Healthcare and bulk medical gas system requirements

Since the late 1990s the regulatory requirements for installing and maintaining bulk systems that supply medical gases to healthcare facilities have been continuously evolving with new and upgraded requirements. In 2013 the latest in this evolutionary process, a new training and qualification requirement for bulk medical gas system verifiers is being introduced.

Since the late 1990s the regulatory requirements for installing and maintaining bulk systems that supply medical gases to healthcare facilities have been continuously evolving with new and upgraded requirements. In 2013 the latest in this evolutionary process, a new training and qualification requirement for bulk medical gas system verifiers is being introduced.

This latest evolution is focused on ensuring the individuals who inspect and approve these installations for use have the appropriate training and knowledge to comprehend the myriad of regulations that now apply. This article will recap those requirements and take a look at how this latest requirement will potentially affect the medical gas industry and the firms that install and maintain bulk medical gas systems.

The regulatory environment
Today there are four separate entities that promulgate and/or enforce requirements for bulk healthcare medical gas (HMG) systems.

The first and most well recognized entity is the Food and Drug Administration (FDA). Since HMG systems store and dispense on-demand a prescription pharmaceutical throughout a facility where they are installed, FDA regards them as falling within their prevue to regulate. HMG systems are essentially field assembled medical devices that perform a similar function to many other commonly used medical devices, such as insulin pumps and on demand intravenous drug delivery systems.

The regulations that the FDA applies to HMG systems can be found in the Code of Federal Regulations (CFR) Title 21, Section 211. These regulations cover everything from training and qualification of employees to testing, validation, maintenance, and documentation of all associated activities. FDA regulations are legally mandated requirements for all firms involved with HMG systems.

The second entity establishing requirements for HMG systems is the National Fire Protection Association (NFPA). NFPA requirements begin as a consensus model code developed and published by NFPA. These codes are subsequently adopted by local/state municipalities, where they gain the force of local law. Where FDA regulations are somewhat general and more interpretative in nature, NFPA requirements are fairly prescriptive and detailed. The two primary NFPA publications affecting requirements for HMG systems are NFPA 99 and NFPA 55.

The third entity is the Compressed Gas Association (CGA), who publishes an industry consensus document describing the medical gas industries thoughts on compliance requirements for installing and maintaining HMG systems. Due to the interpretive nature of FDA regulations CGA publication #M-1 provides some specificity on the actions firms need to take to comply with FDA regulations. CGA M-1 is a consensus publication which is referenced in NFPA codes. Firms installing and maintaining HMG systems should be in compliance with the requirements in CGA M-1.

The final entity is the American Society of Sanitary Engineers (ASSE). This association is dedicated to preserving public health and safety through the development and maintenance of product performance and professional qualification standards, whose sole purpose is to protect public health. ASSE is focused on all disciplines of the plumbing industry, one of which is medical gas piping. ASSE develops and publishes standards in two different areas, Product Standards and Professional Standards. The product standards address everything plumbing related, from the performance requirements for backflow devices to drain requirements for home dishwashers. The second area, Professional Standards, contains requirements for the training and qualification for installers and inspectors for a variety of plumbing related topics, one of which – The ASSE 6000 series, entitled Professional Qualification Standards for Medical Gas Systems Personnel – outlines a series of professional qualifications for individuals working with medical gas systems. The latest version of this document (2012) is approved by the American National Standards Institute (ANSI). ASSE standards, like NFPA codes, are as adopted by local municipalities and through that process have the force of law.

Even fewer have probably
ever received appropriate training in FDA Good Manufacturing Practice

The 6000 series contains a variety of standards that cover the qualification of personnel who perform installation, maintenance, inspection and system verification activities at healthcare facilities. The key standards are Standard 6010 – Medical Gas System Installers; Standard 6015 – Bulk Medical Gas System Installers; Standard 6020 – Medical Gas System Inspectors; Standard 6030 – Medical Gas System Verifiers; and the newest addition, Standard 6035 – Bulk Medical Gas Systems Verifiers.

When you look at the output from these four entities there are currently almost 1,500 individual requirements, all of which are applicable to the installation and maintenance of HMG systems.

The evolution of ASSE standards
The ASSE 6000 series of standards establish training and qualification requirements for the various roles individuals perform in installing, maintaining, inspecting, and verifying various elements of medical gas and vacuum systems inside healthcare facilities.

Series 6000 also contains qualification requirements for individuals who are instructors of the various ASSE 6000 standards. An important element to all ASSE 6000 series standards is that an individual must successfully pass a test before they can become accredited under that standard. Another important element is that any training must be performed by an individual accredited as an ASSE instructor.

The ASSE 6000 series of standards began their evolution with 6010, which covers installation and commissioning activities of medical gas and vacuum piping systems inside the healthcare facility. Along with the 6010 standard came the 6020 standard covering Medical Gas Systems Inspectors, and 6030 covering Medical Gas Systems Verifiers. As the various states implemented these standards, they helped to assure the integrity of piped medical gas systems nationwide. Ensuring individuals installing piping systems had the prerequisite training and knowledge they needed cut down on installation errors. Also making sure the individuals who came behind the installers to verify the proper operation of the system prior to releasing the system for use had adequate training and qualifications was another key step in further assuring the quality of medical gas piping systems inside US healthcare facilities. Today, certification to 6010 for installers and to 6030 for verifiers is a ubiquitous requirement throughout the US.

In 2006 ASSE recognized that bulk medical gas systems and healthcare piping systems inside the facility were two totally different animals. In response, they developed and released the 6015 standard which specifically applies to bulk medical gas systems. B&R Compliance has been very active in certifying bulk gas technicians around the US to the 6015 standard. However, one piece of the puzzle remained missing, which was a training and certification program for the verifiers who work with bulk systems.

Currently it is doubtful that the majority of bulk system verifiers have ever received any formal training on the design, operation, installation, and maintenance of HMG systems. Even fewer have probably ever received appropriate training in FDA Good Manufacturing Practice (GMP) requirements as they pertain to medical gases and bulk medical gas systems. The new ASSE 6000 Series Standard – ASSE 6035 – is a move to close this gap.

ASSE 6035
This new standard applies to any individual who tests and verifies the operation of bulk systems for medical gases at healthcare facilities.

Even though NFPA added a requirement that HMG systems be installed in accordance with FDA cGMP regulations in 2005, prior to the introduction of ASSE 6035 verifier qualification has remained primarily focused on the applicable (medical gas piping) sections of NFPA 99. Under this new standard, bulk system verifiers will need to have a much broader understanding of both the systems they are verifying and the regulations applicable to those systems.

The curriculum for qualifying bulk system verifiers will encompass oxygen-rich atmospheres, oxygen cleaning, identification and function of the various bulk system components, system sizing and component selection and analytical requirements for medical gases. Further training in FDA cGMP requirements for both finished pharmaceuticals and medical devices and CGA publication M-1 are also part of the qualification requirements under ASSE 6035.

 

MRI gases medical dewars

Source: Air Products

New verifiers must have a minimum of two years documented experience in the verification and/or inspection of bulk medical gas systems and successfully complete a minimum 32-hour training course that includes a written examination covering FDA cGMP’s, CGA M-1, and applicable sections of ASSE 6000, NFPA 99, and NFPA 55. Verifiers currently certified to ASSE 6030 (medical gas systems) must successfully complete a 16-hour training session covering the same topics.

As local municipalities begin implementing this new ASSE standard we anticipate that individuals currently offering verification services will look to upgrade their certification to the new ASSE 6035, and this is where medical gases firms may start to experience problems, because as the old adage states, a little knowledge can be a dangerous thing. Many of these newly minted ASSE 6035 verifiers will be attempting to pass judgment on a firm’s compliance with CGA M-1 and FDA regulations after having received only 16 hours of training. It is also likely that some ASSE 6035 instructors will be attempting to train verifiers when they themselves have only received 16 hours of additional training in the nearly 1500 regulatory and industry requirements that focus on HMG systems.

We anticipate bulk medical gas system installers will likely encounter verifiers who, early on, may not possess the breadth of background and training they need to adequately understand some of the technical and regulatory details involving HMG systems. Areas we can foresee as potential problem issues would include equipment and system sizing and the installing firm’s compliance with applicable FDA regulations. These potential problems could lead to delays in bringing a new or upgraded HMG system online at a healthcare facility.

Preparing for this new standard
Over the next few years as implementation of this new standard moves forward there are things firms installing and maintaining bulk medical gas systems can do to be prepared when challenged by a newly minted ASSE 6035 verifier.

We strongly recommend firms who install and maintain HMG systems should perform a vendor qualification of any firm they intend or expect to either use or recommend as a bulk medical gas system verifier. During this vendor qualification one of the most important things to determine would be, has the verifier been trained by an instructor who possessed the appropriate experience and background in the gases industry, and did that instructor have the appropriate level of knowledge of FDA, CGA, and NFPA requirements – and, even more important, how those requirements apply to HMG systems.

We anticipate there will be a number of current ASSE instructors who will look to expand their business and offer training for ASSE 6035. It is likely some of these instructors will not possess the background and training that would enable them to adequately train new ASSE 6035 verifiers. By pre-qualifying your verifiers you can avoid any potential site delays over misunderstandings regarding how your system complies with the myriad of regulatory requirements.

We recommend firms ensure their verifiers have the appropriate training and accreditation (or credentials) from a qualified and independent third party organization such as the Medical Gas Professional Health Care Organization (MGPHO). MGPHO is the professional association for firms that inspect and verify medical gas piping systems, and is dedicated to advancing the safe design, manufacture, installation, maintenance, and verification of medical gas and vacuum systems through education. Using ASSE 6035 verifier’s that have received their training and accreditation through MGPHO is a way of ensuring that they are adequately trained and qualified in bulk medical gas systems.

Another step in the verifier qualification process would be to ensure they have operating procedures for conducting and documenting any activities pertaining to HMG’s, and that their employees have received documented training in those procedures. We further recommend determining how the contents of those procedures stack up against the requirements found in FDA, CGA, and NFPA for items such as personnel qualification, process documentation, and quality control unit activities. If a verifier does not have HMG specific procedures, if their employees have not been training in those procedures, or their procedures do not align with FDA, CGA and NFPA requirements, then it is probable that their knowledge of the regulatory requirements for HMG systems is not quite up to the task.

A final suggestion for firms that install and maintain HMG systems is to ensure the documentation associated with installation and maintenance activities facilitate easy site verification of compliance to all regulatory requirements by the bulk system verifier. You will need to coordinate with your verifier what documentation they will need to examine to approve the system. Ensuring you can produce the appropriate documentation for the verifier at the site should eliminate potential delays in putting the system online.

Like all changes to regulatory requirements, there will be a learning curve for both verifiers
and firms that install and maintain HMG systems, but ultimately the implementation of the new ASSE 6035 Bulk Medical Gas Verifier Qualification Standard will help to further assure the quality and integrity of piped medical gas systems in the US.

News reference http://www.gasworld.com/specialty-gas-report/healthcare-and-bulk-medical-gas-system-requirements-a-further-evolution/2001891.article

Comments are now closed for this article.