NFPA 99 has long been recognized in the health care technology management profession as a fundamental guide for managing medical equipment. The 2012 edition represents a major revision of the document that will have a substantial impact on our work as clinical engineers and biomedical equipment technicians.
Why was a major revision needed? One reason was that since its first edition in 1985, NFPA 99 has been a sort of mash-up of various earlier documents. For that reason alone, a thorough review of the document’s scope and its internal consistency was in order.
Another reason was to recast NFPA 99 from “standard” to “code.” In NFPA jargon, standards are akin to guidelines that organizations may choose to follow. On the other hand, codes mandate very specific minimum requirements and are suitable for adoption and enforcement by legal authorities. The two best-known NFPA codes are NFPA 70 National Electrical Code and NFPA 101 Life Safety Code, both of which have the force of law in many jurisdictions.
Soon after the 2005 edition of NFPA 99 was released, the National Fire Protection Association (NFPA) initiated a project to completely rewrite the document, with a target of 2010 for a revised edition. A proposed 2010 edition was rejected in June 2009 and returned to the committee for further review. The primary concern at that time was that the many changes in content and format needed to be better integrated. Also, some of the proposed changes were highly controversial.
After extensive review and editing by the NFPA 99 technical committee, a proposed 2012 edition was created. That proposal was formally accepted at the NFPA’s Association Technical Meeting in Boston in June 2011. The result is the official 2012 edition of NFPA 99 Health Care Facilities Code.
One fundamental change in NFPA 99 (2012) is a move from basing requirements on the type of occupancy to basing them on patient risk. In the 2005 edition there were separate chapters for hospitals, nursing homes, and other occupancy types. Requirements for electrical and medical gas systems and equipment were based on the type of occupancy in which they were installed.
However, in recent years there has been a proliferation of different types of patient care facilities, many with substantial overlap in terms of patient acuity and risk. In an alternative approach, NFPA 99 (2012) defines four Building System Categories that represent different levels of patient and staff risk that could result from system and equipment failures.
Category 1: Failure of such equipment or systems is likely to cause major injury or death of patients or caregivers. Systems are expected to work or be available at all times to support patient needs.
Category 2: Failure of such equipment is likely to cause minor injury to patients or caregivers. Systems are expected to provide a high level of reliability. However, limited short durations of equipment downtime can be tolerated without significant impact on patient care. Category 2 systems support patient needs but are not critical for life support.
Category 3: Failure of such equipment is not likely to cause injury to patients or caregivers, but can cause patient discomfort. Normal building system reliabilities are expected. Such systems support patient needs, but failure of such equipment would not immediately affect patient care. Such equipment is not critical for life support.
Category 4: Failure of such equipment would have no impact on patient care and would not be noticeable to patient in the event of failure.
For all major building systems, health care facilities will need to conduct a risk assessment process to determine which categories those systems fall into. The results of the risk assessment will determine what requirements of the code are applicable to those systems.
NFPA 99 (2012) also expands the definition of a Patient Care Room to include “any room of a health care facility wherein patients are intended to be examined or treated.” In parallel with the risk-based approach for defining Building System Categories, four types of patient care rooms are defined.
Critical Care Room: A room in which failure of equipment or a system is likely to cause major injury or death of patients or caregivers.
General Care Room: A room in which failure of equipment or a system is likely to cause minor injury to patients or caregivers.
Basic Care Room: A room in which the failure of equipment or a system is not likely to cause injury to the patients or caregivers but can cause patient discomfort.
Support Room: A room in which failure of equipment or a system is not likely to have a physical impact on patients or caregivers.
Health care facilities will need to identify their Patient Care Rooms and define the type of each room. This process will determine which aspects of the code apply.
Electrical Safety Inspection
NFPA 99 (2012) offers the organization greater latitude in defining test procedures and schedules for medical equipment. This brings the code into agreement with current practice and the standards of accrediting agencies such as The Joint Commission. For example, with regard to testing intervals, paragraph 10.5.2.1.1 says only that “the facility shall establish policies and protocols for the type of test and intervals of testing for patient care-related electrical equipment,” without the more prescriptive language of previous editions.
A potentially far-reaching change in NFPA 99 (2012) eliminates the requirement for routine electrical safety testing. Specifically, paragraph 10.5.2.1.2 says that “all patient care-related electrical equipment used in patient care rooms shall be tested in accordance with 10.3.5.4 (which addresses chassis leakage current) or 10.3.6 (which addresses lead leakage current) before being put into service for the first time and after any repair or modification that might have compromised electrical safety.”
According to commentary in the handbook version of the code, “The technical committee has decided that there is now sufficient experience to justify using the approach of performing the tests for touch and leakage current at the time of incoming inspections and following patient care-related equipment repairs or modification. This is considered both a more effective method to ensure patient electrical safety and a more judicious and focused use of technical resources.”
In many health care facilities, a substantial portion of the scheduled inspection and maintenance effort has consisted of electrical safety testing. We now have decades of experience showing that routine electrical safety testing is of little benefit to patient safety, particularly when compared to the cost of such testing. In the absence of a requirement in NFPA 99 (2012) for such testing, it will be hard to justify the continued allocation of scarce resources for this purpose.
Some people I have talked to in the profession expect to continue routine electrical safety testing, at least temporarily, on the theory that it is important for medical equipment to be regularly located and looked at, even if electrical safety testing itself is of little value. However, in the long run, we will need to move toward “evidence-based maintenance” or “reliability-centered maintenance,” in which we focus our resources on activities that produce benefits worth their cost.
Previous editions of NFPA 99 included a chapter on requirements for manufacturers. Over the years, many members of the health care technology management profession have pointed to a requirement in that chapter for manufacturers to provide service manuals with their equipment. However, there has been little success in getting uncooperative manufacturers to provide manuals as a matter of compliance with NFPA 99.
The chapter on manufacturer requirements has been removed from NFPA 99 (2012). This is in recognition of the fact that design and manufacturing requirements are addressed in great detail in other codes and standards. The 2012 edition of NFPA 99 has sharpened its focus on operational and maintenance issues, which are not well addressed by other codes and standards, and has moved away from design and manufacturing issues.
However, in the interest of effective maintenance, NFPA 99 (2012) still includes a requirement for manufacturers to provide service manuals. Indeed, it goes on at some length to specify the type of information that must be included in these manuals, hopefully forestalling the prospect of service manuals so brief as to be useless. Will the requirements of this edition be more effective than those in previous editions? Time will tell.
Isolated Power Systems
The most controversial change in the 2012 edition is in regard to isolated power systems, particularly for operating rooms. As specified in NFPA 70 National Electrical Code, an isolated power system (and the associated line isolation monitor, or LIM) are generally required in any operating room that is designated as a “wet location,” as defined in the code. It is important to keep in mind that, in this context, a “wet location” is not a place that simply gets wet from time to time; it’s a location in which patients and clinicians are normally subject to conditions that require the use of special electrical distribution systems to protect them from electrical shock.
Based on the best evidence, the consensus in the clinical engineering community is that isolated power systems do not provide significant safety benefits for OR staff and patients, especially when the cost of these systems is considered.
In the 2005 edition of NFPA 99, the decision to designate an area as a wet location was made by the hospital’s governing board. Ideally, this decision was based on policies developed by the engineering staff. However, in the 2012 edition an operating room is presumed to be a wet location (now referred to as a “wet procedure location”) unless a specified risk assessment process determines that it is not. In other words, despite the evidence and engineering consensus, the default is installation of isolated power. For this reason, an evidence-based risk assessment process should be conducted whenever the issue of an isolated power system arises.
It remains to be seen if the various authorities having jurisdiction (AHJ) will adopt and enforce NFPA 99 (2012). Because the document has been recast as a code rather than a standard, there is more potential for governmental entities to specifically adopt NFPA 99 as code (rather than simply including it in a list of referenced standards, as is done now in many states). This would likely result in a higher level of enforcement of NFPA 99 provisions. The 2012 edition of the document includes an Annex that provides a sample ordinance for use by government agencies to formally adopt NFPA 99.
Neither the Centers for Medicare and Medicaid Services (CMS) nor The Joint Commission has yet to specifically address adoption of NFPA 99 (2012). The Joint Commission’s general stance on codes and standards is to immediately follow CMS when it moves to a new edition of a code or standard. Historically, CMS has been slow to adopt new editions because to do so may require federal legislation to amend the applicable regulations. However, there have been some recent efforts within CMS to move more quickly toward the latest standards of practice.
As clinical engineers, biomedical equipment technicians, and others in the health care technology management profession, we should keep our eyes open for implementation of NFPA 99 (2012) by the various AHJ that are relevant to our organizations. In the meantime, it would be prudent for us to plan ahead for implementation of the new edition. We can certainly move forward, in cooperation with our colleagues in facilities engineering, to define Building System Categories and types of Patient Care Rooms that are found within our facilities.
If we have construction projects coming that involve electrical systems in operating rooms, we should get ready to conduct a risk assessment regarding the need for isolated power. And we should start thinking, individually and as a profession, about how to proceed if we choose to do away with routine electrical safety inspections.
So get a copy of NFPA 99 (2012) and start familiarizing yourself with it. You can order online, and you can get either an Adobe Acrobat (PDF) version, which will allow you to search the document more easily, or a printed version. My recommendation, however, is to get the handbook version. The handbook includes the full text of the code plus lots of explanatory material and helpful illustrations. It is a bit more expensive, but worth every penny when trying to get a sense of such a complex document.
There are interesting times ahead. Stay tuned!
Matthew F. Baretich, PE, PhD, is a member of 24×7‘s editorial advisory board and president of Baretich Engineering, Fort Collins, Colo (www.baretich.com.) He is a consultant in clinical engineering, health care facilities engineering, and health care-related forensic engineering. For more information, contact.