Device Standardization Can Be Dangerous

By William A. Hyman

Standardization is often cited as a means for adding to patient and/or staff safety. However, this may be confused with standardizing on the multiple products of a particular manufacturer for reasons other than product performance. These two types of standardization might be called performance standardization and business standardization. The safety argument for performance standardization takes the general form of asserting that if everyone does some process the same way, or uses the same device, this will always be good. Despite such general claims and assumptions, performance standardization can only be beneficial if what is made the standard is, in fact, an optimal method or device.  If suboptimal, then such standardization can degrade safety rather than enhance it, while also creating the belief and the assertion that improvement has been achieved when this is not in fact the case.

Business standardization may take the form of using only the various products of a particular manufacturer. This is likely to be a cost or logistical convenience consideration rather one of safety that arises from the individual characteristics of each product. In some regulated areas such as blood borne pathogens a business case may not be used as the basis for selecting products that help protect against accidental sharps injuries. Manufacturer standardization might also arise from compatibility considerations, although this should be the end result of a safety assessment rather than the basis for selection.

Actual performance and safety improvement requires appropriate consideration of what type of standardization is being considered, the basis for the standardization, and whether the proposed standardization is, in fact, universally appropriate.

Types of Standardization for Safety
Safety standardization can take many forms related to processes and/or equipment. Process standardization can specify information flows, abbreviations, vocabulary, or activities such as pre-surgical “timeouts.” Information flows can include such things as handoff communications, electronic records and their dropdown menus, pre-printed forms, etc. The inconsistent use of abbreviations has been identified as a cause of error, but agreeing on what abbreviations to use does not automatically mean that proper usage will be obtained and confusion eliminated. Electronic communications can share the attribute that they can be helpful if they are well-designed and properly executed, but dangerous if they are not. In some circumstances, electronic forms can stifle communication and dropdown menus have been shown to have limitations in proper completion and execution, and therefore to generate, rather than reduce, errors. The extensive discussion in the last few years of the frustrations of electronic health records (EHRs) has shown that merely having a structured EHR is not good enough to enhance safety and efficiency without assurances that the EHR information input and extraction is consistent with desirable clinical processes.

Medical devices are frequent targets of standardization, although not always with good reasons. If only one model of a generic type of device is used, it is sometimes argued, training will then be simplified, user familiarity enhanced and errors reduced. But this assumes that the best designed medical device for the purpose is the one being used and that it is universally applicable for all clinical activities in which the use of this type of device may arise. If an error-prone device is selected, simplified training will not overcome its inherent difficulties. In addition, when diverse clinical activities and patient needs would benefit from different devices, standardization on only one device will result in less than optimum-and possibly dangerous-performance for at least some activities.

An Example From “Safety” Syringes
The appropriate selection of syringes that provide a healthcare facility’s staff with protection from needlestick injuries is mandatory under OSHA regulations. There are a number of designs of such products that are collectively called “safety syringes” or “safety-engineered syringes.” Despite the use of the word “safety” in many of their product names, these devices have different use characteristics, and they can provide different degrees of reduction in needlestick injuries, if any reduction at all.

In addition to varying degrees of safety, some products may be best suited for only a subset of syringe-based activities. For example, a fixed-needle device is most appropriate for injection and less applicable for accessing needleless connectors. A removable needle with a non-Luer thread also limits such connections. Similarly, a safety needle device in which the safety feature is activated when the full contents are expelled may not be applicable in situations where only part of the contents of the syringe is to be used, or where the same syringe is to be filled several times for the same patient as in the operating room. Devices that target specific applications may not be candidates for safety syringe standardization, but that does not mean that they would not enhance safety when their use is appropriate. On the other hand, safety syringes based on conventional syringes and needles may be more versatile but offer less protection to the user, i.e. they may have a higher injury rate than less versatile alternatives. In this case, standardizing on versatility would put healthcare workers at greater risk of injury.
Suppose, for example, an application-specific safety syringe can prevent 100 percent of needlestick injuries for its intended purposes, while a more versatile device prevents only 30 percent of needlesticks. If there are 1,000 uses over some period, standardized use of the 30 percent-safe device will result in 300 needlestick injuries. If the 100 percent-safe devices can be used in 50 percent of applications, then those uses will result in zero needlesticks. If the 30 percent-safe device is used in the other 50 percent of applications, there will be 150 needlesticks, for a total of 150 needlestick injuries for the combined use of the two products. Thus, standardizing on the 30 percent-safe device results in 300 sticks, while using the better device where it can be used, and the marginally-safe device elsewhere, results in half as many total needlesticks. This is illustrated in the chart below.

Of course, the numerical results will differ with the relative safety of the two devices and their relative use. However, the principle will remain the same. Standardizing on a device with inferior (or marginal) safety performance just for the sake of standardization will result in greater overall needlestick injuries to the detriment of the clinical staff using the devices. Staff injuries also disrupt hospital activities and increase costs.

It can be noted here that needlestick prevention was the subject of failed standardization even before the safety-engineered era. The call for “no needle recapping” and the increased availability of sharps containers, with associated training, was a standardized approach to preventing needlestick injuries. These efforts failed because the real world of clinical use did not conform to the imagined ideal environment of each user carefully carrying contaminated needles and syringes to a sharps container that was not overfilled or otherwise dangerous. The new Occupational Safety and Health Administration (OSHA) requirements to use safety-engineered syringes, based on a legislative mandate, recognized that the old standard didn’t work and that a new standard was required. Similarly, standardizing on a safety-engineered device based on factors other than actual safety leads to the wrong outcome. The personal safety of syringe users should not be sacrificed to the false notion that standardization is always desirable.

Device selection should be based primarily on which device provides optimal performance and safety for the application, even when this process leads to the use of varying products for different purposes. Standardization in the form of using only product should not be accepted as a valid argument unless it can be shown that such standardization actually does overcome some specific risk related to the use of different devices for different purposes. If training on multiple devices is an issue, then it must actually be shown that the training challenge cannot be overcome and that it creates more risk than the use of the best device in each practice area. Other factors such as supply chain simplification and cost should be considered only after patient and staff safety issues have been resolved.

Remember, “one size fits all” often results in a rather poor fit.

William A. Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University and adjunct professor of biomedical engineering at The Cooper Union. His primary areas of professional activity are medical device design, system safety and human factors, and clinical engineering. He is contributing editor of the Journal of Clinical Engineering and has served as a consultant for the FDA, NIH, NASA and medical device companies. He currently participates in the ANA Sharps Injury Prevention Stakeholders group. Hyman is a recipient of the American College of Clinical Engineering’s Lifetime Achievement Award, and he is Fellow Emeritus of the Biomedical Engineering Society. He has published and presented on the subject of syringe needle safety.