Featured News

Physician Fee Schedule Overview:

The conversion factor has decreased from $33.29 to $32.35 (2.8$) for CY2025.  This basically negates the 2.93% increase in CY 2024. 

• Extended several telehealth waivers through 2025.  
  • Direct supervision expanded to include audio/video real-time communications, excluding audio-only, but only for services assigned a PC/TC indicator of "5", such as a 99211 (Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional) utilized for nurse visits. 
  • There are several updates to telehealth E&M services, that I'll continue to review and provide updates on as needed.
• CMS is changing the direct to general supervision requirement for Physical, Speech and Occupational Outpatient Therapy Services in private practices.  All other outpatient therapies i.e.. HBOT, was not included, but it will be interesting to see if UHMS comments on this going forward.  
• CMS continues to examine ways to treat skin substitutes products as incident-to supplies under PFS rate setting.  They continue to evaluate how they will reimburse for these services going forward, but are not recommending any changes at this time for CY 2025.
  • One statement did state that skin substitutes will be added to the product category that are not considered Part B rebatable drugs.  (Section III.I)
• CMS continues to review opportunities for improving Global Surgery Payment Accuracy.  This includes providers in the same group being able to bill separately for services post-surgery by a member of the same group.  In addition, there is a change for care provided outside the surgical group, that is a common scenario impacting our providers when receiving post-surgical wound care referrals.  
  • Improvements in the transfer of care payment structure, including a modifier to denote follow-up care by a provider not in the same group or specialty of the surgeon. 
  • G0559 - Post-operative follow-up visit complexity inherent to evaluation and management services addressing surgical procedure(s), provided by a physician or qualified health care professional who is not the practitioner who performed the procedure (or in the same group practice) and is of the same or of a different specialty than the practitioner who performed the procedure, within the 90-day global period of the procedure(s), once per 90-day global period, when there has not been a formal transfer of care and requires the following required elements, when possible and applicable
• G0465 - Autologous platelet rich plasma (prp) or other blood-derived product for diabetic chronic wounds/ulcers, using an fda-cleared device for this indication, (includes as applicable administration, dressings, phlebotomy, centrifugation or mixing, and all other preparatory procedures, per treatment).  Pricing for this code will be mapped to 15275 and finalized reimbursement of $770.83 for CY2025.  Individual MACs will need to be monitored.  

2024-25382.pdf

OPPS Overview: To be published on 11/27/2024

• OPPS payment rate for outpatient departments in CY 2025 will increase by a factor of 2.9%.  There continues to be a 2.0 percentage point reduction for hospitals that fail to meet outpatient quality reporting requirements.  
• HBOT G0277 - CY 2024 $132.21 to CY 2025 $137.90 per 30 minute segment.   CMS-1809-FC | CMS
• Skin substitutes will continue to be assigned to high/low categories in CY 2025 with the same methodology as CY 2024.  There is no further mention of the reduction in products approved in the final rule or LCDs at this time.  

UPDATED – While the Alliance is working on providing our members with a more detailed summary of these final rules, we wanted to provide this update as a result of incorrect information being placed in the original November 1, 2024 summary. The bolded language is new.

All of the CY 2025 final Medicare payment rules were issued late in the afternoon on November 1. Below we have provided a brief summary of the some of the wound care provisions.

View full article: click here

A quality program for a hyperbaric facility must be designed to achieve accreditation and be sustainable over the long term. Maintaining a quality program that aligns with UHMS Hyperbaric Facility Accreditation requires a consistent focus on process improvement, staff engagement, and proactive management practices. Here’s how to sustain a high-performing quality program after accreditation.

1. Embed Continuous Monitoring and Assessment

Once a quality program is in place, routine monitoring and assessment are essential to ensure it remains effective. Key strategies include:

• Regular Audits: Conduct periodic internal audits to verify compliance with policies, safety protocols, and clinical standards. Audits should cover patient care practices, chamber maintenance, and documentation to detect any gaps early.
• Performance Reviews: Key performance indicators (KPIs) should be reviewed routinely. They should reflect clinical outcomes, patient safety, equipment reliability, and patient satisfaction.
• Benchmarking: Compare facility data against industry standards and other accredited facilities to identify areas where your facility may excel or need improvement.

Regular monitoring allows the facility to quickly address any emerging issues and prevent lapses in quality or safety.

2. Conduct Routine Policy and Procedure Updates

Healthcare standards, technology, and best practices in hyperbaric medicine continually evolve, and policies should adapt accordingly. Maintain the quality program by:

• Annual Policy Review: All policies and procedures must be reviewed annually to ensure they remain current. Policies must also be updated in response to new regulations, standards, and emerging clinical evidence in hyperbaric medicine.
• Staff Involvement: Staff should be involved in policy reviews and revisions to ensure that protocols are practical, up-to-date, and have buy-in from those implementing them.
• Documentation: To ensure continuity and compliance, keep thorough records of all policy changes and communicate them effectively to the entire team.

Routine updates help ensure the quality program evolves alongside the codes, standards, and guidelines.

3. Maintain a Strong Focus on Staff Training and Competency

Maintaining high staff competency is vital for long-term quality and safety in a hyperbaric facility. Training should be treated as an ongoing priority:

• Regular Training: Provide periodic refresher training on critical protocols, such as chamber operations, emergency response, and patient management in hyperbaric settings. Schedule regular simulation exercises and mock drills to ensure staff are confident in handling emergencies.
• Continuing Education: Encourage staff to pursue advanced certifications and participate in ongoing education opportunities, especially in areas relevant to hyperbaric medicine and patient safety.
• Performance Evaluations: Conduct regular competency assessments to ensure staff meet required skill levels. Targeted training sessions address skill gaps and align the team with the facility’s quality goals.

A well-trained team reinforces the quality program, as staff are better prepared to deliver consistent, safe, high-quality care.

4. Foster a Culture of Continuous Quality Improvement

A Continuous Quality Improvement culture sustains the quality program by engaging all staff in identifying and implementing improvements. Key steps include:

• Quality Committees: Hold regular meetings with a quality committee that includes representatives from clinical, safety, and administrative roles. This committee can identify improvement opportunities, review data, and monitor the progress of quality initiatives.
• Feedback Mechanisms: Encourage staff and patients to provide feedback on their experiences within the facility. Use this information to identify trends, address concerns, and refine practices.
• Root Cause Analysis and Action Plans: For any adverse events, conduct root cause analyses and establish corrective action plans. Monitor the effectiveness of these actions and make adjustments as needed.

Embedding Continuous Quality Improvement at all facility levels keeps quality improvement central to daily operations. This ensures that small issues are addressed before they escalate and fosters a proactive approach to excellence.

5. Prioritize Comprehensive Documentation and Record-Keeping

Accurate, up-to-date documentation is fundamental to sustaining a quality program and complying with accreditation standards over time. Effective documentation practices include:

• Consistent Record Maintenance: Ensure meticulous record-keeping for all procedures, patient care activities, incident reports, equipment maintenance logs, and staff training records.
• Review and Archiving: Regularly review records to verify accuracy and completeness. Archive older documentation according to compliance standards while ensuring relevant data is readily accessible for quality audits and assessments.
• Electronic Health Records (EHR): Where possible, utilize electronic health records and quality management software to streamline documentation, track performance metrics, and automate reminders for policy reviews or maintenance activities.

Quality documentation practices demonstrate the facility’s commitment to transparency and accountability, both of which are essential for sustaining accreditation.

6. Prepare for Ongoing Accreditation Surveys

Preparing for periodic reaccreditation surveys helps maintain readiness and reinforces a quality culture. Tips for staying prepared include:

• Mock Surveys: Conduct mock surveys that simulate the accreditation process to ensure all standards are consistently met. Identify and address any areas of concern that emerge during these simulations.
• Self-Assessments: Perform regular self-assessments of quality practices. Encourage staff to approach each self-assessment as a learning opportunity rather than a compliance exercise.
• Continuous Readiness Training: Treat accreditation as a year-round process, ensuring that the facility remains survey-ready and that any necessary corrective actions are implemented well before reaccreditation.

Preparing proactively helps the facility maintain high standards and positions it to adapt seamlessly to future changes in accreditation criteria.

7. Engage Leadership and Staff in Quality Goals

Active leadership involvement and staff engagement are crucial for maintaining a high-functioning quality program. Strategies to keep the team invested include:

• Leadership Rounds: Regularly conduct leadership rounds, allowing leaders to interact with staff, observe quality practices, and identify any challenges firsthand.
• Transparent Communication: Keep open lines of communication about the facility’s quality goals, performance metrics, and areas for improvement.
• Recognition and Rewards: Acknowledge staff who contribute significantly to quality improvement. Implement reward programs to celebrate achievements, reinforce desired behaviors, and maintain morale.

A quality program is most effective when all team members understand its purpose and feel valued for their contributions.

Conclusion

Maintaining a quality program in a hyperbaric facility requires constant attention to safety, staff training, policy updates, and improvement initiatives. By embedding Continuous Quality Improvement, documenting meticulously, and keeping the facility survey-ready, a hyperbaric facility can meet UHMS accreditation requirements. More importantly, a sustained focus on quality improves patient outcomes, enhances operational efficiency, and reinforces the facility’s reputation as a leader in hyperbaric medicine.

Congratulations to these Facilities!

July 2024:

Reaccredited:

Garnet Health Medical Center-Catskills
Harris, NY

Garnet Health Medical Center-Orange
Middletown, NY

*McKay-Dee Hospital*
Ogden, UT

Oneida Health
Oneida, NY

Virginia Hospital Center
Arlington, VA

WellSpan Ephrata Community Hospital
Ephrata, PA

WellSpan Good Samaritan Hospital
Lebanon, PA

August 2024

Reaccredited:

*David Grant USAF Medical Center*
Travis AFB, CA

*MedStar Georgetown University Hospital*
Washington D.C.

September 2024

Reaccredited:

Corewell Health Lakeland Hospitals Niles
Niles, MI

Lakeview Hospital
Bountiful, UT

Nuvance Health Vassar Brothers Medical Center
Poughkeepsie, NY

Redlands Community Hospital
Redlands, CA

* With Distinction*

Greetings from all of us here at UHMS!

As 2024 draws to a close, I am humbled by the tremendous progress made in advancing the undersea and hyperbaric medicine specialty. Thanks to our members' and volunteers' unwavering support and dedication, we’ve strengthened our community, expanded our reach (a bigger tent), and furthered our mission to promote the safe and effective practice of hyperbaric medicine.

Here are some key highlights of our collective accomplishments this year:

1. Strengthening Education and Certification Pathways

UHMS's directly sponsored and jointly provided educational programming continues to be the cornerstone of our specialty. It serves the spectrum of learning from basic to advanced using all learning modes, from in-person meetings to enduring material programs.

Learners worldwide attended our programming this year, and the UHMS experienced record attendance at many of our meetings and courses. This demonstrates that members of our specialty are thirsty for knowledge and committed to lifelong learning.

We are working to strengthen our certification programs by formalizing the continuous certification process around each certification pathway. This should be complete by the end of Q1 2025.

One of the certification programs is the UHMS Physician Training in Diving Medicine Course (PTDM), held in La Jolla, CA. The UHMS has hosted this DMO course for over 40 years, and according to Dr. Simon Mitchell, it is the best diving medicine course in the world.

I was honored to be invited to attend and participate in the diving practicum day. While I have attended different parts of the course over the years, this was the first time I witnessed the ‘magic’ that happens during this full day of in-water diving practicums. Stations included extracting unconscious divers from the water, navigating an underwater obstacle course on SCUBA with body (manikin) retrieval, rebreather orientation and diving, diving skills and checklists, and more. Hats off to Drs. Pete Witucki and Dick Sadler for planning and executing another stellar program, as well as for all the faculty. In addition, we’d like to express our heartfelt appreciation for Spencer Lynch and the LFJCC for the use of their aquatic center, Oceanside Lifeguards Blake Faumuina and Greg Trebbe, technical dive instructor Jay Gardner, rebreather instructor Todd Wynn, and Drs. Dan Popa and Christanne Coffey.

I appreciate the quote from Abigail Adams, the wife of POTUS No. 2, John Adams; “Learning is not attained by chance, it must be sought for with ardor and diligence.” Data shows that education, experience, and certification are essential differentiators from a practice and patient outcomes perspective.

2. Expanding Public and Professional Awareness

Raising awareness of the vital role hyperbaric medicine plays in healthcare has been a key focus this year.

3. Advocating for Broader Access to Care

Our advocacy efforts have yielded meaningful progress in ensuring HBO₂ is accessible and recognized as an essential treatment modality.

• Insurance Coverage Wins: We partnered with stakeholders to secure expanded coverage for HBO₂ to treat the late effects of radiation therapy, compromised skin grafts and flaps, avascular necrosis (AVN), and other conditions.
• Policy Advocacy: We successfully engaged with the Alliance of Wound Care Stakeholders and federal and state policymakers to emphasize hyperbaric medicine's cost-effectiveness and efficacy compared to standard care.

4. Advancing Research and Innovation

UHMS has continued to lead in driving evidence-based advancements in hyperbaric medicine.

• Research:UHMS continues to fund research and data analysis to validate existing diagnoses as well as emerging indications, like inflammatory bowel disease and Crohn's, traumatic brain injury, and post-COVID recovery.
• Publications: We published numerous papers on the cost-effectiveness and efficacy of hyperbaric medicine, solidifying our role as a trusted authority in the field.

5. Enhancing Member Services and Global Reach

Membership is the core of the UHMS, and we continue to be hyperfocused on creating value for members and Corporate Partners.

Looking Ahead to 2025

While we celebrate these accomplishments, we know much work still needs to be done. In 2025, our focus continues to be mission, mission, mission.

~

I will return to my soapbox momentarily to repeat my message from the Q1 issue of Pressure.

We need your help. The physician, advanced provider, nurse, therapist, and technician should take responsibility for seeking and maintaining certification and completing 12 hours of continuing education annually. Hospitals, management providers, and chamber manufacturers are accountable for supporting and promoting hyperbaric facility accreditation and providing urgent and emergent hyperbaric medicine care for all patients.

This is a call to action for everyone involved in hyperbaric medicine: to get engaged, get educated, get certified, get your facility accredited, and show that you're doing what you claim to do, particularly around delivering optimal outcomes and treating patients of all acuities regardless of payor source.

Please review our position statement on Certification Matters: UHMS POSITION STATEMENT.

The UHMS tent is wide open, so please come in and join us to make our specialty vibrant and viable for generations to come!

UHMS Finances

I am pleased to report that UHMS's Financial position remains strong.

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

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. For more information, visit 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 some good news in the new year on the IRB front, where members of our community can come to the UHMS for the Institutional Review Board's 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, visit the UHMS website at https://www.uhms.org/funding.html.   

QUARC

To better understand the field's challenges, log in and visit the QUARC page at 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, as well as the UHMS's responses and guidance.

The chairs of QUARC request that you let us know as soon as possible about any unusual denials or challenges with physicians gaining access to insurance panels for HBO2 services. 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 better serve you, please email me at jpeters@uhms.org or call at 561-776-6110 extension 100.

As always, our success is a testament to the dedication and passion of our members. Thank you for your continued contributions to advancing our field and improving patient outcomes worldwide.

Together, we are making a difference, one breath at a time.

John Peters

2025 will be the 40^th year of the Baromedical Nurses Association!  The BNA will celebrate this exciting event at the annual Hyperbaric Nurses Day in April!  All are welcome to join us for great presentations and free CEUs for BNA members, which are offered at a fee of $15.00 for non-BNA members. 

A little history:  It is my honor that I participated in the decision to form the Baromedical Nurses Association in 1985and have been an active member since then. 

The following statements are from: Minkiewitz White, K and Baker, T, Baromedical Nurses Association History, The Textbook of Hyperbaric Nursing, Best Publishing Company 2002 pp 1-4.

• The Undersea Medical Society (UMS) was available at that time (before they added Hyperbaric to their name), and nurses could be associate members.
• Nurses were involved in developing hyperbaric programs, training nurses and others to care for patients receiving HBO therapy, and starting to write about the Baromedical nursing experience in nursing and other scientific journals.
• We wanted to come together as nurses to discuss the problems and patients we were dealing with daily.
• So, after much groundwork by Diana Greenburg, assisted by Valerie Messina, a meeting was held in Long Beach, California, as part of the 1985 Joint Conference, UHMS ASM/Tenth Annual Conference on Clinical Application of Hyperbaric Oxygen.
• At the meeting, 35 nurses voted to establish the Baromedical Nurses Association. The enthusiasm and energy at the initial meeting were fantastic!
• We were a nursing organization for nurses by nurses. The mission was approved. The functions were identified as:
  • To define and implement standards of practice
  • To promote ongoing educational endeavors for nurses practicing in Baromedical nursing and to educate other nurses regarding this specialty.
  • To support research validating the concepts inherent in Baromedical nursing and the publication and dissemination of these findings
  • To promote professional activities that enhance the effectiveness of Baromedical nursing in the overall healthcare system
• We elected Diana De Jesus-Greenburg as our first president and decided to hold a meeting with the UHMS scientific meeting to promote attendance.
• We also voted to obtain the services of a legal firm
• Plans began immediately for a credentialing system, and all in attendance went home with a sense of pride and wonderment that a new organization had been born.

The present:

The BNA board and BNA members continue to actively work together by mentoring, publishing books and articles, being involved in research, presenting papers at BNA and UHMS meetings, serving on BNA, UHMS, and Associates committees, being active nurse members of the UHMS Accreditation team as nurse surveyors, and having nursing representation on the UHMS Board of Directors.     

The future:

Whether you are a new or a seasoned hyperbaric nurse, your views and input count!  Everyone’s perspective and experience add so much to the overall success of our field.  The only requirement is your passion for what you do.  Your input and view are valuable.  Everyone’s perspective and experience add so much to the overall greatness of this organization.

We look forward to everyone attending the 2025 Baromedical Nurses Association - Hyperbaric Nurses Day annual celebration in April!

Have you checked out the forum on the BNA website lately? You are encouraged to visit https://hyperbaricnurses.org/ for more information on BNA activities and contacts.

Regulatory compliance for a medical device manufacturer is a process that continually evolves for the device's lifecycle. In the hyperbaric industry, the ASME:  American Society of Mechanical Engineers is the author of the pressure vessel construction standards. In 1911, the American Society of Mechanical Engineers established the Boiler and Pressure Vessel Committee to formulate standards for constructing steam boilers and other pressure vessels such as hyperbaric chambers. The ASME’s function is to establish the rules of safety that govern the construction and design of pressure vessels. (ASME BPVC.VIII.1-2021) These codes and rules provide hyperbaric design engineers’ with the applicable regulations they must follow for the original design of the hyperbaric device throughout the entire device life cycle.

Many people ask me what I am asked the most about hyperbaric chambers; I respond by saying people ask me, “How do I know your chamber is safe.”   It is a great question, which I enjoy answering, and I wish more people would ask safety-oriented questions. Safety in the hyperbaric industry is a fundamental aspect of the spectrum of use for providing hyperbaric treatment. Safety is the fundamental theory behind hyperbaric didactic technical training, behind the facility's design, and safety considerations are incorporated into the design codes of the hyperbaric device. Let us take a closer look at the role of the hyperbaric design elements.

To understand the design elements of a hyperbaric chamber, let me share the design inputs that occur during the design process. The engineering team sets out to establish a set of requirements from all the stakeholders. These requirements are design input requirements or (DIR), and they formulate the basis of each complete hyperbaric model design submitted to the FDA for review and approval. The design input requirements encompass certain aspects that could be described as intuitive and some that are driven by regulatory codes and standards. These user requirements could include gurney design and comfort, gurney wheel rolling and locking capability, the height of the gurney, and hyperbaric user technical requirements such as the size of gauges, ability to reach controls, mattress safety and comfort, patient entertainment, ease of use of door handles, door locking mechanism and so forth. In addition, the engineering team will learn the clinical requirements, such as the depth of treatment required, air break needs, gas flow, communications requirements, and other aspects of the design that intersect with the clinical performance of the chamber.

Design inputs then also need to consider the manufacturing environment requirements, which are exhaustive, such as production device considerations to include specialized equipment, staffing, temperature of components, cranes and lifts, lighting, and other aspects that may not be as intuitive in the design process. From there, the input of the quality control team, sales and marketing team, and other related inputs, such as the markets for product sales, must be identified. In addition, practical design elements such as packing and shipping requirements must be understood. Lastly, manufacturing personnel are consulted, and their list of inputs will be considered as part of the design requirements. Obtaining all the design input requirements from external and internal stakeholders is necessary and is part of the formal file submission to the FDA. This process is intended to be exhaustive and considers the needs of every stakeholder, including patients, HBO technicians, physicians, facility, and environmental staff, as well as all those stakeholders at the physical manufacturing plant. The DIR inputs can number into the hundreds to fully ensure the chamber design considers all aspects of medical device utilization.

Now, the most impactful aspects of the DIR are those of the regulatory design input requirements imposed on the engineers. These are critical in terms of the safety and efficacy of the device and are the building blocks for the longevity of the design. These codes and regulations are the fundamental standards that guide the design's structural integrity and the device's ability to perform to the specified requirements. As noted, the ASME formulates the regulations that a manufacturer must follow during the hyperbaric chamber design per these codes and standards. These codes and standards provide the mechanical design inputs to the entire device. These component designs will affect device installation requirements, the installation environment, the operational pressures, the composition of materials utilized, and aspects of the structural integrity of a chamber. The essential codes for designing and manufacturing pressure vessels guide our industry's safety. The codes and standards should include:

Codes and Standards for Hyperbaric Design

• ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy
• ASME Boiler and Pressure Vessel Code, Section VIII, Division 1 – Pressure Vessels
• U. S. FDA Requirement 21 Code of Federal Regulations, Part 820
• NFPA 99, Health Care Facilities
• EN ISO 60601-1, Medical Electrical Equipment Basic Safety

At Perry, The SIGMA series pressure vessels are stamped with the ASME Boiler and Pressure Vessel Code “U” Stamp, stamped with the PVHO-1 Stamp, and are registered with the National Board of Boiler and Pressure Vessel Inspectors. Perry Baromedical Corporation operates a Quality Management System certified to ISO 13485:2016 for the following scope: the Design, Development, Manufacture, and Service of Hyperbaric Chambers. Perry Baromedical Corporation is a Registered Medical Device Establishment. It is important to note that not all manufacturers maintain a “U” stamp or comply with the above standards and codes.

The codes and standards are not only the building blocks for hyperbaric design, but they also become the set of regulatory specifications that a manufacturer must adhere to for the lifecycle of that device. This comprehensive process generates a document called the Technical Service Requirements, referred to as Tech Specs or building services specs, or BSRs. This is the one document above all others that we want to ensure is in front of potential facility operators because it is the official publication from the manufacturer and provides a quick reference to the list of all applicable codes and standards in one easily accessible format. The Tech Spec BSR is where I can point to show a customer which safety standards our devices comply with. The BSRs fundamentally answer and address safety design questions. For hyperbaric facilities in the planning process, this document will help determine the necessary changes and modifications to a hyperbaric suite. It will help shape the critical and essential facility modification needs or build-out requirements. These BSR Tech Specs are the guiding documentation for hyperbaric facility design. With a new hyperbaric location, there are important and impactful decisions for consideration regarding the location of med gas, piping distance considerations and issues, fire suppression needs, lighting needs, flooring type, and essential elements embedded into the hyperbaric BSR technical specifications. An important part of the new hyperbaric facility design is the evaluation of safety measures in this build-out process. The BSRs become the guidance document for review by fire marshals, architects, facility planning teams, and all others involved in the hyperbaric facility design. The BSRs can also be utilized to ensure that a consumer compares applicable devices to applicable devices when completing the due diligence in selecting their hyperbaric equipment. These BSRs are also helpful during a JCAHO or UHMS Accreditation visit. They serve as the ultimate reference document to list the applicable standards for an auditor to review and list the associated FDA 510K number.

 While the BSRs are utilized by newcomers to the industry, it can be complex to negotiate the myriad quantity of data found on the internet. Most unfortunately, the adoption of the standards is not uniform across the manufacturers of Class B devices. Specifically, we are encountering devices imported into the US that are not FDA-cleared. This improper importation practice is taking place specifically to get around that device's lack of codes and standards. We are learning that device parts, not fully assembled devices/chambers, are imported into the US and assembled somewhere in the US, posing as a “made in USA product” but only assembled in the US without proper FDA premarket 510K clearance.

 So, how does the consumer/purchaser ensure that all the regulatory compliance for said device exists? The best way to ensure device comparison is to obtain the manufacturer’s specifications to delineate: 1. The manufacturer publishes applicable codes; 2. To ensure the device is FDA-cleared, and 3. the device meets the design requirements for PVHO-1. As our industry continues to grow, we all play a role in ensuring proper information is shared and encourage the comparison of chambers. Ask about the manufacturer’s quality management system (QMS). Look up the product listing on the FDA website. Ask about the manufacturer's last quality system audit. All legitimate manufacturers in the US are audited annually. We pay agencies to complete a third-party audit to ensure compliance with our QMS system. Further, when these standards change and are updated, the manufacturer, in turn, must update device standards to continue to comply. Manufacturers participate in regulatory compliance audits to demonstrate to an audit agency that said manufacturer continues to meet companywide QMS compliance to the codes and standards.

Safety and regulatory compliance never stop for the medical device industry. We proudly want our safety record to be reviewed, evaluated, and monitored. We all play a role in the ongoing safety of the hyperbaric industry. Facility operators, physicians, clinicians, architects, engineers, hyperbaric technicians, med gas pipers, and all of us on the hyperbaric device side are working to drive more safety into everything we do. We must embrace and encourage regulatory compliance so that the standards and codes become equally deployed across our spectrum from device manufacture to facility operation.

Submitted By:
Mary Pat Finn, MHA, President
Perry Baromedical Corporation

Dear Members of the Undersea and Hyperbaric Medical Society (UHMS),

First and foremost, as President of the UHMS, I would like to extend everyone a happy, healthy, and prosperous holiday season as we move into the final months of 2024.  As we close this year, we will also enter the nomination period for UHMS board positions, beginning on December 3^rd.  Please come forward with nominations for candidates you believe best serve the society.  I would also like to encourage our new and young members to volunteer to help on UHMS Committees or Councils.  Our volunteers must be the next generation of experts.

Additionally, I would like to reinforce the value of hyperbaric facility accreditation and UHMS membership. Reach out to colleagues who may not be members but are enthusiastically practicing UHM. Also, reach out to centers that have yet to participate in the UHMS Accreditation Program. As we move forward, the accreditation process may be linked to the ability of hyperbaric centers to be reimbursed by CMS and private insurance carriers. Don’t be left behind.

With great enthusiasm, I share some transformative developments for our organization. Our society has long been committed to advancing the science, clinical practice, and applications of hyperbaric and undersea medicine. This year, we are embracing a new chapter to enhance our collective impact and broaden our reach.  In June 2025, we will resume a joint annual scientific meeting with the Aerospace Medical Association (AsMA) at the Hyatt Regency in Atlanta, Georgia.  This partnership represents an exciting convergence of expertise as both organizations explore extreme environments' physiological challenges—whether undersea, at high altitudes, or beyond. This collaboration will deepen our scientific and clinical insights and foster new, multidisciplinary research opportunities that will benefit both fields. Our annual meetings will now be co-hosted for the next five years, a commitment that reflects our shared dedication to growth and mutual learning.

Additionally, I am pleased to announce a leadership role that underscores our society’s evolving relationship with AsMA, the society from which we were born. John Peters, who has served as UHMS Executive Director with steadfast dedication for over a decade, has accepted an invitation to serve as Executive Director of the Aerospace Medical Association as well. With the full support of the UHMS Executive Board, John has signed a contract, crafted in collaboration with AsMA, to assume this dual role pending final approval from their board. We are confident that his leadership across both organizations will enhance alignment and foster collaboration, creating more enriching opportunities for our members.

Importantly, John has assured us that his commitment to UHMS remains unwavering. He has pledged to maintain his dedication to our society, with a contingency to step down from the AsMA role if it ever conflicts with his responsibilities here. His dedication, experience, and vision for the UHMS and AsMA make this a powerful step forward for both organizations.

I am excited about what lies ahead. This partnership elevates our annual scientific meetings and allows us to share valuable expertise with colleagues in aerospace medicine, many of whom are UHMS members. We are embarking on a journey that will strengthen both organizations and deepen the value we provide to our members and the broader medical community.

I am also pleased to share some recent achievements that reflect our society’s commitment to excellence in hyperbaric medical education and training. This past month, we celebrated the graduation of an additional 28 students from our P.A.T.H. program (Physician Advanced Training in Hyperbaric Medicine) at Northwell Health Phelps Hospital in Sleepy Hollow, New York. This accomplishment marks a significant step forward as we expand physicians' knowledge and expertise in undersea and hyperbaric medicine.

The PATH program remains robust and continues to thrive, underscoring the high demand for advanced training and the dedication of our educational teams. PATH participants have educated themselves beyond the Introductory Course in Hyperbaric Medicine (ICHM) they were required to successfully complete before the PATH program.  They have now moved on to better provide specialized hyperbaric care, and in doing so, they help reinforce our mission to improve patient outcomes through cutting-edge research and evidence-based practice.

We look forward to seeing how these graduates will contribute to our field and further the impact of hyperbaric medicine in their communities. The success of these programs reaffirms the UHMS’s role as a leader in undersea and hyperbaric medicine education by training physicians who will serve alongside our fellowship-trained and board-certified Undersea and Hyperbaric Medicine physicians.  Doing so assures that our specialty remains in capable hands for years to come.

I am also thrilled to share a remarkable milestone in our ongoing efforts to expand physician expertise in dive medicine. This past June, the Physician Training and Dive Medicine (PTDM) course reached a new record, training an unprecedented number of physicians from the United States and Canada in San Diego, California. Under the dedicated leadership of Dr. Pete Witucki, our UHMS immediate president, this two-week, 80-hour program combined intensive didactic sessions with hands-on, practical in-water training that challenged and inspired each participant.

The enthusiasm and energy these students showed throughout the program were substantial, and it was clear that they found the curriculum rewarding and rigorous. After completing the PTDM course, each participant will take a comprehensive post-program examination. Once they pass this final step, they will receive their certificates of completion and earn the prestigious DMAC 2D certification. This certification equips them to evaluate, diagnose, and manage medical conditions specific to divers, a vital skill set that strengthens our community’s ability to support safe diving practices.

This achievement underscores the importance and success of our PTDM program in preparing physicians for the unique demands of dive medicine. We are proud to see our society’s training initiatives reach new heights, and we look forward to the positive impact these newly trained professionals will have within the diving and hyperbaric medical communities.

As we look ahead to our annual scientific meeting in early June 2025 in Atlanta, Georgia, I want to reiterate that this year’s event will be held in collaboration with the Aerospace Medical Association, bringing together two dynamic fields for an unparalleled educational experience. This partnership represents a unique opportunity to broaden our perspectives and deepen our understanding of the science and medicine of extreme environments. The ASM planners from the UHMS and AsMA meet weekly to prepare for this event. We will have exciting keynote speakers this year, including Chris Lemons, highlighted in the documentary film “Last Breath” (2019), which centers on his harrowing experience in September 2012 while conducting maintenance work approximately 100 meters below the North Sea.  Chris faced a life-threatening situation when his umbilical cable—providing essential breathing gas, heat, and communication—was severed due to a malfunction in the support vessel’s dynamic positioning system. Remarkably, despite being stranded on the seabed with only a few minutes of emergency breathing gas from his bailout bottle, Chris survived for over 30 minutes until rescue teams found him lifeless and eventually resuscitated him.

I’m looking forward to hearing about Chris’s description of his return to life experience.

I encourage each of you to participate actively in this year’s meeting. We invite you to submit abstracts showcasing any noteworthy cases you’ve managed using hyperbaric medicine and highlighting ongoing research efforts within your hyperbaric centers. Sharing these insights enriches the scientific value of our gathering and fosters collaboration and innovation across our field. Your contributions—whether through presenting cases or research findings or simply engaging with fellow members of the UHMS and AsMA—are vital to making this a memorable and enlightening meeting.

Together, we can ensure it is one of our most impactful and educational gatherings yet. I look forward to seeing each of you there and witnessing the vibrant exchange of knowledge that our community does best. 

Thank you for your continued support and enthusiasm for the UHMS and these important initiatives as we make significant strides forward. It makes me proud to serve as the President of the UHMS. See you all in June!

Warm regards,

Owen J. O’Neill, MD, MPH, FUHM
President, Undersea and Hyperbaric Medical Society

Transcutaneous oximetry (TCOM or PtcO2) has arguably been the gold standard in assessing microvascular flow and predictive wound healing using hyperbaric oxygen therapy.

In the 1950s, the relationship between skin oxygen levels and arterial blood oxygenation was investigated, which initiated the later development of tools to measure transcutaneous oxygen levels. (Schmid, H. 1959).

As the technology improved, enhancements such as heated electrodes were introduced to improve accuracy, and the devices were eventually introduced into clinical practice, particularly when assessing patients with peripheral vascular disease and diabetes and measuring wound healing and tissue viability.

As the use of hyperbaric medicine in wound healing increased, TCOM was a natural choice for obtaining measurements to predict the success of healing with hyperbaric oxygen and measure the progress of improvement in vascularity by measuring the level of oxygen in interstitial fluids.

The National Board of Diving & Hyperbaric Medical Technology (NBDHMT) pioneered the certification of hyperbaric medical provider competency. It incorporated the application and interpretation of TCOM results into its certification competency to assure that the individual being “certified” was competent in administering TCOM testing. That testing included attending the didactic portion of the theory and skills and performing three proctored TCOM procedures under the supervision of a skilled technologist, physician, or nurse. This has been the standard of care since the early 1990s.

In September 2024, it was announced that the NBDHMT would no longer require the performance of three proctored tests to qualify for the certification examination. This was in recognition of the evolution of vascular testing that included the development of many different technologies to assess vascular patency and the increased cost of the TCOM devices with a concomitant low reimbursement for the procedure.

Even though proctored testing is no longer required, the competency of staff remains the responsibility of the facility leadership and should not be ignored with this change of policy. Regardless of the modality used to assess vascular patency, the facility is still responsible for the accuracy and clinical application of the chosen modality.

References:

H. Schmid, "Transcutaneous oxygen and carbon dioxide tension," *Archives of Surgery*, 1959.

Data from the Multicenter Registry were used to challenge the conclusions of a recently published paper in Retina on the treatment of central retinal artery occlusion (CRAO) with HBO2.

The article by Kalaw et al., Evaluation of Retinal Artery Occlusion and its Visual Systemic Prognosis after Hyperbaric Oxygen Therapy ¹, reported on a retrospective cohort of 27 patients and concluded that “Patients who develop retinal artery occlusion do not regain vision acuity after hyperbaric oxygen therapy. “

In a letter to the editor of Retina, the registry consortium pointed out that the patients in this study had an average of 40.6 hours between the onset of symptoms and the time to initiate HBO2 treatment. This delay was likely too long for HBO₂ to immediately impact vision. Additionally, patients with certain occlusions (cilioretinal artery), which usually have a better prognosis, were excluded from the analysis.

The registry data show that patients treated at Registry centers have, on average, an improvement in vision. The Registry currently includes 55 eyes with CRAO or branch retinal artery occlusion (BRAO), who received HBO₂ the same day as their initial visual acuity measurement and had at least one treatment. This is twice as many people in the Kalaw et al. study.  Figure presents pre- and post-visual acuity measurements in this cohort and shows that 44% of patients regained visual acuity, similar to what is seen in other studies.

Figure 1. Visual acuity (Logarithm of the Minimum Angle of Resolution (LogMAR)) pre- and post-HBO₂, all eyes are treated for CRAO or BRAO in Registry on the same day as the initial visual acuity measurement.

The registry provided a robust and data-driven response to an underpowered, retrospective study. This study, because it was published in a top ophthalmology journal, could affect ophthalmologic practice and lead to individuals not getting HBO₂ who otherwise would benefit from the treatment. The ability to contest these results with prospectively collected data from diverse centers demonstrates the value of consistently collected registry data for the future of hyperbaric medicine. 

References

1. Kalaw FGP, Chartrand N, Wedekind L, Chen JS, Lin AC, Koretz Z, Meller L, Oca M, Jagadeesh V, Wilson K, Walker E, Freeman WR, Toomey CB. Evaluation of Retinal Arterial Occlusion and its Visual and Systemic Prognosis after Hyperbaric Oxygen Therapy. Retina. 2024. Epub 20240814. doi: 10.1097/IAE.0000000000004253. PubMed PMID: 39163734.