Over the course of the last twelve years, with the implementation of the Needlestick Safety & Prevention Act, needlestick injuries during phlebotomy procedures have decreased, and the number of safety-engineered devices available has increased. As manufacturers strive to improve safety-engineered devices, healthcare facilities are tasked with determining what the best and safest options are for their employees as well as their patients.
There are several desirable features for safety-engineered devices used for phlebotomy procedures. These features are identified by multiple sources and are widely accepted in the healthcare industry:
- The device does not require the use of a needle or is needleless.
- The safety feature is an inherent attribute of the device.
- The device works in a passive manner and does not require activation by the user. (When user activation is required, it allows the user’s hands to remain behind the exposed sharp and the safety feature can be activated using a single hand.)
- The user is able to clearly discern when the safety feature of the device is activated.
- The safety feature cannot be deactivated and performs reliably when used according to manufacturer’s instructions.
- The device is easy to operate.
- The device is safe and effective for use with patients.
Though not all of these characteristics are practical or feasible in every situation, the ultimate goal of any safety-engineered device is to reduce sharps injuries.1
According to one multi-center study, safety devices can be categorized by the amount of user intervention that is required to activate the safety feature: passive or fully automatic, semi-automatic, or manually activated, either with a toppling shield or a sliding shield:
- Passive: safety shield is automatically activated through use of the device.
- Semi-automatic: activation is manual, by pushing a plunger or button that then automatically engages the safety shield.
- Manual: a sliding or toggling shield requires manual activation and engagement by the user.
Of these categories, the study found that passive devices had the lowest rate of needlestick incidents. Though passive devices may be associated with higher cost, the need for less training that is required and the fact that activation does not rely on user compliance may justify the added expense. However, the study also showed that many of the injuries that occurred with non-passive devices were attributable to incorrect user activation, incomplete activation, or device failure (according to the user). Because of that and the many factors that contribute to acceptance of a new safety device, which include training, ease of use, technique, and perceived user and patient safety, among others, it is all the more important that a thorough and well planned evaluation and implementation program be in place to facilitate the conversion to passive devices and ensure that employees are using the device in the correct and safest manner.2
Process of evaluation
As technology advances and new safety devices become available, healthcare facilities are responsible for evaluating these devices to determine if they are appropriate for use in their environment. This evaluation should be based on the safety of the device rather than what people are comfortable with or “used to.”
To accomplish an unbiased and successful evaluation based on the merits of the safety device, it is important that the laboratory plan the process carefully and be cognizant of potential resistance to change. In planning for such an event, a team is usually formed to determine what the criteria are for evaluating the device. Whether this is to comply with the requirements for annual assessment of new safety devices as they become available, to seek a safer device that will minimize risk, or to maintain an established level of safety and reduce cost, it is important that these goals be made clear to the employees who will be evaluating the safety-engineered device.
A survey should also be developed that allows the evaluation team to fairly assess the merits of the safety device relative to the goals of the evaluation. The survey should address the characteristics detailed earlier to avoid vague responses based on nothing more than user preference and, instead, to elicit information that will result in choosing the safest device for the facility.
Once the reasons for a safety evaluation are identified, the next step is to create an evaluation team. This is most successful when the number of participants is limited to a small group that is receptive to change, routinely collects blood as part of their job description, and can objectively assess the merits and characteristics of the device. Once the team is assembled, team members should be trained in proper use of the device according to the manufacturer “Instructions for Use.” They should also be allowed time to become proficient with the device before the true assessment begins.
To implement or not?
Though selection of devices to evaluate may take some time, the actual evaluation process can feasibly be completed in one to two weeks. This will allow sufficient time for participants to be trained on use of the device, perform a reasonable number of venipunctures to gain proficiency, and then complete an evaluation to capture pertinent information.
Completed surveys are assessed for the strengths and weaknesses of the device with regard to usefulness and safety. It is important to follow up with the evaluation team to discuss comments and obtain additional feedback in the event that there are concerns that can be resolved with additional training or education. A sound decision can then be made on whether or not the safety device will be implemented.
Ensuring successful implementation
Introducing new technology into the laboratory can be a daunting task. However, much of the anxiety can be avoided by having a well thought-out and thorough training plan. Because safety devices are used by nursing staff as well as laboratory personnel, the plan must include nurse educators or supervisory staff as well.
Facilities should work with the manufacturer to establish a training plan. Training may involve technical representatives rotating to various areas of the hospital and training all staff or, in many instances, a train-the-trainer approach is more practical. This is an opportunity to involve individuals who were part of the evaluation team in assisting not only with the training of other personnel, but also with overcoming some of the resistance to change. They can also play a role in ongoing training and competency assessment. Training videos and educational literature from the manufacturer are also helpful in this regard.
The overriding goal, of course, is to choose a device that is safe for healthcare personnel who draw blood and safe for the patients as well. By carefully assessing new technology, conducting an evaluation with clearly defined criteria, and providing the appropriate training and support during implementation, healthcare facilities can successfully identify the right fit for their environment.
- NIOSH Alert: Preventing Needlestick Injuries in Health Care Settings. U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS. Publication No. 2000-108.
- Tosini W, Ciotti C, Goyer F, et al. Needlestick injury rates according to different types of safety-engineered devices: results of a French multicenter study. Infect Control Hosp Epidemiol. 2010;31(4):402-407.