HEAL TH SAFETY FOR THERAPEUTIC HYPERBARIC FACILITIES

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THE BRITISH HYPERBARIC ASSOCIATIONHEALTH & SAFETY FORTHERAPEUTIC HYPERBARICFACILITIES:A CODE OF PRACTICE

THE BRITISH HYPERBARIC ASSOCIATIONHEALTH & SAFETY FOR THERAPEUTICHYPERBARIC FACILITIES:A CODE OF PRACTICEDr. J. BroomeDr. A. P. ColvinMrs. J. A. WelhamDr. S. WattMr. R. Gough-AllenMr. D. AlcockMr. P. LonsdaleDr. P. JamesMr. S. Munro

CopyrightThe British Hyperbaric Association2000Published byThe British Hyperbaric AssociationJacqui Welham (Secretary)Total Control (Anglia) LtdBecketts CottageBungay RoadHempnallNorwich, NR15 2NGTel: 01508 498600Printed byPage BrosMile Cross LaneNorwichNR6 6SAISBN 0 952 7623 2 3ACKNOWLEDGEMENTSThe BHA commissioned a working pany with the aim of drafting this Code of Practice.Working pany members were: Dr. J. Broome Chairman, Dr. A.P. Colvin, Mrs. J.A.We/ham, Dr. S. Watt. Mr. R. Gough-Allen. Mr. D. Alcock, Mr. P. Lonsdale, Or. P. James,Mr. S. Munro.The document draws heavily, both in wording and format, on the "Cox Repon'' and theApproved Codes of Practice for the 1998 Diving at Work Regulations. Severalindividuals, who were not pan of the original working party. made substantialcontributions to the text. editorial process, or the provision of meeting facilities: specificthanks go to Dr. Steve Doheny, Mr. David Head and Ms. F. Hirst of the HSE. Mr 0.Elner of DERA. and Dr. A. Pitkin of /NM.The BHA is grateful for assistance from the HSE as consultee in the formation of thedocument.Jon BroomeChairman, BHA Health & Safety working Pany

HEALTH & SAFETY FOR THERAPEUTIC HYPER BAR IC FACILITIES:A CODE OF PRACTICEFOREWORDTherapeutic hyperbaric facilities are usually complex, operated by a multi-disciplinaryteam and use a method of treatment which has unique physical hazards in addition tothe usual risks of medical therapy. Thus within therapeutic hyperbaric units themanagement of safety and health is of paramount importance. This should includecareful risk assessment, supervision and control of all operations by competentpersonnel, implementation and review of safe systems of work and particular referenceto information, instruction and training of all staff.This Code gives practical guidance on the safe operation of therapeutic hyperbaricfacilities for British Hyperbaric Association members who currently represent thoseproviding therapeutic hyperbaric care to the National Health Service. It is thus intendedfor use by the Department of Health & National Health Service management, HealthAuthorities, Hyperbaric Therapy Providers, Hyperbaric Unit Medical Directors and allwho may require to purchase or provide therapeutic hyperbaric care. Although primarilyintended for use within the United Kingdom, it may be of some value to those elsewhere.The Code has been written with the intention of being goal setting rather thanprescriptive. This has the advantage that as health and safety legislation evolves thenhyperbaric therapy providers will be able to adapt and utilise good standards andpractices without necessarily making this Code redundant.The British Hyperbaric Association believes that this code provides a useful basis onwhich to build good health and safety practice within therapeutic hyperbaric facilities. Ithas undergone widespread consultation within the BHA including all hyperbaric facilityMedical Directors and the Health and Safety Executive.As Chairman it is most satisfying to write this Foreword for what should be an importantstep forward in safety and health for the practice of hyperbaric medicine in the UnitedKingdom.Dr. AP. ColvinChairman, British Hyperbaric Association3

HEALTH AND SAFETY FOR THERAPEUTIC HYPERBARIC FACILITIES: A CODEOF 72.Explanation and Intention of the CodeOfficial Status of the CodeWho Wrote the CodeScope and Areas Covered by the CodeSources of Information (See Annex C)Historical BackgroundCategories of chambersDEFINITIONS2.1.1.2.1.22.1.32.1.42.1 .52.1.63.Therapeutic hyperbaric chamberChamber compressionTherapeutic hyperbaric facilityPatientHyperbaric treatmentHyperbaric treatment teamBACKGROUNDLegal Requirements4.STAFFING AND SAFE WORKING PRACTICES4.14.2Standard Operating ProceduresStaff al DirectorHyperbaric Duty DoctorSupervising Chamber OperatorChamber AttendantMonoplace AttendantEngineering and technical staffPersonnel and 7Hyperbaric Therapy ProviderMedical DirectorHyperbaric Duty DoctorHyperbaric Facility ManagerSupervising Chamber OperatorAssistant ChamberChamber Attendant

4.3.8 Monoplace Chamber Operator4.3.9 Nursing4.3.10 Engineering and Technical Staff4.3.11 Safety Director4.4Hyperbaric Treatment Teams and Associated Working Practice4.4.14.4.24.4.34.4.44.4.54.5Hyperbaric Treatment Team.Minimum Team SizeNumbers of Medical AttendantsOver-lapping FunctionsPersonnel not employed by the Hyperbaric Therapy ProviderMedical Fitness and Health Surveillance of Staff4.5.14.5.24.5.34.5.4Pre-employmentDay-to-day fitness: Staff ResponsibilitiesReporting Of Work-Related Illness In StaffCertification of Medical Fitness4.6 Risk Assessments4.6.1 Generic hazards in hyperbaric facilities4.6.2 Specific hazards in hyperbaric facilities4.6.3 Quantity of breathing gas4.6.4 Noise4.6.5 Decompression illness after hyperbaric treatment4.6.6 Altitude changes after therapeutic hyperbaric exposure4.6.7 Oxygen toxicity4.6.8 Thermal stress4.6.9 Fire safety4.6.1 OElectrical safety4.6.11 Manual handling4.7Hyperbaric Facility Systems Procedures4.8Patient Reception, Treatment and Disposition4.9Transfer Under Pressure4.10Equipment4.10.1 Face masks, hoods, or mechanical ventilators4.10.2 Gases4.10.3 Storage cylinders4.10.4 Breathing gas supply4.10.5 Oxygen4.10.6 Communications4.10.7 Equipment to carry and lift patients5

4.11Maintenance Procedures4.11.1 Periodic examination, testing and certification4.11.2 Planned maintenance system4.11.3 Equipment register4.11.4 Written scheme of examination5.EMERGENCY PROCEDURES5.15.2Medical EmergenciesSystem EmergenciesANNEX A:ANNEX B:ANNEX C:DOCUMENTATION AND RECORD KEEPINGEXPOSURE LOG DETAILSAPPLICABLE LEGISLATION6

HEALTH AND SAFETY FOR THERAPEUTIC HYPERBARIC FACILITIES:A CODE OF PRACTICE1. INTRODUCTION1.1Explanation and Intention of the CodeThis Code is goal setting and is intended to enable different Therapeutic HyperbaricFacilities to adapt and use existing good standards and practices to meet therequirements of existing Health and Safety legislation. The guidance in the Code relatesto the safety of personnel working in or adjacent to the hyperbaric facility, and to otherswho may be affected by the operation of the facility. It does not relate to the medicaltreatment procedures used for the management of patients unless these procedureshave potential impact on patient safety or the health of others.1.2Official Status of the CodeThe British Hyperbaric Association (BHA) has compiled and issued this booklet with advicefrom the Health and Safety Executive. The guidance advises specifically on the applicationof British health and safety legislation to those providing hyperbaric treatment; it is intendedto assist BHA members and others in meeting their duties under health and safetylegislation. The guidance is aimed at all those involved in providing hyperbaric treatment,including employers, managers and clinicians. It may also be of use to employees and theirrepresentatives with regard to the current standards for the safe operation and use ofhyperbaric facilities.Although this Code does not have the same legal status as an Approved Code of Practice.Health and Safety Inspectors may refer to it as illustrating good practice.1.3 Who Wrote the CodeThe Health and Safety Committee of the BHA wrote the Code.1.4Scope and Areas Covered by the CodeThe Code applies to all therapeutic hyperbaric facilities that provide recompression orhyperbaric oxygen therapy, either emergency or elective, to patients. It does not apply tofacilities operated by Diving Contractors as a requirement of the Diving at WorkRegulations (DWR) 1997, solely for the treatment of divers employed by the contractor.except where such facilities are also operated as a medical facility for other patients.Similarly, the Code does not apply to facilities operating under the Compressed Airregulations 1996. The Code covers all therapeutic hyperbaric facilities operated in theUnited Kingdom by BHA members.Under this Code, guidance for ensuring the health and safety of patients undergoinghyperbaric treatment should also apply to human subjects in physiological experimentsinvolving hyperbaric exposure7

1.5Sources of Information (See Annex C)1.6Historical BackgroundHyperbaric chambers were originally established on a wide scale for the treatment ofdecompression illness and the bulk of chambers remain solely or principally to supportdiving activities or compressed air tunnelling. Hyperbaric oxygen treatment is, however,also used for medical treatments unrelated to decompression illness and there areseveral conditions for which it is generally accepted as being helpful. These arespecified in the European Committee for Hyperbaric Medicine Consensus document(See Annex C) and in Undersea and Hyperbaric Medical Society Hyperbaric OxygenCommittee Reports (See Annex C). Both these documents are subject to periodicupdate.The Faculty of Occupational Medicine of the Royal College of Physicians set up aWorking Party in 1991 under the chairmanship of Professor R I McCallum to examinethe minimum acceptable standards of patient care, medical supervision and generalsafety of hyperbaric chambers using compressed gases in medical treatment. Thedeliberations of this initial Working Party were discussed widely and as a result of itsreport, a second Working Party under the chairmanship of Dr R A F Cox, Vice-Dean ofthe Faculty, was established with the remit to produce a Code of Good Working Practicefor the Operation and Staffing of Hyperbaric Chambers for Therapeutic Purposes. Thisreport was accepted by the British Hyperbaric Association and was published by thefaculty of Occupational Medicine in May 1994. The "Cox Report" report categorisedtherapeutic hyperbaric chambers into four categories, which are redefined in thefollowing section.1.7Categories of ChambersCategory 1 (Multiplace) Chambers - Comprehensive hyperbaric facilities capableof supporting the treatment of patients who are critically ill, from any cause, andwho may require hyperbaric intensive care.Category 2 (Multiplace) Chambers - Facilities capable of receiving elective oremergency referrals for any accepted application of hyperbaric oxygen therapy,but excluding patients who are critically ill at the time of referral or are consideredlikely to become so.Category 3 (Multiplace) Chambers - Facilities without some of the capabilities ofCategories 1 or 2, which are sited specifically to support diving projects (eithercommercial or recreational) and work in compressed air. These facilities shouldalso be capable of providing elective treatment of residual symptoms ofdecompression illness.Category 4 (Monoplace) Chambers - Facilities operating at relatively lowpressure and without an air-lock capability. The expectation is that such8

chambers providing a treatment service on behalf of the NHS or the private healthcare sector would normally be sited within the boundaries of, or in very closeproximity to, a hospital. These facilities should be capable of receiving electiveand emergency referrals of patients in any diagnostic category where the MedicalDire tor or Hyperbaric Duty Doctor supervising the treatment judges that arequirement to have access to the patient during hyperbaric treatment is unlikely.Normally monoplace chambers are not suitable for the immediate treatment ofacute decompression illness.All therapeutic hyperbaric facilities in any of the above categories must have buildings,plant and equipment, and administration and organisational structures that are "fit forpurpose". To that end, therapeutic hyperbaric facilities of all categories must conduct ahazard and risk assessment of the working environment. This assessment should bedocumented and made accessible to hyperbaric facility staff by incorporation in amanual of Standard Operating Procedures or equivalent.2.DEFINITIONS2.1.1 A therapeutic hyperbaric chamber is a pressure vessel capable of accommodatingone or more persons with the purpose of providing medical treatment. Therapeutichyperbaric chambers may be mu/tip/ace or monop/ace. Multiplace chambers are largerstructures intended to hold two or more persons (including the attendant(s) for medicaltreatments); they may have two or more compartments to allow access and egress ofmedical staff and equipment while maintaining pressure. They are usually pressurised withair or a helium/oxygen mixture. Monoplace chambers are smaller, single compartmentstructures in which a patient (normally in a seated or recumbent position) is observed by theattendant from outside the chamber. Monoplace facilities usually operate at relatively lowpressure and are normally pressurised with oxygen or air.2.1.2 For the purposes of this Code, chamber compression is defined as a period ofincreased pressure within a therapeutic hyperbaric chamber of greater than 100 mB (1 OkPa)above ambient atmospheric pressure for the purposes of treatment, trials, training or testing.2.1.3 A therapeutic hyperbaric facility consists of the therapeutic hyperbaric chamber(s)together with associated plant and buildings, staff (both technical and medical), and aspecific administrative organisation.2.1.4 Under this Code, a patient is any person suffering from a medical condition or injury,who occupies a therapeutic hyperbaric chamber during chamber compression with thepurpose of altering the natural course of their medical condition or injury. Different gasmixtures, including compressed air, may be breathed by the patient during their occupancyof the chamber. This definition of a patient includes persons with radiation tissue injury orany other condition who receive prophylactic hyperbaric oxygen prior to surgery, andpersons who are control subjects in therapeutic trials of hyperbaric therapy.2.1.5 Hyperbaric treatment is defined as period of increased pressure to greater than 100mB (1 OkPa) above ambient atmospheric pressure, within a therapeutic hyperbaric chamber,for the purposes of treatment of a patient. as defined above.9

2.1.6 The hyperbaric treatment team consists of all medical and technical personneldirectly involved with the hyperbaric treatment of a patient.3. BACKGROUNDLegal requirementsBritish health and safety legislation gives responsibility for health and safety to thosewho create, manage and work with risks related to employment. This is achievedthrough the Health and Safety at Work etc. Act 1974, which places a duty on allemployers to ensure, so far as is reasonably practicable, the health safety and welfareat work of all their employees and those not in their employment. It further defines thatduty in particular to "the provision of such information, instruction, training andsupervision as is necessary to ensure so far as reasonably practicable, the health andsafety at work of employees". The Act also places duties on self employed people,employees and certain individuals such as directors and managers.The Management of Health and Safety at Work (Amendment) Regulations 1994specifically refer to compressed air work and relates this to the health and safety ofpregnant mothers, but the Diving at Work Regulations 1997 and the Work inCompressed Air Regulations 1996 both exclude medical workers using compressionchambers for therapeutic purposes from their requirements. Nonetheless, most otherhealth and safety legislation, such as the Noise at Work Regulations 1989, the ManualHandling Operations Regulations 1992, the Confined Spaces Regulations 1997 and thePressure Systems Regulations and Transportable Gas Containers Regulations 1989(this set of Regulations is due to be replaced in the near future by the Pressure SystemsSafety Regulations) applies to hyperbaric health care workers in the same way as itapplies to other employees (See Annex C)4. STAFFING AND SAFE WORKING PRACTICES4.1Standard Operating ProceduresEach therapeutic hyperbaric facility should develop its own Standard OperatingProcedures (SOPs), which document the detailed working practice for all anticipatedactivities within the facility. SOPs should contain all such information and instructions asare necessary, including emergency procedures and contingency plans, to give advice,to guide, or to regulate the behaviour of those taking part in the functioning of the facility,either in a medical or technical capacity. SOPs should be reviewed periodically andupdated as appropriate when conditions change.All staff should possess or have immediate access to a copy of the SOPs, and befamiliar with the guidance contained therein, relevant to their position.10

4.2Staff CompetenciesCompetence can be based on training and assessment and/or experience. However asno . . th.erapeutic. hyperbaric facilities are likely to be the same a period offan:i1.11 nsat1on and induction training will be required within individual hyperbaricfac1l1t1es.Personnel currently employed in therapeutic hyperbaric facilities in Britain come from avariety of occupational backgrounds and have largely acquired their knowledge withoutthe benefit of formal training. Such training in the various clinical and technical skillsrequired for the safe operation of a therapeutic hyperbaric facility is in its infancy inGreat Britain. The Code acknowledges this, and also recognises that different facilitiesmay use their staff in different ways, with different individual competency requirements.Nonetheless, all staff must be competent to do the work expected of them and,ultimately, the responsibility for assessing competence of a member of the hyperbarictreatment team lies with the Hyperbaric Therapy Provider. Therefore, clear roles andresponsibilities need to be defined and recorded on appointment or promotion of staff.The following scheme may be used for guidance.4.2.1 The Medical Director should be a registered medical practitioner; a postgraduatequalification in a relevant speciality is an advantage. He/she should have practicalexperience and be competent in all medical aspects of therapeutic hyperbaric facilityactivities. His/her competence will be consistent with the types of patients accepted fortreatment by the facility in which he/she works.4.2.2 The Hyperbaric Duty Doctor will be expected to acquire experience and trainingwhile in post. He/she should only be allowed to work unsupervised by his/her medicaldirector once he/she has demonstrated his/her competence in a range of standardtreatments. Arrangements should be made to ensure that he/she has access to adviceand assistance from a more senior colleague when working unsupervised. He shouldnormally be passed medically fit to work under pressure.4.2.3 Only the Hyperbaric Therapy Provider can appoint a Supervising ChamberOperator and this must be done in writing. No formal qualification currently exists.There are a number of people who have formal training in the operation of hyperbaricchambers but for different operational circumstances i.e. diving and work in compressedair. For the immediate future on site training from scratch or based on previousexperience will be the norm. for Supervising Chamber Operators in the context oftherapeutic hyperbaric facilities.When considering competence of a candidate for a Supervising Chamber Operator'sposition, the Hyperbaric Therapy Provider should consider the candidate's technicalknowledge, experience, practical attributes. reliability, ability to conduct hyperbarictreatments in a safe manner in the context of the specific technical demands of thepressure system and intended clinica

4.6.5 Decompression illness after hyperbaric treatment 4.6.6 Altitude changes after therapeutic hyperbaric exposure 4.6.7 Oxygen toxicity 4.6.8 Thermal stress 4.6.9 Fire safety 4.6.1 O Electrical safety 4.6.11 Manual handling 4.7 Hyperbaric Facility Systems Procedures 4.8 Patient Reception, Treatment and Disposition

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