Natural rubber latex sensitisation in health and social care
SIM 07/2011/06
Summary
This Sector Information Minute (SIM) provides guidance to Inspectors on the sensitisation risks associated with Natural Rubber Latex (NRL) in health and social care. It replaces SIM 07/2003/24.
Background
1. Natural Rubber Latex (NRL) is a milky fluid obtained from the Hevea brasiliensis tree, which is widely grown in South East Asia. NRL is an integral part of thousands of everyday products. As with many other natural products, NRL contains proteins to which some individuals may develop an allergy.
2. NRL can be found in many products within health and social care. It has been extensively used in the manufacture of medical gloves (non sterile examination gloves, surgical gloves) because it is a very durable and flexible material giving wearers a high degree of dexterity, sensitivity and microbiological protection. It is also used in a range of medical devices.
The problem
4. NRL proteins can cause asthma and dermatitis. Although rare, more serious allergic reactions, such as anaphylaxis, are also possible. The amount of exposure needed to sensitise susceptible individuals is unknown. Once sensitised, further exposure, even to low levels, may cause a reaction. Greater exposure increases the risk of sensitisation and allergic symptoms.
5. NRL proteins can cause type I (immediate) hypersensitivity. In addition, the products manufactured using NRL proteins contain other chemicals that can cause irritant reactions and/or type IV (delayed) hypersensitivity reactions. Typical skin and respiratory problems associated with the use of NRL single-use gloves are:
- Irritation, known as irritant contact dermatitis. NRL proteins are primarily associated with allergy, rather than irritation, so if irritant contact dermatitis develops in association with NRL glove use, the cause may be something other than NRL proteins – eg chemical additives in the gloves, sweating/occlusive effects of the gloves, or skin contamination caused by incorrect glove use. The signs and symptoms of irritant contact dermatitis can include redness, soreness, dryness or cracking of the skin. This type of reaction is not an allergic response. Once the irritant has been identified and its use discontinued, symptoms will disappear and not reoccur.
- Type lV allergic reactions, or allergic contact dermatitis. This is an allergic response to the chemical additives, known as accelerators, used in the manufacture of NRL gloves. The signs and symptoms may be indistinguishable from those of irritant contact dermatitis, and so diagnosis will require clinical assessment. Sensitisation can take months or years, but once sensitised, a type IV allergic response occurs between 10-24 hours after exposure and can get worse over the subsequent 72 hours.
- Type l allergic reactions are immediate allergic reactions to NRL proteins and in rare cases can result in anaphylactic shock. Clinical reactions can involve the skin, eyes, mucous membranes and respiratory system, including localised or generalised rash (urticaria), inflammation of the mucous membranes in the nose (rhinitis), red and swollen eyes with discharge (conjunctivitis) and asthma.
NRL in healthcare products
6. Single use disposable gloves. The use of gloves as part of infection control within healthcare rose exponentially during the 1990s. There are a number of different types of gloves available. All single-use gloves may present a particular risk of latex allergies, however using low-protein, powder-free, gloves is unlikely to lead to new cases of latex allergy. Additionally the health of individuals with existing latex allergy is not put at significant risk if colleagues use either low‑protein, powder‑free latex gloves or latex-free gloves.
7. Powdered gloves pose a risk, not only to the user but also to sensitised people in the area. This is because the proteins in NRL gloves leach into the powder, which becomes airborne when they are removed, leading to potential inhalation of the proteins.
8. Other Medical Products. NRL is not only used in disposable gloves, but can also be found in a number of medical products, such as catheters, elasticised bandages, wound dressings, etc. It can also be found in the packaging for a number of medical products. While these may pose a low risk of sensitisation, they can pose a significant risk (eg anaphylactic shock) to sensitised patients or healthcare workers.
9. The majority of healthcare products containing NRL are 'medical devices' as defined by the Medical Devices Regulations 1999. Therefore their manufacture and provision are regulated by the Medicines & Healthcare Products Regulatory Agency (MHRA).
Recent research
10. In 2008, the NHS Plus Occupational Health Clinical Effectiveness Unit in association with the Royal College of Physicians, produced evidence‑based guidelines for the occupational aspects of latex allergy management.
12. The evidence and the conclusions from the NHS Plus Occupational Health Clinical Effectiveness Unit report confirm that:
- Using low-protein, powder-free, single-use latex gloves in the workplace is unlikely to lead to new cases of latex allergy
- Individuals with an existing latex allergy should take latex-avoidance measures
- The health of individuals with existing latex allergy is not put at significant risk if colleagues use either low‑protein, powder‑free latex gloves or latex-free gloves. An exception might be if the affected employee has anaphylaxis. However, in all cases where employees have work related medical conditions, competent medical advice should have been sought.
HSE position
13. HSE's policy on exposure to NRL proteins is:
- NRL proteins can cause asthma and dermatitis and although rarely, more serious allergic reactions (anaphylaxis)
- COSHH and its associated ACOPs apply where there is potential exposure to NRL proteins in the workplace
- Employers must carry out a suitable and sufficient assessment of the risks to health caused by the exposure to NRL proteins (Reg. 6)
- Employers must prevent or adequately control exposure (Reg. 7)
- Employers must implement suitable health surveillance for employees exposed or likely to be exposed to NRL proteins (Reg. 11)
- provide information, instruction and training for people who may be exposed to NRL proteins Reg. 12)
14. It therefore follows that employers should carefully consider the risks when selecting gloves in the workplace, because of the importance of latex gloves as a source of exposure to NRL proteins.
Inspector action
15. When assessing the selection of glove use and the management of NRL inspectors should ensure organisations follow HSE's glove selection guidance. In summary this means organisations should:
- Decide whether or not protective gloves are required at all to perform the task (the law requires that other means to prevent exposure should be considered in preference to personal protective equipment)
- If protective gloves are needed, they must be suitable. This means they provide adequate protection against the hazard and are suited to the wearer, the work and the environment in which they are used.
- To ensure suitability, consider the work (substances handled, other hazards, type and duration of contact), the wearer (comfort and fit) and the task (eg need for dexterity; infection control issues). This is required to decide on the most suitable glove type, eg single use or reusable, and the material they are manufactured from.
- If the employer's assessment leads to latex as the most suitable glove type for protection against the hazard, then:
- Latex gloves should be low-protein and powder‑free. 'Low‑protein' means manufactured to the standards in EN420
- Individuals with existing allergy to NRL proteins should avoid latex and should not use latex gloves. Employers must provide suitable alternatives.
- Suitable health surveillance for occupational asthma must be in place. However, given that the risks of developing occupational asthma are considered to be low, a low level of health surveillance is likely to be sufficient. Examples of typical health surveillance approaches are given in the article "Standards of Care for occupational asthma" developed by the Group of Occupational Respiratory Disease Specialists (GORDS), which is co-ordinated by HSE.
- Where the use of gloves may result in direct or indirect exposure to members of the public (eg single-use latex gloves used in patient care) the employer must undertake an assessment of the risks of such exposure and adopt suitable control measures to ensure the health of others is protected
- Employers must be able to demonstrate that they have carried out an assessment (as set out above) to select which (if any) type of gloves they should provide. They must also be able to demonstrate that they have an effective glove use policy in place that, for example, takes account of those employees that may have a latex allergy.
- Whenever protective gloves are used (regardless of the material), employers should provide information, instruction and training to employees on how to use them properly to protect themselves. This should include information on latex allergy if appropriate.
- Whenever protective gloves are used (regardless of material), employers must consider the need for and, if appropriate, implement suitable health surveillance for work-related dermatitis ie regular skin checks.
Application of EMM to NRL
16. At present there is no specific guidance on the application of the Enforcement Management Model to sensitisers in general or NRL in particular. General guidance on the application of EMM to health issues is contained in OC130/5. Guidance on the application of EMM to chemicals is contained in OC273/19
17. Gap analysis
- In circumstances where inspectors identify a lack of, or an inadequate risk assessment for the selection of glove use:
- Actual risk would result in significant personal injury (health effect) and a ' possible ' likelihood of injury.
- The benchmark for exposure is 'significant personal injury with nil/neg likelihood of injury.
- The risk gap is therefore moderate
- The standard is 'Defined'
18. Initial Enforcement Expectation
Where inspectors identify those circumstances as described in para 17 the initial enforcement expectation is that of improvement notice.
19. Strategic Factors: Action to improve the management of NRL risk is in the public interest. It benefits the wider community, as staff sensitised to NRL can often not work in the same environments, to the detriment of patient care.
Effective management of NRL protects vulnerable groups. Action will have a positive and long-term effect upon the dutyholder, area, and Sector.
Guidance and sources of information
- HSE leaflet INDG320 'Latex & You'. Leaflet for healthcare workers who may be exposed to latex in the course of their work.
- HSE Publication MS24 'Medical aspects of occupational skin disease'
- HSE Publication MS25 'Medical aspects of occupational asthma'
- Medicines & Healthcare Products Regulatory Agency (MHRA) Many NRL containing products within healthcare are 'medical devices' and therefore guidance is produced by MHRA
- Department of Health. HSC1999/186 'Latex medical gloves and powdered latex medical gloves: reducing the risk of allergic reaction to latex and powdered medical gloves.
- The Latex Allergy Support Group – The group raises awareness of latex allergy, provide support for those affected, and promote the safe and appropriate use of latex products and equipment.
- The National Patient Safety Agency (NPSA) leaflet 'Protecting people with allergy associated with Latex'
Support and contacts
Daniel Hutley, Health and Social Care Services Unit.