Healthcare Professionals and Medical Gloves

 Healthcare professionals are constantly exposed to potentially harmful infectious agents, e.g. HIV, 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. What are medical gloves? Made of Prevent polymer harmful infections Powdered or powder-free

For surgical and medical Disposable procedures Medical Types (Commonly available)

Examination Surgical latex Natural rubber latex Vinyl (PVC) Polychloroprene Nitrile Polyisoprene Different Glove Materials

Different barrier properties & Different glove qualities Barrier Protection

The most important glove function:

Ability to provide very effective barrier protection against blood pathogens and harmful infections Barrier Capability Glove failure during use

Natural Rubber Latex PVC or Vinyl

Nitrile, Polychloroprene, Nitrile, Polychloroprene, Polyisoprene Polyisoprene

PVC or Vinyl Natural Rubber Latex

As shown by many research studies (Ref: www.latexgloves.info) 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, 965-999 Comfort and Fit

Ability of gloves : to stretch to remain soft conform to hand Latex

Nitrile Vinyl

Latex > Nitrile > Vinyl 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: 607-612 Tactile Sensitivity

Latex >> Synthetics Discomfort and Poor Fit

• Hand pain • Hand fatigue • Carpal Tunnel Syndrome

Hamper hand movements during clinical procedures - may lead to unnecessary procedural errors Glove Selection

Gloves Tasks NR latex gloves • Surgical procedures High risks • Handling of Polyisoprene chemotherapy drugs Polychoroprene • Intensive care Nitrile • Emergency

NR latex Medium risks • Non-invasive Polychloroprene medical Nitrile procedures

NR latex • Dispensing medications Low risks Nitrile • Cleaning Vinyl • Non-medical chores Aspects of Interest

Potential Health Risks: • Latex protein allergy • Chemical toxicity (DEHP)

Environmental Impact 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% Type I - Latex Protein Allergy

Latex gloves with: High residual proteins High powder content

Cause of allergy Manufacturing Improvements

Low protein powder-free latex gloves in hospitals

. Eliminate sensitization; . Significant reduction in incidence of reactions; . Healthcare workers using these gloves can now work alongside their latex allergic co-workers with no heightened allergy concerns Solution to Allergy Problem

For majority of For latex allergic healthcare workers individuals

Low-protein Nitrile, Polyisoprene, NR latex, Polychloroprene Nitrile & others Health Risks

Chemical Toxicity of Phthalates

Vinyl (PVC) gloves often contain Phthalates, particularly the highly toxic DEHP Plastizicer: 30-50% in vinyl products 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) 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) DEHP/phthalate can leach out from vinyl gloves:

 when in contact with patients during medical procedures

 when in contact with food during food handling  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 2001.  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 Impact on Environment

• Raw materials • Disposal of end-products Natural Rubber Latex

Green material – environmentally- friendly:

 Sustainable and renewable resource  Biodegradable 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 NR Latex Gloves

 Excellent barrier protection against blood pathogens and infections;  Unsurpassed comfort, fit, durability, tactile sensitivity, and high resistance to puncture and tear;

 Contains no toxic plasticizer, eg. DEHP;  Environmental friendly, biodegradable;  Low-protein gloves – low risk to allergy.. Nitrile Gloves

 Good barrier  Durability  High puncture resistance  Resistant to oil  Tactile sensitivity – varies  No latex proteins

Excellent candidate for latex sensitive individuals 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. Standard Malaysian Glove for Quality Certification

. A voluntary certification scheme for latex examination gloves . Establishes requirements for 4 Ps:  Pin holes  Physical properties POWDER-FREE POWDERED  Protein content  Powder content

. Operated by the Malaysian Rubber Board, an ISO/IEC Guide 65 body, authorized by Standards . Assurance that SMG gloves comply with the requirements of stringent technical specifications

Quality Management

Quality management system ISO 9001 or its equivalent Quality Inspectorate to ensure specification compliance Testing laboratories ISO/IEC guide 17025 accredited Barrier Integrity and Protein Content

Requirement SMG Other standards

Freedom of Holes 1.5 1.5 – 2.5 (AQL) Stringent low (EN, ASTM, ISO) defective rate

50 200 Extractable Protein (Powder-free) (ASTM) 2 Content (μg/dm ) Very low protein limit 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.” 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. Malaysia is not only the world’s largest exporter of NR latex gloves, but also world’s No. 1 supplier of Nitrile gloves Malaysia is currently exporting to >190 countries

Supplying about 60 % of the world’s demand For more information about Malaysian Rubber Export Promotion Council

Please visit: www.mrepc.com

Thank you for your attention