The interpretation of codes and standards is one of the areas of the certification in clinical engineering (CCE) examination under the topic of “Technology Management.” This section contains 25% of the CCE examination. For a complete list of CCE examination topics, see the 2008 Candidate Handbook for Certification in Clinical Engineering, at www.accefoundation.org/certification.asp.
A clinical engineer should have a good understanding of the codes and standards that pertain to the use of medical equipment in the hospital. “Codes and Standards” is also one of the topics in the CBET, CRES, and CLES examination—see the Applicant Handbook, available at www.aami.org/certification/download/handbook.2008.pdf.
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There are thousands of organizations, including various state and federal agencies, that promulgate voluntary and mandatory standards for the health care field. These organizations issue standards, clinical practice guidelines, laws, and regulations. These organizations also disseminate a variety of requirements for different types of equipment (eg, imaging, nuclear, anesthesia, and respiratory), electrical safety, fire safety, power distribution, medical gas systems, clinical laboratories, and blood banks. The terms “codes,” “standards,” and “regulations” are often used interchangeably.
Defining Standards
A standard establishes a minimum level of performance and is used to standardize test methods, specifications, definitions, or practices. Most standards are voluntary. Examples include the standards developed by The Joint Commission, the Association for the Advancement of Medical Instrumentation (AAMI), the American Association of Blood Banks (AABB), the National Fire Protection Agency (NFPA), and the College of American Pathologists (CAP).
Compliance with a standard is mandatory only when required by an Authority Having Jurisdiction (AHJ). According to NFPA 99 (2005 edition), an AHJ is “an organization, office, or individual responsible for enforcing the requirements of a code or standard, or for approving equipment, materials, an installation, or a procedure.” For example, the Arizona Administrative Code, Title 9, refers to NFPA 99 and other standards. This makes NFPA 99, which is a voluntary standard, into a mandatory requirement.
What Is a Code?
A code is a system of standards relating to a particular topic. Government or private entities may adopt it in whole or in part. For example, the 2002 California Electrical Code incorporates the full text of the 2002 National Electrical Code (NEC) with amendments, changes, or deletions. Enforcement of the code lies with the government (local, state, or federal) turning the standards into regulatory documents. Examples of codes include NEC (NFPA 70) and Life Safety Code (NFPA 101). Compliance with a code is mandatory only when required by an AHJ.
Understanding Regulations
A regulation is a document that is issued by a government entity. It may include in whole or in part a standard or—in lieu of inclusion—a reference to a standard. It has the force of law from the start. Examples include the Code of Federal Regulations, the California Code of Regulations, and the Arizona Administrative Code.
Facing Limitations
The standards and regulations are based on past experience and can inhibit modernization or limit progress. Usually, their scope is limited and could be inappropriate for unforeseen situations. When using a standard, it is important to know the origin, the background, and the last revision date. Participation in the development of standards and regulations requires time and money, which many individuals and small organization cannot afford.
A Checklist in Using a Standard
When using a standard, it is important to know which organization was involved in the development. As standards go through a process of periodic revision and update, it is essential to know when it was developed or last revised and when the future revision will come. You need to know if the standard is mandatory and which organization requires compliance.
The voluntary organizations of interest to clinical engineers and BMETs include The Joint Commission, CAP, AABB, NFPA, AAMI, American Osteopathic Association, Underwriters Laboratories, International Organization for Standardization, American National Standards Institute, and the Accreditation Association of Ambulatory Health Care. The federal agencies of interest to clinical engineers and BMETs include the FDA, Federal Communications Commission, Occupational Safety & Health Administration, and the Nuclear Regulatory Commission. State agencies and local agencies also may issue regulations that govern the use of medical equipment in hospitals in their states and local jurisdictions.
Review Questions
- Compliance with a clinical engineering standard is mandatory only when____.
- It is an AAMI standard
- It is recommended by ACCE
- It is required by an AHJ
- All of the above
- Which of the following is not a voluntary standards organization?____
- The American Osteopathic Association
- The American National Standards Institute
- The Federal Communications Commission
- The Joint Commission
- A ____ has the force of law from the start.
- Regulation
- Standard
- Guideline
- None of the above
- The following standard-making organization(s) is/are of interest to clinical engineers and BMETS ____.
- The Joint Commission
- The College of American Pathologists
- The American Association of Blood Banks
- The National Fire Protection Association
- All of the above
- The Arizona Administrative Code (Title 9) refers to NFPA 99. This makes the NFPA 99, which is a voluntary standard, into ____.
- A requirement for all the health care facilities in Arizona only.
- A requirement for all the health care facilities in all the 50 US states.
- A requirement only if a health care facility in Arizona chooses to follow NFPA 99.
- None of the above
See the answers
Arif Subhan, MS, CCE, is a senior clinical engineer, Masterplan, Chatsworth, Calif, and chair, education committee, ACCE. For more information, contact .
