6 BSACI Guidelines for the Investigation of Suspected Anaphylaxis 23 during General Anaesthesia 7 Advanced Life Support Guidelines 23

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1 Management of Latex Allergy: Reducing Latex Sensitisation & Allergic Reactions Classification: Clinical Guidelines Lead Author: Dr. Shreekar Yadthore Additional author(s): Dr. Hana Alachkar and Sister Lucy Common (Immunology) Authors Division: Anaesthetics, Division of Surgery and Neurosciences Unique ID: 25TD(HS)15 Issue number: 3 Expiry Date: 2017 Contents Section Page Who should read this document 2 Key practice points 2 Policy 2 1 Introduction to Latex 2 2 Allergy Description 4 3 Management in the Wards and Community 6 4 Management in the Theatres 7 5 The Role of the Anaesthetist 8 6 What do to in an emergency 9 BSACI guidelines for the investigation of suspected anaphylaxis during general anaesthesia 7 Treatment 10 8 Latex Avoidance 10 9 Testing for Latex Allergy Reporting and Collecting Data References and Bibliography Roles and Responsibilities 12 Appendix 1 List of Common Items that contain Latex 14 2 Screening Questionnaire for Latex Allergy 15 3 SRFT Contacts for Patient Referral 17 4 Anaesthetic Anaphylaxis Referral Form 18 5 AAGBI Anaesthesia Guidelines for Suspected Anaphylactic 23 Reactions 6 BSACI Guidelines for the Investigation of Suspected Anaphylaxis 23 during General Anaesthesia 7 Advanced Life Support Guidelines 23 Page 1 of 24

2 Document control information (Published as separate document) 24 Document Control Policy Implementation Plan Monitoring and Review Endorsement Equality analysis Who should read this document This document is relevant to all All clinical staff and patients in Salford Royal NHS Foundation Trust and in the community. Key Practice Points Natural Rubber Latex is produced from raw milky sap of Hevea brasiliensis tree. The manufacturing process is complex and involves various chemicals. The risk of latex allergy in the general population is 1.4% Certain groups are at increased risk (high risk individuals). This document describes a Screening Questionnaire For Identification Of Latex Allergy Patients (Appendix 2). Reactions range from immediate allergy (incl. anaphylaxis) to contact dermatitis. Key precautions include hand washing and avoidance of latex products. Effective communication and clear documentation involving all stakeholders from admission to discharge will reduce the risk of exposure. Treatment of anaphylaxis is based on advanced life support guidelines. All suspected cases of anaphylaxis should be reported on the AIR system and referred to tertiary allergy centre. Suspected dermatitis reactions should be referred to immunology clinic or occupational health for specialist immunology or dermatology input. Policy Introduction to Latex The term Latex in this document refers to Natural Rubber Latex (NRL) which is produced by Hevea brasiliensis tree that grew originally in the Amazon rainforest but is now grown commercially in Asia. The raw milky sap is obtained by tapping the tree and subject to a complex manufacturing process with various chemicals. About 90% of harvested rubber is processed by acid coagulation into dry sheets or crumbled particles for the manufacture of rubber thread products, rubber seals or pneumatic vehicle tyres. The remaining 10% of harvested rubber is non-coagulated and ammoniated; it is used mostly in the manufacture of rubber gloves and other dipped products, such as condoms and balloons. Dipped rubber products are responsible for most of the published allergic reactions to latex. Page 2 of 24

3 Depending on the manufacturing process, latex may contain variable waterstable, heat and chemically stable antigenic (antigen = antibody generator) protein groups designated Hev b 1 to Hev b 13. Latex can be present in many products of daily household use and health care. Their content in various medical products varies considerably between different batches due to use of different manufacturing methods, varying industry standards and processing time. Of the several health care products in the hospital, latex gloves are widely used because of their excellent elasticity, durability, tactile properties (making them easy to don with low microbial/fluid penetration rate offering protection against viruses and bacteria) and finally low cost. However, the incidence of anaphylaxis to latex is considerably less than would be suggested by the prevalence of positive skin tests or positive IgE (Immunoglobulin E) tests. It appears that the incidence may be waning, at least in some countries; possibly as a result of a change or decline in the use of latex gloves. Latex sensitization refers to positive latex skin test or positive serum latexspecific IgE whereas Latex allergy refers to evidence of latex sensitisation plus a compelling clinical history or positive latex challenge test. (Middleton s 7 th edition). Certain patient groups are more susceptible to latex anaphylaxis (see below). High Risk Individuals Between 5-10% of the population is sensitized to latex (Middleton s 7 th edition) whereas the risk of latex allergy in the general population is 1.4% (BSACI guidelines 2009). The following groups are at increased risk: Patients with atopy (asthma, eczema, allergic rhinoconjunctivitis or hay fever) Children undergoing multiple surgical procedures, such as spina-bifida Children undergoing surgery at a very young age Patients with severe dermatitis of their hands Healthcare professionals Patients with allergy to fruits; most frequently avocado, banana, chestnuts, kiwi fruit, potato and tomatoes Industrial workers using protective gear Occupational exposure to latex Page 3 of 24

4 Allergy Description The reactions caused by exposure to Latex and its additives can be categorized into the following. 1. Immediate allergic reaction 2. Allergic contact dermatitis 3. Irritant contact dermatitis Immediate Allergic Reaction (type I hypersensitivity) An immediate life threatening reaction caused by latex proteins on exposure to direct contact or inhalation of latex particles which directly sensitises the patient and causes inflammation of the nose and eyes, itching, swelling of the skin and its deeper layers, bronchospasm, cardiovascular collapse and death. B-cells produce IgE after exposure to latex. Latex particles cross-link with latex specific IgEs which are bound to high affinity IgE receptors on the mast cell, leading to mast cell activation and degranulation releasing histamine and other inflammatory mediators. Allergic Contact Dermatitis (type IV hypersensitivity) Allergic contact dermatitis is a delayed onset immunological reaction (T-cell mediated) to the chemical additives contained in latex products characterised by an acute eczematous inflammation of the skin often with vesicle formation typically appearing hours after exposure. Subsequently, the skin may become dry, crusted and thickened. The initial reaction is localized but can spread with repeated exposure. The causative agents involve chemical additives such as accelerators, antioxidants, preservatives or colourants. Irritant contact reactions reduce the barrier properties of the skin and allow absorption of larger amounts of chemicals or proteins. This is thought to increase the risk of latex sensitisation. Irritant Contact Dermatitis (Irritation) Irritant contact dermatitis is the most common reaction to latex. It is described as non-allergic skin rash characterized by redness, itching, dryness, cracking, scaling and vesicle formation. The changes are benign and non-life threatening and may be due to repeated hand washing, sweating or rubbing under the glove due to residual soaps and detergents in prolonged contact with the gloved skin surface. Direct contact with the medical product is not needed for sensitisation to latex. Allergenic latex proteins are also adsorbed on the glove powder which, when the latex gloves are snapped on and off, become airborne and can be directly inhaled. Direct latex exposure at mucosal or serosal surfaces also occurs by repeated use of rubber catheters or gloves used intra-operatively during abdominal or urologic surgery. Page 4 of 24

5 Serious anaphylactic reactions have occurred in many different settings including contact with toy balloons and condoms, vaginal deliveries, barium enema examinations, dental procedures, with rubber gloves, while donning gloves and during abdominal or genitourinary surgery. Immediate Allergic Reaction Type I hypersensitivity Contact Dermatitis Allergic Type IV hypersensitivity Contact Dermatitis Irritant Onset Minutes to Hours Hours to Days Hours to Days Symptoms Itching, Swelling of tongue and throat, Inflammation of nose and eyes, Difficulty in breathing, Drop in blood pressure Eczema like changes to the skin Redness, itching, dryness, cracking, scaling and vesicle formation Skin changes Reaction involves Can involve all the skin layers B lymphocytes and Mast Cells Can spread from initial affected area T lymphocytes Localised to area of contact Life threatening Yes No No Cause Antigenic Latex Chemical additives Residual soaps proteins latex manufacture beneath the glove Page 5 of 24

6 Management in the Wards and Community The presence or possibility of latex allergy should be sought from every single patient and those suspected at being high risk. The admitting team should document the type of allergic reaction to latex (anaphylaxis or contact dermatitis) and inform the nursing team and the concerned medical, surgical, radiology, theatre and anaesthetic teams as early as possible so as to enable planning of required procedures. Latex allergy should be highlighted in the ward in the form of an Red Wrist (Latex) allergy band. The Allergy section of the patient s hospital/community records and Electronic Patient Records (Allscripts Sunrise) must be updated to indicate the type of Latex allergy (Anaphylaxis or Contact Dermatitis). This information should be part of both the nursing and medical handovers on a daily basis. All patient contact should be done after hand washing. Latex free gloves is recommended for use in all clinical areas of the hospital and in the community. They can be ordered from the Purchasing & Supply Department or requested from the hospital theatres in an emergency. Latex content of drugs can be sought from the SRFT pharmacist. A list of latex containing products is given in appendix 1. Upon discharge from the hospital, information regarding latex allergy should be documented in the discharge summary for the GP and the district nurse so that precautions can be continued to be taken in the community. Page 6 of 24

7 Management in the Theatres Peri-operative precautions The outpatient or pre op assessment clinic will be an ideal place for assessment of high risk individuals prior to surgery. A screening questionnaire (Appendix 2) can be used to direct referral to the immunology clinic. (Appendix 3 for list of contact phone numbers). Latex allergy should be recorded in the allergy section of the patient s hospital records and electronic patient records (Allscripts Sunrise). The theatre staff including scrub staff, ODPs, recovery staff, anaesthetists and other support staff should be informed well in advance so as to plan any procedure. A vast majority of the gloves in the theatre complex are powder free non-latex gloves. The classic precautions of preparing the theatre the night before and allocation of sufficient time (15 minutes in laminar flow and 30 minutes in theatres with lower air changes after preparatory cleaning) to reduce aerosolised non rubber latex particles in the theatre atmosphere relates to when powdered gloves were in use and the risk of latex particles being adsorbed was high. This procedure is no longer necessary. The practice of providing a barrier between the patient and monitoring equipment is obsolete. For example - covering sphygmomanometer tubing with a stockinette or placing gamgee padding between the ECG wires and the skin of the patient. The above practice is obsolete with the advent of powder free non latex gloves and the majority of equipment being either latex free or packed in a latex free environment. There is no evidence that premedication with an antihistamine or steroid is useful. Drugs for the treatment of anaphylaxis should be readily available. The anaesthetic and surgical areas must contain only latex free products. It is imperative to check and procure latex free products in these patients for example latex free urinary catheters. In some circumstances, this information may not be available from the product label or Medicines Information Centre. The individual health care company may have to be contacted (or through its website) for more information. Only latex-free dressings and tapes should be applied. Page 7 of 24

8 The role of the anaesthetist: 1. Providing acute treatment of anaphylaxis according to advanced life support guidelines. (Please see appendices 5 and 6). 2. Taking timed blood samples for mast cell tryptase: Brown Top (Serum Gel Z/ 7.5 ml). The initial sample is to be taken as soon as feasible after resuscitation has started. The second sample is to be taken 1 2 hours after the start of symptoms. The third sample is to be taken either at 24 h or in convalescence (for example in a follow-up allergy clinic). 3. The third sample is a measure of baseline tryptase levels as some individuals have a higher baseline. Serum tryptase release is associated with mast cell activation and peaks quickly within an hour of the onset of the reaction. A normal tryptase does not rule out anaphylaxis. 4. Ensuring that the samples are labelled with the time and date and liaising with the biochemistry and immunology department as soon as possible. The samples can be stored in the fridge (4 deg Celcius) out of hours. 5. Notifying patient and referral to a nationally recognized allergy centre specializing in drug allergy including anaphylaxis during anaesthesia if unknown cause of anaphylaxis. Discuss with immunology clinic if in doubt. (Please see appendix 3). 6. Providing a detailed record of events with timings of all drugs administered in relation to onset. (Please see appendix 4). 7. Notifying the lead anaesthetist for anaphylaxis of each case of suspected latex anaphylaxis to ensure that referral takes place. 8. Logging the incident on the online Adverse Incident Reporting / Datix System (under Reporting Systems) Updating the Allergy section of the patient s hospital records and Electronic Patient Records (Allscripts Sunrise) to indicate the type of Latex Allergy (anaphylaxis or contact dermatitis). Upon discharge from the hospital, updating the discharge summary for the GP and the district nurse so that precautions can be continued to be taken in the community. Page 8 of 24

9 Anaesthetist's role: immediate action to support investigation of anaphylaxis during anaesthesia The British Society for Allergy & Clinical Immunology (BSACI) guidelines for the investigation of suspected anaphylaxis during general anaesthesia. Clinical & Experimental Allergy. Volume 40, Issue 1, pages 15-31, 15 Dec 2009 Page 9 of 24

10 Treatment The treatment of anaphylaxis is set out in the advanced life support guidelines. (Please see appendix 7). All other non-life threatening reactions to latex should be reported to the Immunology Clinic or Occupational Health for further specialist input. Latex Avoidance The use of latex gloves peaked in the decade after the introduction of universal precautions (Centre for Disease Control 1987). This led to an increase in the incidence of latex allergy and increased awareness of the problem in the health care setting. However, in the last few years, availability of Latex free products and non-powdered latex free gloves has been responsible for minimising the risk posed by Natural Rubber Latex products. It still remains a small but important problem for all health care professionals and patients. There are occasions when the labels of certain health care products do not mention the presence of latex. Whilst most of the products will have a latex free label, it might be difficult to ascertain the presence or absence of latex from the manufacturers in an emergency setting. Explanation of terms New terms have been explained in the text of this document. Page 10 of 24

11 Testing for Latex Allergy If the clinical history is positive or equivocal, the patient should be referred to the Immunology Clinic for testing before the surgical procedure. Both skin testing and in vitro assays detect the presence of a latex-specific IgE antibody in the skin and serum, respectively, and do not necessarily predict clinical presentations such as anaphylaxis. Immediate hypersensitivity to Latex is investigated by the following tests. 1-Skin Prick Tests - Skin testing with allergen extracts is the most sensitive means of detecting IgE antibody to Latex. Skin testing extracts to determine latex protein allergy have included commercial extracts and latex glove extracts. There is no standardized latex extract available. The commercial extracts have up to 93% sensitivity (true positives). 2-In Vitro Tests - In vitro tests measure latex specific IgE antibodies in the serum of the patient by the ImmunoCAP System (Phadia, Sweden), this includes testing for the Component Resolved Diagnosis. In vitro testing should be done in the following circumstances: To confirm results of skin testing; When skin testing is considered too dangerous to perform; When skin testing is not available. The diagnostic sensitivity of in-vitro testing is variable between 53-96%. So, a negative latex-specific IgE test does not rule out a latex allergy 3-Challenge test - Latex allergy can be confirmed by a challenge test, which can be a blind challenge. A wet glove is applied on the back of the patient with rotating movement for 2 minutes and any response is read after minutes. Further details can be obtained from the immunology clinic. Reporting and Collecting Data Incident should be reported and logged onto the online Adverse Incident Reporting / Datix system (see under Reporting Systems) for all patients who are suspected of developing anaphylactic reactions to latex. The issues related to the event should be discussed at the relevant clinical governance meeting for appropriate further action. In addition, the allergy section of the patient s hospital records and Electronic Patient Records (Allscripts Sunrise) should be updated. All referrals for suspected latex allergy should be made either through Occupational Health or the Immunology Clinic for further specialist advice. Page 11 of 24

12 References Guidelines for the Management of Latex Allergies 1996, American Latex Allergy Association Latex Allergy: An Update Hepner Castells Anesth Analg 2003;96: University Policy on latex allergy Hughes Marinho pdf Chapter 58 Natural Rubber Latex Allergy. John W Yunginger Middleton's Allergy: Principles and Practice, 7th Edition Expert Consult 2009 BSACI guidelines for the investigation of suspected anaphylaxis during general anaesthesia Clinical & Experimental Allergy Volume 40, Issue 1, pages 15-31, 15 DEC Suspected Anaphylactic Reactions Associated with Anaesthesia. Anaesthesia 2009, 64 pages http:// Roles and responsibilities Role of the Anaesthetist Detect and identify the reaction as suspected anaphylaxis to latex Provide acute treatment in case of anaphylaxis Take timed blood samples for mast cell tryptase, immediately after onset and at 1-2 hours post reaction Inform patient of latex allergy and refer to Immunology Clinic at SRFT Add Allergy alert to patient s hospital records and electronic patient records (Allscripts Sunrise) Report to MHRA (if reaction to latex in devices) Role of Immunologist Identify cause of reaction i.e. confirm latex allergy Provide a written report to referring consultant, copied to GP, surgeon, dentist and patient Give patient information about Medic-Alert ( and advise registering and obtaining jewellery Add Allergy alert to patient s hospital records and electronic patient records (Allscripts Sunrise) Report to MHRA (if reaction to latex in devices) Page 12 of 24

13 The admitting Doctor and Nurse will: Check the electronic patient records (Allscripts Sunrise) and written medical notes for latex allergy alerts Identify patients who present a risk of latex sensitisation Put into place notices and red wrist band which indicate that latex allergy precautions are in place Ensure that all relevant staff are informed of the need to follow specific latex allergy precautions Secretarial Ensure that all theatre staff are informed in advance about latex allergy so as to plan any theatre procedure Ensure that ward staff are informed in advance about latex allergy so as to plan patient admission and discharge All Trust Clinical Staff will: Comply with the identification of patients who pose a risk of latex sensitisation and allergy Inform the admitting medical team about any issues or concerns relating to the identification measures Add Allergy alert to patient s hospital/community records and electronic patient records (Allscripts Sunrise) Put into place notices and red wrist band which indicate that latex allergy precautions are in place Ensure that all relevant staff are informed of the need to follow specific latex allergy precautions Ensure patient confidentiality at all times. Appendices 1 - List of common products that may contain latex 2 - Screening Questionnaire For Identification Of Latex Allergy Patients 3 - Contacts for Latex Allergy 4 - Anaesthetic Anaphylaxis Referral Form 5 - AAGBI guidelines 6 - BSACI guidelines 7 Advanced Life Support guidelines Page 13 of 24

14 Appendix 1 List of common products that may contain latex (List is not exhaustive) Medical products Household products Gloves Blood pressure cuffs Catheters Wound drains Adhesive tape Elastic bandages Electrode pads Bulb syringes Enema syringes Ventriculo-peritoneal shunts Finger cots IV access injection ports and IV tubing Manual resuscitators Penrose surgical drains Pulse oximeters Stethoscope tubing Stretcher mattresses Surgical masks Tourniquets Vascular stockings Rubber tops of multi-dose vials Bite blocks Dental coffer dams Leukoplast Sleek Lymphatic Compression Hosiery Prosthetics Adhesives Balloons Carpet backing Condoms Contraceptive diaphragms Elasticated fabrics Feeding nipples Household gloves Diapers and incontinence pads Infant pacifiers Rubber bands Erasers Shoes Bicycle helmets Hosiery Page 14 of 24

15 Appendix 2 Screening Questionnaire For Identification Of Latex Allergy Patients Name Hospital Number Date of Birth / / Referring Doctor 1. History of typical allergic problems (type I) after contact with latex/natural rubber containing products? 1A. Latex-containing products/exposures/high risk groups; list not exhaustive (tick all that apply): -urological or neurological congenital problems, or other conditions requiring multiple surgeries or interventional procedures, particularly if from early childhood cardiac procedures, surgeries, dental, rectal or pelvic examinations, other) products tomato 1B. Allergic reactions (type I) experienced (tick all that apply): -runny nose and sneezing; red-itchy-watery eyes anaphylaxis (severe life-threatening generalized or systemic hypersensitivity reaction with rapidly developing airway and/or breathing and /or circulation problems, usually associated with skin or mucosal changes) Page 15 of 24

16 2. History of typical delayed hypersensitivity problems (type IV) after contact with latex/natural rubber? 2A. Delayed hypersensitivity reactions (type IV) experienced (tick all that apply): Dry skin, redness, itching, rash, cracking, chapping, scaling, excoriation, weeping and blister formation in skin areas exposed to: -containing products lorhexidine-containing products. ACTIONS If answered NO TO ALL QUESTIONS: Patient unlikely to have latex - no further action required If answered YES to any question in SECTION 1 Patient may have latex allergy Refer to the Immunology Clinic with a copy of this screening questionnaire ECTION 2 Patient may have delayed hypersensitivity to latex. Refer to the Dermatology Consultant with a copy of this questionnaire FOR SRFT STAFF, if answered YES to any question, refer to the Occupational Health Department in addition to the above. Page 16 of 24

17 Appendix 3 Contacts for Latex Allergy Immunology Clinic Immunology Specialist Nurse Ms. Lucy Common Consultant Immunologist Dr. Hana Alachkar Lead Anaesthetist for Anaphylaxis (secretary) Consultant Anaesthetist Dr. Liesel Bethelmy Dermatology Clinic /1039 Dermatology Specialist Nurse Sister Julie Mannion Anaesthesia Reaction Clinic at Manchester Royal Infirmary (Contact via Secretary Ms.Joanne Walton) (Fax number) Consultant Anaesthetist Dr. Nigel Harper Page 17 of 24

18 Appendix 4 Salford Royal NHS Foundation Trust Anaesthetic Anaphylaxis Referral Form Patient details Name Date of birth Hospital / NHS Number Address Telephone Referring clinician (address for correspondence) Name Address Telephone Anaesthetist (if different from above) Name Address Telephone Patient s GP Name Address Telephone Surgeon Name Address Telephone Page 18 of 24

19 Details of the Reaction Date of the reaction - day/ month/ year Time of onset of reaction - Suspected cause of the reaction 1) 2) 3) Proposed surgical procedure: Was surgery completed? Yes No If no, has another date for surgery being scheduled? Yes No Urgency of future surgery Details of the reaction Symptom/ Sign Onset Time (24 h clock) Time resolved (24 h clock) Severity (Mild/Moderate/Severe) Hypotension Lowest BP / mmhg Tachycardia Bradycardia Bronchospasm Cyanosis/ desaturation Angioedema Urticaria Arrhythmia Flushing Itching Other (specify) Lowest SpO2 Page 19 of 24

20 Drugs administered BEFORE the onset of the reaction. In addition, please include time of tracheal intubation, LMA insertion, and any other relevant event Drug/Procedure Time over which administered ( STAT or in min:sec) Time (24 hr clock) Route Intravenous fluids given BEFORE the onset of the reaction with approximate start times 1... : 2... : 3... : Drugs given AFTER the onset of the reaction Drug / Fluid Time over which administered ( STAT or in min:sec) Time (24 hr clock) Route Page 20 of 24

21 Intravenous fluids given AFTER the onset of the reaction with approximate start times 1... : 2... : 3... : 4... : Comments on response to treatment.... Outcome Survived: Yes No Transfer to: Ward HDU ICU Other Anaesthetic techniques and procedures Latex free environment? Yes No Central venous access Time: h Skin prep Type of CVC Was a coated catheter used? Yes No Neuraxial blockade Spinal Epidural Epi-spinal Skin Prep Drug/Procedure Time over which administered ( STAT or in min:sec) Time (24 hr clock) Route Page 21 of 24

22 Peripheral nerve blockade Type of block(s) : Skin Prep Drugs given for peripheral nerve blockade. Drug Time over which administered ( STAT or in min:sec) Time (24 hr clock) Route Urethral catheterisation Time h Antiseptic solution.... Urethral lubrication/local anaesthetic.. Type of catheter (eg latex, silastic etc) Skin preparation for surgery and start of surgery Time skin preparation h Skin Prep - Time surgery commenced:...h Time surgery completed h Investigations performed prior to referral (please give results if known) Were blood samples taken for Mast Cell Tryptase measurement? Yes No First sample Second sample Third sample Time : Date / / Result. Time : Date / / Result... Time : Date / / Result. Other bloods tests: Test: Time : Date / / Result.. Test: Time : Date / / Result.. Case discussed at a multidisciplinary meeting? Yes Reported to the Anaphylaxis Lead Consultant? No Date / / By whom Page 22 of 24

23 Appendix 5 AAGBI guidelines Appendix 6 BSACI guidelines Appendix 7 Advanced Life Support Guidelines Page 23 of 24

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