O35 COST ACTION B 14 : EDITING RULES OF GOOD PRACTICE FOR HYPERBARIC MEDICINE.

Transcription

1 O35 COST ACTION B 14 : EDITING RULES OF GOOD PRACTICE FOR HYPERBARIC MEDICINE. Jean-Louis Méliet, Jordi Desola, Antonio Simao Gata, Roly Gough-Allen, Robert Houman, Jacek Kot, Christian Risby Mortensen, Peter H. Mueller, Seppo Sipinen Background First initiated by 9 countries, the COST action B 14 "Hyperbaric Oxygen Therapy" (HBO) involves 16 European nations represented in a Management Committee (MC). Delegate members sit into working groups in charge of developing international cooperations and clinical studies in the field. From the very beginning of the works, it appeared that safety is the key question in HBO: if not controlled, beyond casualties and damages, it is likely to alter patients and users confidence and impede applications and development of this therapy. The safety of the therapy was then considered under two different aspects: safety of chambers, supplies and accessories, and safety rules for conducting HBO sessions. The first one was allocated to the working group "Technical aspects" (WGT, see R. Houman s et al. paper), and led to negotiation of a European harmonised standard for therapeutic hyperbaric chambers, still in process under the aegis of CEN (European Committee for Normalisation). In Gdynia, Poland, April 2001 were held a plenary session of COST B 14 MC and the last WGT meeting (1). It was recognised that the on-going normalisation process did not cover all aspects of medical hyperbaric safety: operating, staffing and training issues would be disregarded in this frame. On suggestion of WGT, the MC approved the constitution of a new Working Group "Safety" (WGS), the effective working members of which from the beginning appear in the author s list. The mandate of WGS was defined as: - to follow the normalisation process of hyperbaric chambers by the CEN (Task Force 127); - to elaborate "Recommendations of Good Practice for Hyperbaric Medicine". For the first point, WGS appointed a delegate to CEN TF 127 as an external representative, in order to express the COST B 14 opinion in the negotiations and report to WGS and the MC on the state of the process. This CEN agreed arrangement is effective since the last TF 127 meeting in Göteborg (Sweden), May For the second point, a strategy was elaborated according to the mandate and the term of the COST program. Methods An analysis of the concept of "Safety" led us to consider three different points: the safety of facilities, in connection with operating and maintenance procedures; the safety of patients, which must be guaranteed from welcome to discharge, from diagnosis to healing or end of care; the safety of staff, in order to avoid adverse effects of working under pressure. In order to be accepted by the European nations having already ones, these rules shall comply with existing national regulations and not be a simple arithmetic sum of them. In this goal, the following texts were considered by the WGS: national regulations (from Belgium, Finland, France, Germany, Greece, Italy, Portugal, Spain); texts from Medical Hyperbaric associations: the British Hyperbaric Association: Health & Safety for therapeutic hyperbaric facilities: a Code of Practice (2); Guide to Fire Safety Standards for Hyperbaric Treatment Centres (3); The Training and Education of Hyperbaric Unit Personnel (4); European Committee for Hyperbaric Medicine (ECHM): Recommendations for Safety in multiplace medical hyperbaric chambers (5); Educational and training standards for the staff of hyperbaric medical centres (6); Coordinating Committee of Hyperbaric Medical Centres (Spain, 7) The objective of the working group was then to produce a synthesis document gathering all the different aspects of safety, excepted the manufacturing aspects which will be covered by the on-going normalisation process. In order to make the process easier, the group decided to work on the basis of an existing document covering most of the required aspects and to amend it in accordance with our objectives. The BHA document (Health & Safety for therapeutic hyperbaric facilities: a Code of Practice) was detained. WGS members agreed upon some modifications of the framework and addition of ECHM standard for education. 116

2 State of the process The decided outline of a future COST document entitled "Rules of Good Practice in HBO therapy" is as follow: Acknowledgments 1. Introduction 2. Definitions This chapter gives a set of definitions of the therapy techniques (hyperbaric therapies and hyperbaric oxygen therapy), facilities (centre for hyperbaric medicine, hyperbaric facility, hyperbaric chamber system, hyperbaric therapeutic chamber, each including the lower rank ones, see fig. 1), devices and equipment, session and treatment. 3. Staffing The different functions required to carry out a treatment (a session) are listed here, with description of their respective responsibilities (medical director, hyperbaric physician, hyperbaric nurse, supervisor, attendant, chamber operator and technician), whose competencies and education are referred to ECHM documents (6). The minimum team for a session in a multiplace chamber is defined in functions (supervision, chamber operating, patient attendance, emergency assistance) as in size (three people: one hyperbaric physician, one attendant, one operator). For sessions using monoplace chambers, only three functions were identified (no attendant inside) ensured by two people (one hyperbaric physician and one operator). 4. Equipment & 5. Gas supply These paragraphs give references to CEN and ISO applicable standards. 6. Procedures This chapter makes mandatory an operating manual developed by each centre, and accessible at any time by each member of the crew. It shall contain: the description and the specific risk analysis of the facility, the standard and emergency operating procedures. The content is given in the annexes of the document. 7. Patient safety This chapter, still to be written up at this date, will consider the patient management: reception, treatment, preparation for the sessions, watching during the sessions and follow-up. 8. Annexes In annexes, appear long or technical items giving details on some prescribed subjects: Documentation (list) to be held by each centre (drawings, descriptions, maintenance procedures and journal ); Education: ECHM standards; Outline of operating manual. Up to today, six meetings of the working group have been held, during and between the Cost B14 MC meetings, the latest on the occasion of this 26th EUBS Annual meeting. One of the first questions we faced at was to write definitions of so obvious terms than "hyperbaric oxygen therapy". After long and tough discussions, a consensus was reached on the requisite of three coexisting elements: oxygen, given to breathe under an ambient pressure higher than the local atmospheric pressure, inside a hyperbaric chamber. 117

3 Then it appeared necessary to clarify the different concepts in describing facilities: the texts we were considering used the same words for different items. A consensus was finally reached (fig 1 & 2). To be discussed by all MC members definitions were put on a discussion list on the oxynet website. They did not meet with opposition. 118

4 Conclusion The pressing necessity of such a work appeared as soon as 1992 when, under the chairmanship of Pr David Elliott, the European Diving Technological Committee (EDTC) proposed to the European Communities to standardise practices in professional diving, including operational and medical (treatment and fitness) procedures as well as educational standards. Because of a slight number of people involved at the European scale in professional diving, a joint EDTC EU meeting was not followed by decisions. Then, the First ECHM Consensus Conference (Lille, 1994) devoted to main indications of HBO pointed out that some European countries did not have any regulation or Code of Practice in this field, and that a harmonisation process should be initiated. It is greatly to the credit of COST Action B14 "Hyperbaric Oxygen Therapy", under Pr Daniel Mathieu s chairmanship, to have made possible such a process. Its second, but not least merit is to have allowed numerous European experts to meet, work together and know each others, sometimes even weaving bonds of friendship. From a more general point of view, this work, which must be completed by July 2003 at the end of COST Action B14, focused on safety for patients, staff and environment, represents a synthesis of previous thoughts. Issued as recommendations, it may will be used as a reference by European nations for issuing or updating their own regulation or Code of Practice in Hyperbaric Medicine. References 1. COST Programme. Working Group T final report. [cited July 2002]. Available from: URL: 2. Broome J, Colvin AP, Welham JA, Watt S, Gough-Allen R, Alcock D, Lonsdale P, James P, Munro S. Health & Safety for therapeutic hyperbaric facilities: a code of practice. Welham J, editor. Norwich (UK): The British Hyperbaric Association; Sponsored by Total Control (Anglia) Ltd. 3. Gough-Allen R, Abrahams J, Allen M, Elner D, McClue G. Guide to Fire Safety Standards for Hyperbaric Treatment Centres. Ross JAS editor. Aberdeen (UK): The British Hyperbaric Association; Bryson P, Florio J, Gough-Allen R, Grogan P, Hamilton-Farrell M, Philips N, Poole D, Tarry J. The Training and Education of Hyperbaric Unit Personnel. Ross JAS editor. Aberdeen (UK): The British Hyperbaric Association; Recommendations for Safety in multiplace medical hyperbaric chambers. Mathieu D, editor. Lille: European Committee for Hyperbaric Medicine; Desola J, Wendling J. Educational and training standards for the staff of hyperbaric medical centres. Desola J editor. Barcelona: European Committee for Hyperbaric Medicine; Desola J. Safety at work in hyperbaric medicine. Prevention of accidents in hyperbaric facilities. Perspectives from Spain. Barcelona: Coordinating Committee of Hyperbaric Medical Centres; Main authors address and Jean-Louis Méliet EASSA Cellule projets 1 place Alphonse Laveran Paris Cedex 05, France jl.meliet@wanadoo.fr Jordi Desola CRIS Unidad de Terapeutica Hiperbarica Hospital Cruz Roja Dos de Mayo, Barcelona, Spain jordi.desola@acmcb.es Antonio Simao Gata Centro de Medicina Hiperbarica - Hospital da Marinha Campo de Santa Clara Lisboa, Portugal cmhiperbarica@vizzavi.pt 119

5 Roly Gough-Allen London Hyperbaric Medicine Ltd Whipps Cross University Hospital Leytonstone London E11 1NR, UK Robert Houman Centre d'oxygénothérapie hyperbare, Hôpital Militaire Reine Astrid Bruynstraat Brussels Belgium Jacek Kot Institute of Maritime and Tropical Medicine, National Center of Hyperbaric Medicine Powstania Styczniowego str 9B PL Gdynia, Poland Christian Risby Mortensen H:S Rigshospitalet Anætesi-og operationsklinikken HovedOrtoCentret Afsnit 4132 DK København Ø, Denmark crm@dadlnet.dk Peter H. J. Müller Aerztlicher Direktor des HBO-Zentrums Rhein-Neckar Diakonissenkrankenhaus Mannheim Speyerer Str D Mannheim, Germany hbo-mannheim@t-online.de Seppo Sipinen Research Institute of Military Medicine Mannerheimintie 164 PO box Helsinki, Finland seppo.sipinen@sotlaakl.inet.fi 120