POLICY & PROCEDURE Scope Service Wide Program Campus

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1 Eastern Health Draft Post Frank Thien s Comments POLICY & PROCEDURE Scope Service Wide Program Campus XX Folder: Clinical Policy Manual Index No Sub-Section: Perioperative Services Sponsor: Subject: Management of the Latex sensitive patient in the Operating Suite Approving Body New Policy Effective Date: Review Date: Current Policy Review Date: Date Reviewed: Related Policy/s 1. PURPOSE To provide a safe environment in the operating suite for patients with who are at risk for sensitisation to Latex, have a Latex sensitivity, or a suspected or confirmed latex allergy. 2. DEFINITIONS Procedure for Care of patients with Latex Allergy Page 1 of 14 October 05

2 Product Information Latex Natural Rubber Latex Dry Natural Rubber Synthetic Rubber Latex is the sap of the commercial rubber tree (Hevea brasilienisis). A complex mixture of water soluble plant proteins. Natural rubber is derived from latex. Also known as Natural rubber latex. (NRL) Natural rubber product which is made from latex Involves the use of coagulated natural latex dried or milled sheets. Less likely to cause a latex allergic reaction, however has still caused reactions and should be avoided in a latex allergic patient Made from petroleum. Does not cause allergic reactions Reactions to Latex Irritant contact dermatitis Type IV delayed Hypersensitivity or Allergic Contact Dermatitis Type I immediate Hypersensitivity There are three distinct reactions that may occur on exposure to latex: Irritant Contact Dermatitis, Type IV delayed hypersensitivity, Type I immediate hypersensitivity. The most common reaction to Latex products. A nonallergic (Non immune mediated) skin reaction caused drying action of corn starch (in gloves) and/or other irritant chemicals found in gloves, exacerbated by sweating, frequent hand washing, and glove irritation. The skin has a rash characterised by redness, dryness, scaling, blistering and cracking. The break in skin integrity may predispose latex sensitisation. This reaction is immune mediated. May be caused by latex proteins and/or chemical additives used during the manufacturing process of the latex product. Causes skin reactions 6 to 72 hours after contact can be mild to severe (skin becomes dry crusted and thickened to oozing skin blisters). An allergic reaction mediated by IgE antibodies. Responses are urticaria, allergic rhinitis, conjunctivitis (itchy watery eyes), asthma, angioedema and anaphylaxis within minutes to an hour of exposure. Severity varies from mild to life threatening. Categories of susceptibility to Latex Latex Allergy Latex Alert Latex Sensitive Sensitization Sensitivity Refers to the Type I hypersensitivity reaction on exposure to latex. The reaction can be life threatening (anaphylaxis). Confirming Latex allergy requires further testing Refers to patients who are at high risk for sensitisation to latex, or have a suspicious history, or have a Type IV hypersensitivity reaction to latex. Suspected allergy, at risk history A term sometimes used to denote Latex alert patients Rendering a person sensitive to a substance causing an allergic response in that person. A clinical response that develops after sensitization. Procedure for Care of patients with Latex Allergy Page 2 of 14 October 05

3 Environment Types Latex Safe or Minimal Latex Environment Latex Free Area Areas where health care workers and patients are most unlikely to have an allergic reaction to an exposure to Latex. These areas may not be latex free but latex exposure is minimal. Areas which are totally free of products which contain latex. 3. BACKGROUND Latex is a processed plant product manufactured from sap of the rubber tree Hevea braziliensis (Weeping Wood Tree). The latex sap is processed with several chemicals which help give it its properties which make it useful in the health care setting: excellent barrier qualities, deformability, elasticity, tactile sensitivity and high tensile strength. In the 1980s the use of Universal Precautions promoted by the Centres for Disease Control and Prevention (to prevent the spread of HIV and Hepatitis B and C viruses) lead to a 25 fold increase in the use of latex gloves. Incidence of Latex anaphylaxis has been associated with the increase in use of latex gloves. Latex is the second most common cause of anaphylaxis in theatres. With the increase in demand for latex gloves, manufacturing practices changed resulting in gloves with increased amounts of latex proteins. Cornstarch used in powdered gloves (to help with donning the gloves) absorbs the latex proteins. The powder acts as a carrier for latex. Latex is ubiquitous in the health care setting. Moreover there is no requirement for Manufacturers to label their products with the latex content. Health Care workers are exposed to latex particles and become sensitised. Seventeen percent of health care workers may be sensitised to Latex. Health Care workers who work in a glove powder free environment are less likely to have latex antibodies than those who work in an environment where glove powder is used. In 2005 the NSW Department of Health published a latex strategy, to reduce the occupational hazards of latex for health care workers, and to minimize the risk for patients who are allergic to latex. This document provides description for management of patients who are latex allergic, or should avoid latex because they are at high risk for developing latex allergy with repeat exposure. It is based on the NSW Department of Health publication: Latex Allergy Policy Framework and Guidelines for Prevention and Management. 25 th Feb GUIDELINES/PRINCIPLES 4.1. Establishment of a theatre environment low in latex. Reduce the number of products which contain latex, where clinically appropriate, and economically reasonable Create and maintain a list of products and their latex status. Keep a list of alternatives which can substitute for latex containing products Theatre Holding Bays should be latex safe areas so that patients can be received without risk of exposure to Latex. Procedure for Care of patients with Latex Allergy Page 3 of 14 October 05

4 4.2. Remove powdered Latex gloves from the theatre suite Removing powdered gloves from the operating suite environment significantly reduces the work required to prepare the theatre for a patient with latex allergy Greatly reduces latex sensitisation for staff members 4.3. CSSD a minimal Latex area By making CSSD a minimum latex area products and packages from CSSD will not have Latex particles on them and can be used safely with patients who are Latex allergic. Make CSSD a minimal latex area by Removing latex gloves from the area Latex is denatured by steam so reprocessing of instruments is unnecessary Removing all other latex containing products from CSSD 4.4. Identify patients at risk of exposure to Latex Identify patients who are latex allergic by specifically asking for a history of latex allergy. A questionnaire can help to identify patients with latex allergy. Identify the type of reaction to latex. A patient can be labelled as latex allergic if they develop allergic symptoms within one hour of exposure to latex, including the development of a rash, rhinoconjunctivitis, asthma, anaphylaxis. If there is a suspicion of latex allergy, but diagnosis is not confirmed, confirm the diagnosis by further testing, where possible. Treat these patients as Latex Allergic. Confirmation tests can be delayed until after surgery. The confirmatory test for latex allergy is initially a Latex RAST. If negative the patient should be referred for Skin Test. Confirmation of latex allergy is important and patients should have appropriate counselling and health advice following confirmation of latex allergy If not latex allergic, identify patients who are at high risk for latex sensitisation. The questionnaire can assist. Patients who are at high risk for latex sensitisation, or who have a type IV hypersensitivity reaction to latex (contact dermatitis) are categorised as LATEX ALERT patients. Patients who are at risk of latex sensitisation but have no symptoms from latex exposure, eg health care workers, should be classified as Latex Alert as well. Latex Alert patients should have minimal exposure to latex. However, Surgeons who prefer to use latex gloves should be allowed to use latex gloves with these patients. If it is not possible to identify latex risk for a patient the patient should be treated as if latex allergic. This includes emergency patients. Summary: Treat as Latex Allergic: Allergic symptoms on exposure to latex Patients who develop a rash within 60 minutes of exposure to latex Suspicious history of above. Management: No latex exposure for these patients. No Latex. Proceduralists cannot wear latex gloves because of risk of anaphylaxis Treat as Latex Alert: Patients with occupational exposure to latex but have no symptoms Other non allergic reactions to latex including irritant or contact dermatitis, rashes developing >60 minutes after latex exposure. Procedure for Care of patients with Latex Allergy Page 4 of 14 October 05

5 Food allergies related to latex Atopic Patients. Management: Minimal exposure to latex. Proceduralists can wear latex gloves 4.5. Management of patients at risk Patients who have latex allergy should be looked after in a latex safe environment. Check lists will ensure all preparation tasks are done The list of equipment / consumables and their latex status and suitable substitutes should be readily available for reference Sign post all entries Ensure that all staff are aware of the patient's latex status 4.6. Education An education program should be established to: Educate staff about Latex and the health issues for health care workers Patients who are at high risk for latex sensitisation and allergy Management of latex allergic patients 4.7. Latex Coordinator Establish a latex coordinator for theatre The latex coordinator will: Ensure compliance to this procedure Ensure that the protocol is evaluated and relevant Act as a resource for matters relating to the handling of latex, latex allergic patients, patients who are latex alert, and staff Monitors equipment and consumables for latex content Continues work towards creating an environment that is always latex safe, where practicable Creates and maintains a database of equipment and consumables which contain latex, those that do not, and those which are suitable substitutes for items which contain latex Facilitate appropriate management of staff who are concerned about latex sensitisation 4.8. Prophylaxis Pharmacological prophylaxis using H1 or H2 blockers or steroids (hydrocortisone) is controversial. Avoidance of latex exposure is the mainstay of prevention of allergic reaction 4.9. Preparedness for treating latex anaphylaxis Staff should be prepared to diagnose and treat an anaphylactic reaction 4.10.Cardiac arrest trolleys Resuscitation and cardiac arrest trolleys should be latex free Procedure for Care of patients with Latex Allergy Page 5 of 14 October 05

6 5. PROCEDURE (For a patient with latex allergy) This document assumes that the environment does not have powdered latex Gloves 5.1. Identification As part of the nursing admission process every patient should have their latex allergy status checked. This would be done as part of the drug allergy questioning. Specific questions to help are listed in the appendix. Following the questioning patients can be treated as Latex Allergic, Latex Alert or that no particular latex precautions need be applied Notification Notify Operating suite from preadmission clinic or Emergency department or ward. Place identification band on patient to alert staff regarding latex allergy. Alert all Perioperative areas to details of latex sensitivity including preop hold, anaesthetic staff, scrub/ scout staff and post anaesthetic care unit staff. Consult with Surgical Staff regarding booking and patient status When transferring the patient ensure that the next area is aware of the latex status and is ready to receive the patient prior to transfer Theatre Preparation Remove all latex gloves and substitute with alternative. Remove all latex containing equipment including disposables and provide latex free alternatives. Use Check list to ensure all tasks are done Signpost all theatre doors to alert staff to latex isolation Sterile set up Use non latex sterile gloves Check all equipment and consumables to ensure that they are latex free If no latex free substitutes available notify surgeon and anaesthetist, this may necessitate some change of technique to reduce latex exposure Monitor latex free listings prior to opening of sterile stack for scrub/scout or anaesthetics/pacu purposes Transferring the Latex Allergic Individual Because the theatre suite is powder free the patient can be transferred to the Holding Bay that has been checked to ensure that latex gloves have been removed Place a sign Latex Allergy Patient on the patient s bed. Both nurse and technician wash hands and have latex free gloves available Shower cap style theatre caps do not have latex. Use the red cap to denote allergy alert. Ensure that the receiving area has been notified of the latex status of the patient and that the area is ready to receive the patient Intraoperative Management of the Latex Allergic Individual Refer to latex safe check list to ensure that preparation is complete Refer to latex free database to ensure all items used are latex free Nursing staff and medical staff to prepare in case of anaphylaxis 5.7. Postoperative Management of the Latex Allergic Individual Check all items to be used in PACU are latex free All latex gloves in PACU should be removed to prevent accidental use Monitor for signs and symptoms of latex exposure Liaise with ward staff regarding continued latex free management Procedure for Care of patients with Latex Allergy Page 6 of 14 October 05

7 5.8. Restocking/ Cleaning Operating room is cleaned as usual and is ready for immediate use 5.9. Latex Folder Latex Folder contains instructions, check lists, product list of stock, both for scrub/ scout and anaesthetic/pacu, detailing latex content Listings of Latex free alternatives Latex Isolation Door signposts (purple) Bed card and trolley isolation signposts (purple) Note that a Latex Free Box is not considered necessary as most equipment and consumables are latex free Latex Alert patient Where ever possible avoid latex exposure. Allow proceduralists to use latex gloves Non Powder Free Environment This document assumes that the environment does not have latex gloves with powder (ie powder free environment). If the environment uses powdered latex gloves additional procedure must take place, outlined below: Patients who are latex allergic need to be first on the list Patients who are latex allergic need to cared for in a theatre that has been prepared by resting the theatre (theatre is not used, and no staff movement) for 3 hours, then damp dusting surfaces Staff need to change clothes to remove latex on corn starch / aero allergens that has settled on clothing Staff need to ensure that their hands are free of latex by washing prior to attending the area with the patient at risk. Theatre need to be notified in advance to ensure that the patient is first on list, and that theatre preparation has been completed before the patient is sent for Patient is transferred directly to the operating suite / anaesthetic room (already made latex safe) Plan and prepare a closed operating room. Limit the number of staff from entering theatre (as the staff may have aeroallergen on clothing) All staff entering room should don clean clothes and wash their hands to remove latex particles. Those staff in the room should remain in the room while the patient is in the room, or repeat the change of clothes and hand washing. These precautions may necessitate an outside staff member to pass equipment to inside personnel Sterile set up needs to take place in theatre which has been prepared (rather than in theatre core). Recovery must occur in a prepared room (3 hours rest, damp dusted) looked after by staff with fresh clothing keeping the patient in theatre may be the safest and easiest option Patients who are Latex Alert need not follow this strict avoidance of contact with aero allergens but ideally these patients should not be exposed to aeroallergens Future management of Latex allergic patients Patients with suspicious history of latex allergy but not confirmed should be referred for further testing to confirm allergy. Patients who are confirmed should be referred for counseling and management of their allergy. Procedure for Care of patients with Latex Allergy Page 7 of 14 October 05

8 Documentation of their latex allergy should be in the alert section of the patient history 6. EQUIPMENT Latex Free Folder is to be kept in an area with easy access for quick reference. This location should be well publicised 7. Outcome Measure / KPI No relevant patient related KPI at present. 8. Dissemination Strategy OH&S Committee meeting OHS annual management training schedule Latex Coordinator Operating Suite Clinical Nurse Educators (Nursing) Department of Anaesthesia CMEs Via Division of Surgery General Memos sent from Medical Directors office 9. Related policies Occupational Health and Safety Latex Policy Staff Occupational Health and Safety Latex Policy Patient Procedure for Care of patients with Latex Allergy Page 8 of 14 October 05

9 10.REFERENCES AORN Latex Guideline Standards, Recommended Practices and Guidelines Brehler, R; Kutting, B. 2001, Natural Rubber Latex Allergy: A Problem of Interdisciplinary Concern in Medicine, Archives of Internal medicine, 161, (8), Dakin, M.J. and Yentis, E.S.M., 1998, Latex allergy: a strategy for management, Anaesthesia, 53: De Moraes Lopez, MH Baena; Mendes Lopez, R Aparecida. 2000, Latex Allergy in Health care Personnel, AORN Journal, 72, (1), 42 43, Gehring, LL; Ring, P. 2000, Latex Allergy: Creating a Safe Environment, Dermatology Nursing, 12, (3), Kam, P.C.A., Lee, M.S.M. and Thompson, J.F. 1997, Latex allergy: an emerging clinical and occupational health problem, Anaesthesia, 52: Kim, KT; Graves, PB; Safadi, GS; Alhadeff, G, Metcalfe, J. 1998, Implementation Recommendations for Making Health Care facilities Latex Safe, AORN Journal, 67, (3), National Institute for Occupational Safety and Health, 1997, Preventing allergic reactions to natural rubber latex in the workplace, Publication 97/135. New South Wales Department of Health Latex Allergy: Policy Framework and Guidelines for the Prevention and Management. Document No PD2005_490 Published 25 th Feb 05. Ross, S., 1999, Rationalising the purchase and use of gloves in health care, British Journal of Nursing, 8, (5), Spicer, M. and Richardson, M., 1998, Risky business: pre-powdered gloves or powder-free gloves in the operating suite?, International Journal of Health Care Assurance, 11, (6), The Australasian Society of Clinical Immunology and Allergy, 1998, Guidelines for hospital management of allergic patients. White, I.R., 1997, Setting standards for product selection: allergy prevention, European Journal of Surgery, Suppl. 579, (163), Yip, E., 1998, Latex protein allergy and the latex gloves, IV Connections, 6, (2), 4-6. ACORN Standards Draft 2004 Hepner DL and Castells MC: Latex Allergy: An Update. Anaesthesia and Analgesia 2003;96: Holzman RS, Chair of Task Force on Latex Sensitivity, Committee on Occupational Health of Operating Room Personnel (Jonathon D Katz Chair), American Society of Anesthesiologists: Natural Rubber Latex Allergy: Considerations for Anesthesiologists. NSW Health: Latex Allergy Policy Framework and Guidelines for Prevention and Management. 25 th Feb 05 Procedure for Care of patients with Latex Allergy Page 9 of 14 October 05

10 Appendix 1 Questionnaire 1. Are you allergic to latex? 2. Have you ever had itching, redness, swelling or hives within 60 minutes of: (i) wearing latex/rubber gloves (ii) blowing up balloons (iii) wearing or contact with condoms (iv) dental work? 3. Have you ever had itching or swelling of lips, mouth, tongue or throat within 60 minutes of eating bananas, avocado, kiwi fruit or chestnuts? If answers to 1 to 3 are yes then treat as LATEX ALLERGIC. 4. Do you have hayfever, asthma or eczema? 5. Do you have any other rashes with bandaids, rubber or latex products 6. Are you exposed to latex through work. Yes to questions 4 to 6 treat as Latex alert. Avoid latex contact but allow latex surgical gloves. Procedure for Care of patients with Latex Allergy Page 10 of 14 October 05

11 Appendix II Latex equipment database Work Area: Anaesthetics example to be populated Date: October 05 Notes for reviewers: The list needs to be easy to find the equipment / consumable. I recommend grouping items into categories based on clinical use eg IV equipment giving sets, IV cannula, dressings etc. Each line item need not be given a separate entry eg IV cannulae can have one entry: Insyte IV cannulae sizes 24 to 14g, Manufacturer, No latex, Latex content on pack. The database could be on line with cross references. It could also be tailored to the each environment so that if the surgical ward list comes up it doesn t show everything in the hospital. Because many items are common to lots of areas, the idea of a centralised database has appeal. However local latex coordinators will still need to have input because of products that might be unique to their area. This is of particular importance if the product does not have a latex alert label and the Latex Coordinator has had to get the information direct from manufacturer. That we still need a database of products which contain do not contain latex as well as those that contain latex is because not all products have latex alert labelling. Furthermore there is literature that recommends protection for products at EH that are safe eg theatre caps. This document becomes the authoritative reference. I suggest one latex database manager with input from local latex coordinators Name Model No Manufacturer Latex Status Central Lines Swan Ganz Catheter Latex in balloon Comment No substitute Terumo syringes All sizes Terumo No Drug Vials Esmeron No Norcuron No Ketalar No Flopen Yes Bupivacaine Pharmacia No Ben Pen CSL Yes Polybags Bupivaine, ropivaine Astra Zenica Yes Dry natual rubber in port membrane does not come into contact with the solution or the patient. Metronidazole Pharmacia No Ceftriaxone Roche No Bicarb 8.5g/100 mls Pharmacia Yes In stopper Procedure for Care of patients with Latex Allergy Page 11 of 14 October 05

12 Appendix III Latex Safe Room Check List for preparation Remove all boxes of latex gloves from Operating room Remove all boxes of latex gloves from Anaesthetic room Put out nitrile glove boxes Put Latex alert signs at theatre entries (x3) and Anaesthetic room entry Frequently asked Questions: Anaesthesia latex free (often referred to in documents to check latex status) The following items, often referred to in documents on latex allergy, are latex free at Box Hill Hospital: All Face masks Hudson Face masks Rebreathing bags NIBP cuffs and tubing are latex free Manual Blood pressure cuffs and sphygmomanometer tubing ECG dots (3M) are latex free Syringes (Terumo) are latex free Operating room mattress, arm boards, pads Procedure for Care of patients with Latex Allergy Page 12 of 14 October 05

13 Appendix IV Latex Free Folder Contents for theatre (To be populated) Procedure for Care of patients with Latex Allergy Page 13 of 14 October 05

14 Appendix V: Rashes difference between Contact Dermatitis and Irritant Dermatitis a guide Reaction Onset Signs Immune Mechanism Irritant (most common) Delayed or Type IV (Contact Dermatitis) Immediate or Type I Gradual over days Erythema, chapped, fissured skin, scaling 6 to 48 h Acute: erythema, pruritus, vesicles or cracking, crusting, desquamation of skin Within minutes; rarely > 2 hrs Chronic: dryness, scaling, fissuring,thickening and darkening of skin Swelling, pruritus, urticaria, (wheal) erythema (redness) and may be accompanied by asthma, rhinoconjunctivitis, oedema, hypotension, collapse (anaphylaxis) Note: a rash developing within 60 minutes of contact with latex is highly likely to be the Type I Hypersensitivity reaction, that is LATEX ALLERGY. None Delayed type T Cell mediated Type I immediate Procedure for Care of patients with Latex Allergy Page 14 of 14 October 05

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