Upload
magdalene-stevens
View
216
Download
0
Embed Size (px)
Citation preview
Updates on Inter-agency work on Medical Devices
IPC Meeting, WHO Geneva6th June 2014
IPC Meeting, WHO, Geneva, Switzerland6th June 20142 |
Medical devicesMedical devices
Interagency list for reproductive , maternal, new born and child care
Technical specifications– Nomenclature
UNCLSC– 3 types of commodities involving 13 medical devices
Pricing survey
Future / on going Publications
Compendium of innovative health technologies
Pneumonia diagnostics.
IPC Meeting, WHO, Geneva, Switzerland6th June 20143 |
BackgroundBackground
2011
2008
2010
IPC Meeting, WHO, Geneva, Switzerland6th June 20144 |
IPC Meeting, WHO, Geneva, Switzerland6th June 20145 |
Objective. Provide a publication containing a list with the essential interventions and medical devices related to them.
UNFPA, UNICEF and WHO in collaboration with specific WHO areas:
• Injection Safety• Blood transfusion• Safe Surgery• Diagnostic and Laboratory• Reproductive Health• Maternal Health• Neonatal Health• Waste management• STI’s• Infertility• Cancer
Meetings held– June 2012- Copenhagen– August 2012-Geneva– November 2012- Geneva– February 2013- Copenhagen– January 2014- Copenhagen
Interagency list of medical devices for reproductive, maternal, newborn and child health
Interagency list of medical devices for reproductive, maternal, newborn and child health
IPC Meeting, WHO, Geneva, Switzerland6th June 20146 |
Copenhagen, Denmark. June 27th-29th 2012Copenhagen, Denmark. June 27th-29th 2012
United Nations Population Fund (UNFPA)
– Dr. Yves Bergevin, Senior Maternal Health Advisor, Coordinator, Maternal Health Thematic Fund, TD
– Dr. Kabir Ahmed, Technical Adviser, Commodity Security Branch
– Ms Wilma Doedens, Technical Adviser, Humanitarian Response
Unit – Ms Agnes Chidanyika, Technical Specialist– Ms Isabel Lucas Manzano, Technical Consultant
World Health Organization (WHO)
– Ms Adriana Velazquez Berumen, Coordinator of Medical Devices Unit, Essential Medicines and Health Products Department
– Ms Åsa Cuzin-Kihl, Department of Reproductive Health and Research; Research Capacity, Policy and Programme Strengthening
– Dr Metin Gulmezoglu, Department of Reproductive Health and Research
– Ms Lisa Hedman, Essential Medicines and Health Products
United Nations Children’s Fund (UNICEF)
– Dr Hanne Bak Pedersen, Deputy Director, UNICEF Supply
Division– Dr Kim Eva Dickson, Senior Adviser (Maternal and Newborn
Health), Health Section UNICEF HQ– Dr Helene Moller, Chief, Health Technology Centre, UNICEF
Supply Division – Mr Francisco Blanco, Chief, Medicines & Nutrition, UNICEF
Supply Division– Mr Thomas Sorensen, Chief, Knowledge Management, UNICEF
Supply Division– Ms Etleva Kadilli, Contracts Manager, Medical Unit, Health
Technology Centre, UNICEF Supply Division– Dr David Muhia, Contracts Manager, Medicines & Nutrition,
UNICEF Supply Division– Ms Monique Supiot, Technical Officer, Health Technology
Centre, UNICEF Supply Division– Mr Ludo Scheerlinck, Technical Officer, Medical Unit, Health
Technology Centre, UNICEF Supply Division– Mr Henrik K. Nielsen, Technical Specialist, Medicines &
Nutrition, UNICEF Supply Division– Ms Clara Aranda-Jan, Consultant, Medical Unit, Health
Technology Centre, UNICEF Supply Division
FIRST MEETING
IPC Meeting, WHO, Geneva, Switzerland6th June 20147 |
Geneva, Switzerland. August 6th-7th 2012.Geneva, Switzerland. August 6th-7th 2012.
United Nations Population Fund (UNFPA)
– Ms Isabel Lucas Manzano, Technical Consultant
– Ms Wilma Doedens, Technical Adviser, Humanitarian
Response Unit
World Health Organization (WHO)
– Ms Adriana Velazquez Berumen, Coordinator of Medical Devices Unit, Essential Medicines and Health Products Department
– Ms Lisa Hedman, Essential Medicines and Health Products
– Ms Clara Aranda-Jan, Consultant, Medical Devices Unit, Essential Medicines and Health Products Department
– Ms Alicia de Hoyos Reyes, Intern, Medical Devices Unit,, Essential Medicines and Health Products
Department
– Dr Viviana MANGIATERRA, Scientist
– Dr Meena NATHAN CHERIAN, Medical Officer, Clinical Procedures Unit
– Ms Anita SANDS, Technical Officer, Diagnostic and Laboratory Technologies
– Dr Selma KHAMASSI, Medical Officer, Clinical Procedures Unit
– Dr Neelam DHINGRA-KUMAR, Coordinator Health Policy, Development and Services
– Ms María Mercedes PEREZ GONZALEZ, Technical Officer, Diagnostic and Laboratory Technologies
United Nations Children’s Fund (UNICEF)
– Ms Monique Supiot, Technical Officer, Health
Technology Centre, UNICEF Supply Division
SECOND MEETING
IPC Meeting, WHO, Geneva, Switzerland6th June 20148 |
United Nations Population Fund (UNFPA)
– Ms Isabel Lucas Manzano, Technical Consultant– Ms Wilma Doedens, Technical Adviser, Humanitarian Response Unit
United Nations Children’s Fund (UNICEF)
– Ms Clara Aranda, Technical Consultant– Ms Monique Supiot, Technical Officer, Health Technology Centre, UNICEF
Supply Division
World Health Organization (WHO)
– Ms Adriana Velazquez Berumen, Coordinator, Diagnostic Imaging and Medical Devices, Essential Medicines and Health Products
– Ms Alejandra Velez Ruiz Gaitan, Technical Officer, Diagnostic Imaging and Medical Devices, Essential Medicines and Health Products
– Ms Alicia De Hoyos Reyes, Intern, Diagnostic Imaging and Medical Devices, Essential Medicines and Health Products
– Ms Anita Sands, Technical Officer, Diagnostic and Laboratory Technologies, Essential Medicines and Health Products
– Dr Maurice Bucagu, Medical Officer, Policy, Planning and Programmes– Dr James Farukai Tsimba Chitsva, Technical Officer, Blood Transfusion Safety,
Health Policy, Development and Services – Dr Mario Festin, Lead Specialist, Promoting Family Planning
– Dr Selma Khamassi, Medical Officer, Clinical Procedures Unit, Health Policy, Development and Services
– Dr Viviana Mangiaterra, Scientist, Research Capacity, Policy and Programme Strengthening
– Dr Meena Nathan Cherian, Medical Officer, Clinical Procedures Unit, Health Policy, Development and Services
– Dr Severin Ritter Von Xylander, Medical Officer, Policy, Planning and Programmes
– Ms Susan Wilburn, Technical Officer, Interventions for Healthy Environments
Geneva, Switzerland. November 12-14th 2012.THIRD MEETING
IPC Meeting, WHO, Geneva, Switzerland6th June 20149 |
MethodologyMethodology
From the Copenhagen meeting and the workshops held at WHO the following was agreed:
– Life cycle and continuum of care of mother and newborn to be considered:• Family Planning• Pregnancy• Childbirth• Post-natal and mother• Newborn
– Level of delivery of intervention:• Community level (Includes Health Post)• First level (Includes Health Center)• Referral level (Includes District Hospital and Referral Hospital)
IPC Meeting, WHO, Geneva, Switzerland6th June 201410 |
Interventions were reviewed according to evidence-based guidelines from WHO and with specialists.
IPC Meeting, WHO, Geneva, Switzerland6th June 201411 |
IPC Meeting, WHO, Geneva, Switzerland6th June 201412 |
Health Care Facilities consideredHealth Care Facilities considered
Health Post
Health Center
District Hospital Referral Specialized Hospital
IPC Meeting, WHO, Geneva, Switzerland6th June 201413 |
IPC Meeting, WHO, Geneva, Switzerland6th June 201414 |
InterventionsInterventions
Medical DevicesMedical Devices
FAMILY PLANNING TEMPLATEFAMILY PLANNING TEMPLATE
IPC Meeting, WHO, Geneva, Switzerland6th June 201415 |
Interventions for NewbornInterventions for Newborn
IPC Meeting, WHO, Geneva, Switzerland6th June 201416 |
Medical DevicesMedical Devices
IPC Meeting, WHO, Geneva, Switzerland6th June 201417 |
Special notesSpecial notes
Part A. Special notes related to program• Safe blood and Clinical transfusion• Diagnostic tests & Laboratory• Injection safety • Surgery and Anesthesia• Decontamination and sterilization at healthcare facilities• Health care waste management
Part B. Special notes related to medical devices• Regulations for medical devices• Health Technology Management• Label and instructions for use for medical devices• Units and biomaterials used for medical devices• Surgical instruments stainless steel• Surgical sutures• Textiles used for linen and clothing in healthcare facility
IPC Meeting, WHO, Geneva, Switzerland6th June 201418 |
Groups of medical devicesGroups of medical devices
Groups of medical devices
1. Grouping of common medical equipment by clinical area in health-care facility
2. Grouping of common surgical instruments by surgical procedure
3. Grouping of medical device consumables by size and capacity
IPC Meeting, WHO, Geneva, Switzerland6th June 201419 |
Interagency list of medical devices for reproductive, maternal, newborn and child health , June 2014
Interagency list of medical devices for reproductive, maternal, newborn and child health , June 2014
To come
IPC Meeting, WHO, Geneva, Switzerland6th June 201420 |
UN Commission on life saving commodities
UN Commission on life saving commodities
Defining a list of overlooked life-saving commodities for women and children
Identifying key barriers preventing access to and use of these commodities
Recommending innovative action to rapidly increase both access and use
IPC Meeting, WHO, Geneva, Switzerland6th June 201421 |
Reproductive health commodities Resuscitation devices for newborn
asphyxia
• Female condom • Self-inflating neonatal resuscitation bag
with masks for pre-term(size 0) and term(size 1) babies
Injectable antibiotics for newborn sepsis • Electric or foot operated suction
machine/pump, negative pressure less than 100mm Hg, with 1 bottle
• Syringe 2 mL with needle 23 G 25 mm• (with re-use prevention feature)
• Suction catheter , length 50 cm, single
use, conical tip, Fr # 8
• Syringe 2 mL with needle 23 G 25 mm (without re-use prevention feature)
• Single use suction bulb
• Sharps container, for used syringes/needles
• Multi-use suction bulb that can be
opened, cleaned and sterilized
• Infant scale less than 20 kg • Training mannequin/simulator for
neonatal resuscitation
• Clinical thermometer, non-mercury • Infant stethoscope
List of medical devices for UN Commission on Life Saving Commodities
List of medical devices for UN Commission on Life Saving Commodities
IPC Meeting, WHO, Geneva, Switzerland6th June 201422 |
Dosage for NeonatesDosage for Neonates
IPC Meeting, WHO, Geneva, Switzerland6th June 201423 |
Tools for country assessment v1
Tools for country assessment v1
IPC Meeting, WHO, Geneva, Switzerland6th June 201424 |
Technical specifications by UN agencies, can harmonization be possible?
Technical specifications by UN agencies, can harmonization be possible?
UNICEF Supply catalogue
https://supply.unicef.org/
UNFPA AccessRH
https://myaccessrh.org/
UNOPS UN Webbuy
https://unwebbuy.org/WB has requested
IPC Meeting, WHO, Geneva, Switzerland6th June 201425 |
Other sources of technical specificationsOther sources of technical specifications
NGO’s, countries…
IPC Meeting, WHO, Geneva, Switzerland6th June 201426 |
1. Medical Device Specification
2. Name and Coding
3. General
4. Technical1. Technical Characteristics
2. Physical Characteristics
3. Energy Source
4. Accessories, Spare Parts, Consumables
5. Bidding / Procurement Terms / Donation Requirements1. Environmental and Departmental Considerations
2. Standards and Safety
3. Training and Installation
4. Warranty and Maintenance
5. Documentation
Technical Specifications
IPC Meeting, WHO, Geneva, Switzerland6th June 201427 |
Example of Female Condom(1)Example of Female Condom(1)
6 WHO Category
7 Generic name Female condom
8Specific type or variations
9 GMDN name Female condom, Hevea-latex and Female condom, non latex
10 GMDN code(s)4772147722.
11 GMDN category10 Single-use devices11 Assistive products for persons with disability
12 UMDNS name Condoms, Female
13 UMDNS code 18079
14 UNSPS code 53131622
15 Alternative name(s)
ContraceptiveFemidomCondomsCondoms, femalePouch, intravaginalProphylactic
16 Alternative code(s)
MS 35772, 206402008MS 43386MS 10985, 10985MS 18079, 18079MS 34045, MBUMS 44542, 289906000
NAME, CATEGORY AND CODING
17 KeywordsContraceptive device, Pregnancy prevention, prevention of sexually transmitted infections(STI) including HIV, AIDS, syphilis, gonorrhoea, chlamydia, trichomoniasis
18 GMDN definition
47721; A Hevea-latex sheath with rings on either end that is inserted into the vagina before coitus to prevent sperm from gaining access to the female reproductive tract and/or to prevent the transmission of sexually transmitted infections (STI) between sexual partners. This is a single-use device.47722; A sheath made of synthetic polymers (e.g., polyurethane or nitrile) with rings on either end that is inserted into the vagina before coitus to prevent sperm from gaining access to the female reproductive tract and/or to prevent the transmission of sexually transmitted infections (STI) between sexual partners. It typically includes a lubricant to minimize friction during coitus. This is a single-use device
NomenclatureGMDN, UMDNS, UNSPS
Which nomenclature to use?
IPC Meeting, WHO, Geneva, Switzerland6th June 201428 |
Example of Female Condom(2) Example of Female Condom(2)
19 Clinical purpose Barrier to prevent unwanted pregnancy and transmission of STIs and HIV
20 Level of institution Individual level, as given in the user leaflet/labelling
21 Clinical department/ward Not applicable
22Overview of functional requirements
Lines vaginal canal and is designated to be retained in vagina during sexual intercourse to prevent unwanted pregnancy and transmission of STIs. The external component of the devices can provide coverage to the external female genitalia.
23 Risk Classification
Class C (GHTF Rule 17)Class Ⅱ b (EU)Class Ⅱ (Japan)Class Ⅲ (USA)
PURPOSE OF USE
24 Detailed requirementsFemale condoms come in different designs and materials therefore Dependent on manufacturer's specifications and WHO/UNFPA specifications and ISO standard.
25 Displayed parameters Female condoms come in different designs and materials therefore Dependent on manufacturer's specifications and WHO/UNFPA specifications and ISO standard.
26 User adjustable settings Not applicable
TECHNICAL CHARACTERISTICS
Risk classificationIMDRF/GHTF (International Medical Device
Regulators Forum/ Global Harmonization Task Force) http://www.imdrf.org/
IPC Meeting, WHO, Geneva, Switzerland6th June 201429 |
30Sterility status on delivery (if relevant)
N/A
31 Shelf life (if relevant)The claimed shelf life shall be not less than three years and not more than seven years subject to confirmation by appropriate stability data
32Transportation and storage (if relevant)
The inner boxes shall be packed into plastic or other waterproof lining bags, which will be placed in three-wall cartons made from weather-resistant corrugated fibreboard with a bursting test strength of not less than 1900 kPa.The inner boxes will be marked in a legible manner to facilitate identification in case of subsequent query.
The carton flaps shall be secured with water-resistant adhesive applied to not less than 75% of the area of contact between the flaps, or with water-resistant tape, 75 mm wide, applied to the full length of the centre seams and extending over the ends by not less than 75 mm. The cartons may be secured by plastic strapping at not less than two positions. Alternatively, wire-bound, cleated plywood or nailed wood boxes are acceptable when lined with a waterproof barrier material.The barrier material must be sealed at the edges with waterproof tape or adhesive, and there must be no sharp protrusions inside the boxes.
The exterior shipping carton, like the inner box, shall be marked with information about the contents in a clearly legible manner. Information should be printed on two adjacent sides. The following information should be included in the inner box marking and exterior shipping carton. The information shall include:• a description of the contents;• Lot identification number;• month and year of manufacture (including the words Date of Manufacture, Month, Year) in language(s) to be specified by the purchaser. The year shall be written as a four-digit number and the month as a two-digit number;• month and year of expiry (including the words Expiry Date, Month, Year) in language(s) to be specified by the purchaser. The year shall be written as a four-digit number and the month as a two-digit number;• name and address of the manufacturer and/or supplier;• number of female condoms contained in the carton;• the consignee details;• instructions for storage and handling.
33 Labelling (if relevant) N/A
34Context-dependent requirements
Female condoms should be stored away from extreme heat (not more than 35 degrees C), be protected from moisture and direct sunlight in a well ventilated environment.
PACKAGING
ENVIRONMENTAL REQUIREMENTS
PackagingShelf life, transportation,
Labelling
Example of Female Condom(3)
Example of Female Condom(3)
IPC Meeting, WHO, Geneva, Switzerland6th June 201430 |
Example of Female Condom(4)Example of Female Condom(4)
46 Risk Classification Class C (GHTF Rule 17), Class Ⅱ b (EU, Australia), Class Ⅱ (Japan, Canada), Class Ⅲ (USA)
47Regulatory Approval / Certification
FDA approval(USA); CE mark(EU)
48 International standards
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes (European Union, Canada and Australia)ISO 14971:2007 Medical devices -- Application of risk management to medical devicesISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratoriesISO 2859-1:1999 Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspectionISO 10993–1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management processISO 10993–5: 2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicityISO 10993–10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitizationISO 11346:2004 Rubber, vulcanized or thermoplastic -- Estimation of life-time and maximum temperature of useISO 4074:2002 Natural latex rubber condoms -- Requirements and test methods Cor 1:2003 Cor 2:2008ISO 25841:2011 Female condoms -- Requirements and test methods
49Reginal / Local Standards
ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms (USA)
50 Regulations
US regulations21 CFR part 820; 21CFR Section 884.5330 (USA); EU regulationsCouncil Directive 93/42/EEC Directive 93/68/EEC (CE Marking)
STANDARDS AND SAFETY
Standards: e.g. Quality management systems(ISO13485), Standards for electric devices(IEC),Female condoms-- requirements and test methods(ISO25841)
Which standards to include?
IPC Meeting, WHO, Geneva, Switzerland6th June 201431 |
WHO technical specifications of 70 medical devices including UNCLSC devices
WHO technical specifications of 70 medical devices including UNCLSC devices
1Abortion suction system
2Anaesthesia Ventilator
3Bilirubinometer
4Capillary patient thermometer
5Cardiovascular ultrasound
6CPAP unit
7Cryosurgical Unit
8Darkroom Automatic X-ray Film processor
9Daylight Automatic Xray Film Processor
10Diagnostic spirometer
11Electrocardiographic monitor
12Examination Treatment Light
13Floor Scale electronic
14Floor Scale mechanical
15Foetal cardiac monitor
16Foetal vacuum extraction
17General purpose Electrosurgical Diathermy
18General purpose Tabletop Centrifuge
19General purpose Ultrasound
20 Incubator Infant Stationary
21 Infant Resuscitation Table22 Infrared thermometer, ear23 Infrared thermometer, skin24 Intensive-care ventilator25Laboratory urine analyser IVD26Laboratory water bath27Laryngoscope28Manual Emergency Suction System29Microscope Light30Mobile basic diagnostic x-ray system, analogue31Mobile basic diagnostic x-ray system, digital32Mobile flouroscopic x-ray system, analogue33Mobile flouroscopic x-ray system, digital34Neonatal physiologic monitoring systems35Non-rechargeable professional semi-automated external defibrillator 36Obstetrical table, line-powered 37Obstetrical table, manual38Operating light (fixed) 39Ophthalmoscope, direct 40Otoscope, direct
41Overhead infant phototherapy unit 42Peak Flow Meter43Physiologic Monitoring System44Portable Ventilator Electric45PulseOximeter Line Powered46PulsoOximeter Battery Powered47Scale Patient Infant48Single Channel Electrocariograph49Sphygmomanometer
50Stationary Basic Diagnostic Xray System Analogue
51Stationary Basic Diagnostic Xray System Digital
52Stethoscope mechanical53Suction system54Syring Pump55Thermometer laboratory56Transport infant incubator
57Universal operating table electrohydraulic
58Universal operating table electromechanic
59Universal operating table hydraulic60Unwrapped steam sterilizer61Viewbox X-ray
62 Female condom63 Syringe 2 mL with needle 23 G 25mm (with re-use prevention feature)64 Syringe 2 mL with needle 23 G 25mm (without re-use prevention feature)65 Sharps container, for used syringes/needles66 Self-inflating neonatal resuscitation bag with masks for pre-term and term babies67 Suction catheter , length 50 cm, single use, conical tip, Fr# 868 Single use suction bulb69 Multi-use suction bulb that can be opened, cleaned and sterilized70 Training manikin/simulator for neonatal resuscitation
IPC Meeting, WHO, Geneva, Switzerland6th June 201432 |
1) WHO technical specifications should be tailored appropriately by users according to the specific situation, e.g. local standards and legislation; local regulations and conditions; languages; electrical range, capacities, utility environment and other local specific conditions. 2) Technical characteristics of WHO technical specifications are indicate basically appropriate standard equipment for low- and middle- income countries. 3) The number of accessories, consumables, spare parts and other components indicates usual and/or ideal number, not mandatory. 4) For tender purposes, should consider not only medical equipment itself, also related services to be able to use the equipment, e.g. installation, supplier testing, training, warranty.
1) WHO technical specifications should be tailored appropriately by users according to the specific situation, e.g. local standards and legislation; local regulations and conditions; languages; electrical range, capacities, utility environment and other local specific conditions. 2) Technical characteristics of WHO technical specifications are indicate basically appropriate standard equipment for low- and middle- income countries. 3) The number of accessories, consumables, spare parts and other components indicates usual and/or ideal number, not mandatory. 4) For tender purposes, should consider not only medical equipment itself, also related services to be able to use the equipment, e.g. installation, supplier testing, training, warranty.
ConsiderationConsideration
IPC Meeting, WHO, Geneva, Switzerland6th June 201433 |
Three Dimensions to Consider When Moving Towards Universal Coverage
Health systems financing: the path to universal coverage. Executive Summary ,The World Health Report, WHO/IER//WHR/10.1, 2010
IPC Meeting, WHO, Geneva, Switzerland6th June 201434 |
WHO Global medical devices pricing survey 2014WHO Global medical devices pricing survey 2014
• Collect data in different stakeholders and settings• Statistical analysis• Report findings of the pricing survey
Global medical devices pricing survey
IPC Meeting, WHO, Geneva, Switzerland6th June 201435 |
Safety and quality .
Regulatory institutions
Innovation Universities
Medical devices industry
HOSPITAL SERVICES BIOMEDICAL
ENGINEERING: SELECTION, USE , MAINTENANCE OF
EQUIPMENT
HTA, SELECTION OF PRIORITY
MEDICAL DEVICES MEDICAL DEVICES FOR REIMBURSEMENT, FOR
COVERAGE ,
IPC Meeting, WHO, Geneva, Switzerland6th June 201436 |
Medical devices technical seriesMedical devices technical series
IPC Meeting, WHO, Geneva, Switzerland6th June 201437 |
Books on medical devices for 2014-2015:
– Regulations
( pre-market, post-market)– Safe use of
medical devices– Human resources – Decommissioning
IPC Meeting, WHO, Geneva, Switzerland6th June 201438 |
Image of the linkage with data sourcesImage of the linkage with data sources
IPC Meeting, WHO, Geneva, Switzerland6th June 201439 |
WHO medical devices information system (MEDEVIS)the development in 2014WHO medical devices information system (MEDEVIS)the development in 2014
Medical device information
Procedural use of medical devicesAreas of use within a given
health care system
Clinical information
linkage
• Disease related to procedure• Clinical indication
• Region/healthcare system• Type of facility• Group of healthcare section
• Procedural information• Regulatory information• Procurement information• Assessment information
• Device name• Description/Definition• Technical information• Picture• Economic information
Global Atlas,MDs by health care facilities…
Pricing survey,Compendium,Nomenclature….
Interagency list,Other sources…
Technical specifications,Other sources..
IPC Meeting, WHO, Geneva, Switzerland6th June 201440 |
Structure of MEDEVIS web tool as per WHA60.29
Structure of MEDEVIS web tool as per WHA60.29
- Review data sources and linking points- Design appropriate data-structure for MEDEVIS to
be able to link various data sources
IPC Meeting, WHO, Geneva, Switzerland6th June 201441 |
2010 call for innovative technologies that address global health concerns: outcomes2010 call for innovative technologies that
address global health concerns: outcomes
IPC Meeting, WHO, Geneva, Switzerland6th June 201442 |
2011-2013 Compendium2011-2013 Compendium
IPC Meeting, WHO, Geneva, Switzerland6th June 201443 |
IPC Meeting, WHO, Geneva, Switzerland6th June 201444 |
Pneumonia: UNICEF and WHO
Pneumonia: UNICEF and WHO
Pneumonia is the leading cause of death in children worldwide.
Pneumonia kills an estimated 1.4 million children under the age of five years every year – more than AIDS, malaria and tuberculosis combined.
Pneumonia can be caused by viruses, bacteria or fungi.
Pneumonia can be prevented by immunization, adequate nutrition and by addressing environmental factors.
No diagnostic method is available for low resource settings.
+Novel Diagnostic Tools for Childhood Pneumonia
Prevention Diagnosis Treatment
Pneumococcal vaccination
Other vaccines
Access to antibioticsVitamin A
MalariaPneumonia
Other infections
Bacterial PneumoniaViral Pneumonia
Respiratory Rate
Oxygen Saturation Fever
BIOMARKERS: PCT, CRP, Lpc-2, Heptoglobin…
Cra
ckles
Ch
est
X-r
ay
Treatment
Access to antibioticsVitamin A
Treatment
Access to antibioticsVitamin A
TreatmentAntibiotic Resistance
Tachycardia
Wh
eezin
g
+Country survey , 2013 data:
IPC Meeting, WHO, Geneva, Switzerland6th June 201447 |
Country survey on Medical devices. Update 2013.
Country survey on Medical devices. Update 2013.
IPC Meeting, WHO, Geneva, Switzerland6th June 201448 |
Approved medical devices for national procurement or reimbursement
Approved medical devices for national procurement or reimbursement
IPC Meeting, WHO, Geneva, Switzerland6th June 201449 |
Lists of devices per facility or clinical procedureLists of devices per facility or clinical procedure
Examples:
Per hospital
Per health center
Per area of care:– ICU– Surgery
Per disease– H1N1– HIV– Vaccines
IPC Meeting, WHO, Geneva, Switzerland6th June 201450 |
WHO Regions
Country Publications
WHO Medical Devices Publications (2008-2014)
IPC Meeting, WHO, Geneva, Switzerland6th June 201451 |
Next steps…Next steps…
– Circulate for revision: the interagency book on medical devices for essential interventions on reproductive, maternal, new born and child care. And publish.
– UNCLSC define final tech specs, PQ available, regulatory pathway
– Harmonize the format of the technical specifications?– Nomenclature work?– Participate in the pricing survey?– Participate in the evaluation of the innovative technologies? For
the compendium on innovative technologies?– Participate in the next books:
• Decommissioning of medical devices• Safe use of medical devices.
IPC Meeting, WHO, Geneva, Switzerland6th June 201452 |
Thank you !Thank you !
www.who.int/medical devices