Copyright:  Chris Wheatley
Latex Allergy

Latex allergy may be seen as the latest ‘issue’;
but it isn’t going to just go away.

 Introduction

It has been estimated that up to 30% of the population has atopic allergy and 43% of NHS staff suffer from some sort of skin irritation. Within these groups a latex sensitivity of 10% has been calculated - which is 3% or 1.5 million of the British population who are at risk.(Turner, Occupational Health 1997; 49:2, 57-60) (Bandolier I)

 The AIDS epidemic of the 1980s prompted a massive increase in the use of latex gloves for healthcare workers who are increasingly at risk due to the increased use of ‘economic’ latex gloves and enhanced sensitivity from other latex products also encountered in daily work. (Packham) (Bandolier I)

 Sometimes sensitivity is encountered from the chemical accelerators used in the manufacturing process. It should be noted that Glove powder is just a carrier of latex proteins not the primary allergen. Likewise the strength of detergent used in hand washing ‘soap’ is a critical factor - especially if the frequency is high and no emollient or skin aftercare treatments are provided; broken skin may lead to further sensitisation via the ingress of allergens. (Charous) 

This phenomenon also affects our patients of course but with the added complications from internal and external contact with common medical products containing latex, which may not be clearly marked as containing latex. Urinary catheters, breathing systems and wound drains are an example of the internal risk and retainer bands on oxygen masks or adhesive dressings knitted with latex are an external contact example.  (Clancy)

Gloves are an example of both!
Manufacturers have not marked a number of newer and safer Latex substituted products as such.
Why is a complete mystery and an obvious commercial blunder.

 At-risk sufferers are loosely divided into two categories. (Gell and Coombs 1969 – summarised)

 Type IV reaction - which can be described as an immune response to chemical allergens, such as chemical accelerators used to set the latex during the manufacturing process. These are seen as skin reactions, erythemia blisters, constant itching and broken skin (prone to infection), pruitus, eye irritation, respiratory wheezing / shortness of breath and chronic rhinitis. (hand photo, skin reaction)

  Type I reaction – is an immune response caused by protein allergies. Individuals could suffer a life threatening anaphylactic reaction from something as simple as contact with a rubber latex glove, latex condom or even the dust from a latex rubber product.

An almost immediate hypersensitivity reaction occurs within 30 minutes and may result in anaphylaxis with the triad
of hypotension, rash and bronchospasm. The rash is not always immediately seen.
Serum mast cell trypase levels are high during an episode and up to 4 hours afterwards.

Note:Whilst tests may confirm anaphylaxis, they will not identify latex as the allergen and results are not available immediately!

How to discover a history of latex allergy:

The route of exposure to latex can often change the physical manifestation of the reaction.
Discuss with the patient (or their parent if a child);

 Any rashes or itch after wearing rubber gloves, elastic in clothing or condom contact.
Why?  Pruitus, contact dermatitis or eczema are signs of a cutaneous reaction. (TUC press release, 8/8/2001)

 Ask about nasal congestion, sneezing, weeping eyes or itching after being in a latex environment, e.g. the doctors exam room, theatre or even ‘special adult parties’.
Why? Airborne exposure causes rhinitis, conjunctivitis and asthma. (TUC press release 12/12/2001)

 Discuss any funny symptoms after blowing up party balloons; reactions after dental work, X-Ray procedures (e.g. barium enema) or minor surgical examinations or procedures.
Why? Mucosal or intravenous exposure can result in anaphylaxis or angiodema.(Hollnberger)

 Ask about food allergies and asthma or hay fever.
Why? Bananas, avocadoes and chestnuts all have similar protein sensitivity profiles.

Likewise patients with hay fever, asthma (atopy) or multiple drug allergies are also likely to be allergic to latex. (Stern) 

A guide to creating a latex-free environment:

  • The patient should be first on the morning list to allow latex dust to settle, then damp dust the Theatre.
  • Remove all latex components at least 12 hours beforehand, including all glove boxes!
  • Label theatre doors as     LATEX - FREE ENVIRONMENT   and tell the office and the coffee room!
  • Prepare drug therapy in advance, especially epinephrine (adrenaline).
  • Establish good IV access, preferably a short ‘fat’ 14G cannulae (less flow resistance)

Make sure that primary equipment is latex free and certified as such, e.g.

Syringes
(most are now non-latex,
but check!)

Blood pressure cuffs
(older cuffs have latex bladders
and tails) 

Adhesive dressings
(not elastoplast! Some
packaging is latex sealed too)

Latex stoppers on drug vials and IV sets
(most are not marked)

Tourniquets and exsanguinators
(The Rhys –Davies is latex!)

Gloves
(sterile and non-sterile)

Reservoir bags on breathing circuits and ‘cheap’
older resuscitator bags

Urinary catheters
(98% are latex or have
latex balloons)

ETT tubes, laryngeal masks , airways are mostly non-latex.

Ventilator bellows
(neoprene =ok)
Latex seals are common!

Wound drains, if they stretch, they probably are latex!

Rubber bands!

Nurse Theatre cap elastic!

 If in doubt – AVOID it and use something obviously safer!

 A number of manufacturers, especially British and German have already made the commitment to eliminate all
natural rubber latex in their product range and actually label it as such – which is helpful.

 How to recognise Intra-operative anaphylaxis (Adapted from Levy JH, The Allergic Response)

Whilst 90% of allergic drug reactions (mostly muscle relaxants) occur within 3 minutes, latex reactions can be delayed by up to 60 minutes whilst enough transmucosal absorption of antigen occurs. Symptoms may be mild clinical changes or life threatening reactions known as anaphylactic shock – classically a combination of cutaneous, respiratory and cardiovascular symptoms.

1.       Cutaneous:

    Urticaria and flushing
    Periorbital and perioral oedema
    Angioedema affecting the tongue and oropharanyx

2.       Respiratory:

    Laryngeal oedema presented as stridor
    Bronchospasm – wheezing, increasing airway pressures
    Pulmonary oedema – hypoxemia, decreasing pulmonary compliance and ausculatory crackles

3.       Cardiovascular:

    Hypotension
    Tachycardia
    Pulmonary hypertension
    Decreased systemic vascular resistance

Caution: Unhelpfully anaphylaxis has been known to mimic symptoms of aspiration,
pulmonary embolism, myocardial infarction and vasovagal reactions!

 Primary treatment

·        Stop all contact with latex – especially gloves and catheters
·        Commence airway maintenance with 100% oxygen
·        Discontinue all anaesthetic agents (as feasible)
·         Ensure intravenous access – short ‘fat’ 14g cannulae are ideal.
·         Give 2-4 litres of crystalloid to restore intravascular volume

·        The pharmaceutical agent of choice is epinephrine (adrenaline)

Failure to respond to vasopressors other than epinephrine is a classic characteristic of anaphylaxis.
A suggested starting dose of 10 ug (or 0.1 ug/kg) escalating rapidly to higher doses depending on the response.
If IV access cannot be established – subcutaneous epinephrine in larger than normal doses can be given.
(300 – 500 ug or more)

 Caution: Hypotensive epinephrine doses are not the same as cardiovascular collapse. Starting with 1mg may
result in hypertension, myocardial ischemia or even a stroke. Start small and increase the dose, result dependent.

 Secondary treatment

 This may include the following strategies:

·        Corticosteroids, 0.25 – 1 g hydrocortisone or 1 –2 g methylprednisolone
·         Cateacholamine infusions, epinephrine 2 – 4 ug/min or more
·         Antihistamines – 0.5 – 1 mg/kg diphenhydramine (Benadryl)
·         Aminophylline 5 – 6 mg/kg over 20 mins. for persistent bronchospasm
·         Sodium Bicarbonate 0.5 1 mEq/kg for persistent hypotension with severe acidosis
·         Airway evaluation – prior to extubation,  preferably in an ICU environment.

 It should be noted that the most common sign of anaphylaxis in the anaesthetised patient is circulatory collapse caused by capillary leak and peripheral vasodilatation which results in a decrease of venous return.

Unexplained Hypotension may the first indicator. Remember a rash is not always seen, especially if sensitisation is from internal contact.

Blood Tests

Histamine levels acutely increase and decrease very rapidly.
Serum mast cell trypase are higher than normal and may remain so for 3-4 hours after the incident.
Complement C3 and C4 tests at 30 mins. post event, 1 and 4 hours will show progressive increases.
IgE levels will be increased.   (adapted from Stern)

 Note: These tests are NOT available immediately and still do not identify latex as the cause.
Usually one EDTA tube specimen and one clotted sample are required by the labs.

Discussion and Conclusion

The biggest problem with the latex issue is that most medical staff do not acknowledge its existence, as I have personally discovered whilst researching this issue since 1996. Things are changing however.

Towards the end of this year a new European standard (EN 455-3) will be brought into force requiring manufacturers to standardise their labelling and analytical methods of measurement, as well as forcing them to
provide residual chemical information.

The UK Medical Devices Agency have been somewhat slow off the mark to highlight the seriousness of the issue; but have expressed concerns about the low level of adverse reaction reporting – stressing the need for more education and training in professionals. (DB 9601 & SN 9825)

There are, however, no mandatory requirements and no national guidelines or ‘templates’ for Health Institutions to make realistic risk assessments or any recommendations as to how to proceed to avoidance strategies. The RCN have launched their own latex awareness initiative and pressure group; but this really needs more and constant publicity. 

I personally have been asked to advise ‘post-event’ on latex avoidance issues, where latex products were used with known and documented latex-sensitive individuals because of inadequate product documentation or simple lack of preparation by the health team. On all occasions a simple substitution would have been possible; (photo: catheters)  but the lack of an available up-to-date database and assigned individual responsibilities was causal.

To this end I have created an intranet web site for my hospital complete with product photographs to aid speedy identification at my own expense (£2,500); unfortunately unlike other enlightened trusts there has been no offer of financial assistance!

There is now enough current evidence on latex sensitisation / allergy incidents in both staff and patients (Charous) to suggest that a ‘non-latex’ policy and a planned course of prevention and reaction to incidents must be provided by all health providers. This may involve a box or trolley of known ‘safe’ substitute products as a temporary solution; but there is no reason why a planned product substitution for non-latex products cannot take place.

When product suppliers visit us we must ask for latex contents of all products, not just gloves, and ask about the packaging as well! (photo: Dressings)

Hospitals, Clinics, GP surgeries and Dental practices have a duty of care to ensure a safe environment under Heath & Safety law. The same law that industry has to comply with. We have a duty to ensure that that all staff have a basic understanding of the latex issue and know how to avoid becoming sensitised themselves.

The NHS has a known poor record of risk management – only adopting a common reporting tool in the last 12 months- yet it is the largest employer in Europe! The obvious next step is to reduce the levels of cumulative exposure in health institutions which could easily be achieved without great expense by product substitution and commercial pressure through end-user choice.

Patients are expressing their rights to expect a safe health experience and you may have noticed a plethora of television advertised compensation companies willing to assist.

Likewise health workers injured through latex contact when safe alternatives were available have a legal argument for compensation from management. (Bandolier II) 

Recently a firm of reputable Solicitors, Malik, Leigh, Day & Co., reported to the TUC conference, (TUC 13th July 2002) their experiences of representing a number of latex-sensitive claimants. All Type I cases had to permanently surrender their jobs and make significant life style adjustments. The cost of loss of earnings, pension benefits and retraining expenses coupled with the domestic cost of replacing latex-containing carpets, sofas and bedding easily ran into six figure sums.

 To quote Ms. Sapna Malik (solicitor), “Economics alone dictate that effective preventative action must be taken by employers and regulators to ensure that the incidence of latex allergies is abated.”

Senior Medical staff and government safety advisors have advised that a non-latex policy plan be followed absolutely whenever a patient has a history or shows sensitivity to latex products and act as a safe practice guide to avoid future sensitivity in patients and staff.

 Statement:
This site is still being expanded and updated - as far as can be ascertained all information is correct
and has been verified in writing from all manufacturers mentioned.
It is possible to amend and add further details of products and suppliers if asked.

However I must stress that this list is not absolute; manufacturing processes, packaging and products  do change, hopefully for the better and towards complete non-latex status.

A number of manufacturers, especially British and German have already made the commitment to eliminate all natural rubber latex in their product range. Unfortunately not all have marked their products clearly!
Manufacturers written confirmation of Non-latex Compliance products on this site have been obtained.
They may be viewed on request.

Many thanks are due to Dr Matthew Sames, Consultant Anaesthetist and SMH Risk Group Chairman, for his encouragement, support and positive nature throughout the compilation & creation of this report.

This site has been produced in the authors own time, expense, computing and photographic equipment, understandably retains full copyright.     CjW ©

Chris Wheatley BSc FIOT RODP (FAETC I&II)
Senior Critical Care Clinical Technologist
ICU, Stoke Mandeville Hospital
Aylesbury, Bucks, HP21 8AL          
Any helpful comments can be sent to: chris.wheatley@smh.nhs.uk

About the author: Chris Wheatley BSC. FIOT RODP is the Senior Critical Care Clinical Technologist at Intensive Care, Stoke Mandeville Hospital in Aylesbury, Buckinghamshire. He holds the City & Guilds 752 in Anaesthetics & Surgery; the City & Guilds 730 Teaching Certificates parts I&II, two professional photographic qualifications and a BSc. in Technology. He is a member of the Society of Critical Care Technologists and a Fellow of the Association of Operating Department Practitioners and a long-term campaigner for better occupational safety standards for critical care staff and is a Type IV allergen sufferer, which includes cats!

References

Bandolier I ‘Evidence based healthcare’ website, John Radcliffe Hospital Oxford www.jr2.ox.ac.uk/bandolier/bandopubs/NHSSlatex.html

Bandolier II ‘Cost Burden of latex’  www.jr2.ox.ac.uk/bandolier/booth/mgmt/Latexcost.html

Charous BL, An update on occupational latex allergy, American academy of allergy, asthma and Immunology, 56th AGM, 2000

Clancy J, McVicar A, Cox J, Physiology and anatomy, a homeostatic approach,  London, Edward Arnold 2001

Gell PG, Coombs RR (eds.) Clinical aspects of immunology. Philadelphia, FA Davis 1969

Hollnberger H, Gruber E, Frank B, Severe anaphylactic shock without exanthema in case of unknown latex allergy and review of the literature, paediatric anaesthesia 12: 544-551, 2002

Levy JH, “The allergic response” discussed in ‘Clinical anaesthesia’ 2nd ed., Barash PG, Cullen BF, Stoelting RK (eds.)

Medical Devices Agency UK www.medical-devices.gov.uk/

Moore E, (RN) Latex policy, Southampton General Hospital 1998

Packham, Chris; Essentials of occupational  skin management, Limited edition press (via Amazon) 1998,

Stern, Dr. Martin; Consultant Clinical Immunologist at Glenfield Hospital, Leicester and at Leicester Royal Infirmary. Asthma and Allergy Information and Research (AAIR) website 1997, 1999, 2001

TUC net press releases via   www.tuc.org

TUC Conference  13th July 2002  www.tuc.org.uk/h_and_s/tuc-5219-f0.cfm

Turner, Occupational Health 1997; 49:2, 57-60

Wheatley C et al, Care and peri-operative management of patients with latex allergies. ‘Latex-free’, a discussion, Technic, Feb-April 1998

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A mirror of the official Stoke Mandeville Hospital intranet website, with equipment photographs, dedicated to hospital issues can be found at       http://www.wheatley37.fsnet.co.uk/index.html       © CjW

 

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Version 5  - Sept 2002