Healthcare Professionals and Medical Gloves

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2 Healthcare Professionals and Medical Gloves Healthcare professionals are constantly exposed to potentially harmful infectious agents, e.g. HIV, Hepatitis B & C, and Ebola. They need protection during their course of work, especially when in contact with contaminated blood and body fluids. One safety measure is the use of appropriate medical gloves.

3 What are medical gloves? Prevent harmful infections For surgical and medical procedures Made of polymer Powdered or powder-free Disposable

4 Medical Glove Types (Commonly available) Examination Natural rubber latex Vinyl (PVC) Nitrile Surgical Natural rubber latex Polychloroprene Polyisoprene

5 Different Glove Materials Different barrier properties & Different glove qualities

6 Barrier Protection The most important glove function: Ability to provide very effective barrier protection against blood pathogens and harmful infections

7 Barrier Capability Glove failure during use Natural Rubber Latex PVC or Vinyl Nitrile, Polychloroprene, Polyisoprene Nitrile, Polychloroprene, Polyisoprene PVC or Vinyl Natural Rubber Latex As shown by many research studies (Ref:

8 An unusual notable feature of NR latex gloves is: Resealing Properties Their ability to reseal when encountered tiny punctures thereby providing enhanced barrier protection against infectious micro-organisms Ref: (i) Hasma & Othman Latex Conference 2001, RAPRA - Germany (ii) Broyles, O/Connell, Korniewicz - J. Clin. Microbiol (2002) 52,

9 Comfort and Fit Ability of gloves : to stretch to remain soft conform to hand

10 Latex Nitrile Vinyl Latex > Nitrile > Vinyl

11 Durability of Medical Examination Gloves NR latex Nitrile > > > Vinyl Polychloroprene U.S. F.D.A. Assessment of the Durability of Medical Examination Gloves, J. Occupational & Environmental Hygiene, 2004; 1:

12 Tactile Sensitivity Latex >> Synthetics

13 Discomfort and Poor Fit Hand pain Hand fatigue Carpal Tunnel Syndrome Hamper hand movements during clinical procedures - may lead to unnecessary procedural errors

14 Glove Selection High risks Gloves NR latex gloves Polyisoprene Polychoroprene Nitrile Tasks Surgical procedures Handling of chemotherapy drugs Intensive care Emergency Medium risks NR latex Polychloroprene Nitrile Non-invasive medical procedures Low risks NR latex Nitrile Vinyl Dispensing medications Cleaning Non-medical chores

15 Aspects of Interest Potential Health Risks: Latex protein allergy Chemical toxicity (DEHP) Environmental Impact

16 What is Latex Protein Allergy? Type I allergy of immediate hypersensitivity Type I allergy can be caused not only by latex proteins, but also by some foods like fish, crab, peanut, banana, water melon, kiwi etc. Symptoms include watery eyes, runny nose, asthma and in rare cases, anaphylactic shock. Prevalence for latex protein allergy is 1% for the general public, and higher among healthcare workers, 0.6% - 10%

17 Type I - Latex Protein Allergy Latex gloves with: High residual proteins High powder content Cause of allergy

18 Manufacturing Improvements Low protein powder-free latex gloves in hospitals Eliminate sensitization; Significant reduction in incidence of latex allergy reactions; Healthcare workers using these gloves can now work alongside their latex allergic co-workers with no heightened allergy concerns

19 Solution to Allergy Problem For majority of healthcare workers For latex allergic individuals Low-protein NR latex, Nitrile & others Nitrile, Polyisoprene, Polychloroprene

20 Health Risks Chemical Toxicity of Phthalates Vinyl (PVC) gloves often contain Phthalates, particularly the highly toxic DEHP Plastizicer: 30-50% in vinyl products

21 The most widely used Phthalates DEPH : di-2-ethyl-hexyl- phthalate (dominant plastizer in PVC) DIDP: di-isodecyl phthalate, DINP: di-isononyl phthalate, and BBP: benzyl-butyl phthalate (foamed PVC as flooring material)

22 Adverse Effects of DEHP Toxic to liver, kidney and heart Causes reproductive problems: o Toxic to Sertoli cells (sperm production) o Reduced fertility o Ovarian dysfunction o Structural changes in testes Decrease hormone production in females Fetus malformation Listed as probable human carcinogen (EPA, NIOSH)

23 DEHP/phthalate can leach out from vinyl gloves: when in contact with patients during medical procedures when in contact with food during food handling

24 Warning on Use of Vinyl (PVC) Medical Devices U.S. FDA on 12 July 2002 Vinyl Gloves with DEHP not to be used in Food Handling - Japanese Ministry of Health on 14 June Ban on soft PVC toys with phthalates (DEHP) for young children EU Commission 1999 Ban on sales of toys for children containing more than 0.1% of DEHP, DINP or DIDP - California law 2008

25 Impact on Environment Raw materials Disposal of end-products

26 Natural Rubber Latex Green material environmentallyfriendly: Sustainable and renewable resource Biodegradable

27 Synthetic gloves Raw materials often toxic or carcinogenic Not biodegradable, disposal by burning releases harmful substances, e.g. dioxin, cyanide, HCl, etc. Disposal by landfill leaching of chemicals into the soil, contaminating ground waters

28 NR Latex Gloves Contains no toxic plasticizer, eg. DEHP; Environmental friendly, biodegradable; Low-protein gloves low risk to allergy.. Excellent barrier protection against blood pathogens and infections; Unsurpassed comfort, fit, durability, tactile sensitivity, and high resistance to puncture and tear;

29 Nitrile Gloves Good barrier Durability High puncture resistance Resistant to oil Tactile sensitivity varies No latex proteins Excellent candidate for latex sensitive individuals

30 VINYL (PVC) Gloves Because of their inferior barrier properties: Vinyl gloves should be used only for light tasks that are not involved in contacts with blood or body fluids. Indiscriminatory replacement with vinyl gloves in hospitals could expose healthcare professionals to undesirable health risks, and caution should be taken.

31 Standard Malaysian Glove for Quality Certification A voluntary certification scheme for latex examination gloves Establishes requirements for 4 Ps: Pin holes Physical properties Protein content Powder content POWDER-FREE POWDERED Operated by the Malaysian Rubber Board, an ISO/IEC Guide 65 body, authorized by Standards Malaysia Assurance that SMG gloves comply with the requirements of stringent technical specifications

32 Quality Management Quality management system ISO 9001 or its equivalent Quality Inspectorate to ensure specification compliance Testing laboratories ISO/IEC guide accredited

33 Barrier Integrity and Protein Content Requirement SMG Other standards Freedom of Holes (AQL) 1.5 Stringent low defective rate (EN, ASTM, ISO) Extractable Protein Content (μg/dm 2 ) 50 (Powder-free) Very low protein limit 200 (ASTM)

34 Occupational Safety & Health Administration (OSHA) U.S. Department of Labor 2008 Bulletin recommends Powder-free NRL gloves with lower allergenic protein content as a choice for barrier protection against infectious agents if NRL gloves are used. Employees who are allergic to latex be provided with alternate suitable non-nrl gloves as their choices for use.

35 For Latex Allergic Individuals Hospitals should make available suitable synthetic gloves with effective barrier for individuals who are latex allergic. Non-latex gloves such as good quality nitrile, polychloroprene or polyisoprene should be considered.

36 Malaysia is not only the world s largest exporter of NR latex gloves, but also world s No. 1 supplier of Nitrile gloves

37 Malaysia is currently exporting to >190 countries Supplying about 60 % of the world s demand

38 For more information about Malaysian Rubber Export Promotion Council Please visit:

39 Thank you for your attention