The Associate Townhall concept was introduced to provide a venue for topics related to Hyperbaric Medicine, but may not meet the threshold for continuing education units.  The associate council wanted to offer topics to the Associate membership that expanded their overall knowledge in the Diving and Hyperbaric Medicine world.

The Townhall meeting for November 2023 was an interesting case study in which hyperbaric treatments were used to enhance the healing involved, even though the primary reason for the success was the skill and talent of the surgeons involved.

Lily Daniali, MD, FACS, a multiple board-certified plastic surgeon at Swedish Medical Center in Englewood, Colorado, made the presentation. In addition to her practice in plastic surgery, she was also the Medical Director of the Center for Wound Healing, with certification in hyperbaric medicine. Swedish Medical Center is a Level One Trauma Center, an ABA-accredited burn center, and a UHMS-accredited Hyperbaric Medicine facility.

This case involves a degloving injury of the face in a 57-year-old man who had an unfortunate encounter with a mama bear. The incident resulted in multiple traumas, including a degloving injury to his mid-face, which was a total detachment of his nose and surrounding tissue. After the attack, the avulsed facial tissue was lying on the ground next to the victim, and he had the presence of mind to place that tissue in his pocket. He was intubated on-site in Wyoming for transport to Swedish, where he was immediately assessed and stabilized by the trauma team.

Over the next three years, he underwent multiple surgeries. Although indicated, he was not treated in hyperbaric due to his critical care status during this initial treatment regime. Although the entire case was interesting, one of the fascinating aspects was “parking” the intact nose and surrounding tissue on the patient’s forearm to provide circulation to preserve the tissue. At the same time, they prepare the site for reimplantation.

You can view the photos of the injury and the various steps taken to reach the end result, including preserving the patient's function and appearance/identity. This written description does not do justice to the skill of the surgeons treating a trauma of this complexity.

UHMS members can access this recording and other town hall presentations at the following link -  

Associates Town Hall Meetings - Undersea & Hyperbaric Medical Society (uhms.org)

As I write this message, we have just concluded the UHMS Physician’s Training in Diving Medicine Course (PTDM)2023. We had a great turnout with 44 physicians in attendance, including the HBO fellows and several Wilderness Medicine Fellows. The class was very engaged, asked great questions, and was more than willing to get involved in the hands-on teaching. In addition to exceptional lectures by some of the world experts, we had several days of practical experience, which included: Myringotomy Lab using 3D printed ear models (thank you, Dr. Charles Coffey, Head and Neck surgeon), Hyperbaric Simulation Day (thank you, Adrian Garay for the use of your facility and chambers), Pool Day (thank you, Dr. Richard Sadler for arranging all the diving gear and instructors), Surface Supplied Diving Day with Emergency Procedures(thank you, US Navy SWRMC Command for providing this training and allowing the students to turn valves and operate your chamber).  This is the fourth year we have run this course, and I am always so impressed by the engagement of the students and the talent of the instructors. Next year, the course will run from October 14-24, 2024.

Other great educational opportunities offered through the UHMS include:

• Medical Examination of Divers Course: offered every year in September in New Orleans.
• PATH Course: modules are offered online, and the next hands-on simulation day is April 5, 2024, in Hawaii.
• Gulf Coast Chapter Meeting: March 9, 2024 topic: Wound Care
• Mid-West Chapter Meeting: May 4,2024 topic: Diving Medicine
• Pacific Coast Chapter Meeting: August 10, 2024 topic: Clinical HBO
• Northeast Chapter Meeting:October 12, 2024 topic: Hyperbaric Safety

I encourage all of you to take advantage of the myriad educational opportunities that our society offers.

Mark your calendars for the UHMS Annual Scientific Meeting 2024, June 12-15, in New Orleans.

As we prepare to close the books on another year and usher in a new one, focus on our mission remains the priority.

We are facing significant challenges shaping our specialty. Challenges like the erosion of the practice of medicine, the decline in 24/7 urgent and emergent programs, the dismissive nature of some healthcare executives of the value clinical hyperbaric medicine brings to their patients and communities, and the yo-yo-ing of CMS policy and payment are top of mind.    

Of those challenges, the latter one has us on edge. The UHMS QUAR Committee posted a message last week about an unexpected cut in the HOPD G0277 rate.

“The UHMS has become aware of a payment change published in the OPPS (Outpatient Prospective Payment) Final Rule for 2024. G0277, predicted to be about $134/30 minutes, was valued at $73.64 (national unadjusted reimbursement rate). There is a comment period for errors in the published document. Because there was no mention of hyperbaric oxygen in the Proposed Rule in July, there should not have been any substantive change in the Final Rule."

We believe this precipitous drop is a mistake on CMS’s part. However, our response options are limited because this rate is published in the Final Rule. So, the immediate goals are to get CMS’s attention about the significant reduction and, following, present data showing why the 2024 rate is an error. 

We will achieve these goals by working alongside our Corporate Partners and the Alliance of Wound Care Stakeholders. 

The other challenges I mentioned deserve the same intense attention from the field’s stakeholders as we’re devoting to the current payment issue. If we can do this, we will move the needle and control our destiny rather than be subjected to someone else’s.

On a far happier note, UHMS continues to expand its relationship with the Aerospace Medical Association (AsMA). After a successful joint meeting in Reno in 2022 and thoughtful consideration after reviewing the attendees’ feedback, both Governance teams agreed to hold joint Annual Scientific Meetings beginning in Atlanta in 2025 through 2030 in Houston, TX, when AsMA will celebrate its 100^th anniversary.   

This strategic alliance will benefit UHMS attendees in three ways. One, meeting costs, including hotel, will be lower as all rooms are negotiated at Government per diem rates; two, UHMS attendees will benefit from meeting locations we’ve typically been priced out of; and last, access to expanded relevant educational content.

This change will make our meeting next year in New Orleans much more memorable, especially with the smaller, more intimate venue at the Astor Crowne. Please join us and register early to reserve your room.

As I mentioned in my last note, next year’s election cycle has numerous officer and director positions coming open, including the President-Elect, Vice President, Treasurer, 2 Members-at-Large (MAL), including our MAL military active-duty, and Associate Nurse Representative-elect. Look for the call for nominations in mid-December.

UHMS Finances

Despite the challenges, UHMS continues to perform well financially; through October, UHMS’s financial position was positive.

Our balance sheet remains healthy, with operating, savings, and investment accounts continuing to hover at near-all-time highs.

Certification Matters

We continue to receive questions about technician and nursing certification. The UHMS’s position is unchanged in that we believe that all team members involved in providing care to patients in hyperbaric medicine should be certified, and our position statement - The Importance & Recognition of Hyperbaric Certification for Technicians & Nurses can be found here - UHMS POSITION STATEMENT.

Congratulations to the Q4 Associate Scholarship Award winners, Sarah Juba and Steph Simmons.  They each are awarded tuition-free attendance to a UHMS-approved Introductory Course in Hyperbaric Medicine. Of course, this program is required to sit for UHMS-recognized hyperbaric certification exams.  

Member Benefits

As a reminder, UHMS members receive three free CE/CME credits upon joining or renewing. This benefit represents an immediate $40 savings for Associate members and $60 for Regular members annually. 

Associate Member Town Hall

Members are invited to attend the UHMS Associate Council town hall meeting on the second Thursday of every quarter, where invited speakers present on relevant topics that apply to our specialty.

Corporate Partners

If you are a UHMS Corporate Partner, please attend our monthly Corporate Partner Town Hall meeting series. These are held on the 1^st Wednesday of every month at 12 PM and are intended to be an open forum for discussing the challenges and successes your businesses and practices are experiencing and to create momentum and collaboration where appropriate.    

If your organization wants to educate the UHMS membership about the care provided or the goods and services offered, consider joining our Corporate Partnership Program. See https://www.uhms.org/corporate-memberships.html.  

MEDFAQs

The UHMS offers its version of “ask the experts.” MEDFAQs can be found at the following URL – https://www.uhms.org/resources/medfaqs-frequently-asked-questions-faq.html, and is a valuable tool for our membership.

If you are familiar with MEDFAQs, check back, as new Q&As are posted regularly.

Research

The UHMS Research Committee continues to be very active. We hope to announce good news in the new year on the IRB front, where members of our community can come to the UHMS for their Institutional Review Board needs.

We are soliciting donations from our members for two research initiatives. One is the Continuous Glucose Monitor study (https://www.uhms.org/cgm-hyperbaric-oxygen-study), and the Multicenter Registry for Hyperbaric Oxygen Therapy at Dartmouth (MRHBO2) continues seeking funds for free hospital membership. The MRHBO2 is funded entirely via grants, not by the registry's participating hospitals - https://www.uhms.org/donate-to-the-multicenter-registry-for-hyperbaric-oxygen-therapy.html.

Remember that donations to the UHMS Funds for Research and Policy Advancement are tax-deductible. For more information, check out the UHMS website –  https://www.uhms.org/funding.html. 

QUARC

To better understand the field’s challenges, log in and visit the QUARC page – https://www.uhms.org/resources/quarc.html. Here, you will find impending legislation and other relevant policies on the provision and limitations of HBO₂ coverage and the UHMS’s responses and guidance.

The chairs of QUARC are requesting that any unusual denials or challenges with physicians gaining access to insurance panels for HBO2 services, let us know as soon as possible, please – jpeters@uhms.org.

UHM

If you are a UHMS member, we are happy to announce a new search feature for previous issues and articles from UHM/UBR - https://www.uhms.org/publications/uhm-journal/download-uhm-journal-pdfs.html. Currently, the feature works with keywords.

If you have a suggestion or comment on how we can serve you better, please email me directly at jpeters@uhms.org or call me at 561-776-6110 extension 100.

It is my pleasure to serve you, our membership, and I continue to look forward to hearing from you.

John Peters

CLICK HERE FOR THE FORM

DESCRIPTION OF MEDICAL DEVICE APPROVAL PROCESS – CLASS ‘A' MULTIPLACE CHAMBERS 

PURPOSE 

The following Medical Device Approval Process is a generic process that has been endorsed by the Hyperbaric Oxygen Safety Committee of the Undersea and Hyperbaric Medical Society as a method that may be used to systematically document the evaluation and risk mitigation of medical devices to be connected to or used inside a Class ‘A’ Multiplace Chamber. This approval process was formatted using the current edition of the National Fire Protection Association (NFPA) 99 Health Care Facilities Code, 2021 Edition, Chapter 14 and other codes invoked by this chapter. This process is intended to serve as an aid in the selection, testing, modification, documentation, and approval of medical devices for use in the Class ‘A’ Multiplace chamber environment. The user of this document may choose to add other testing as deemed appropriate by their institution. 

SCOPE 

This document is intended to be used by Safety Directors/Coordinators and Medical Directors of Multiplace Hyperbaric Facilities, working jointly with the facility's Biomedical, Managerial and Administrative Teams. 

NOTE: The term Hyperbaric Safety Director is a title used for convenience. This individual may have a different title. 

HYPERBARIC MEDICINE MEDICAL DEVICE APPROVAL TEAM 

The establishment of a Hyperbaric Medicine Medical Device Approval Team is recommended and may consist of the following members: 

Hyperbaric Medicine Safety Director (HSD) Hyperbaric Medicine Medical Director (HMD) 

We also recommend that the following individuals are involved in the process: Hyperbaric Medicine Manager/Supervisor 

Hospital Biomedical Engineering Representative Hospital Administrative Representative 

All members of the Medical Device Approval Team are expected to review the Medical Device Approval Form for each new or modified medical device. At minimum, the HSD and HMD should indicate their approval by signing the Medical Device Approval Letter prior to use in the hyperbaric chamber. The Medical Device Approval Team may approve the device as presented or with conditions which must be specified on the Letter of Medical Device Approval. The Medical Device Approval Team must determine if each subsequent device of the same make and model must be individually tested and to what extent. 

1. No testing required on subsequent devices
2. Each subsequent device receives full functional testing
3. Each subsequent device receives abbreviated testing as determined by the HSD and theBiomedical Engineering Representative.

REFERENCE DOCUMENTS 

Access to the reference documents below are needed to complete and verify code requirements: 

1. NFPA 99: Health Care Facilities Code (2021)
2. NFPA 70E: National Electrical Code
3. ANSI Z136.3 American National Standard for Safe Use of Lasers in Health Care
4. NFPA 101: Life Safety Code
5. NFPA 53: Recommended Practice on Materials, Equipment, and Systems Used in Oxygen-EnrichedAtmospheres
6. CGA Compressed Gas Safety Guidelines
7. ASME PVHO -1 and -2

NOTE: Other electrical engineering Codes and Standards may be required by your institution. 

PROCESS 

1. Requests for medical device approval should be submitted to the HSD for consideration.
2. The HSD will pass the device, manuals, and approval forms to the Biomedical Engineeringrepresentative for visual inspection and schematic review.
3. The device will be disassembled to whatever extent is necessary to complete the examination.
4. Post inspection, the HSD may pass the device approval forms directly to the medical device reviewboard if reasonable data exists from the manufacturer, other facilities, or journal documentation.
5. If inadequate data exists, the HSD will enlist the assistance of appropriate personnel to performdevice testing.
6. Upon completion of successful testing, all documentation of the testing process will be forwardedto all medical device review board members for review and approval.
7. All team members are required to sign-off on each device prior to use in the hyperbaric chamber.Any member of the medical device review board may disapprove a device or request furtherdocumented evidence or testing at any time prior to approval.
8. All paperwork will be coordinated and maintained by the HSD.

CLICK HERE FOR THE FORM

The Multicenter Registry for Hyperbaric Oxygen Treatment includes 26 centers that agree to enter standard outcome measures on all the patients they see. These data are being published to inform the medical community about the uses of hyperbaric oxygen treatment and the outcomes. 

Recent Manuscripts from The Multicenter HBOT Registry 

Two manuscripts based on registry data have been submitted recently and are under review: 

Manuscript #1, Submitted to the Journal of Medical Internet Research: 
“Emerging Indications for Hyperbaric Oxygen Treatment: A Registry Cohort Study” 
Hideaki L. Tanaka, MD et al. for The Multicenter Registry for Hyperbaric Oxygen Treatment Consortium 

This retrospective study describes the outcomes from cases within the registry that were outside of the 14 established diagnoses approved for HBO₂ by UHMS. It highlights how that information can potentially promote further study of and use of HBO₂. 

Summary of other indications. Some of the indications were case series with several cases.  Others were case reports of individual cases. 

Fistula Discharge Crohn’s Violin Chart 
Reported fistula discharge pre and post HBO2 in patients with Crohn’s disease who had complete pre and post HBO2 data

Manuscript #2, Submitted to the Journal of Urology : 
“Patient Reported Outcome Measures following Hyperbaric Oxygen Therapy for Radiation Cystitis: Results from the Multicenter Registry for Hyperbaric Oxygen Therapy” 
Rachel Moses MD, MH, et al., for The  Multicenter Registry for Hyperbaric Oxygen Treatment Consortium 

This was a prospective cohort study looking at registry patients treated for radiation cystitis.  The results show a significant association between HBOT and improved patient-reported urinary symptoms. 

Urogenital distress inventory scores
Urogenital Distress Inventory scores pre/post HBO₂

Hematuria Scores pre and post HBO₂
Mean and median Radiation Therapy Oncology Group (RTOG) hematuria scores pre and post HBO₂ therapy

The multicenter registry is a valuable tool for evaluating standardized treatment outcomes, both in established and emerging indications for HBO₂.

If your center is not already contributing to the registry, please consider joining the consortium! More information may be obtained through this link:

Multicenter Registry for Hyperbaric Oxygen Therapy - Undersea & Hyperbaric Medical Society (uhms.org)

Introduction

What is the rationale behind having a prohibited items assessment/checklist for each hyperbaric unit? The hyperbaric safety program forms the cornerstone of every hyperbaric medicine service, offering essential guidance to identify and mitigate the potential risks and hazards associated with hyperbaric oxygen therapy. In certain circumstances, the risk cannot be eliminated (e.g., removing a wound care product), and mitigating measures must be taken to reduce the risk potential. National Fire Protection Association(NFPA) Healthcare Facilities Code 99, Appendix A for Chapter 14 Hyperbaric Facilities(NFPA 99-14) provides a flow chart that should be followed to determine the risk of patient care items that may be introduced into the hyperbaric environment. ⁽¹⁾ The Hyperbaric Safety Program, as a standard process, should require that every patient care item introduced into the hyperbaric environment have a risk assessment completed prior to use in the chamber. 

The NFPA Risk Assessment Flow Chart

The NFPA 99-14 risk assessment flow chart is a detailed process for effectively making decisions on the safety of patient care product(s) in a hyperbaric environment. ⁽¹⁾ Products may include wound care dressings, textiles, other related products, and patient care devices.

_______________________________________________________

The risk assessment flow chart provides a methodical decision-making process that considers safety concerns such as spontaneous heat production, static electricity, flammable vapor, ignition temperature, and the total fuel load. Unfortunately, the aforementioned risk assessment tool does not provide a means for documentation of the risk assessment, nor does it attempt to quantify the significance of the risk.  A.14.3.1.6.4.3 of the NFPA 99 2021 advises: "The hyperbaric facility should maintain a “use list” and a “do not use list” of items that have been evaluated for hyperbaric use.” In addition to this list, it is important to keep documentation on file explaining the risk assessment for each item. Hence, the facility-specific foundation requires an “exceptions log.”

Each area within the assessment tool should be evaluated independently. The risk assessment evaluation begins by obtaining the Safety Data Sheet (SDS) for the product or potentially prohibited item and answering several basic questions. Sometimes there is no specific SDS for wound care/dressing items. However, one can find SDS information of the contents found within the dressing or product (e.g., Xeroform is not found, but petroleum jelly is.) 

Specifically, what is a potentially prohibited item? Can the item or product be removed before commencing treatment? If removal is not an option, are there viable alternatives, and what measures must be taken to minimize the associated risks? For instance, does the item generate heat, and what steps can be taken to mitigate this risk if it does?

Evaluating risks in our current practice poses difficulties because the necessary information for conducting a thorough assessment might not be readily accessible.  Guidance to the following questions can be unclear: 

1. Understanding the purpose of the NFPA 99-14 Appendix A published flow chart
2. Finding the answers to the questions that are posted in the flow chart (e.g., often answers are assumptions)
3. How to proceed when information is not readily available
4. Wound care dressing and product safety data sheets (SDS) routinely do not report all the information needed.
5. Completing the current process does not provide the necessary detail to identify the level of risk, the exposure potential, and the consequences if the item is allowed into the chamber.
6. Completion of the current process does not guarantee adequate documentation. Further effort must be invested into documenting the decision process.

In this document, we propose a scoring system, specific decision tree, and standardized evaluation process to identify and mitigate potential safety go/no go risks in the hyperbaric chamber environment.

Burman’s Risk Scoring System

Quantifying risk magnitude through a practical scoring approach.

When considering a material, dressing, disinfectant, piece of equipment, or other product for use in a hyperbaric chamber, a consistent process should be followed to ensure that any identified real risks can be effectively mitigated.

Generally, very few products are manufactured specifically for hyperbaric use or evaluated and declared effective and/or safe by manufacturers. However, in equal measure, many typical healthcare products do not present any significant risk of endangering patients, staff, or facilities.

Medical products require FDA approval prior to marketing and sale, but even with this approval, this does not apply in many cases to cover a hyperbaric medicine application. In order to meet the FDA requirements for off-label use, the medical director is required to decide both in the best interests of the patient and with due regard to safety. ⁽²⁾

The exposure of patients, staff, and equipment to the hyperbaric oxygen environment will always present some risk, which should be evaluated and mitigated as much as is practically and realistically achievable.

A risk assessment process based on identified hyperbaric facility hazards should allow each item to be properly evaluated and an appropriate risk level determined, enabling the risk management team and the medical director to make an appropriate decision.

Types of Risks

Three risk categories need to be considered: fire, mechanical and physiological. Items under consideration should be evaluated to determine whether any or all of these categories apply and, if so, what the magnitude of the risk would be.

Definitions

Risk: a risk can be defined as the probability of an exposure to a hazard leading to negative consequences. This, in turn, allows each of the above three identified areas of concern to be scored, using a Likert Scale, for probability, frequency of exposure, and severity of potential consequences.

• Fire hazards: fire has been proven to be the greatest of the risks encountered in hyperbaric chambers through the review of more than 95 years of experience in this field. ⁽³⁾ Items introduced into the hyperbaric environment should be considered in terms of a potential source of fuel, an ignition source, and exposure to oxygen to promote and accelerate combustion.
• Mechanical hazards include anything that leads to⁽⁴⁾:
  • Undesired release of compressed gas from the chamber: even small volumes of compressed gas represent a large amount of potential energy. Should this energy be released suddenly, the effects on adjacent structures and personnel can be devastating. The release could result from failure of the vessel or the associated piping or if the chamber is modified in a manner contrary to the original code or standard of design and construction.
  • Impaired access: any restriction on escape or impedance to rescue and firefighting efforts posed by the chamber creates a hazard in case of an emergency.
  • Reduced visibility through the chamber: reduced or restricted vision of chamber operators reduces their effectiveness as safety monitors (e.g., an external fixator that scratches the chamber acrylic window).
  • Collapse or rupture during changes in pressures: for instance, sealed or semi-sealed containers that are not adequately vented left inside the chamber will either collapse under pressure (possibly resulting in adiabatic heating of the contents and thus imposing a fire or explosion risk); or explode on resurfacing if the gas trapped within the container cannot escape during the depressurization.
  • Malfunction, disruption, or inoperativeness of many standard items when placed in service under hyperbaric conditions, including the implosion of lamps and vacuum tubes (e.g., cathode ray tubes in medical monitors), overloading of fans due to a higher gas density, inaccurate operation of flowmeters, pressure gauges, and regulators.
• Physiological hazards⁽⁴⁾: Physiological hazards for the purpose of the Risk Assessment Tool include only those arising as a result of mechanical, electrical, or other safety malfunctions. For instance:
  • General hazards: these include electric shock or overheated materials leading to acute burns, CO poisoning, intoxication by products generated during the combustion of materials (e.g., cyanide and chlorine).
  • CO₂ intoxication: should the ventilation or air exchange system malfunction or be inadequate, CO₂ levels could rise to toxic levels (due to the increased atmospheric pressure).
  • Rapid depressurization of the chamber may lead to barotrauma, discomfort, and/or hypoxia. This hazard may result when overpressurization occurs, and the relief valve is activated.
  • Uncomfortably high noise for the patient may occur during compression and subsequent ventilation.
• Probability of an accident: the likelihood that an incident or accident, such as combustion due to fire/explosion, mechanical failure of the chamber, or undesired physiological event, will happen as a result of exposure to the hazard
  • Frequency of exposure: how often will the facility, occupant, or staff member be exposed to the hazard if no mitigation actions are taken.
  • Severity of potential consequences: severity of the outcome, should an accident occur

Risk Score =probability x exposure x consequence

The Go No-Go Risk Assessment Tool with Burman’s Scoring System

NFPA recommends that hyperbaric facilities utilize the NFPA risk assessment flowchart to assess dressings and items that have not been evaluated or deemed safe for use in the hyperbaric chamber. However, several challenges (as described above) prevent widespread use of the NFPA risk assessment flow chart. Most importantly, completion of the published flow chart does not provide the necessary detail to identify the level of risk, the exposure potential, and the consequences if the item is allowed into the chamber.

The Go No-Go Risk Assessment Tool addresses this gap by combining the NFPA risk assessment flow chart and Burman’s Risk Scoring System. Combining the two tools with an easy-to-use interface will provide the hyperbaric facility with a robust go/no-go documentation and mitigation tool. 

Example:

Wound-care medication product, applied by a physician that cannot realistically be removed prior to hyperbaric oxygen treatment.

The potential hazards are fire and a potential reaction to the product through exposure to an elevated partial pressure of oxygen.  The initial risk assessment could be considered as follows:

1. Fire:

• Identifying risks:
  • Fuel – The product Safety Data Sheet (SDS) should be consulted to determine whether any volatile vapors can be released at expected chamber temperatures and elevated partial pressure of oxygen (this information is not always easy to obtain – the manufacturer may need to be consulted).
  • Ignition source – in the event of any potentially flammable materials, the required heat to initiate a fire is relatively low.

• Assigning scores: 
  • Probability of a fire: 3 (combustion possible if any flammable vapors can be released)
  • Exposure: 4 (less than twice a day)
  • Consequence: 5 (potentially catastrophic)

• Quantifying the risk level
  • Risk level 3 x 4 x 5 = 60
  • A score of 60 represents high risk - risk mitigation is needed prior to use. Ensuring no flammable vapors can be released, grounding the patient, and ensuring prohibited items are excluded from the chamber would reduce the probability of fire to a 1 (new risk score 1 x 4 x 5 = 20). In addition, a damp towel could be placed over the dressing area to further protect against any possible ignition.

2. Physiological:

• Identifying risks:
  • Amended uptake of medication/dressing product.
• Quantifying the risk level:
  • No possibility for any human reaction would yield a risk score of 1 x 4 x 0 = 0
  • Potential reaction of medication with oxygen (not as yet been reported): 3 x 4 x 3 = 36
  • A score of 36 represents a medium risk – treatment is not advised if this specific product is used.

Impression

Risk assessments and mitigation steps taken should be undertaken in writing and presented to the medical director for endorsement.

Reference:

1. Technical Committee on Hyperbaric and Hypobaric Facilities (HEA-HYP). 14. Hyperbaric Facilities. In: (NFPA) National Fire Protection Association, editor. NFPA  99: Health Care Facilities Code Handbook. 2021st ed. Quincy, MA: NFPA; 2021.
2. FDA. “Off-Label” and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices | FDA [Internet]. 1998 [cited 2021 Feb 21]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices
3. Sheffield PJ, Desautels DA. Hyperbaric and hypobaric chamber fires: a 73-year analysis. Undersea Hyperb Med. 1997 Sep;24(3):153–64.
4. Burman F. Risk Assessment Guide for Installation and Operation of Clinical Hyperbaric Facilities. 6th ed. San Antonio, Texas USA: International ATMO, Inc.; 2019.
5. Burman F, Mize J, (2023). "Prohibited Item Risk Assessment ". In Worth E, Song E, (Eds.) , WoundReference. Available from: https://woundreference.com/app/topic?id=prohibited-item-assessment. Retrieved on 9/28/23.

Why should one pursue Hyperbaric Facility Accreditation when it is voluntary?

The UHMS Hyperbaric Facility Accreditation establishes a set of standards in consultation with industry experts, incorporating the codes and regulations of the industry. These standards encompass various aspects such as patient safety, training, record-keeping, and equipment maintenance.

Patient care assurance is of utmost importance in the hyperbaric industry. When a hyperbaric organization meets national health, quality, and safety standards, patients can be assured that they recieve the best care possible. One way for hyperbaric to ensure compliance with current standards and regulations is by obtaining voluntary accreditation. This accreditation not only assures compliance but also serves as a benchmark for measuring an organization's performance.

Moreover, the accreditation process can help an organization highlight its strengths, reaffirm its commitment to compliance, and drive continuous improvement. Achieving and maintaining accreditation is beneficial in many ways, such as helping organizations maintain compliance with codes and standards, keeping up-to-date with industry standards, stimulating quality improvement, improving accountability and transparency, and enhancing the capacity of the department to provide high-quality programs.

Preparing for accreditation takes a comprehensive review of how an organization functions. It is a long and intensive process that helps identify areas of risk. Organizations must conduct a thorough assessment of their processes, policies, and procedures related to hyperbaric codes and standards. This assessment helps identify any gaps in compliance. Updating policies, procedures, and training materials requires collaboration with administrators and leaders. By taking a proactive approach to risk management, organizations can identify gaps in compliance and adjust procedures to ensure safety. This results in safer processes and fewer mistakes.

Once the organization is prepared, external surveyors will conduct an on-site survey to determine if the organization should be accredited. The surveyors are industry experts and peer reviewers from other accredited hyperbaric facilities.

Receiving a recommendation from the Food and Drug Administration (FDA) to get Hyperbaric Facility Accreditation can significantly boost patient confidence in your facility and attract more patients. Being accredited gives you an advantage over your competitors, as potential patients are more likely to choose an accredited facility over one that is not accredited. Accreditation helps to enhance the quality of care provided, which results in higher patient satisfaction. Satisfied patients are more likely to recommend your facility to others and return for future medical assistance.

Accreditation is an investment worth considering. Ultimately, it can provide numerous benefits for your organization. Hyperbaric Facility Accreditation aims to strengthen your organization and demonstrate that you offer high-quality care. Obtaining and maintaining accreditation provides benchmarks for measuring your organization's performance. The process also helps you stay compliant with codes and standards and remain up-to-date with industry best practices. Achieving accreditation is a valuable accomplishment that can enhance your organization's reputation and credibility.

 Congratulations to these Facilities!

JULY 2023

Reaccredited:
Griffin Hospital, Derby, CT
Nuvance Health Northern Dutchess Hospital, Rhinebeck, NY

AUGUST 2023

New:
HyOx Medical Treatment Center, Marietta, GA
White Plains Hospital, White Plains, NY

Reaccredited:
OhioHealth Riverside Methodist Hospital, Columbus, OH

SEPTEMBER 2023

Reaccredited:
AdventHealth Hospital Carrollwood, Tampa, FL
AdventHealth Hospital Carrollwood at Brandon, Brandon, FL
AdventHealth Hospital Tampa, Tampa, FL
CoxHealth, Springfield, MO
St. Luke's Hospital, Cornwall, NY

* With Distinction*