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Standards and Codes

Can you provide a resource that outlines the inspection requirements for a monoplace chamber that has met the 10 year/10000 dive design life necessary for ongoing use of the chamber?
Published: 16 March 2015

Can you provide a resource that outlines the inspection requirements for a monoplace chamber that has met the 10 year/10000 dive design life necessary for ongoing use of the chamber?

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding the current ASME PVHO rules for a monoplace chamber that has met the 10 year / 10,000 cycle design life:

We advise you to purchase the most recent edition of ASME PVHO-2. If your department has a firewall we might suggest purchasing the hard copy instead of the pdf as the pdf is actually a link to the “cloud” and you may have trouble with using it with your hospitals IT security.

https://www.asme.org/products/codes-standards/pvho2-2016-safety-standard-pressure-vessels-human

As you know, the design life is 10 years.  During that time, following PVHO-2 is optional.

There is a required 10-year Maintenance Viewport Inspection that in the past we had to pull the end plates off the monoplace in order to inspect the seals and portions of the acrylic that cannot be seen under the seal. This normally meant sending the monoplace chambers back to the manufacturer or having a third party come out and do this on site.  The current edition of the code has an alternative method that can be used without dissembling the chamber.

The service life can be longer than the design life if you follow the rules of PVHO-2.

For medical systems in a protected environment that means adding 10 years, but you need to follow the rules for Operational, Maintenance and Seat & Seal inspections years 11-20. By default, the service life of monoplace chambers is currently 20 years.  A multiplace has more windows and there are destructive testing rules for those windows.

The annual or 18-month Maintenance inspections need to be completed by a qualified person.

If you have not done so already we would strongly encourage you to send someone to an acrylic maintenance course.  The owner of the vessel is responsible for training, record keeping and maintenance.

Respectfully,

The UHMS Safety Committee

 

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Is there a requirement for how much humidity is required in the room that houses monoplace chambers? I have looked at the NFPA and it addresses multiplace chambers.
Published: 06 November 2015

Is there a requirement for how much humidity is required in the room that houses monoplace chambers? I have looked at the NFPA and it addresses multiplace chambers.

Thank you for your question. The UHMS HBO2 safety committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the medical director and safety director of your facility.

There are no codes we are aware of specifically regarding humidity control in the monoplace hyperbaric suite.

There is language in NFPA 99 for the class A chamber, non-mandatory in the annex A 14.2.4.3.2 and humidification allowed 14.2.4.3.5. These do not answer your question and are specifically for the class A chamber not the room housing the chamber.

It is accepted that 50-60 percent humidity will nearly eliminate static potential. 14.3.1.5.3* Personnel states that antistatic procedures are under the safety directors responsibilities whenever atmospheres greater than 23.5 % O2 are used.  In our opinion this relates to the class A chamber not the room housing the chamber. A14.3.1.5.4.3 (3) discusses static and humidity in regards to a risk assessment for a wound dressing.

Grounding is a critical part of operating monoplace hyperbaric chambers. Ensure that the chamber and patient are grounded and document the findings.

Humidity is mentioned in an out of print UHMS guideline (pdf on the UHMS web site under Safety) and in the 2005 edition of the 101 Handbook for anesthetizing locations. Some monoplace facilities have added humidity controls to their rooms; some facilities have humidity as a function of the as built design of the HVAC system. The majority of monoplace hyperbaric suites we are aware of do not do anything in regards to controlling humidity in the room.

Respectfully,

The UHMS Safety Committee

 

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Are there current guidelines pertaining to the number of HBO2 technicians that need to be present during a hyperbaric treatment?
Published: 03 May 2016

Are there current guidelines pertaining to the number of HBO2 technicians that need to be present during a hyperbaric treatment?

Published Date:   5/2016
Review Date:       5/2019

Thank you for your question. The UHMS HBO2 safety committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the medical director and safety director of your facility.

The National Fire Protection Association (NFPA) 99 Health Care Facilities Code, 2018 edition 14.3.1.4.2 States that the medical director and safety director shall jointly develop the minimum staffing qualifications, experience, and complement based on the following.

  1. Number and type of hyperbaric chambers in use
  2. Maximum treatment capacity
  3. Type of hyperbaric therapy normally provided

The UHMS Guidelines for Hyperbaric Facility Operations, 2nd edition provides guidance in section 3, Staffing Guidelines.

The UHMS position statement: Minimum-staffing guidelines of multiplace hyperbaric facilities: Click here for paper

Posted September 2018 at https://www.uhms.org

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Can chambers be used for off-label treatment if it is not listed on the chambers 510K approval?
Published: 16 March 2016

Can chambers be used for off-label treatment if it is not listed on the chambers 510K approval?

Published Date:           03/2016
Review Date:              03/2019
Due Review:               03/2022


Thank you for your question. The UHMS HBO safety committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the medical director and safety director of your facility.

The Food and Drug Administration (FDA) does not practice medicine. The 510K premarket notification is a manufacturer’s document submitted to the FDA. A physician may use a device outside of the parameters listed on the 510K. This is a practice known as “Off-Label” use of a drug or device by a physician as their license allows. However, they cannot advertise or market the fact that they are using the drug or device for an off-label indication. The marketing restriction applies not only to the manufacturer but to the user of the device. The FDA has issued warning letters to facilities to promoting the use of a hyperbaric chamber for off-label indications. However, if a physician deems it in the best interest of the patient, he or she may use a device for something for which its approval was not given.

Physicians have a responsibility to justify any medical decision, utilizing good judgment and proper risk management. They must be able to provide this justification before their peers. For example; using a ventilator in a chamber which does not have FDA clearance is not improper, so long as it is a medical device and the physician has assessed all of the risks prior to use.

Considerations for using a “bag” chamber or any hyperbaric chamber for non-approved indications:

  • If a physician does this, his controlling body should surely sanction this?
  • If advertised as medicine, then surely there are consequences if there is no healthcare practitioner?
  • If the chamber is in a public place, surely the local fire marshal or pressure vessel inspector has some jurisdiction?
  • In the USA the National Fire Protection Association (NFPA) 101 Life Safety Code refers any occupancy to the NFPA 99 Health Care Facility Code for hyperbaric medicine.
  • The European College of Hyperbaric Medicine has stated: “If it is a non-recognized treatment, you can only do this as part of an ethically approved project and not for reimbursement.”

References:

The National Fire Protection Association, NFPA 101, Life Safety Code, 2018 edition

The National Fire Protection Association, NFPA 99, Health Care Facilities Code, 2018 edition

510(K) Definition: A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval. Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm


DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

I am unable to find documentation regarding specifications for the required smoke hood for multiplace chambers. The ones we have on hand are about to reach their expiration date & that particular brand does not seem to be available at this time. There is
Published: 18 May 2016

I am unable to find documentation regarding specifications for the required smoke hood for multiplace chambers. The ones we have on hand are about to reach their expiration date & that particular brand does not seem to be available at this time. There is

Published Date:   5/2016
Review Date:       5/2019
Due Review:        5/2022


The National Fire Protection Association, NFPA 99 Health Care Facilities Code, 2018 edition, chapter 14: 14.2.4.5.3* states, “A means for respiratory and eye protection from combustion products allowing unrestricted mobility shall be available outside a Class A or Class B chamber for use by personnel in the event the air in the vicinity of the chamber is fouled by smoke or other combustion products.”

This requirement may be met by several different devices; these range from umbilical-supplied smoke hoods and self-contained breathing apparatus, to the emergency escape hoods. Whichever device you choose, you must also meet any OSHA and local authority requirements for training, maintenance, documentation and medical fitness to wear the device.

NFPA does not specify the type of device only that you have one.

We suggest that the selection of the device depends on the type of chamber and patients treated at your facility, together with the degree of emergency support to the unit, the distance to the nearest area of safety and the number of patients that need to be evacuated. These factors have a bearing on the length of time that the operator needs to be able to remain in a smoke-filled area. Emergency drills with the various devices should be carried out to evaluate how they will work in your environment. Work with the manufacturer of your facility and engage the industrial hygienist in your hospital. Document your decision process, maintenance and training. The

UHMS accreditation survey probes HBOV 2.0, 2.1, 2.2, 2.3, 2.4 and 2.5 addresses this question as well. The survey does not specify the type of alternative breathing air apparatus.

For references see:

Rubicon, http://rubicon-foundation.org/ (http://rubicon-foundation.org/)

  • NFPA Mandated SCBA Type Capability Within Clinical Hyperbaric Facility: An Analysis of the Types and Frequency of use, Canterbury B; Baker B
  • Chamber Fire Safety, Schmidt, TC; Dorr VA; Hamilton JR RW
  • Selecting Smoke Hoods for Hyperbaric Facilities, Wood S
  • NFPA 99, 2015 edition, chapter 14 Hyperbaric Facilities
  • UHMS Clinical Hyperbaric Facility Accreditation Manual (Rev1)
  • NIOSH, “NIOSH RESPIRATOR SELECTION LOGIC,”
  • OSHA Regulations standard 29 CFR personal protective equipment 1910.134 respiratory protection

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet. If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility. Information provided on this forum is for general educational purposes only. It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

NFPA99 14.2.9.1.1 states all communication equipment inside a hyperbaric chamber shall meet the requirements set forth in 14.2.8.3.16 This states that the electrical "rating" of chamber speakers shall not exceed 28V rms and 25W. are we to assume that a higher rated speaker can be used inside the class B chamber? Just looking for little more clarification on this statement.
Published: 06 August 2016

NFPA99 14.2.9.1.1 states all communication equipment inside a hyperbaric chamber shall meet the requirements set forth in 14.2.8.3.16 This states that the electrical "rating" of chamber speakers shall not exceed 28V rms and 25W. are we to assume that a higher rated speaker can be used inside the class B chamber? Just looking for little more clarification on this statement.

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: NFPA 99 14.2.9.1.1

The UHMS SC is not able to provide a formal interpretation of NFPA code. Jonathan Hart NFPA Staff Liaison, gave an informal response to this question in the NFPA XChange, members only section of the NFPA website. Mr. Hart has given us permission to duplicate his reply and disclaimer (below). In addition to Mr. Hart’s reply, the UHMS SC response can be found below.

Response from Jonathan Hart (NFPA):

“The answer from the language in the code is clear that there is no leeway provided. It applies to the maximum rating of the speaker and therefore any speaker with a rating higher would not be in compliance. An alternative approach could be argued under the Equivalency clause of Chapter 1 provided it were acceptable to the AHJ involved in the decision. My discussions with committee members on this topic indicate that there needs to be a bigger discussion within the committee next code cycle to determine the purpose of this clause and clarify if it is truly the rating we are worried about or the output of a system to the speaker itself. Because it is not clear as of now, the code has to stand on its own as written.

Important Notice: Any opinion expressed in this correspondence is the personal opinion of the author and does not necessarily represent the official position of the NFPA or its Technical Committees. In addition, this correspondence is neither intended, nor should it be relied upon, to provide professional consultation or services.”

Response from UHMS SC:

Throughout the Hyperbaric Facilities chapter of NFPA 99 (2015 edition), one consistent protection strategy is to limit power levels in Class B (monoplace) chambers more so than in Class A chambers. To this end, communication systems for Class A and Class B chambers are addressed differently in different sections of the code. Section 14.2.8.3* Wiring and Equipment Inside Class A chambers, and all the subsections of 14.2.8.3 were intended for multiplace chambers. Section 14.2.8.6 Additional Wiring and Equipment Requirements inside Class B chambers, was intended for monoplace chambers.

The wording of paragraph 14.2.9.1.1 implies that all communications equipment located inside a chamber (monoplace or multiplace) should comply with the requirements of the section intended for multiplace chambers. Because of the difference in power limits, it would be inappropriate for monoplace chambers to use electrical design rules from a section intended for multiplace chambers. A Tentative Interim Amendment (TIA) to NFPA 99 has been proposed to alter the wording of paragraph 14.2.9.1.1 in order to avoid future confusion about this issue.

We would encourage you to get involved with the NFPA code process. The 2018 edition of NFPA 99 is in its second draft and there is no mechanism to add new business at this point. If you have specific changes you would like to see, please consider making a public input for the 2021 edition of NFPA 99 when that cycle is open.

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Are HBO centers required to have EKG/ECG monitoring equipment readily available?
Published: 03 May 2016

Are HBO centers required to have EKG/ECG monitoring equipment readily available?

Published Date:   5/2016
Review Date:       5/2019

Thank you for your question. The UHMS HBO2 safety committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the medical director and safety director of your facility.

This depends on the acuity of the patients you are treating and the qualifications of the medical staff: this should be congruous with your stated scope of services. We are not allowed to lower the level of care.  For facilities in a Health Care that would mean, yes, you would need to be able to monitor EKG/ECG as there will most likely be inpatients or emergencies where monitoring would already be in place and to discontinue it would be incorrect.

For a facility with outpatients only, this might mean that you would not be required to monitor patients with EKG/ECG during hyperbaric oxygen therapy. We would caution you to be aware of the patient population you serve and especially the stated scope of such services.

If you do monitor this also implies that you have qualified personnel available that can interpret what they are seeing on the monitor and provide ACLS / BLS support as necessary. It also stands to reason that any equipment used to monitor patients must be integrated safely into the chamber system.

For reference please see:

NFPA 101, 2018 edition, Chapter 3 Definitions, 3.3.196.7* Health Care Occupancies, https://www.nfpa.org accessed 6-4-2019

UHM 2016, Vol.43, No1 – Hyperbaric programs across the United States. Walter Chin, Laura Jacoby, Olivia Simon, Nisha Talati, Gracelene Wegrzyn, Rachelle Jacoby, Jacob Proano, Susan E. Sprau, Gerald Markovitz, Rita Hsu, Ellie Joo

DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

What is the evidence for limiting linens in a monoplace chamber to a minimum of 50% cotton/polyester blend? I understand the fire risks of synthetic fibers, but why is the cutoff 50%?
Published: 24 November 2016

What is the evidence for limiting linens in a monoplace chamber to a minimum of 50% cotton/polyester blend? I understand the fire risks of synthetic fibers, but why is the cutoff 50%?

Published Date:      11/2016
Review Date:         11/2019


Thank you for your question. The UHMS HBO2 safety committee can provide information to assist you in answering your question, but the ultimate responsibility for these types of questions rests with the medical director and safety director of your facility.

The SC recommends submission of the question to the National Fire Protection Association, NFPA, 99 Health Care Facilities Code (http://www.nfpa.org). The NFPA has a process for the formal interpretation of these types of questions. There are several members of the SC that are also committee members of NFPA 99. Therefore, we need to add the disclaimer that this is our opinion and not a formal interpretation of the NFPA code. Please see an excerpt below copied from the 2018 NFPA 99, Health Care Facilities Handbook:

14.3.1.6.4.1 Except where permitted in 14.3.1.6.4.3, silk, wool, or synthetic textile materials, or any combination thereof, shall be prohibited in Class A or Class B chambers.

14.3.1.6.4.2 Garments permitted inside of chambers shall be as follows:

(1) Garments fabricated of 100 percent cotton or a blend of cotton and polyester fabric shall be permitted in Class A chambers.
(2) Garments fabricated of 100 percent cotton, or a blend of cotton and polyester fabric containing no more than 50 percent polyester, shall be permitted in Class B chambers.

Why is this important?

The intent of this paragraph is to make common textiles an option in hyperbaric chambers.  The amount of polyester is limited in Class B chambers to reduce the amount of static electricity.  In general, cotton generates less static charge than synthetic material.  However, pure cotton tends to produce lint, and accumulated lint or dust in a hyperbaric chamber is an easily ignitable fuel. Selection of textiles for the hyperbaric chamber should be based on a variety of factors, including comfort, lint production, ignition temperature, static-producing properties, and fuel load of the material.  The percentage of polyester in a cotton/polyester blend can have an effect on all of these factors.

Since the 2015 edition of the NFPA 99 code, a differentiation was made between the garments permitted inside of Class A and those permitted in Class B chambers.  There is a maximum limit on the percentage of polyester permitted in blends that are allowed in Class B chambers.  This is based on the different risks for each type of chamber.  Class A chambers typically maintain an oxygen concentration below 23.5 percent and have fire suppression capability; the opposite can be said for Class B chambers.

A.14.3.1.6.4.2 Selection of textiles for the hyperbaric chamber should be based on a variety of factors, including comfort, lint production, ignition temperature, static-producing properties, and fuel load of the material.  The amount of polyester in a cotton/polyester blend will likely have an effect on all of the factors.

Historically, all synthetic fabrics were prohibited from the chamber.  Previous editions of this code allowed an “antistatic blend of cotton and polyester” because of one specific fabric – a blend of cotton and polyester with steel fibers to make it conductive.  This blended fabric was intended for surgical scrubs, but its conductive properties made it a good choice for hyperbaric garments.  The polyester in the fabric was acceptable because the conductive properties of the fabric actually afforded some protection from static production that cotton fabric did not.  This particular fabric is no longer made.  Selection of textiles has always been about balancing various safety concerns; primarily fire-resistance and static production.  For further guidance on selecting appropriate textiles, see A.14.3.6.4.3.

14.3.5.6  All other fabrics used in the chamber, such as sheets, pillow cases, and blankets, shall conform to 14.3.1.6.4.1 and 14.3.1.6.4.2”

Respectfully,

The UHMS Safety Committee


DISCLAIMER

Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Is there any regulations concerning the entry door(s) to a chamber room being secured with a punch code system?
Published: 08 February 2017

Is there any regulations concerning the entry door(s) to a chamber room being secured with a punch code system?

I work in a clinic setting with wound care on one side of the building and I am alone on my side with HBO2. My boss would like to put a push button code lock on my door and I'm wondering if this is permitted? If there was a fire I'm concerned about the Fire Department not being able to get in. Does anyone have a similar issue? Is it ok to have this type of device on the HBO2 room door? We need some type of Safety policy and procedure for an active gunman in the building and I’m not sure how to go about this.


Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Security is a real concern and we agree that Hyperbaric Facilities need to develop Policy and Procedures to manage active shooter / Code Silver, Bomb threats and other security concerns. We are required by NFPA 99, chapter 14, to have emergency drills on a regular basis. These threats should be added to your emergency response plans.

The SC would refer you to your local Authority Having Jurisdiction (AHJ). There are codes and regulations regarding locked doors. For guidance you can start with NFPA 101 Life Safety Code, 2012 edition, 7.2.1.5 Locks, Latches and Alarm Devices and NFPA 99, 2012 edition, Chapter 13, Security Management. Work with your local AHJ and Safety and Security department, possibly Emergency Management, to complete a threat assessment. These resources will help decide if a key pad is necessary.

In general we see no issue with a cipher lock on the entrance to the hyperbaric suite. In fact, we are aware of many facilities with ID badge, card access, push button locks and even keyed doors entering the room housing the chamber(s). The Fire Department will be able to gain access in the event of an emergency. Consideration should be given to enabling not only the Fire Department, but other responders such as code teams or security. The chamber room can be considered a restricted area, with authorized entry only. The concern is that evacuation in the event of an emergency is not hindered. There must always be an exit path, and the lock mechanism must not impede egress (or ingress of authorized personnel).

We also note that a chamber operator working alone is concerning. NFPA 99, 2015 edition, chapter 14 requires that there be a qualified chamber operator at the control panel with visual and audible communication with the occupants any time the chamber is in use. We would encourage the use of the UHMS Guidelines for Hyperbaric Facility Operations, 2nd edition, Section 3, Staffing Guidelines, to staff the chamber operation. Consider how to insure the safety and security of the single operator and any patients being treated, as described in this question. Is there a communications link for immediate help? Consider a panic button or regular rounding (closed circuit video feed?) by someone to check on the chamber operator and patients to provide support as needed. During your emergency drills, do you have the help you need to manage the number of patients?

 
DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

Is it allowable to use a "clean agent" extingishing system in place of sprinklers in a center with monoplave chambers. I cannot find anything in the NFPA99 book regarding clean agent systems.
Published: 02 May 2017

Is it allowable to use a "clean agent" extingishing system in place of sprinklers in a center with monoplave chambers. I cannot find anything in the NFPA99 book regarding clean agent systems.

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: The use of a Clean Agent extinguishing system in the room housing monoplace chambers

Current code language allows a water mist protection system. Currently a Clean Agent extinguishing system would not be allowed. (see 14.2.1.2 below).

The 2015 edition of the code14.2.1.2* A hydraulically calculated automatic wet pipe sprinkler system meeting the requirements of NFPA 13, Standard for the Installation of Sprinkler Systems, or an automatic water mist fire protection system installed in accordance with NFPA 750, Standard on Water Mist Fire Protection Systems, shall be installed in the room housing a class A, Class B or Class C chamber and in any ancillary equipment rooms.

The local AHJ could sign off on a Clean Agent System under NFPA 99, 2015, 1.4 Equivalency.

Some Clean Agents are not benign and others may be deemed acceptable. In any case life safety of the hyperbaric staff and patients must be considered.

The Vinegar, et al. PBPK data for HFC-227ea (FM-200) is shown in Figures 6-8A and 6-8B.

UPDATE (3/01/2018): According to the 2018 edition of the code, a clean agent fire protection system in accordance with NFPA 2001 is permissible in the room housing Class A, Class B, or Class C chambers.

Graphical PBPK Data for FM 200Figure 6-8A. Graphical PBPK Data for FM-200

Is there any regulation covering safety issues associated with interrupting or distracting the HBO2 Tech during an initial treatment, thus placing the patient at risk d/t the potential break in observation? As clinical coordinator I have argued that during treatments, the HBO2 room (we have one monoplace chamber) be regarded as off limits for ordinary business that can wait, and in the instance of initial treatments, off limits to all but the supervising HBO2 physician.
Published: 04 June 2018

Is there any regulation covering safety issues associated with interrupting or distracting the HBO2 Tech during an initial treatment, thus placing the patient at risk d/t the potential break in observation? As clinical coordinator I have argued that during treatments, the HBO2 room (we have one monoplace chamber) be regarded as off limits for ordinary business that can wait, and in the instance of initial treatments, off limits to all but the supervising HBO2 physician.

SC Regulations covering safety issues concerned with distracting the chamber operator.

The SC is not aware of a specific regulation regarding the disruption of the chamber operator during an initial treatment.

NFPA 99, 2018 chapter 14, has several requirements that are related to this question:

14.3.1.1.4.6 Requires that the chamber operator must be physically present and maintain visible and audible contact with the patient and / or chamber console during manned operations.

14.2.1.1.7 Requires that when used for hyperbaric operations the room or rooms housing the chambers shall be for the exclusive use of the hyperbaric operation.

The intent is to insure that the chamber operator is present and that there are only HBO2 related activities going on in the room housing the chamber during manned operations.

The UHMS facility Accreditation surveyors will also look for the chamber operator present during manned operations as per NFPA 99.

The FAA does have a requirement for pilots, that points to the concern of distractions during critical procedures:

https://urldefense.proofpoint.com/v2/url?u=https-3A__en.wikipedia.org_wiki_Sterile-5FCockpit-5FRule&d=DwIFAw&c=II16XUCNF0uj2WHDMBdftpHZzyfqZU4E6o4J8m7Yfh-XF5deecOtjPXuMFvj1uWy&r=3v01jMk9_EMv8N-Id5zKywNsK5JVIlG--RKOIWA2SN8&m=-tRtvBb9q_OgzvuCkjp2vyy4gTO0yj4EgUeIMNgmw84&s=fhm8BYQka3a8cLEPQ9dkBaPndRSrpMz0CP5hIV-sEqI&e

Distracted driving is a major concern for all of us on the roads.

The initial treatment for a patient can be a critical event, where any difficulty pressurizing or anxiety with the new experience may impact their willingness to continue therapy. These things including other emergencies, can occur at any time, and not just the initial treatment. We recognize the concern with distracted chamber operator being a potential safety hazard.  This is a risk that is managed on the local level. We also recognize that there can be HBO2 related activities occurring in the chamber area. We encourage you to work with your medical director, administration and the hyperbaric safety director to create a procedure that answers your concerns in your specific conditions.

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members can provide medical diagnoses or recommendations for equipment over the internet.  The responsibility for medical diagnoses and treatments resides with the medical director; approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.

Is equipment with a brush motor prohibited in a mutiplace environment? When searching the NFPA 99, 2018 version I could not find anything specific about a brush motor in the hyperbaric environment.
Published: 11 June 2018

Is equipment with a brush motor prohibited in a mutiplace environment? When searching the NFPA 99, 2018 version I could not find anything specific about a brush motor in the hyperbaric environment.

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information, guidance and an opinion; however, the ultimate responsibility for these types of questions lies with the medical director and safety director of your facility.

SC Reply: Regarding brushed motors in the multiplace environment.

Brushless DC motors do not spark as they do not have brushes (satisfies the intention of NFPA 99, 2018, 14.2.9.3.11 & 14.2.9.3.13). For this reason, they are considered to be safer, especially where contained in a pressure-proof housing, or purged so as not to allow oxygen-enriched air to enter. These are user-specific decisions, based on risk assessment & mitigation. In short, we see brushless DC motors in purged housings being used.

The SC is not aware of specific wording in regulation to this effect as it could lead to misunderstandings as to what is safe. It is only safe if the risk is identified & understood, and mitigated.

The requirement for motors is stated in NFPA 99 as follows:

14.2.9.3.13 Exposed Live Electrical Parts.

No exposed live electrical parts shall be permitted, except as specified in 14.2.9.3.13.1 and 14.2.9.3.13.2.

14.2.9.3.13.1 Exposed live electrical parts that are intrinsically safe shall be permitted.

14.2.9.3.13.2 Exposed live electrical parts that constitute patient monitoring leads, which are part of electromedical equipment, shall be permitted, provided that they

meet the requirements of 14.2.9.3.17.

14.2.9.3.14* Motors.

Motors located in the chamber and that are not a component of medical equipment shall meet one of the following requirements:

(1) They shall comply with 501.125(A)(1) of NFPA 70.

(2) They shall be totally enclosed in accordance with 501.125(A)(2) or 501.125(A)(3) of NFPA 70.

and

14.2.9.3.17 Portable Patient Care–Related Electrical Appliances.

14.2.9.3.17.1 The appliance shall be designed, constructed, inspected, and maintained in accordance with Chapter 10.

Referring to the NEC (NFPA 70), 2014 (draft version):

501.125 Motors and Generators.

(A) Class I, Division 1. In Class I, Division 1 locations, motors, generators, and other rotating electrical machinery shall be one of the following:

(1) Identified for Class I, Division 1 locations

(2) Of the totally enclosed type supplied with positive pressure ventilation from a source of clean air with discharge to a safe area, so arranged to prevent energizing of the machine until ventilation has been established and the enclosure has been purged with at least 10 volumes of air, and also arranged to automatically de-energize the equipment when the air supply fails

(3) Of the totally enclosed inert gas-filled type supplied with a suitable reliable source of inert gas for pressurizing the enclosure, with devices provided to ensure a positive pressure in the enclosure and arranged to automatically de-energize the equipment when the gas supply fails.

One can also refer to the NFPA 99, 2018 section on switches (which is what the brushes in a DC electric motor do):

14.2.9.3.11 Switches.

Switches in the fixed wiring installation shall be waterproof.

14.2.9.3.11.1* Switch make and break contacts shall be housed in the electrical enclosure so that no sparks from arcing contacts can reach the chamber environment.

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members can provide medical diagnoses or recommendations for equipment over the internet.  The responsibility for medical diagnoses and treatments resides with the medical director; approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.

Our hyperbaric unit is a HOPD, are we required to have a carbon monoxide (CO) detector?
Published: 27 March 2018

Our hyperbaric unit is a HOPD, are we required to have a carbon monoxide (CO) detector?

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: CO Monitor required in the hyperbaric suite.

The CMS has adopted the 2012 Edition of NFPA 101, Life Safety Code and NFPA 99, Health Care Facilities Code, therefore the Joint Commission and others are also referencing those documents during surveys. We do not know the occupancy classification of your building, it may well be that a carbon monoxide monitor is required.

The 2012 edition of NFPA 101 9.8 Carbon Monoxide (CO) Detection and Warning Equipment states that; “Where required by another section of this Code, carbon monoxide (CO) detection and warning equipment shall be provided in accordance with NFPA 720, Standard for the Installation of Carbon Monoxide (CO) Detection and warning Equipment”  

We would encourage you to work with your safety personnel, industrial hygienist and follow the guidance of the surveyor. CO monitors are not expensive and are valuable tools for the safety of your staff and patients.

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

I have a question for you. I thought I had the answer to this from when I worked in a mono place setting but the question has come up again. As long as there is a CHT present in the clinic, can a non CHT operate a multi place panel for a treatment?
Published: 19 July 2018

I have a question for you. I thought I had the answer to this from when I worked in a mono place setting but the question has come up again. As long as there is a CHT present in the clinic, can a non CHT operate a multi place panel for a treatment?

Thank you for your question. The UHMS hyperbaric oxygen safety committee (SC) can provide information but the ultimate responsibility for these types of questions is with the medical director and safety director of your facility.

Regarding: A chamber operator qualifications.

Thank you for your question. There a several answers to this question and the comments below would apply to both class A and class B chambers. The responsibility of staffing complement falls to the Medical Director and the Safety Director, depending on staff qualifications / experience, type(s) and number of chambers, number and acuity of patients, location of the chamber(s) (hospital or freestanding clinic?) and number of patients treatments occurring simultaneously.    

NFPA 99 Health Care Facilities Code, 2018 edition, 14.3.1.4.6 requires that during chamber operations , with occupant(s) in the chamber, the operator be physically present and maintain visible and audible contact with the control panel and chamber occupants. It is important that a qualified chamber operator be present during chamber operations. Please reference the Annex note under A 14.3.1.3.2.

The definition of “Qualified Person” is important to this topic. For this reply, the definition is taken from the NFPA 99, 2018 edition, 3.3.151, “Qualified Person. A person who, by possession of a recognized degree, certificate, professional standing, or skill, and who by knowledge, training, and experience, has demonstrated the ability to do the work.” 

There are other standards and regulations in place outside of the USA. In the USA, we are aware of at least one state, (Ohio) that requires the chamber operator to be a CHT.

If you are preparing for a UHMS Hyperbaric Facility Accreditation survey, there are line items you will need to address. These include,  accreditation concentration areas, Hyperbaric Operations, HBOO1.4 “During manned operations, the hyperbaric chamber operator is physically present and maintains visual or audible contact with hyperbaric chamber control console at all times.”, and Hyperbaric Human Resources, HBOHR 2.2 “At least one Clinical Hyperbaric Registered Nurse (CHRN) or Certified Hyperbaric Technologist (CHT) is on duty in the clinical area at all times when a patient is receiving hyperbaric treatment”, HBOHR 2.3 “A minimum of one hyperbaric technician or trained hyperbaric staff member is on duty in the hyperbaric facility when non-treatment hyperbaric chamber operations are ongoing.”

The UHMS Guidelines for Hyperbaric Facility Operations, 2nd edition also lists requirements for staffing class A and class B hyperbaric chambers.

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.

We have 2 monoplace chambers and are looking to upgrade our treatment area. What type of flooring is acceptable?
Published: 24 June 2018

We have 2 monoplace chambers and are looking to upgrade our treatment area. What type of flooring is acceptable?

The UHMS safety committee is not in a position to make recommendations on flooring material in a hyperbaric chamber room. We can provide some guidance that may help you in your decision process.

  • We suggest you contact your chamber manufacturer and review their recommendations or requirements for additional guidance.
  • The National Fire Protection Association (NFPA) 99 Health Care Facilities, 2018 edition, chapter 14 Hyperbaric Facilities, does not specify the type of material for the flooring of a monoplace room, only that the floor be able to carry the weight.
  • NFPA 101, Life Safety Code 2018 edition requires that all hyperbaric facilities regardless of the occupancy be treated as a health care facility. NFPA 101 Interior floor finish shall comply with 101, 10.2. You will need to make certain that the tiles you choose meet 101 and your local authority having jurisdiction (AHJ) approval.
  • We are aware of facilities that use conductive tiles or conductive wax finish.
  • We are aware of facilities that have chosen to use nonconductive tiles and apply a standard wax to protect the flooring.
  • We are aware of several facilities that use VCT or seamless sheet vinyl flooring.
  • The user should verify that the selected flooring has an indentation rating capable of handling the weight of the chamber and the patient.

DISCLAIMER
Neither the Undersea and Hyperbaric Medical Society (UHMS) staff nor its members are able to provide medical diagnosis or recommend equipment over the internet.  If you have medical concerns about hyperbaric medicine you need to be evaluated by a doctor licensed to practice medicine in your locale, which can provide you professional recommendations for hyperbaric medicine based upon your condition. The responsibility of approving the use of equipment resides with the physician and safety director of the facility.  Information provided on this forum is for general educational purposes only.  It is not intended to replace the advice of your own health care practitioner and you should not rely upon it as though it were specific medical advice given to you personally.