Making the Best Use of Your Sharps Injury Log
By William A. Hyman
The Occupational Safety and Health (OSHA) Bloodborne Pathogens Standard (1910.1030) mandates the maintenance of a sharps injury log (1910.1030(h)(5)(i). The key elements of this log are an identification of the product being used by type and brand, the work area where the incident occurred, and an explanation of how the incident occurred. There are at least two ways to think about the sharps injury log requirement. One is that it is merely a regulatory burden that is maintained only because there is a requirement to do so. The other perspective is that regulatory burden or not, it can in fact be a useful tool for recording and analyzing sharps injuries to identify actions that could be taken to reduce the incidence of injuries. Such use is implied by the requirement at 1910.1030(d)(2)(ii) to examine engineering controls on a regular schedule to ensure their effectiveness.
If the log is to be useful, the first requirement is that the information collected be accurate and thorough. With respect to product identification, it is essential that the information identify the actual, commercially available product that was being used. This information will become critical to evaluating whether products with claimed safety features are achieving their stated objective. Thus syringe or safety syringe are clearly not acceptable since such terms to do not identify a specific product. Furthermore, even descriptions such as Brand X syringe or Brand X safety syringe are not adequate because Brand X may produce a number of different products under the same brand name, and even under the same model name. The standard thought test for adequacy of the description must be, Could I purchase the identical device on the basis of the information recorded?
An adequate description of the event is even more challenging, but equally essential to the use of the log as a safety improvement tool. The description should be sufficient to mentally recreate not only the general situation of use (e.g., giving injection, drawing blood), but to detail the exact primary and secondary tasks being undertaken when the stick occurred. For example, for an injection, the primary task can be divided into a number of steps, including: obtain syringe, unwrap/uncover, load, engage patient, inject, support patient, operate safety feature, transport to disposal, and dispose. Secondary tasks might include responding to an unplanned patient response or another event. With respect to the real-world value of safety features, it is critical to identify if the injury occurred before, during, or after the manual activation of the safety feature.
Injuries associated with using the safety feature might suggest that the feature is difficult to use, or that the design introduces additional means of injury that even the non-safety version of the product does not have. Safety features that require the use of both hands are of particular concern because any time the other hand is brought into use, the opportunity is presented to stick that hand. Correct use of the safety feature and the adequacy of the associated training will also be of interest in the subsequent analysis. However, remember that failure to operate a device correctly should not always be attributed to the user or the training involved. The principles of human-factors engineering tell us that a device that is overly difficulty to use, or one whose use is inconsistent with ongoing user tasks, should be viewed as a design or system problem rather than a user problem. Furthermore, if the user intentionally didnt operate the safety feature, it is very important to determine why he or she made this decision. It is obvious here that a safety feature not used offers no protection. If the injury occurred during disposal, it becomes important to identify whether the safety feature had been activated, the brand and model of the sharps disposal box, and whether the injury came from the current device, or a previously disposed of device. Note that the latter injury can be far more disturbing because the patient on whom that sharp was used may not be able to be identified.
As noted above, non-standard conditions and use situations must also be identified. For example, the need might have arisen to put a used syringe down before the safety feature could be activated or a sharps box used, or the sharps container may have been full. A used syringe might also be inadvertently dropped, requiring retrieval before it can be safety-activated or disposed of. Such retrieval must always be looked at as a high-risk situation. Putting down a syringe may be a function of the reality of patient care and the demands on the nurse or other care giver. These situations are important to identify for subsequent system improvements. Other needle and non-needle sharps have similar sequences of use, and distractions.
The ultimate test of the situation description is whether the scenario could be recreated based on the information provided, up to and including the moment of the sharps injury. One ongoing task associated with the sharps injury log should be a regular data review to assure the quality and completeness of the information, and to undertake reporting improvements as necessary.
FDA Medical Device Reporting (MDR)
It should also be remembered that sharps injuries are subject to Food and Drug Administration (FDA)-mandated Medical Device Reporting (MDR) requirements if the injured person requires medical intervention. In addition to the general requirements of the MDR program (http://www.fda.gov/cdrh/mdr/), there is an FDA guidance document available for sharps injuries in particular (http://www.fda.gov/cdrh/osb/guidance/250.html). The latter notes that such reporting is required even if the event is attributed to user error.
With an accurate and complete sharps injury log, periodic review should be undertaken to determine key trends in the data. In this regard, the data can be analyzed with respect to departments, time of day, specific users, specific activities and sharps product in use at the time of the injury. If injury-prone departments are identified, the tasks and activities of these departments can be further investigated to identify why they are generating a large number of the reported injuries. Identification of injury-prone shifts or individuals may suggest unique training or workload situations. Injury-prone products may suggest a problem with the design of the device, especially in the case of an allegedly safety-engineered
device. Since such devices were selected and purchased with the specific intent of reducing or eliminating inadvertent sharps injuries, their failure to do so should be of particular concern. As noted above, the failure of such devices to achieve their goal may occur because the design is not adequate or realistic, or because training and supervision has not achieved effective use. When safety-engineered products continue to result in sharps injuries, it is appropriate to re-evaluate the selection of that specific product as compared to alternative products. Analysis of these situations should result in a corrective action plan and subsequent follow-up to ensure that this plan has been fully deployed, and that it is effective in reducing needlestick injuries.
William A. Hyman is a professor in the Department of Biomedical Engineering at Texas A&M University.