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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:

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 (e.g. 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:

HSE Position

13. HSE's policy on exposure to NRL proteins is:

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 (http://www.hse.gov.uk/skin/employ/gloves.htm).  In summary this means organisations should:

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

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 & sources of information

Support and contacts

Daniel Hutley, Health and Social Care Services Unit.

Updated2013-07-10