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Instructions for Using the Sample Screening Form

Adapting the Form
The form can be modified to reflect your specific clinical needs by adding criteria that reflect your practice or deleting criteria that are not appropriate for your practice. For example, if your patient population consists primarily of children, you may choose to add criteria that reflect the use of the device in small mouths.

Obtaining Feedback
In the screening phase, include a representative of each type of dental personnel that will be using or handling the device. Be sure that each person completing the form has a sample of the safer device as well as the traditional device in front them.

Interpreting the Results
Once the form has been completed by all personnel, discuss the results to determine whether to proceed to the next phase – evaluating the safer device in the clinical setting. In making this decision, some criteria may be more important than others. For example, clinical and safety feature considerations may be more important than the general product (e.g., availability of the device) or practical considerations (e.g., instructions and packaging). If the responses to many criteria are "Does Not Meet Expectations" or "No," then you should consider other safer devices, otherwise, evaluate the device in the clinical setting.


Sample Screening Form
Dental Safety Syringes and Needles

This form collects the opinions and observations of dental healthcare personnel who screen a safer dental device to determine its acceptability for use in a clinical setting. This form can be adapted for use with multiple types of devices. Do not use a safer device on a patient during this initial screening phase.


Date:________________________

Product: Name, brand, company:
_________________________________________________________________________
Your position or title:
_________________________________________________________________________
Your occupation or specialty:
_________________________________________________________________________

Clinical Considerations Does Not Meet Expectations Meets Expectations Exceeds Expectations
1.The device permits the exchange of cartridges during treatment on the same patient.123
2.The weight and size of device is acceptable.123
3.I have a clear view of the cartridge contents when aspirating.123
4.The size and configuration of the syringe or needle permits a clear view of the injection site and needle tip.123
5.No excessive force is required to activate or control the plunger.123
6.The size and configuration of the syringe or needle permits use in all mouth sizes and access to all areas of the mouth.123
7.The device permits multiple injections on the same patient.__No__Yes
8.The device is capable of aspiration before injection.__No__Yes
9.The needle is compatible with a reusable syringe.
[For safety needles without syringes only.]
__No__Yes
Does the product meet the needs of your clinical practice based on the above criteria?__No__Yes
10.The worker's hands can remain behind the sharp during activation of the safety feature.123

Safety Feature Considerations

11.The safety feature can be activated with one hand.123
12.The safety feature is integrated into the syringe or needle.123
13.The safety feature provides a temporary means of protecting the needle between injections.123
14.A visible or audible cue provides evidence of safety feature activation.123
15.The safety feature is easy to recognize and use.__No__Yes
16.Once activated, the safety feature permanently isolates the needle tip and cannot be purposefully or accidentally deactivated under normal use conditions.__No__Yes
17.The safety feature activates by itself.__No__Yes

General Product/Manufacture Considerations

18.The manufacturer can provide the device in needed quantities.123
19.A full range of needle sizes and lengths is available.123
20.The company provides free samples for in-use evaluation.123
21.The company has a history of responsiveness to problems123

Practical Considerations

22.The device is packaged conveniently.123
23.The device is easy to remove aseptically from the package.123
24.Instructions are included in the packaging.123
25.Instructions are easy to follow and complete.123
26.Instructions are provided in more than one form (paper, videotape, Web site, or computer disk).123
27.Use of the safety device will not increase the volume of sharps waste.123
28.The shape and size of available sharps containers will accommodate disposal of this device.123
29.This is a single use, disposable device.__No__Yes
30.The device should be considered for further clinical evaluation.__No__Yes


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