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that can conduct electricity directly to the heart. A formal risk assessment by an appropriate expert should be performed, followed by suitable modification, before such equipment is used close to patients. 4.4 Non-EU equipment Equipment purchased outside the European Union may not carry CE marks. For advice concerning such equipment, see Medical Devices Regulations 2002 [5]. Use of non-CE marked medical devices may leave the clinician, and their employer, open to liability that would otherwise be assumed by the manufacturer. 4.5 Permissible devices supplied without CE marking There are three exceptions permissible for a device to be supplied without a CE mark: • Custom Made – this is a single device designed and manufactured specifically for a specific patient as prescribed by a healthcare professional. • Device undergoing clinical investigations – the device must be labelled as such and have the necessary approval (see CA. ISO 14155). • Exceptional use on humane grounds. For both Custom Made and Clinical Trial devices the manufacturer must adhere to all other requirements for compliance. 9
5. Responsibility of manufacturers and suppliers 5.1 The Consumer Protection Act, Liability for Defective Products Act, and the Medical Devices Regulations The Consumer Protection Act 1988 (CPA) in Britain, the Liability for Defective Products Act 1991 (LDPA) in Ireland, and the Medical Devices Regulations in Great Britain and Ireland which implement the EC Medical Devices Directives into law, embody the current legislation which describes the manufacturer’s responsibility with regard to equipment. 5.2 General responsibilities The CPA, LDPA and Medical Devices Regulations place absolute responsibility for the safety of products on the manufacturer. In the event of a defect causing injury, the manufacturer can be sued by any injured party, i.e. the patient or the purchaser. This is provided that the device has been used for its intended purpose, and in accordance with the manufacturer’s instructions. Negligence need not be proved and it is not possible for the seller to escape liability by exclusion clauses in the contract of sale. The manufacturer’s responsibility, as described in the CPA and LDPA, ends ten years after delivery of the equipment. After ten years, the purchaser, but not the patient, could still sue the manufacturer under the Sale of Goods Act in Britain or the Sale of Goods and Supply of Services Act in Ireland but it would probably be difficult to convince the court that the equipment was still ‘as supplied’. 5.3 Compliance with the regulations and the competent authority To place a device on the market a medical device manufacturer must be in compliance with the applicable European 10
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Recommendations for the Safe Transf
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CONTENTS Section I Summary and Reco
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SECTION II - BACKGROUND In 1996 the
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SECTION IV - ORGANISATION AND COMMU
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SECTION V - STAFFING REQUIREMENTS A
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A p p ropriate re s p i ra t o ry s
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SECTION VII - THE TRANSFER The tran
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SECTION VIII - EQUIPMENT AND DRUGS
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SECTION IX - EDUCATION AND TRAINING
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SECTION X - RESOURCE IMPLICATIONS F
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APPENDIX I INDICATIONS FOR INTUBATI
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APPENDIX III ADDITIONAL INFORMATION
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AAGBI SAFETY GUIDELINE Suspected An
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GUIDELINES Suspected Anaphylactic R
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eturn of airway reflexes with desfl
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Table 6 Dosing schedule for thrombo
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A review and meta-analysis by the S
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numbers of staff are needed to roll
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Table 7 Equipment for managing obes
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11. Schneider HJ, Glaesmer H, Klots
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44. Edholm D, Kullberg J, Haenni A,
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75. McKay RE, Malhotra A, Cakmakkay
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21 Portland Place, London, W1B 1PY
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This guideline was originally publi
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Anaesthesia 2015 Barker et al. | Gu
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Out of Hours Activity (Anaesthesia)
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Considerations for anaesthetists Th
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OAA / AAGBI Guidelines for Obstetri
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Contents 1. Key recommendations 2 2
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2. Introduction This is the third v
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Recommendations Medical staff The t
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appointed directly from other count
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Peripartum care Pre-operative asses
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Intravenous patient-controlled opio
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depression. In the absence of contr
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of clinical deterioration, as recom
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5. Training and education Each obst
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• Skills and drills training: ana
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• The midwife caring for a woman
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7. Support services, equipment, fac
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Equipment for PCA must be available
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8. The future The delivery of healt
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The following national guidelines s
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19. Obstetric Anaesthetists’ Asso
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At the first meeting held on 9 th M
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Methods to estimate/establish publi
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Recommendations The WP recommends:
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Anaesthesia, 2007, 62, pages 1199-1
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Anaesthesia, 2007, 62, pages 1199-1
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OPTION 3 - PRESUMED CONSENT. ‘Pre
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Power of Attorney) while requiring
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Needle-stick injury and HIV testing
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egain capacity, and the absence of
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treatment if it was understood that
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Management of hypertension before e
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AAGBI Safety Guideline Management o
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Malignant Hyperthermia Crisis Task
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MEMBERSHIP OF THE WORKING PARTY Dr
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Section 1 Recommendations 1. Transf
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Section 3 Introduction In 1997 it w
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This process may require many telep
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Section 6 Accompanying the patient
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Section 7 Monitoring, drugs and equ
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heavily congested areas, but not al
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APPENDIX 1 Departure checklist Do a
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13. Bercault N, Wolf M, Runge I, Fl
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21 Portland Place, London W1B 1PY T
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Membership of the Working Party Dr
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Infection control in anaesthesia An
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AAGBI SAFETY GUIDELINE Immediate Po
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Guidelines Immediate post-anaesthes
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Whitaker et al. | Guidelines: Immed
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The Royal College of Anaesthetists
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Contents ❚ Foreword 4 Introductio
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Introduction ❚ The Good Anaesthet
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Related guidelines and sources of i
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Domain A: knowledge, skills and per
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Domain B: safety and quality Attrib
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Domain C: communication, partnershi
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Domain D: maintaining trust Attribu
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Day Case and Short Stay Surgery 2 P
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GUIDELINES Day case and short stay
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Guidelines: Day case and short stay
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