We have had several examples recently of new standards (and regulations) replacing older versions, accompanied by discussion in each case of whether the new version was better than the old. One of these occasions involved pronouncements by the Centers for Medicare & Medicaid Services (CMS) and The Joint Commission (TJC) on the maintenance of medical devices following the manufacturer’s guidance versus (where not separately precluded) following an alternate equipment maintenance program. Another involved the use or non-use of power-strips, which was also triggered by TJC and CMS, and concerned in part which version of NFPA 101 (the National Fire Code Protection Association Life Safety Code) should be referenced.
You may also remember NFPA going hither and yon on isolated power and what is or is not a “wet” location. The FDA is not idle here either: With respect to the degree of appropriate regulation of “medical apps”, the agency first established them as Class I medical devices, but then more recently offered the possibly troubling approach of saying they are medical devices, but then proposing to ignore them.
Risks and Resources
A core question here is whether a new standard is always an improvement on the old. However, this question cannot be addressed until we first agree on what makes one standard “better” than another. Standards in our business aim in general to improve safety with a reasonable expenditure of human and financial resources. Improving safety (that is, reducing but usually not eliminating risk) is, we like to think, a technical question. What is the risk? Will doing X reduce the severity and/or frequency of the risk? Then there is the perhaps more difficult question of how much will risk be reduced, and the often overlooked corollary: Will we be able to measure the risk reduction, if any?
The question about the resources involved in reducing risk is not strictly a technical one, since it involves value judgments on how limited resources should be expended. In this regard, those creating a standard are rarely the ones who will have to implement it and pay for it. Here we must resist the if-only-one-life-could-be-saved argument, because, however appealing, it is not realistic. An analogy (subject to my father’s admonition that most analogies are odious and that one stinks in particular) is found in the availability of EMS services. I live in a large building with many older people. There is a risk of heart attack among the residents. We would all be safer if there was an ambulance staffed with EMS personnel permanently parked in front of our building. This would decrease response time and maybe make a difference in survival. But this would be true for every other building as well, and it is not economically feasible to have an ambulance in front of every building. So we collectively settle for a hoped-for maximum response time by more-remote emergency services.
The Standards Process
The process of developing standards, with varying degrees of openness, is supposed to lead to a collective judgment on what makes sense given what we think we know about the risks, whether that knowledge is based on real data or urban legend. The latter includes Ralph Nader essentially making up people being electrocuted in hospitals, and publishing this supposed fact in the well-known, technically oriented Ladies’ Home Journal in 1971. Nader’s article ultimately led to mandatory scheduled electrical safety testing and, now, its residual application to, for example, loaner equipment.
It is not surprising if this collective judgment behind standards development varies over time, including reversing itself, and re-reversing itself. There is also a possibility of participants in the process exercising self interest. For example, manufacturers have sometimes been accused of setting unreasonable maintenance and repair requirements because of the income that can be derived from such activities. A similar assertion sometimes heard is that authorities inclined toward dictatorial behavior create requirements without understanding their implications. Banning power taps received such criticism. In the past, the Environmental Protection Agency proposed banning ethylene oxide (EtO) sterilization because of the hazard to workers—until the medical community loudly explained how essential EtO sterilization is. It has also been the case that some of the people responsible for creating a standard then become consultants on how to meet the standard. Did they have this mind when they helped create a standard so complex that it requires a consultant to explain and implement it?
The BMET/CE/HTM community has a collective responsibility to support the development and application of reasonable standards, and to diligently apply those standards, especially when an entity with authority mandates it. Compliance with truly voluntary standards raises separate questions of whether or not to endorse their perceived value, and the liability and public relations exposure that might go along with not following a standard, even where the standard is not mandatory. Support of standards development includes being involved in the standards development process both as the actual writers of standards and as active participants in public comment periods, where applicable. We must also work together toward both developing new standards and changing or retiring existing standards when needed. Our professional organizations (and our accreditation agencies) play an important role here in both creating and revising standards, and in speaking with a strong yet studied voice when things need to be changed.
For the most part, standards are developed and revised with good intentions, but the process by which this happens is not flawless. As a result there are good standards, and not-so-good standards, and sometimes good, better, and worse are cyclical.
William A Hyman, ScD, is professor emeritus, Biomedical Engineering, at Texas A&M University, College Station, Tex, and adjunct professor of Biomedical Engineering at The Cooper Union, New York.