Interagency List of Essential Medical Devices for Reproductive Health

Publication date: 2008

    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). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. 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  various  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 interventions  to be considered, the products nomenclature, the products classification to be used and the  addition of technical specifications per product listed.   The criterion for a device to be included 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/  5  • WHO. Costing blood transfusion services. Available at:  http://www.who.int/bloodsafety/transfusion_services/en/Costing_BTS_Eng.pdf  • WHO. National blood transfusion services. Available at:  http://www.who.int/bloodsafety/transfusion_services/en/  • WHO. Diagnostics and laboratory technology. Available at:  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/    6    7  Interagency List of Essential Medical Devices for Reproductive Health Structure of the list Medical Devices - Renewable/Consumables 1  Renewable plastic goods  1.1  Tube/catheter/drain  1.2  Gloves  1.3  Miscellaneous renewable plastic    2  Injection devices  2.1  Needles/cannulae  2.2  Syringes ‐ immunization  2.3  Syringes ‐ others  2.4  Sharps waste disposal  2.5  Miscellaneous injection devices    3  Dressing supplies  3.1  Compress/bandage/tape  3.2  Miscellaneous dressing    4  Surgical sutures   4.1  Sutures, absorbable  4.2  Sutures, non‐absorbable    5  Clothing and accessories    6  Medical stationery  Medical Devices - Equipment 1  Anthropometric equipment     2  Medical Diagnostic equipment  2.1  Electrical equipment (*220V)  2.2  Other medical diagnostic equipment    3  Medical utensils  3.1  Steel utensils   3.2  Plastic utensils    4  Sterilization equipment  4.1  Sterilizers   4.2  Containers  4.3  Other sterilization equipment      8  5  Hospital equipment  5.1  Electrical equipment (*220V)  5.2  Others hospital equipment & furniture  5.3  Miscellaneous others equipment    6  Anaesthesia/Resuscitation equipment  6.1  Electrical equipment (*220V)  6.2  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  UNICEF Kits  2  Inter‐Agency Reproductive Health Kits for crisis situations      9    Medical Devices - Renewable/Consumables   "Special note" on units measure and biomaterials used for medical devices   Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (back-up care at sec. health-care level) 1 Renewable Plastic Goods 1.1 Tube/catheter/drain Catheter, urethral, (size:CH), sterile, single use 1.1.1 Catheter,urethral,CH12,ster,s.u. X X 1.1.2 Catheter,urethral,CH14,ster,s.u. X X Catheter, Foley, (size:CH), sterile, single use 1.1.3 Catheter,Foley,CH10,ster,s.u. X 1.1.4 Catheter,Foley,CH12,ster,s.u. X 1.1.5 Catheter,Foley,CH14,ster,s.u. X 1.1.6 Catheter,Foley,CH18,ster,s.u. X Syringe, feeding, (connector tip), (capacity: ml), sterile, single use 1.1.7 Syringe,feeding,catheter tip,50ml,ster,s.u. X X 1.1.8 Syringe,feeding,luer tip,50ml,ster,s.u. X 1.1.9 Extractor,mucus,20ml,ster,s.u. X X Tube, aspirating/feeding, (size:CH), (Length: cm), conical tip, sterile, single use 1.1.10 Tube,asp/feed,CH06,L125cm,conical tip,ster,s.u. X 1.1.11 Tube,asp/feed,CH08,L125cm,conical tip,ster,s.u. X 1.1.12 Tube,asp/feed,CH12,L125cm,conical tip,ster,s.u. X 1.1.13 Tube,asp/feed,CH16,L125cm,conical tip,ster,s.u. X Tube, feeding, (size: CH), (length: cm), luer tip, sterile, single use 1.1.14 Tube,feeding,CH05,L40cm,luer tip,ster,s.u. X 1.1.15 Tube,feeding,CH08,L40cm,luer tip,ster,s.u. X Tube, suction, (size: CH), (length: cm), conical tip, sterile, single use 1.1.16 Tube,suction,CH08,L50cm,conical tip,ster,s.u. X X 1.1.17 Tube,suction,CH10,L50cm,conical tip,ster,s.u. X X 1.1.18 Tube,suction,CH14,L50cm,conical tip,ster,s.u. X X 1.1.19 Tube,suction,CH16,L50cm,conical tip,ster,s.u. X X Airway Guedel 1.1.20 Airway, Guedel, translucent, size 00 X X 1.1.21 Airway, Guedel, translucent, size 0 X X 1.1.22 Airway, Guedel, translucent, size 1 X X 1.1.23 Airway, Guedel, translucent, size 2 X X 1.1.24 Airway, Guedel, translucent, size 3 X X 1.1.25 Airway, Guedel, translucent, size 4 X X 10  Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (back-up care at sec. health-care level) Tube, endotracheal,(size: diam int.), without cuff, sterile, single use 1.1.26 Tube,endotrach,2.5, w/o cuff,ster,s.u. X 1.1.27 Tube,endotrach,3, w/o cuff,ster,s.u. X 1.1.28 Tube,endotrach,3.5, w/o cuff,ster,s.u. X Tube, endotracheal,(size: diam int.), with cuff, sterile, single use 1.1.28 Tube,endotrach,6.5, w/cuff,ster,s.u. X 1.1.29 Tube,endotrach,7, w/cuff,ster,s.u. X 1.1.30 Tube,endotrach,7.5, w/cuff,ster,s.u. X 1.1.31 Tube,endotrach,8, w/cuff,ster,s.u. X Cannula, nasal, Oxygen, 2 prongs + tube, single use 1.1.32 Cannula,nasal,Oxygen,adult,2 prongs + tube, s.u. X 1.1.33 Cannula,nasal,Oxygen,child,2 prongs + tube,s.u. X 1.1.34 Cannula,nasal,Oxygen,neonate,2 prongs + tube,s.u. X 1.2 Gloves Gloves, examination, (material), (size), single use 1.2.1 Gloves,exam,latex,small,s.u. X X 1.2.2 Gloves,exam,latex,medium,s.u. X X 1.2.3 Gloves,exam,latex,large,s.u. X X Gloves, gynaecological, (size: n0), sterile, single use 1.2.4 Gloves,gynaeco,small,ster,s.u.,pair X X 1.2.5 Gloves,gynaeco,medium,ster,s.u.,pair X X 1.2.6 Gloves,gynaeco,large,ster,s.u.,pair X X Gloves, surgical, (size: n0), sterile, single use 1.2.7 Gloves,surg,6.5,ster,s.u.,pair X X 1.2.8 Gloves,surg,7,ster,s.u.,pair X X 1.2.9 Gloves,surg,7.5,ster,s.u.,pair X X 1.2.10 Gloves,surg,8,ster,s.u.,pair X X 1.2.11 Gloves,surg,8.5,ster,s.u.,pair X X 1.3 Miscellaneous renewable plastic 1.3.1 Bag (envelope),plastic,for drugs, approx.10x15cm X X 1.3.2 Bag,urine,collecting,2000ml X 2 Injection devices "Special note" on injection safety 2.1 Needles/cannulae (1) Cannula, Intra Venous short, (size:G), sterile, single use 2.1.1 Cannula,IV short,16G,ster,s.u. X X 2.1.2 Cannula,IV short,18G,ster,s.u. X X 2.1.3 Cannula,IV short,20G,ster,s.u. X X 2.1.4 Cannula,IV short,22G,ster,s.u. X X 2.1.5 Cannula,IV short,24G,ster,s.u. X X 11  Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (back-up care at sec. health-care level) Needle, luer, (size:G & mm), sterile, single use 2.1.6 Needle,luer,19G(1.1x40mm),ster,s.u. X X 2.1.7 Needle,luer,21G(0.8x40mm),ster,s.u. X X 2.1.8 Needle,luer,23G(0.6x25mm),ster,s.u. X X 2.1.9 Needle,luer,25G(0.5x16mm),ster,s.u. X X Needle, scalp vein, (size:G), sterile, single use 2.1.10 Needle,scalp vein,21G,ster,s.u. X X 2.1.11 Needle,scalp vein,25G,ster,s.u. X X Needle, spinal, (size:G & mm), sterile, single use 2.1.12 Needle,spinal,20G(0.9x90mm),ster,s.u. X 2.1.13 Needle,spinal,22G(0.7x90mm),ster,s.u. X 2.2 Syringes - Immunization Syringe, auto-disable 2.2.1 Syringe, auto-disable, 0.5 ml, ster X X 2.2.2 Syringe, auto-disable, 0.05 ml, ster X X 2.3 Syringes - Others (1) Syringe, luer, (capacity:ml), sterile, single use 2.3.1 Syringe,luer,1ml,ster,s.u. X X 2.3.2 Syringe,luer,2ml,ster,s.u. X X 2.3.3 Syringe,luer,5ml,ster,s.u. X X 2.3.4 Syringe,luer,10ml,ster,s.u. X X 2.3.5 Syringe,luer,20ml,ster,s.u. X X (1) RPF (reuse-prevention feature) injection devices should be considered. 2.4 Sharps waste disposal "Special note" on health-care waste management 2.4.1 Safety box, f.used syrgs/ndls, 5L X X 2.5 Miscellaneous injection devices 2.5.1 Infusion giving set,ster,s.u. X X Note: Infusion giving set must be packed/delivered with Infusion (Interagency recommendation) 2.5.2 Infusion giving set, burette 100-150ml,ster,s.u. X X 3 Dressing supplies 3.1 Compress/bandage/tape Compress/bandage/tape,(material), (size) (presentation) 3.1.1 Bandage,elastic,7.5cmx5m,roll X X 3.1.2 Bandage,gauze,5cmx5m,roll X X 3.1.3 Bandage,gauze,8cmx4m,roll X X 3.1.4 Bandage,tricot,tubular,5cmx25m,roll X 3.1.5 Compress,gauze,10x10cm,non-sterile X X 3.1.6 Compress,gauze,10x10cm,sterile,s.u. X X 3.1.7 Gauze,roll,90cmx100m,non-sterile X X 12  Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (back-up care at sec. health-care level) 3.1.8 Tape,adhesive,zinc oxide,2.5cmx5m X X 3.1.9 Tape,adhesive,zinc oxide,perforated,10cmx5m X 3.1.10 Tape,umbilical,3mmx50m,non-sterile X X 3.2 Miscellaneous dressing 3.2.1 Blanket,survival,approx.220x140cm,non-ster X X 3.2.2 Clamp,umbilical,sterile,s.u. X 3.2.3 Cotton wool,500g,roll,non-ster X X 3.2.4 Soap,toilet,bar,approx.110g,wrapped X X 4 Surgical sutures "Special notes" on surgical sutures 4.1 Sutures, absorbable Sutures, (type of thread), (Decimal gauge of thread), needle (shape) (length) (point),sterile, single use 4.1.1 Suture,synthetic,absorbable,DEC1(5/0),need 1/2,18mm,round,ster,s.u. X 4.1.2 Suture,synthetic,absorbable,DEC2(3/0),need 3/8 18mm,round,ster,s.u. X 4.1.3 Suture,synthetic,absorbable,DEC2(3/0),need 3/8,26mm,triangular,ster,s.u. X X 4.1.4 Suture,synthetic,absorbable,DEC3(2/0),need 1/2 30mm,round,ster,s.u. X 4.1.5 Suture,synthetic,absorbable,DEC3(2/0),need 3/8 50mm,round,ster,s.u. X X 4.1.6 Suture,synthetic,absorbable,DEC4(1),need 3/8 36mm,triangularster,s.u. X 4.2 Sutures, non-absorbable Sutures, (type of thread), (decimal gauge of thread), needle, (shape) (length) (point),sterile, single use 4.2.1 Suture,synthetic,non-absorbable,DEC2(3/0),need 3/8 13mm,triangular,ster,s.u. X 4.2.2 Suture,synthetic,non-absorbable,DEC3(2/0),need 3/8 30mm,triangular,ster,s.u. X X 5 Clothing and accessories. "Special note" on standard precautions for health workers & "Special note" on wearing protective equipment 5.1 Apron,protection,plastic,disposable X X 5.2 Apron,protection,plastic,reusable X X 5.3 Drawsheet,plastic,approx. 90x180cm X X 5.4 Glasses,safety, regular size, disposable X X 5.5 Mask,surgical,s.u. X X Others: Medical clothing/linen "Special note" on textiles used for linen and clothing 5.6 Cap, surgical, non-woven X X 5.7 Clogs, plastic X X 5.8 Coat, medical, woven, white X X 13  Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (back-up care at sec. health-care level) 5.9 Drape, surgical woven X X 5.10. Gown, patient, woven X X 5.11 Gown, surgical, woven X X 5.12 Trousers, surgical, woven X X 5.13 Tunic, surgical, woven X X 6 Medical stationery 6.1 Bag, plastic,for health card,11x25cm X X 6.2 Health card X X 6.3 Referral record X X 6.4 Feedback record X X 6.5 Labour record X X 6.6 Partograph X X 6.7 Postpartum record X X 6.8 Intern. form of medical certificate of death cause X X     Medical Devices - Equipment Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (Back-up care at sec. health- care level) 1 Anthropometric Equipment 1.1 Bracelet, identification newborn X X 1.2 Height measuring instrument (0-2m) X X 1.3 Scale,adult/infant, electronic,150kgx100g X X 1.4 Scale,adult, mechanical,150 kg x 500 g X X 1.5 Scale,infant, clinic,metric 16kgx10g X X 1.6 Scale,infant, spring,5kgx25g, w/slings X X 2 Medical Diagnostic Equipment 2.1 Electrical equipment (*220V) 2.1.1 Doppler,fetal heart detector,w/access X X 2.1.2 Scanner,ultrasound,w/access X 2.2 Other medical diagnostic equipment 2.2.1 Flashlight,pre-focused X X 2.2.3 Tape,measuring,vinyl-coated,1.5m X X 2.2.4 Thermometer,clinical,digital 32-43C X X 2.2.5 Timer,respiration for ARI X X 2.2.6 Tongue depressor,wooden,s.u. X X 2.2.7 Tourniquet,rubber,approx.75cm X X 2.2.8 Sphygmomanometer,(adult),aneroid X X 2.2.9 Sphygmomanometer,(child),aneroid X X 2.2.10. Stethoscope,binaural,complete X X 2.2.11 Stethoscope,fetal, monaural X X 14  Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (Back-up care at sec. health- care level) 3 Medical Utensils 3.1 Steel utensils 3.1.1 Basin,kidney,stainless steel,approx.825ml X X 3.1.2 Bowl,round,stainless steel,approx.4L X X 3.1.3 Bowl,stainless steel,approx.180ml X X 3.1.4 Bowl,stainless steel,approx.600ml X X 3.1.5 Tray,dressing,stainless steel,approx.300x200x30mm X X 3.1.6 Tray,instruments,stainless steel,approx.480x330x20mm X X 3.1.7 Tray,instruments,stainless steel,approx.320x200x80mm,w/cover X X 3.1.8 Razor blades,double-edged, s.u./PAC-5 X X 3.1.9 Razor,safety,metal,3-piece X X 3.1.10 Razor, single edge, plastic, s.u. X X 3.1.11 Receptacle,waste,stainless steel,pedal action,approx.21L X X 3.2 Plastic utensils 3.2.1 Basin,kidney,polypropylene,approx.475ml X X 3.2.2 Bedpan,polypropylene,adult X X 3.2.3 Bottle,plastic,approx.250ml,wash bottle X X 3.2.4 Bottle,plastic,approx.1L,w/screw cap X X 3.2.5 Bowl,round,polypropylene,8L X X 3.2.6 Brush,hand,scrubbing,plastic X X 3.2.7 Jar,forceps,polypropylene,approx.180mm,w/o cover X X 3.2.8 Jar,thermometer,polypropylene,approx.110mm,w/o cover X X 3.2.9 Jug,measuring,plastic,approx.1L X X 3.2.10 Receptacle,waste,plastic,approx.13L, w/lid X X 4 Sterilization Equipment "Special notes" on sterilization of reusable medical devices 4.1 Sterilizers Electrical equipment (*220V) 4.1.1 Sterilizer,steam,approx.40L,w/access X X 4.1.2 Sterilizer,steam,approx.100L,w/access X Others 4.1.3 Sterilizer,steam,approx.24L,w/access X X 4.1.4 Sterilizer,steam,approx.39L,w/access X X 4.2 Containers 4.2.1 Basket,sterilizing, approx.120x250x60mm X X 4.2.2 Basket,sterilizing,approx. 240x250x60mm X 4.2.3 Drum,sterilizing,approx.165mm diam X X 4.2.4 Drum,sterilizing,approx.260mm diam X X 4.2.5 Drum,sterilizing,approx.290mm diam X X 4.2.6 Drum,sterilizing,approx.340mm diam X X 4.3 Other sterilization equipment 4.3.1 Indicator,TST control spot X X 15  Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (Back-up care at sec. health- care level) 4.3.2 Papersheet,crepe,for sterilization pack X X 4.3.3 Stove,kerosene,single-burner,pressure X X 4.3.4 Tape, adhesive, for sterilization pack X X 4.3.5 Timer,60 min X X 5 Hospital Equipment 5.1 Electrical equipment (*220V) 5.1.1 Electrosurgical unit,w/access X 5.1.2 Light,examination,mobile,w/access X X 5.1.3 Light,Oper.theatre,mobile,w/access X 5.1.4 Light, Oper. theatre, ceiling,w/access X 5.1.5 Pump,suction,portable,1 bottle,w/access X X 5.1.6 Pump,suction,surgical,2 bottles,w/access X 5.2 Other hospital equipment & furniture 5.2.1 Bed,hospital,standard,w/mattress X X 5.2.2 Bed,hospital,ICU,w/mattress X 5.2.3 Bed,labour/delivery,w/access X X 5.2.4 Bedscreen,hospital,on castors X X 5.2.5 Bucket,kick,stainless steel,on castors X X 5.2.6 Cabinet,bedside,standard X X 5.2.7 Cabinet,instruments,double door X X 5.2.8 Cabinet,medicine,double door X X 5.2.9 Cot,baby,hospital,w/bassinet,on castors X X 5.2.10 Footstool,two steps X X 5.2.11 Stand,infusion,double hook,on castors X X 5.2.12 Stand,single bowl,on castors X X 5.2.13 Stool,adjustable,on castors X X 5.2.14 Stretcher,foldable X X 5.2.15 Stretcher,patient,w/side rails X X 5.2.16 Table,baby dressing X X 5.2.17 Table,examination X X 5.2.18 Table,instr,Mayo type,stainless steel,on castors X X 5.2.19 Table,instr,stainless steel,2 trays,on castors X X 5.2.20 Table,gynaeco,delivery,w/access X X 5.2.21 Table,Oper.theatre,w/access. X 5.2.22 Trolley,dressing,stainless steel,2 trays X X 5.2.23 Trolley,emergency,w/drawers X X 5.2.24 Trolley,soiled linen X X 5.2.25 Wheelchair, adult X X 5.3 Miscellaneous other equipment 5.3.1 Vacuum extractor,Bird,manual,complete.set X 5.3.2 Pump,breast,manual,w/access X 6 Anaesthesia/Resuscitation Equipment 6.1 Electrical equipment (*220V) 6.1.1 Anaesthesia system, free-standing,w/access X 6.1.2 Incubator,newborn,automatic,w/access X 6.1.3 Monitor,patient,portable,w/access X 6.1.4 Nebulizer,atomizer,w/elec.compressor/SET X 16  Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (Back-up care at sec. health- care level) 6.1.5 Oxygen concentrator/SET X 6.1.6 Phototherapy unit, w/access X 6.1.7 Pulse oximeter,portable, w/access X 6.1.8 Pump,infusion,w/access X 6.1.9 Table,resusc,newborn,w/access X 6.1.10 Ventilator, resuscitation (adult-child), w/ access X 6.1.11 Warmer,baby,electric/SET X X 6.2 Other anaesthesia equipment 6.2.1 Laryngoscope,adult/child,set X 6.2.2 Forceps Magill, adult X 6.2.3 Forceps Magill, child X 6.2.4 Pump,suction,foot-operated X X 6.2.5 Resuscitator,hand-operated,adult,set X X 6.2.6 Resuscitator,hand-operated,infant/child,set X X Medical Devices - Equipment: Surgical instruments sets "Special note" on surgical instruments stainless steel 7 Surgical Instruments Sets 7.1 UNICEF surgical instruments sets 7.1.1 Surg.inst.,abdominal /SET X 7.1.2 Surg.inst.,basic surgery /SET X 7.1.3 Surg.inst.,curettage /SET X 7.1.4 Surg.inst.,delivery /SET X X 7.1.5 Surg.inst.,dressing /SET X X 7.1.6 Surg.inst.,embryotomy /SET 7.1.7 Surg.inst.,exam/sut,vaginal/cervical/SET X 7.1.8 Surg.inst.,suture /SET X X 7.2 UNFPA surgical instruments sets 7.2.1 Surg.inst.,abdominal tubal ligation/SET X 7.2.2 Surg.inst.,IUD insertion & removal/SET X X 7.2.3 Surg.inst.,subdermal implant insertion & removal/SET X X 7.2.4 Surg.inst.,laparoscopy/SET X 7.2.5 Surg.inst.,minilaparotomy/SET X 7.2.6 Surg.inst.,non scalpel vasectomy/SET X 7.2.7 Surg.inst.,vasectomy/SET X 7.2.8 Manual Vacuum Aspiration instrument,w/access/SET X X   17    Medical Devices - Medical kits   Item line Product classification/Short description First-level MNH care (services provided close to clients) Referral level (Back-up care at sec. health-care level) Medical kits 1 UNICEF Kits http://www.supply.unicef.dk/Catalogue/ Technical Bulletin No.4 - Midwifery Kit, Complete Technical Bulletin No.5 - Obstetric, Surgical Kit, Complete 1.1 Midwifery kit,1-drugs X X 1.2 Midwifery kit,2-equipment X X 1.3 Midwifery kit,3-renewable X X 1.4 Midwifery kit, supplementary 1a-drugs X X 1.5 Obstetric,surgical kit,suppl.1-drugs X 1.6 Obstetric,surgical kit,suppl.2-equipment X 1.7 Obstetric,surgical kit,suppl.3-renewable X 1.8 Obstetric,surgical kit,suppl.1a-drugs X 1.9 Resuscitation kit,basic X X 1.10. Sterilization, kit C X X 2 Inter-Agency Reproductive Health Kits for Crisis Situations 2.1 Kit 0: Administration kit 2.2 Kit 1: Condom kit: Part A (male) and B (female) 2.3 Kit 2: Clean Delivery kit (individual): Part A (mother) and B (birth attendant) 2.4 Kit 3: Rape Treatment kit 2.5 Kit 4: Oral and Injectable Contraception 2.6 Kit 5: Treatment of Sexually Transmitted Infections 2.7 Kit 6: Delivery kit (Health Facility) 2.8 Kit 7: Intra Uterine Device 2.9 Kit 8: Management of Complications of Abortions kit 2.10. Kit 9: Suture of Tears (vaginal and cervical) and Vaginal Examination kit 2.11 Kit 10: Vacuum Extraction for Delivery (Manual) kit 2.12 Kit 11: Referral level kit for Reproductive Health 2.12.A Part A: Reusable equipment 2.12.B Part B: Drugs and disposable equipment 2.13 Kit 12: Blood Transfusion kit   18        19  Annex 1: Integrated Management of Pregnancy and Childbirth (IMPAC)   First-level MNH care (services provided close to clients) Back-up care at sec. health-care level Routine care (includes care that should be offered to all women and babies) Complications care at first level nclude initial management of complication and referral if necessary). Estimated proportion of target population (e.g. all pregnant women, all childbearing women, all newborns, etc.), who will require treatment is indicated in brackets). Complications care at back-up level Care during pregnancy 1.a. Assessment of mother and fetal well being, information and counselling on care and self care, including birth and emergency plan, breastfeeding and education on danger signs; family planning counselling and advice, recording and reporting. (part of ANC) 1.b. Additional care and counselling for women with special needs (adolescents, previous stillbirth, violence and other social problems) 2.a. Screening of hypertensive disorders of pregnancy (part of ANC) 2.b. Initial management of pre- eclampsia and eclampsia 2.c. Treatment of severe pre- eclampsia, eclampsia (3% of all women during pregnancy, birth and postpartum period). 3.a. Prevention (iron supplementation) and screening for anaemia (part of ANC) 3.b. Treatment of mild to moderate anaemia (Hb:7-11g/dl) 3.c. Treatment of severe anaemia (3-5% of all women during pregnancy, birth, postpartum) 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., ectopic pregnancy <0.5%, placenta praevia and abruption placenta (1%)) 4.c. Treatment of bleeding in pregnancy (treatment of post abortion complications 0.05%, laparotomy 0.03% and c-section 0.5% 5.a. Screening for maternal syphilis (part of ANC), 5.b. Presumptive treatment of syphilis (1-10% of all pregnant women) 6.a. STI/RTI diagnosis (Candida vaginitis, gonorrhoea, Chlamydia, bacterial vaginosis and trichomoniasis), (part of ANC). 6.b. STI/RTI management (Candida vaginitis, gonorrhoea, Chlamydia, bacterial vaginosis and trichomoniasis), (5-10% of all pregnant women) 7.a. Tetanus toxoid immunization (part of ANC) 8.a. Screening for urinary tract infection 8.b. Antibiotic treatment for lower urinary tract infection (4-7% of all pregnant women) 8.c. Treatment of acute pyelonephritis (2% of all pregnant women) 9.a. Diagnosis of malpresentation (part of ANC) 9.c.External Cephalic Version (ECV), (4% of all pregnant women) 10.a. Voluntarily Counselling and Testing (VCT) for HIV (part of ANC) 10.b. Counselling, support and treatment of opportunistic infections among HIV-positive pregnant women with ARV (1-40% of all pregnant women) 10.c. Treatment of opportunistic infections in HIV-positive women with ARV and provision of ARV for PMTCT (1-5% of all pregnant women) Endemic areas 11.a. Antimalarial Intermittent preventive treatment (IPT) and insecticide treated nets (ITNs) (part of ANC) 11.b. Treatment of uncomplicated malaria (5-10% of all pregnant, birthing and postpartum) 11.c. Treatment of complicated malaria (less than 0.5% of all pregnant, birthing and postpartum women) Endemic areas 12.a. Systematic treatment of hookworm infestation (100% of all pregnant women in endemic areas) 20  First-level MNH care (services provided close to clients) Back-up care at sec. health-care level Situational 13.a. Abortion care (where abortion is legal) (1-10%) Care of the mother and the newborn- baby during birth and the first 1-2 hours after birth 14.a. Routine care during labour, birth and the immediate post-partum period, which includes: care and social support during 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. 14.b. Episiotomy (10-15% of all birthing women), Repair of vaginal / perineal tears (10% of all birthing women) 15.a. Detection of prolonged and obstructed labour Initial management and referral of prolonged and obstructed labour and fetal distress (10-15%), Vacuum extraction (3% of all birthing women) Breech delivery; Vacuum extraction; forceps; c-section (10-15% of all birthing women) 16.a. Diagnosis of pre-labour rupture of membrane (PROM) 16.b. Initial management and referral of pre-labour rupture of membranes (PROM) 16.c. Management of pre- labour rupture of membranes (PROM) (5-7%) 17.a. Detection of bleeding 17.b. Initial management of bleeding 17.c. Management of severe bleeding (5%) 18.a. Identification of newborn breathing problems 18.b. Resuscitation, monitoring of breathing and pre-referral treatment of severe cases (4%) 18.c. Management of respiratory distress (2-4%) 19.a. Identification of newborn hypothermia 19.b. Re-warm baby and pre-referral care of severe cases 19.c Management of severe hypothermia (2%) Endemic areas 20.a. Prevent mother to child transmission of HIV (PMTCT) - and providing guidance and support with replacement feeding). 20.b. Administering of ARV 20.c. PMTCT including administering of ARV Care of the mother from 1-2 hours after birth until discharge (24-48 hours at least) 21.a. Prevention (iron and folate supplementation) and detection of anaemia 21.b. Initial management of anaemia (40% of all women during pregnancy, birth and postpartum) 21.c. Management of severe anaemia (including blood transfusion) (3-5%) 22.a. Prevention and control of infections 22.b. Initial management of sepsis (mastitis (5%), perineal (1%), lower urinary tract infection (4%) 22.c. Management of puerperal sepsis (5%) 23.a. Identification of hypertensive disorders 23.b. Initial management of pre- eclampsia / eclampsia and pre- referral care (<1%) 23.c. Management of severe pre-eclampsia / eclampsia (<0.5%) 24.a. Family Planning and decision- making on birth spacing 24.b. IUD insertion (3% of all birthing women) 24.c. Female sterilization (5- 15%) Newborn care from 1-2 hours after birth until discharge (24-48 hours at least) 25.a. Routine care of the newborn: Assessment of wellbeing, detection of complications, cord care, eye prophylaxis; advising mother on breastfeeding and newborn care, post- natal care visits, and danger signs. 25.b. Additional care if preterm, or birth weight less than 2500 or twin (additional care can include: special support for breastfeeding, additional warmth, ensure hygiene, monitor more often). Kangaroo Mother Care (5-10%) 26.a. Breastfeeding support and guidance 26.b. Additional assistance to mother to express breast milk or provide/advice on alternative feeding methods in case of feeding problems (1-40%) 26.c. Alternative feeding methods if baby is unable to feed (5-10%) 27.a. Preventions and control of infections 27.b. Treatment of local infections (cord, skin, eye, thrush) and pre- referral care of severe infections (4%) 27.c. Management of neonatal sepsis (4% all baby) 28.a. Immunization of baby with BCG 29.a. Immunization of baby - OPV-0 21  First-level MNH care (services provided close to clients) Back-up care at sec. health-care level 30.a. Immunization of baby - Hepatitis B (HB-1) 31.c. Management of neonatal tetanus (0.1%) 32.c. Management of severe jaundice (5%) 33.a. Verification of RPR status 33.b. Presumptive single dose of penicillin treatment in asymptomatic baby of RPR positive mother, treat/counsel partner (1-10%) 33.c. Treatment of congenital syphilis, 10 days (1%) 34.a. Identification of babies at risk of infection (in case of PROM> 18 hours or maternal fever) 34.b. Pre-referral treatment with antibiotics (5-10%) 34.c. Presumptive treatment of infection - 5 days (5-10%) 35.a. Identification of babies at risk of TB 35.b. Prophylaxis with isonlazide, postpone BCG, follow-up 36.a. Screening for birth trauma 36.b. Management of mild birth trauma and pre-referral care for severe trauma. 36.c. Management of severe birth trauma 37.a. Screening for malformations 37.b. Pre-referral care for severe malformation and provide advice to parents on mild malformations. 37.c. Management of correctable congenital malformations Endemic areas 38.a. Advise mother to keep baby under treated net. 38.b. Detection and pre-referral care of neonatal malaria 38.c. Treatment of malaria (1%) Post- partum care (mother) - discharge to 6 weeks after birth 39.a. Routine postpartum care, which includes general assessment of mother's wellbeing, information and counselling on nutrition, care and self care; detection of any danger signs; monitoring and recording. 39.b. Mild postpartum depression management (10%) 39.c. Management of postpartum depression (2%) 40.a. Prevention (iron and folate supplementation for 3 months after birth) and detection of anaemia 40.b. Initial management of mild and moderate anaemia 40.c. Management of severe anaemia, including blood transfusion (4% of p,b,p) 41.a. Prevention and control of infections 41.b. Initial management of sepsis puerperal sepsis (5%), mastitis (5%), perineal infection (1%) 41.c. Management of severe puerperal sepsis 3% 42.a. Family Planning and decision- making on birth spacing 42.b. IUD insertion (3% of all birthing women) 42.c. Sterilization (1-5%) Endemic areas 43.a. Antimalarial intermittent preventive treatment (IPT) and insecticide treated nets (ITNs) 43.b. Treatment of uncomplicated malaria (5-10% of all women during pregnancy, birth and postpartum) 43.c. Treatment of complicated malaria (<0.5%) Post natal care (baby), discharge to 4 weeks after birth 44.a. Routine neonatal care of the newborn: Assessment of wellbeing of the newborn and breastfeeding, regular monitoring for detection of complication, advising mother on breastfeeding, newborn care and danger signs. 44.b. Additional follow-up for low birth weight and high risk babies (replacement feeding, isoniazide prophylaxis, orphans, etc.) 44.c. Management of neonatal sepsis and other infections, detection and management of not lethal malformations, care of very low birth weight infants; care of newborns with failure to thrive (5-10%) 22  23  Annex 2: Special notes Special note for units and biomaterials used for medical devices   Special note on packaging and labelling  Special note on injection safety  Special note on health‐care waste management  Special note on surgical sutures  Special note on standard precautions for health workers  Special note on wearing protective equipment  Special note on textiles used for linen and clothing  Special note on sterilization of medical devices  Special note on surgical instruments, stainless steel  24  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:  French gauge  Definition:   Unit that expresses the external diameter in 1/3mm    CH 1 = 1/3 mm  Field of use:   Tubes and drains    e.g.: CH 6 = 2mm or CH4 = 1.33mm  French gauge = F or FG Synonym:   French size, Charrière  Definition:   Unit that expresses the external diameter in 1/3mm    1 FG = 1 CH = 1/3mm  Field of use:   Exploratory catheters, tubes and drains.    Note:    Some  manufacturers offer catheters in Inches    e.g.: 5 FG = CH 5 = 1.66mm = 0.066 INCH  Gauge = G, Ga, Gg, g Synonym:   British standard gauge  Definition:   Unit which expresses the external diameter of the product, in a range,  from 8 to30, corresponding  respectively: 4 to 0.3mm  Field of use:   Short catheters, needles, scalp veins.    The  higher  the  gauge,  the  smaller  the  external  diameter. The  gauge  gives  the  external  diameter,  but  does  not  take  into  account  the  thickness of the wall, so it will not indicate the internal diameter.  e.g.: 22G = 0.7 to 0.9mm ‐ 18G = 1.1 to 1.3mm.    Note:  the gauge/mm correspondence may vary, due  to  figures being  rounded off in conversion from inches to mm.  Inch = In or ’’ Synonym:   In French « pouce »  Definition:   Unit used to express the external diameter of guides for catheters  1 in = 1 inch = 25.4mm  1 mm = 0.04 in = 0.04’’     Field of use:   Guides for catheters.  25    Table of correspondence Gauge/mm and normalized colours  for hypodermic needles (EN‐ISO 6009, Hypodermic needles for  single use ‐ Colour coding for identification)  Dimension in gauge  Nominal ext. Ø in mm  Colour code  29 G  0.3 mm  ‐  27 G  0.4 mm  Grey  26 G  0.45 mm  Brown  25 G  0.5 mm  Orange  23 G  0.6 mm  Blue  22 G  0.7 mm  Black  21 G  0.8 mm  Dark green  20 G  0.9 mm  Yellow  19 G  1.0 mm  Cream  18 G  1.2 mm  Pink  17 G  1.5 mm  Red‐violet  16 G  1.6 mm  White  15 G  1.8 mm  Grey‐blue  14 G  2.1 mm  Light green  13 G  2.4 mm  ‐    Correspondence Charrière/mm Catheters and drains    Endotracheal tubes      NB: OD = Outer Ø, ID = Inner Ø    Biomaterials The  biomaterials  used  in  the  field  of  medical  devices  consumables  are  very  disparate,  covering  all  plastic  substances  intended  for  implanting  in  the  human  body  for  a  fairly  extended period. They are subject to biocompatibility and non‐toxicity criteria.  Polymers The selection of polymers used in the manufacture of medical devices consumables is based  on  criteria  for use,  consumption, product design  (in particular, after  sterilizing  treatment),  fabrication and industrial assembly.     26  Glossary of biomaterials used for medical devices materials Polyolefine          HDPE: high density polyethylene    LDPE: low density polyethylene  PP: polypropylene    Polyether   POM: polyacetal  Polyvinyl        PVC: polyvinyl chloride      EVA: (polyethylene/vinyl acetate  Polyfluorethane  PTFE: polyetraflurethylene  PEF and FEP: polyethylene/propylene  perfluorate  Polystyrene         PS: polystyrene  ABS: acrylonitrile butadiene styrene    Polyurethane   PUR  Polyacrylic        PMMA: polymethyl methacrylic    Silicone   SI: silicone elastomer  Polyamide          PA6            PA6/6 6.10          PA11      Latex  Natural Rubber  Molded  Rubber  (obtained  by  coagulation  of latex)  Sheet Rubber (type of natural rubber)  Cellulose  CA: cellulose acetate   CP: cellulose propionate   CAB: cellulose acetobutyrate  Non‐woven (celluloid)  PE  PP  PA  Linear polyester  Polyglycol  Polydioxanone  PET: polyethylene terephthalate  PC: polycarbonate                    Characteristics sought/Most appropriate materials • Flexibility:   Silicone, Flexible PVC, PUR Thermoplastic PUR, LDPE  • Transparency:   PMMA, PS, Celluloid, PP, PVC, PC, Silicone  • Permeability:   Cellulose, LDPE, Silicone  • Impermeability:   PVC, PET, PA,   • Mechanical strength:   PA, POM, PET, ABS  • Shock resistance:   PA, PC, PUR  • Low coefficient of friction:   PFE, PA, POM, LDPE  • High temperature sterilization:   PFE, Silicone, PA, PET, PC, PP  • High frequency welding:   Flexible PVC  • Low price:  LDPE, PP, HDPE  Steam sterilization of biomaterials (Autoclave) The following table should be used for guidance only.     • Molded rubber:   Satisfactory  • Latex:   Satisfactory  • Sheet rubber:   Satisfactory (not recommended for articles with balloon)  27  • Silicone:   Satisfactory  • EVA:   To be avoided  • PVC:   Not recommended  • Red vinyl:   Satisfactory  • Polyethylene:   To be avoided  • Polypropylene:   Satisfactory  • Polycarbonate:   Satisfactory  • Polyurethane:   To be avoided    Note: manufacturer’s recommendations should always be followed.    28  Special note on packaging and labelling Packaging Any medical device must be supplied in a packaging.  Primary packaging, sterile or non-sterile as appropriate Packaging  in direct contact with the product,  intended to protect one or more  items, and  if  needed, to keep it (them) sterile until use.  EXAMPLES: sachet, plastic box, peel‐off sachet (recommended for sterile items since the transparent  film allows clear identification of the content).  For sterile medical devices:  if  the primary packaging has deteriorated  (cracks, moulds etc.)  the item can no longer be considered sterile. Check the integrity of each unit before use.  Secondary packaging Packaging which  constitutes  the  unit  of  sale  or  the  unit  of  use,  intended  to  protect  the  primary packaging of one or more items until use.  EXAMPLES: cardboard, rigid wrapping. Tertiary packaging Extra  packaging  intended  to  protect  one  or  more  wrapped  items  during  transport  and  storage.  29  Labelling Product labelling shall meet the essential requirements describe in GHTF document   SG1‐ N043R3: Labelling for Medical Devices (including In Vitro Diagnostic Devices)  Labelling on the primary packaging ► The name or trademark of the manufacturer and/or the supplier  ► The article reference of the manufacturer and/or the supplier  ► The details needed to identify the device, ideally in English and in French  (designation, description, composition as appropriate)  EXAMPLE: The packaging of a surgical instrument must bear its designation and  its nominal dimension in cm (= overall dimension or dimension of the active part,  e.g. the blade)  ► The batch number prefixed by the word ʺLOTʺ or equivalent harmonized symbol,  or the serial number prefixed by ʺSNʺ  ► For items with limited shelf live, the expiry date using the words “use before  (month)/( year) or prefixed by ʺEXPʺ or equivalent harmonized symbol  (month)/(year) ► For items without expiry date, the date of manufacture (year) prefixed by the  harmonized symbol, unless this information is already incorporated into the batch  number or the serial number  ► For single use items, the words ʺDO NOT RE‐USEʺ or ʺFOR SINGLE USEʺ or  equivalent harmonized symbol  ► For sterile items, the word ʺSTERILEʺ or equivalent harmonized symbol, plus a  warning which advises to ʺcheck the integrity of the sterile packaging before useʺ  Labelling on the secondary packaging: The same labelling as on the primary packaging, and in addition:  ► Any special storage and/or handling conditions  ► The instructions for use, ideally in English, French and Spanish, or the harmonized  symbol which indicates that the item is supplied with a separate instruction leaflet.  Expiration of medical devices with limited shelf-life Sterile medical devices (example: injection supplies) A sterile  item with an expiry date that has passed can no  longer be regarded as sterile and  must  be  eliminated.  If  the  expiry  date  only  mentions  the  month  and  the  year,  it  is  the  beginning  of  the  month  that  must  be  considered  the  use‐by  date.  How  the  constituent  materials of medical/surgical equipment will change over  time can only be determined by  30  the manufacturer who knows their exact composition. Nevertheless, the expiry date cannot  exceed 5 years from the date of sterilization. This period of validity only applies if transport  and storage are carried out under good conditions (protection from heat, humidity and light)  and for items which have their sterile primary packaging intact.   Non-sterile medical devices (example: adhesive tape) An  item which has passed  its expiry date no  longer has  the properties required  for  its use  and so it should not be used. The period of validity only applies if transport and storage are  carried out under good conditions (protected from heat, humidity and light) and for items of  which have their primary packaging intact.  31  Special note on injection safety To avoid  risks of  transmission of bloodborne pathogens, always use one  single‐use  sterile  needle and one  single‐use  sterile  syringe per patient and per  injection, and  to  reconstitute  each unit of injectable medication.  According  to  WHO  recommendations  on  injection  safety  and  to  ensure  injection  device  security:  • Promote  oral  treatment  and  limit  the  number  of  injections  to  only  those  strictly  necessary. Use oral rehydration to limit the use of drips.  • Use auto‐disable syringes with attached needles for immunization activities.  • Single‐use  syringes  with  a  reuse‐prevention  feature  should  be  considered  for  therapeutic  injections,  mostly  where  local  data  indicate  that  unsafe  practices  are  particularly common.  • Ensure  adequate  supply  of  injection devices. All  injectable medications  are  supplied  with  matching  quantities  of  single‐use  needles,  syringes,  appropriate  diluents  and  safety boxes/sharp containers according to the bundle principle.  • Use  single‐dose  vials  rather  than multi‐dose  vials.  If multi‐dose  vials must  be used,  always pierce the septum with a sterile needle and avoid  leaving a needle  in place  in  the vial stopper.  • Practice  safe  and  rational  use  of  blood  transfusions.  “any  transfusion which  is  not  specifically indicated is specifically contra‐indicated.”  • Collect used needles and syringes in a sharps container according to waste segregation  rules.  References • WHO. Aide memoire on injection safety. Available at:  http://www.who.int/injection_safety/about/country/en/AMENG.pdf  • WHO Guiding principles to ensure injection device security. 2003. Document no. WHO/BCT/03.12  Available at: http://www.who.int/injection_safety/WHOGuidPrinciplesInjEquipFinal.pdf  • WHO‐UNICEF‐UNFPA Joint statement on the use of auto‐disable syringes in immunization services.  1999. Document no. WHO/V&B/99.25.  • WHO. Best infection control practices for intradermal, subcutaneous and intramuscular injections, 2004.  Document no. WHO/BCT/DCT/01.02. Available at:  http://www.who.int/injection_safety/toolbox/en/LeafletBestPracticesPrinter.pdf]  • WHO. Aide memoire on blood safety. Available at:  http://www.who.int/bloodsafety/transfusion_services/en/Blood_Safety_Eng.pdf        32  Special note on health-care waste management Health‐care waste  is  a by‐product  of health  care  that  includes  sharps, non‐sharps,  blood,  body  parts,  chemicals,  pharmaceuticals,  medical  devices  and  radioactive  materials. In order to avoid possible transmissions of infections by health‐care waste,  proper health‐care waste management should be  implemented and promoted  in all  situations.  Health-care waste management includes the following steps: 1. Segregation of the various categories of waste;  2. Storage and collection;    3. Treatment and disposal.  1. Segregation The  four  major  categories  of  health‐care  waste  recommended  for  organizing  segregation and separate storage, collection and disposal are (WHO 2005b):    • sharps (needles, scalpels etc.), which may be infectious or not;  • non‐sharps infectious waste (anatomical waste, pathological waste, dressings,  used syringes, used single‐use gloves);  • non‐sharps non‐infectious waste (paper, packaging etc.);  • hazardous waste (expired drugs, laboratory reagents, radioactive waste,  insecticides etc.).  2. Storage and collection Sharps  should  be placed  immediately  in  safe  sharps  containers, which  are  regularly  collected for disposal.    Non‐sharps infectious waste containers (15‐40l capacity, with lids) should be collected,  emptied, cleaned, disinfected and replaced after each intervention (e.g. in an operating  or maternity unit) or twice daily.    Non‐sharps  non‐infectious  waste  (20‐60l  capacity)  should  be  collected,  emptied,  cleaned  and  replaced  daily;  alternatively,  plastic  bags  may  be  used  inside  the  containers (MSF 2005).    For  the  above  categories  of  waste,  it  is  recommended  that  waste  containers  are  a  maximum of 5m  from  the point of waste generation,  in 2 sets  for each  location,  for a  minimum 3 types of waste. At least one set of waste containers should be provided per  20 beds in a ward (MSF 2005).    Hazardous waste  should  be  collected  and  stored  in  appropriate  labelled  containers  placed  in  a  secure  location.  Radioactive  waste  should  be  stored  in  containers  that  prevent dispersion, behind lead shielding (Prüss, Giroult and Rushbrook, eds. 1999).  33  3. Treatment and disposal Sharps  should  be  disposed  of  in  a  sharps  pit  (buried  drum  in  small  centres  or  emergency structures, concrete‐lined sealed pit in other settings).    Non‐sharps  infectious waste  should be buried  in a pit  fitted with a  sealed  cover and  ventilation pipe, or high‐temperature incinerated. Special arrangements may be needed  for disposing of placentas, according to local custom.    Steam  sterilization  prior  to  disposal,  if  available,  is  a  preferred  option  for  specific  infectious waste such as blood samples, plastic syringes and  laboratory  tests, prior  to  disposal, as this avoids environmental pollution from incineration (Prüss, Giroult and  Rushbrook,  eds.  1999).  It  is  important  to  dedicate  one  specific  autoclave  for waste  sterilization  that  is  different  from  the  one  used  for  sterilization  of  medical  devices  within  the  laboratory. See Diaz & Savage 2003  for details of a  range of processes  for  treating infectious wastes.    Non‐sharps non‐infectious waste should be buried in a pit, a landfill site or recycled. If  space  is  limited,  it should be  incinerated. If this  is not possible,  it may be burned  in a  drum burner. In both cases, ashes and residues should be buried in a pit.    There are several kinds of hazardous waste and each  requires specific  treatment and  disposal methods, which  include encapsulation,  sterilization, burial,  incineration and  long‐term storage. Some wastes, such as pharmaceutical wastes, cannot be disposed of  safely  in  low‐cost  settings  and  should  be  sent  to  a  large  centre  for  destruction  or  returned to the supplier. For guidance on treatment and disposal of hazardous wastes,  see Prüss, Giroult and Rushbrook, eds. (1999). In all cases, national legislation should  be followed.  Waste zone The waste‐disposal zone should be fenced off; it should have a water point, with facilities for  wastewater disposal into a soakaway system or sewer; and it should be located at least 30m  from  groundwater  sources.  Where  an  incinerator  is  used,  it  should  be  located  to  allow  effective operation with minimal local air pollution in the health centre, nearby housing and  crops; and  it should be  large enough for extension  if new pits or other facilities have to be  built. A handwashing point with soap/detergent and disinfectant should be provided.  References • WHO health‐care waste web site. Available at:  http://www.healthcarewaste.org/en/115_overview.html   • WHO. Safe management of wastes from health‐care activities. 1999. Available at:  http://www.healthcarewaste.org/en/documents.html?id=1  • WHO Policy Paper. Health‐care waste management. 2004. Available at:  http://www.who.int/water_sanitation_health/medicalwaste/en/hcwmpolicye.pdf  • WHO. Aide memoire on health‐care waste management. Available at:  http://www.who.int/injection_safety/toolbox/en/AM_HCWaste.pdf  34  Special note on surgical sutures Type of thread Absorbable sutures All the threads proposed are made of synthetic materials of slow absorption type (about 21  days).    No catgut since its use is proscribed for the following reasons:    • The catgut is absorbed in a few days, sometimes in less than 48 hours, and can cause  reactions of rejection or inflammation (it is absorbed through a complex mechanism of  enzymatic  digestion,  while  synthetic  absorbable  threads  are  absorbed  by  simple  hydrolysis).  • The catgut involves a risk of contamination since it is made of bovine gut (BSE: bovine  spongiform encephalopathy) or ovine gut (trembling of sheep).    Selection: Synthetic braided thread.  Non-absorbable sutures Inert thread, monofilament, braided or twisted, made of nylon, polyester, polypropylene or  polyethylene.  Silk  and  linen  have  been  abandoned  in  favour  of  synthetic  threads, which  bring fewer problems of inflammation or rejection.    Selection: Synthetic monofilament   Size of thread The thread size denotes its gauge. Two systems are used for measuring this gauge:    • Decimal size, representing a tenth of the thread diameter, expressed as a DEC number  in the label (DEC2 = thread with a diameter of 0.20 mm)  • USP  size, which  ranges  from  10/0  to  4,  expressed between brackets  in  the  label  (the  more zeros in the number, the finer the thread).  Thread with needle • Threads  with  needles  have  an  average  length  of  75  cm.  The  needles  are  either  of  triangular  section  (to  pass  through  the  skin more  easily),  or  of  round  section  (less  traumatic for the majority of tissues).  • Sutures which  have  to  be  threaded  onto  needles  are more  traumatic when  passing  through tissues, increasing the risk of accident; consequently they have to be avoided.  35  Type of needle Suture needles are defined by their curvature (longitudinal shape), their body (cross section),  their length and their diameter.  Needle shape 1. Curved needle, 1/2 circle (= half) (= 4/8)  Deep sutures, stomatology, ENT,  gynaecology…      2. Curved needle, 3/8 circle  General surgery, vascular sutures…    3. Straight needle  To be avoided (more dangerous than curved  needles).    Needle point Round‐bodied  suture needles  taper gradually  to a point whereas  triangular‐bodied  suture  needles have cutting edges along three sides.    1. Round‐bodied  Sutures  of  soft  tissues, mucous membranes  and vessels.      2. Triangular‐bodied  Sutures of muscles and skin.    36  Special note on standard precautions for health workers Universal precautions consist of protective barriers that break the chain of micro‐organisms  transmission.  It applies  to blood, all body  fluids, secretions and excretions, non‐intact skin  and mucous membranes.    The protective barriers are simple procedures  to protect health‐care workers, patients, and  attendants/visitors against the risk of infection:    • Handwashing after any direct contact with patients,  • Wearing  of  protective  equipment  for  contact with  body  fluids,  non‐intact  skin  and  mucous membranes,  • Safe  handling  of  needles  and  sharps  to  prevent  needlestick  injuries,  including  preventing two‐handed recapping of needles,  • Safe  injection  practices  to  prevent  transmission  of  bloodborne  pathogens  to  patients  and health workers,  • Safe handling and disposal of medical related waste to prevent transmission of blood  borne pathogens to the health‐care providers, the waste handlers  and the community  at large,  • Safe handling of blood/body fluid specimens,  • Safe removal of blood/body fluid spills,  • Safe personal habits and working practices,  • Specific precautions in obstetric care, in operating theatre, in laboratory,  • Precautions for cleaning, laundry staff,  • Precautions for all health workers (vaccination against tetanus and hepatitis B).  37  Special note on wearing protective equipment Health workers should always wear protective equipment when contact with blood or other  body fluids is anticipated. Universal precautions include the following interventions:    Wearing examination gloves in case of:    • contact with blood, body fluids, mucous membranes or non‐ intact patient’s skin  • contact with objects or surfaces soiled with blood or other body fluids  • for cervical examination during labour  • for post delivery care  • for care of newborn,  • presence of wounds on the hands  • checking and packing of medical devices before sterilization.  Wearing long‐sleeved gloves (gynaecological/uterine gloves) where the hand and fore‐arm  need  to be  inserted  into  the vagina or uterus  (e.g. manual  removal of placenta, uterine  revision…).    Wearing surgical gloves (sterile single use gloves) where rigorous asepsis is required.    Wearing cleaning gloves (reusable rubber gloves) in case of:     • handling and disposal of medical waste  • performing environmental cleaning activities    Wearing  a mask  and protective  glasses  and  a  gown  (and  sometimes  a plastic  apron)  if  blood or other body fluids might splash.    Wearing appropriate clean workwear covering or  replacing “street clothes”: dress, gown  or  tunic and  trousers, with  short  sleeves  to  facilitate hand and wrist washing. Clothing  items are made of easy‐to wash and disinfect material (ideally cotton‐polyester or cotton).    Wearing fluid resistant gown (or apron) and boots when performing procedures that may  generate  splashing  or  spraying  (delivery,  handling  and  cleaning  of  medical  devices,  handling and disposal of medical waste etc.).    Removing protective  equipment  as  soon  as  the  task  is  finished  and discard  in  specific  container  according  the  type  of  equipment  (see  special  note  on  health‐care  waste  management).    Covering all cuts and abrasions with a waterproof dressing.  38  Disinfecting all reusable protective equipment (rubber gloves and apron, boots, protective  glasses) with 0.5% active chlorine solution.    Changing at  least  twice a week gowns,  tunics and  trousers:  (or more often  if necessary):  pre‐disinfect with 0.1% active chlorine solution, wash and iron.    All surgical gown must pre‐disinfect with 0.1% active chlorine solution, wash,  iron and  sterilize by autoclaving.    Washing hands with soap and water after removal of protective equipment.    Using manual or electrical mucous suction devices (never use the mouth tip system).  References • WHO. Aide memoire on health‐care protection. 2003. Document no. WHO/EHT/03.11. Available at :  http://www.who.int/injection_safety/toolbox/docs/AM_HCW_Safety.pdf  • WHO. Aide memoire on infection control. Document no. WHO/EHT/04.15. Available at:  http://www.who.int/injection_safety/AM_InfectionControl_Final.pdf  • Center for Disease Control and Prevention. Guidelines for environmental infection control in health‐ care facilities, 2003. Available at:   http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm  • WHO. Prevention of hospital‐acquired infections. A practical guide. 2nd ed. 2002. Document no.  WHO/CDS/CSR/EPH/2002.12. Available at:  http://www.who.int/crs/resources/publications/drugresist/en/whocdscsreph200212.pdf    39  Special note on textiles used for linen and clothing Single-use non-woven textiles These satisfy less of a medical need but rather reduce the risks linked to contamination and  nosocomial infections. They represent a large volume of contaminated waste which needs to  be eliminated, preferably by incineration.   Non-woven textile used for single-use surgical linen: • Composite material made of 3 layers:  • absorbent non‐woven material with orange peel structure,  • non‐porous, waterproof polyethylene,  • absorbent cellulose voile to absorb the patient’s sweat.    • Sometimes  provided  with  adhesive  area  (fixing  to  the  patient  and  antimicrobial  barrier).    E.g.: surgical mask, surgical gown, surgical towel, surgical cap etc.  Three-layer fabric with outer plastic film layer used in case of SARS or haemorrhagic fever • Material  of  three  layers  made  of  millions  of  high  density  polyethylene  continuous  fibres, heat‐bonded  • Impervious to liquids and aerosols  • Permeable to air and to steam with anti‐penetration barrier for fibres and particles < 1 μ  • Antistatic treated  • Heat‐sealed seams     E.g.: Personal Protective Equipment (PPE), protective mask, protective gown, coverall etc.  Reusable woven textiles Polyester/cotton • Designation: 50% polyester‐50% cotton fabric, heat‐set  • Number of threads: warp: 24, weft: 22   • Metric count: warp: 28, weft: 28  • Weight per m²: 175 g  • Washing: normal, withstands boiling and steam sterilization, resists to 0.5% chlorine  E.g.: surgical gown, surgical towel, medical staff clothing (tunic, trousers), patient tunic etc. Cotton • Designation: 100 % cotton cretonne fabric  • Number of threads: warp: 24, weft: 24  40  • Metric count: warp 28, weft: 28  • Weight per m²: 180 g   • Washing: normal, withstands boiling and steam sterilization, resists to 0.5% chlorine  E.g.: medical staff clothing (tunic, trousers), patient tunic etc.  Comparative results of the tests made on reusable woven textiles • Dusting rates: Polyester/cotton gives off 50% less particles than cotton. Since it pollutes  less, polyester/cotton is particularly recommended for surgical linen.  • Physical properties: Polyester/cotton shows the best physical properties. However,  its  resistance decreases in proportion to use and to the number of sterilization cycles.  • ʺBarrierʺ properties (bacteriological and physical resistance to liquids): New cotton can  absorb  the  equivalent  of  its weight:  high  permeability,  immediate  bacterial  passage.  After the first sterilization cycle, polyester/cotton shows a high level of absorption, but  the permeability is limited due to waterproofing treatments.       41  Special note on sterilization of medical devices Processing of reusable medical devices must be done according the risk of infections (critical,  semi‐critical and non‐critical items) and the heat resistant of the materials (thermoresistant or  thermosensitive devices).  Classification of reusable medical device 1.   Critical items are medical devices that are in contact with sterile parts of the body and  items through which liquids circulate that go into the blood or sterile parts of the body  (e.g.:  surgical  instruments,  compresses,  surgical  drapes,  syringes,  urinary  catheters,  etc.). Critical items must be sterile at the time of use.    • Thermoresistant critical items must be sterilized by steam autoclave between each  patient and kept sterile until use. Thermoresistant materials (can be sterilized by  steam sterilization): stainless steel, glass, latex, rubber, silicone, red vinyl,  polypropylène, polycarbonate, linen, gauze.  • Thermosensitive critical items are for single use only and must not be re‐sterilized or  re‐used. Thermosensitive materials (do not withstand sterilization by steam  autoclave): polyvinylchloride (PVC), ethylene vinyl acetate (EVA), polyurethane  2.   Semi‐critical  items  are  items  that  are  in  contact  with  mucous  membranes  or  superficially injured skin.    • Thermoresistant semi‐critical items must be sterilized by steam autoclave between  each patient but need not necessarily be kept sterile until use.  • Thermosensitive semi‐critical items must be subjected to ʺhigh‐levelʺ disinfection  between each patient.  3.   Non‐critical items are items that are in contact with intact skin and items that are not in  contact with the patient.    Non  critical  items  must  be  regularly  cleaned  and  disinfected  but  not  necessarily  between  each  patient,  except  if  they  have  been  soiled  by  blood  or  other  biological  fluids, or in case of infection requiring isolation (for example cholera and tuberculosis).  Steam sterilizaton method Sterilization  is  the  destruction  of  all  microorganisms.  Saturated  steam  sterilization  is  a  physical sterilization method. It consists of exposure to steam saturated with water at 121oC  for  30  minutes  or  134oC  for  13  minutes  in  an  autoclave  (134oC  for  18  min  for  prions).  Saturated steam sterilization is a reliable and easy to control sterilization method. Saturated  steam  sterilization  represents  the  first  choice  for  medical  devices  resistant  to  high  temperatures and pressure.  42  43  High level disinfection This consists of eliminating vegetative forms of bacteria and viruses (but not bacterial spores)  by  immersion of medical devices  in  a  0.1%  active  chlorine  solution  for  20 minutes). High  disinfection  concerns  a  restricted  number  of  medical  devices  only,  non‐autoclavable  (thermosensitive) and semi‐critical which are  likely  to be reused. After “high” disinfection,  medical devices cannot under any circumstances be considered as sterile.  Methods that are not recommended Boiling Boiling is a form of “high” disinfection and cannot be considered as sterilization. Boiling for  20  minutes  (+  5  minutes  /  1000  m  altitude)  in  a  saucepan  or  other  recipient  eliminates  vegetative  forms of bacteria and viruses,  including hepatitis and HIV viruses, but does not  destroy bacterial spores.  Dry heat sterilizer This method of sterilization does not give any advantage compared with the steam autoclave. Dry  heat  sterilization  is  not  always  effective.  Effectiveness  is  questionable  on  bacterial  spores:  for  example, the destruction of the spores of B. anthracis requires 3 hours heating at 140º C. Dry heat is  inefficient towards prions.     It  is  very  difficult  to  meet  the  conditions  of  correct  dry  heat  sterilization  in  precarious  situations. This method of sterilization poses some practical problems, such as:    • the  high temperature required deteriorates the materials;  • a perfect level surface is needed to use the sterilizer;  • its  use  for  purposes  other  than  sterilization  is  frequent  and  induces  problems  of  hygiene;  • this method is only used for glass and stainless steel items.  References • WHO. Prevention of hospital‐acquired infections. A practical guide. 2nd ed. 2002.  Document no.  WHO/CDS/CSR/EPH/2002.12. Available at:  http://www.who.int/crs/resources/publications/drugresist/en/whocdscsreph200212.pdf      44  Special note on surgical instruments, stainless steel In order  to guarantee good corrosion  resistance, only steels which are completely stainless  may be used  for  surgical  instruments.  Stainless  steels  are  steels  containing percentages of  carbon, chromium, molybdenum, nickel, silicon, manganese and other elements, defined by  the standard EN ISO 7153‐1: Surgical instruments: Metal materials – Part 1: stainless steel.    There are two main types of stainless steel:   Martensitic stainless steels  Austenitic stainless steels  These are quenched, magnetic steels.  They contain:  CARBON => 0,1 to 1 %  • Gives hardness and tensile strength  • Lowers corrosion resistance  CHROMIUM => 12 to 14 %  • Essential alloying element  • Gives corrosion resistance  MOLYBDENUM => 0,2 to 1 %  • Improves the cutting qualities  • Gives corrosion and impact resistance  • Cannot be used for pressure force  instruments, as it makes them brittle  SILICON => 0,5 to 1 %  MANGANESE => 0,4 to 2 %  These are non‐quenched, non‐magnetic steels.  They contain:  CHROMIUM => 16 to 20 %  • Essential alloying element  • Gives corrosion resistance  MOLYBDENUM => 2 to 3 %  • Gives corrosion and impact resistance  NICKEL => 8 to 12 %  SILICON => 0,5 to 1 %  MANGANESE => 0,4 to 2 %  Families of products 1. Pressure force instruments and springs => martensitic steel  • Haemostatic forceps  • Dissecting forceps  • Gripping forceps  • Surgical towel clamp  • Needle‐holding forceps  • Threading forceps  • Clamping forceps  The steel used must be springy and highly impact resistant.  Carbon gives them hardness, while chromium gives them  corrosion resistance. The proportions must be very exact.  Instruments made of these steels have to undergo a complex,  rigorous heat treatment which allows the steel to be hardened;  otherwise they will bend the first time they are used.  Instruments made of these steels must be carefully polished;  the quality of the polishing determines the corrosion  resistance.  2. Instruments that cut by shearing => martensitic steel  • Scissors  • Curettes  • Raspatories  • Gouge shears  • Cutting forceps  The steel used has a higher percentage of carbon than for the  pressure force instruments in order to increase hardness.  The percentage of chromium is the same to give corrosion  resistance, while incorporation of molybdenum makes up the  balance and improves the cutting qualities.    45  3. Instruments that cut by percussion => martensitic steel  • Chisel shears  • Osteotomes  • Gouges  For  the cutting part,  the heat  treatment and polishing are  the  same as for instruments that cut by shearing.  For the non‐cutting part, the heat treatment and polishing are  the same as for pressure force instruments.  4. Static function instruments => martensitic or austenitic steel  • Autostatic retractors  • Long‐handled retractors  • Valves  • Speculums  • Dilators    5. Miscellaneous instruments=> austenitic steel  • Instrument box  • Obstetrical hook  • Manual drill etc.        46  Table of standard grades of steel for surgical instruments  Composition of the steel  Families of products  Type of  steel  C A R BO N   C H R O M IU M   M O LY BD EN U M   N IC K EL   SI LI C O N   M A N G A N ES E  1. Pressure force instruments & springs  Haemostatic forceps  Dissecting forceps  Gripping forceps  Surgical towel clamps  Needle‐holding forceps  Threading forceps  Clamping forceps  Martensitic Martensitic Martensitic Martensitic Martensitic Martensitic Martensitic 0.2 %  0.2 %  0.2 %  0.2 %  0.2 %  0.2 %  0.2 %  13 %  13 %  13 %  13 %  13 %  13 %  13 %      1 %  1 %  1 %  1 %  1 %  1 %  1 %  1 %  1 %  1 %  1 %  1 %  1 %  1 %  2. Instruments that cut by shearing  Scissors  Curettes  Raspatories  Gouge shears  Cutting forceps  Martensitic Martensitic Martensitic Martensitic Martensitic 0.4 %  0.2 %  0.2 %  0.3 %  0.3 %  14 %  13 %  13 %  13 %  13 %      0.5 %  1 %  1 %  1 %  1 %  0.4 %  1 %  1 %  1 %  1 %  3. Instruments that cut by percussion  Chisel shears  Osteotomes  Gouges  Martensitic Martensitic Martensitic 0.5–0.7 %  0.5–0.7 %  0.3 %  13–14 %  13–14 %  13 %  0.5‐0.9 %  0.5‐0.9 %    1 %  1 %  1 %  1 %  1 %  1 %  4. Static function instruments  Autostatic retractors  Long‐handled retractors  Valves  Speculums  Dilators  Martensitic Austenitic  Austenitic  Austenitic  Austenitic  0.3 %  13 %  18 %  16–18 %  16–18 %  18 %      2‐3 %  2‐3 %  8‐10 %  10‐12 %  10‐12 %  8‐10 %    1 %  1 %  1 %  1 %  1 %  2 %  2 %  2 %  2 %  2 %  5. Miscellaneous instruments  Instrument box etc.  Austenitic              Acknowledgements Background Objective of the Interagency List of Essential Medical Devices for Reproductive Health Process Products nomenclature Products classification Products technical specifications Next steps: request for comments and suggestions Additional references Interagency List of Essential Medical Devices for Reproductive Health Structure of the list Medical Devices - Renewable/Consumables Medical Devices - Equipment Medical Devices - Equipment: surgical instruments sets Medical Devices - Medical kits Annex 1: Integrated Management of Pregnancy and Childbirth (IMPAC) Annex 2: Special notes Special note for units and biomaterialsused for medical devices Units Charrière = Ch, CH French gauge = F or FG Gauge = G, Ga, Gg, g Inch = In or ’’ Correspondence Charrière/mm Biomaterials Polymers Glossary of biomaterials used for medical devices materials Characteristics sought/Most appropriate materials Steam sterilization of biomaterials (Autoclave) Special note on packaging and labelling Packaging Primary packaging, sterile or non-sterile as appropriate Secondary packaging Tertiary packaging Labelling Labelling on the primary packaging Labelling on the secondary packaging: Expiration of medical devices with limited shelf-life Sterile medical devices (example: injection supplies) Non-sterile medical devices (example: adhesive tape) Special note on injection safety References Special note on health-care waste management Health-care waste management includes the following steps: 1. Segregation 2. Storage and collection 3. Treatment and disposal Waste zone References Special note on surgical sutures Type of thread Absorbable sutures Non-absorbable sutures Size of thread Thread with needle Type of needle Needle shape Needle point Special note on standard precautions for health workers Special note on wearing protective equipment References Special note on textiles used for linen and clothing Single-use non-woven textiles Non-woven textile used for single-use surgical linen: Three-layer fabric with outer plastic film layer used in case of SARS or haemorrhagic fever Reusable woven textiles Polyester/cotton Cotton Comparative results of the tests made on reusable woven textiles Special note on sterilization of medical devices Classification of reusable medical device Steam sterilizaton method High level disinfection Methods that are not recommended Boiling Dry heat sterilizer References Special note on surgical instruments, stainless steel Families of products

View the publication