By William A. Hyman
The Occupational Safety and Health(OSHA) Bloodborne Pathogens Standard (1910.1030) mandates the maintenance of asharps injury log (1910.1030(h)(5)(i). The key elements of this log are anidentification of the product being used by type and brand, the work area wherethe incident occurred, and an explanation of how the incident occurred. Thereare at least two ways to think about the sharps injury log requirement. One isthat it is merely a regulatory burden that is maintained only because there is arequirement to do so. The other perspective is that regulatory burden or not, itcan in fact be a useful tool for recording and analyzing sharps injuries toidentify actions that could be taken to reduce the incidence of injuries. Suchuse is implied by the requirement at 1910.1030(d)(2)(ii) to examine engineeringcontrols on a regular schedule to ensure their effectiveness.
If the log is to be useful, the first requirement is that theinformation collected be accurate and thorough. With respect to productidentification, it is essential that the information identify the actual,commercially available product that was being used. This information will becomecritical to evaluating whether products with claimed safety features areachieving their stated objective. Thus syringe or safety syringe areclearly not acceptable since such terms to do not identify a specific product. Furthermore, even descriptions such as Brand X syringeor Brand X safety syringe are not adequate because Brand X may produce anumber of different products under the same brand name, and even under the samemodel name. The standard thought test for adequacy of the description must be,Could I purchase the identical device on the basis of the informationrecorded?
An adequate description of the event is even more challenging,but equally essential to the use of the log as a safety improvement tool. Thedescription should be sufficient to mentally recreate not only the generalsituation of use (e.g., giving injection, drawing blood), but to detail theexact primary and secondary tasks being undertaken when the stick occurred. Forexample, for an injection, the primary task can be divided into a number ofsteps, 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 oranother event. With respect to the real-world value of safety features, it iscritical to identify if the injury occurred before, during, or after the manualactivation of the safety feature.
Injuries associated with using the safety feature mightsuggest that the feature is difficult to use, or that the design introducesadditional means of injury that even the non-safety version of the product doesnot have. Safety features that require the use of both hands are of particularconcern because any time the other hand is brought into use, the opportunity ispresented to stick that hand. Correct use of the safety feature and the adequacyof the associated training will also be of interest in the subsequent analysis.However, remember that failure to operate a device correctly should not alwaysbe attributed to the user or the training involved. The principles ofhuman-factors engineering tell us that a device that is overly difficulty touse, or one whose use is inconsistent with ongoing user tasks, should be viewedas a design or system problem rather than a user problem. Furthermore, if theuser intentionally didnt operate the safety feature, it is very important todetermine why he or she made this decision. It is obvious here that a safetyfeature 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 fromthe current device, or a previously disposed of device. Note that the latter injury can be far more disturbing becausethe patient on whom that sharp was used may not be able to be identified.
As noted above, non-standard conditions and use situationsmust also be identified. For example, the need might have arisen to put a usedsyringe 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 beinadvertently dropped, requiring retrieval before it can be safety-activated ordisposed 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 thedemands on the nurse or other care giver. These situations are important toidentify for subsequent system improvements. Other needle and non-needle sharpshave similar sequences of use, and distractions.
The ultimate test of the situation description is whether thescenario could be recreated based on the information provided, up to andincluding the moment of the sharps injury. One ongoing task associated with thesharps injury log should be a regular data review to assure the quality andcompleteness of the information, and to undertake reporting improvements asnecessary.
FDA Medical Device Reporting (MDR)
It should also be remembered that sharps injuries are subjectto 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 forsharps 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 attributedto user error.
With an accurate and complete sharps injury log, periodicreview 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, specificusers, specific activities and sharps product in use at the time of the injury.If injury-prone departments are identified, the tasks and activities of thesedepartments can be further investigated to identify why they are generating alarge number of the reported injuries. Identification of injury-prone shifts orindividuals may suggest unique training or workload situations. Injury-proneproducts may suggest a problem with the design of the device, especially in thecase of an allegedly safety-engineered
device. Since such devices were selected and purchased withthe specific intent of reducing or eliminating inadvertent sharps injuries,their failure to do so should be of particular concern. As noted above, thefailure of such devices to achieve their goal may occur because the design isnot adequate or realistic, or because training and supervision has not achievedeffective use. When safety-engineered products continue to result in sharpsinjuries, it is appropriate to re-evaluate the selection of that specificproduct as compared to alternative products. Analysis of these situations shouldresult in a corrective action plan and subsequent follow-up to ensure that thisplan has been fully deployed, and that it is effective in reducing needlestickinjuries.
William A. Hyman is a professor in theDepartment of Biomedical Engineering at Texas A&M University.