Device Screening and Evaluation Forms
Mandated by the Needlestick and Prevention Act, changes to the Occupational Safety & Health Administration's (OSHA) bloodborne pathogen standard were published January 18, 2001, to take effect April 18, 2001. The revisions clarify the need for employers to select safer needle devices as they become available and to involve employees in identifying and choosing the devices. Prior to the act, only a few dental devices incorporated safety features (e.g., anesthetic syringe needles with sliding sheathes), and most dental healthcare personnel are uncertain about how to select and evaluate the safer devices now available on the market. In collaboration with the American Dental Association and the Training for Development of Innovative Control Technologies Project (a collaboration based at San Francisco General Hospital of frontline healthcare workers, product designers, and industrial hygienists to prevent exposure to blood through better design and evaluation of medical devices and equipment), the Centers for Disease Control and Prevention (CDC) has developed two sample forms (with instructions for use) to assist dental personnel in screening and evaluating devices for clinical acceptability. These forms have been pilot tested with focus groups of different types of dental staff members, including end users and purchasers. To increase the safety of both dental personnel and their patients, we are making these forms available for general use. Although these forms are specific for anesthetic syringes, they can be modified for use with other types of dental devices.
Every dental office should develop and implement a program to prevent sharps injuries to dental personnel and patients. A staff person knowledgeable about or willing to be trained in injury prevention (i.e., a safety coordinator) should be assigned to
- Promote safety awareness,
- Facilitate prompt reporting and post-exposure management of injuries,
- Identify unsafe work practices and devices,
- Coordinate the selection and evaluation of safer dental devices,
- Organize staff education and training,
- Complete the necessary reporting forms and documentation, and
- Monitor safety performance.
Ideally, these activities should be described in a written plan and mechanisms for staff feedback should be available. This feedback will assist the safety coordinator in reviewing the effectiveness of the plan and making the modifications needed.
Information on specific brands and products of safer dental devices can be obtained from vendors, purchasing agents, scientific literature, lists published on the Internet or in trade journals, and other healthcare facilities. A variety of devices should be considered and the choice should not be limited to the product of any one vendor.
Evaluation criteria are used to measure the design and performance of safer devices during the screening and clinical evaluation phases, and differ for each phase. Criteria for the screening phase will help determine whether the device is safe to use on patients, has safety features to protect dental personnel from sharps injury, is readily available for purchase, is easy and practical to use, and is compatible with other equipment. Criteria for the evaluation phase help determine impact on patient care, acceptability by users, and cost. The evaluation criteria for both phases should be unbiased and the evaluation forms should be easy to use and score.
Screening assists dental personnel in making decisions about clinical and safety considerations before evaluating a dental device in the clinical setting. Screening usually consists of physically examining the safer device, then comparing it to the traditional device and established evaluation criteria. No device should be used on a patient before it has been screened to ensure that it meets clinical and patient safety needs.
Device evaluation involves a trial (or pilot test) to determine the acceptability of a safer dental device in an actual clinical setting. This process includes identifying a safer dental device to test, selecting the area of the facility to be used as the test site and the staff who will be the end users of the device, selecting evaluation criteria, and determining how long the test will last. The testing should include plans for quickly bringing back the traditional device should the safer dental device being tested be determined unsafe. The device evaluation should provide the safety coordinator with enough information to make an informed decision on whether to continue using the safer device.