworkers • Wearingprotectiveequipment • Textilesusedforlinenandclothing • Sterilizationofmedicaldevices • Stainlesssteelforsurgicalinstruments. 4 Products technical specifications Technicalspecifications pergenericproductweredevelopedincollaborationwithUNICEF 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‐qualifyingandprocuringthesemedicaldevices. Theseproductspecificationsareavailableonthewebsiteat: http://www.supply.unicef.dk/catalogue/medical.htm Thequantificationofmedicaldevicesneededperinterventionwillbebasedonassessments atnationallevelandwillsystematicallytakeintoconsiderationthefollowingcriteria: • Thehealthsystem:policiesandprotocols. • Thehealthfacility:capacity,activitiesandorganization. • Theexistingreplenishment/inventorysystemfor medicaldevices: renewable/consumableandequipment. 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 DevicesforReproductiveHealtheverytwoyears.Meanwhile,anycommentsorsuggestions regarding the list can be addressed to the Department of Essential Medicines and PharmaceuticalPolicy,WorldHealthOrganization,20AvenueAppia,CH‐1211Geneva27, Switzerland,oremail:par@who.int Additional references • UNICEF.Supplycatalogue.Availableat:http://www.supply.unicef.dk/catalogue • WHO.Medicaldeviceregulations.Globaloverviewandguidingprinciples.2003.Availableat: http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf • WHO.Aide‐memoirefornationalmedicaldevicesadministrations.Availableat: http://www.who.int/medical_devices/publications/en/AM_Devices_EN.pdf • Interagencylistofessentialmedicinesforreproductivehealth,2006.Documentno. WHO/PSM/PAR/2006.1–WHO/RHR/2006.1.Availableat: http://www.who.int/medicines/publications/essentialmedicines/WHO‐PSM‐PAR‐ 2006%20I_Rev.pdf • WHO.Managingnewbornproblems:aguidefordoctors,nurses,andmidwives(IMPAC). Availableat:http://www.who.int/reproductive‐health/publications/mnp/index.html • WHOReproductiveHealthLibrary.Availableat:http://www.who.int/reproductive‐ health/rhl/index.html • WHO.Firstglobalstrategyonreproductivehealth.Availableat: 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 RHandone interagency list for essential medical devices for RH. In2005,the Interagency List of Essential Medicines for Reproductive Health developedbyWHO in. Nextsteps:request for commentsandsuggestions 4 Additionalreferences 4 Interagency List of Essential Medical Devices for Reproductive Health 7 Structure of the list 7 Annex1:IntegratedManagement of PregnancyandChildbirth(IMPAC). its intendedfunctionbysuchmeans. 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