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Safety Program Guidelines

Safety Program Guidelines

Safety Program Guidelines

GUIDELINES

The following guidelines are in place to promote high standards of patient care and operational safety within the hyperbaric program. 

  1. All hyperbaric chambers installed for clinical hyperbaric medicine applications must be in compliance with Food and Drug Administration (FDA) requirements as stipulated in the Safe Medical Devices Act of 1976. Specifically, each hyperbaric chamber used in support of clinical hyperbaric medicine must be cleared for interstate commerce through the 510(k) Pre-market Notification Process.
  2. All hyperbaric chambers and related support systems used to support clinical hyperbaric medicine must be designed, fabricated, and installed in accordance with the requirements of ANSI/ASME-PVHO-l, Safety Standard for Pressure Vessels for Human Occupancy. [1] 
  3. All hyperbaric chambers and related support systems must be installed and operated in accordance with the
    fire safety requirements of the National Fire Protection Association's NFPA 99, Health Care Facilities,
    Chapter 14: Hyperbaric Facilities and cited references.  [1]
  4. As required in NFPA 99, Chapter 14, each clinical hyperbaric facility must designate a Safety Director. [1]
  5. The job knowledge and experience requirements should comply with the guidelines set forth in the staffing and training recommendations as stated in this document.
  6. In accordance with the requirements set forth in NFPA 99, Chapter 14, the Safety Director will work with the governing body of the parent organization and the Hyperbaric Medical Director to develop a comprehensive safety program for all permanent and part-time department personnel. Other guides to assist in the development of this program are:
    1. NFPA 99, Health Care Facilities, Chapter 14   [1] and other NFPA standards
    2. ANSI/ASME-PVHO-l, Safety Standard for Pressure Vessels for Human Occupancy
    3. ASTM (American Society for Testing and Materials) publications.
    4. CGA (Compressed Gas Association) publications.
    5. UHMS publications:
      1. Monoplace Hyperbaric Chamber Safety Guidelines [2] 
    6. International hyperbaric safety standards such as:
      1. British Hyperbaric Association safety guidelines
      2. Australian hyperbaric safety guidelines
      3. European Committee for Hyperbaric Medicine safety guidelines
  7. At minimum, the Safety Program must include the following elements:
    1. Documented safety procedures, which must address:
      1. General facility safety
      2. Specific chamber related operational safety procedures such as fire in the chamber, patient evacuation, contaminated air, equipment failure
      3. How to deal with physiological reactions such as ear pain, sinus pain, oxygen toxicity reactions, claustrophobia.
    2. Documented recurring in-service training for all hyperbaric facility staff on selected safety topics. Training sessions shall consist of fire drills, mock patient emergencies, simulated equipment failure, contaminated air, updates on codes and standards, etc.
    3. Documented preventive maintenance program executed either by local technical personnel or by a third-party maintenance contractor.
    4. Documented major maintenance program for specific hyperbaric facility components such as compressors, control components, fire suppression system components, etc. (as appropriate).
  8. All full- and part-time hyperbaric facility personnel must be aware of the potential hazards associated with the operation of clinical hyperbaric chambers and their related support systems.
  9. Hyperbaric facility safety is the responsibility of everyone directly or indirectly involved in the clinical hyperbaric medicine program.
  10. All technical personnel must pursue continuing education credits in various aspects of hyperbaric facility safety. Refer to UHMS approved hyperbaric facility safety director training.
  1. Development of periodic, third party review of the hyperbaric facility safety program by agencies such as The Joint Commission, the National Board of Pressure Vessel Inspectors, the AMSE, or the UHMS is encouraged.

Review / Revision of Policy

This policy shall be reviewed and, if necessary, revised at least every

year.


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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

REFERENCES

  1. . Technical Committee on Hyperbaric and Hypobaric Facilities (HEA-HYP) 2012. 14. Hyperbaric Facilities. In: (NFPA) National Fire Protection Association ed. Nfpa 99: Health Care Facilities Code Handbook. 2012th ed. Quincy, MA: NFPA, pp. 111–119. .;.
  2. Workman, WT et al. Hyperbaric Facility Safety: A Practical Guide . Date of publication 2017;.
Topic 47 Version 1.0