Can one use and/or obtain a third party (AEM) maintenance company for servicing and repair of their hyperbaric chambers and still meet current accreditation requirements as well as keep in compliance with the Joint Commission?
Revision Date: 08-2019
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.
Regarding: The use of a 3rd party or in-house staff to provide Alternative Equipment Maintenance (AEM), or the necessity to use the Original Equipment Manufacturer (OEM) for service and repair of hyperbaric chambers.
The SC can provide information only and the responsibility of maintaining compliance with the UHMS Accreditation Program and The Joint Commission is with the administration, the medical director and hyperbaric safety director of the facility.
We are not aware of a specific survey probe from a UHMS accreditation survey that requires you to use the manufacturer. There are several references regarding record keeping, PM schedules, and the maintenance of original design specifications.
The Joint Commission (TJC) does have standards for certain facilities that identify when OEM is required and when you can use AEM. Both CMS (December 2013) and The Joint Commission (July 2014) have specific guidelines for hospital preventive maintenance programs. In the most recent revisions there were changes related to AEM Programs. The CMS document has the best guideline on how to appropriately place a piece of equipment on an AEM program and should be read carefully.
Below is a summary of the CMS Hospital Equipment Maintenance Guidelines that was published in a memo on December, 2013 (see attached: survey-and-cert-letter-14-07.pdf).
S&C 12-07-Hospital Superseded: We are updating previously provided guidance to clarify:
- Hospital facilities, supplies and equipment must be maintained to ensure an acceptable level of safety and quality.
- A hospital may adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment by qualified personnel, unless:
- Other Federal or state law; or hospital Conditions of Participation (CoPs) require adherence to manufacturer’s recommendations and/or set specific requirements. For example, all imaging/radiologic equipment must be maintained per manufacturer’s recommendations; or
- The equipment is a medical laser device; or
- New equipment without a sufficient amount of maintenance history has been acquired.
- Hospitals electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish.
There may be good reasons to either use OEM, AEM or a combination of both. Alignment with TJC, CMS and the NFPA requirements, warranty issues as well as defining who is qualified to work on your equipment are important to consider. (It is also possible that the manufacturer will refuse to sell OEM parts and require that their own technicians perform the work.) Hyperbaric chambers are considered by the FDA as class 2 devices. As such, the manufacturer’s recommendations should be followed. Documentation of maintenance and compliance with the manufacturer’s specifications are required to be kept on all equipment per NFPA 99 Codebook, the UHMS Accreditation Manual and the UHMS Hyperbaric Facility Guidelines. UHMS Accreditation Manual, Fourth Edition, HBOM 2.1, HBOM 1.0 – 7.1; NFPA 99, 220.127.116.11.1.1; HFG Section 2, 3, 4
Listed below are some things you may want to consider in addition to the above comments when choosing whether to use the manufacturer, your own staff or a 3rd party contractor for maintenance:
- This issue should be raised during the initial procurement and/or installation contract. Sometimes it is impossible to get an OEM to agree to another contractor performing maintenance, but it is worth the question before a contract is signed.
- A new facility usually has a warranty period and it is unwise to make changes or use other contractors until this period has expired.
- The OEM, where still available or in existence, may have proprietary software installed, making this difficult to circumvent.
- In some cases, the OEM does not offer services that are to the satisfaction of the chamber owner; as such, the owner should be allowed to employ a contracting company on the basis of:
- Proven competence and track record
- Ability to service equipment and provide expertise
- Value-added service that offers at least some degree of investigation into the quality and safety of the maintainer.
- A hyperbaric facility may contain aspects not covered by the chamber OEM – examples are compressors, filtration systems, gas supplies, electrical supplies, computer (patient) monitoring systems, medical equipment and so on. It would be wiser to contact these OEM’s for servicing, unless the chamber OEM has modified the equipment and provided some form of warranty for these changes.
- It is vital to determine that the external (AEM) contractor has a full and working knowledge of the chamber. They must demonstrate this competence to the satisfaction of the chamber owner.
- We encourage you to be mindful of the competence of the person(s) completing the work, observance of safe work behaviours, and the quality of maintenance documentation provided to you. Also, consider the need for follow-up testing after maintenance work has been conducted.
- The contractor must offer a warranty for their work for a period of time after the work has been completed. This is not the same as an OEM warranty when the system is new.
- The contractor should show proof of liability insurance in the event that a mistake is made that would jeopardize the integrity of the chamber or cause harm to personnel or occupants.
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.