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J Am Dent Assoc, Vol 131, No 10, 1443-1448. © 2000 American Dental Association

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	ABSTRACT

TOP ABSTRACT OCCUPATIONAL SAFETY AND HEALTH... MATERIALS AND METHODS RESULTS BLOODBORNE EXPOSURE INCIDENTS CONCLUSION REFERENCES

 
Background. Some government agencies and state legislatures recently have passed regulations mandating the use of safety-enhanced devices, including dental anesthetic safety needles. Little information exists, however, on the efficacy and utility of these types of needles currently on the market.

Methods. The authors evaluated four types of dental safety needles and syringes for clinical acceptability. Two of these devices were deemed unacceptable owing to inherent features identified during the bench test. The remaining two devices were clinically evaluated using an 11-statement survey. Senior dental students completed the survey at one, two, four, five, six and eight weeks from introduction of the devices to a dental school clinic. Junior dental students joined the senior students using one of the devices for the last six months of the evaluation and joined the senior students in completion of a final survey at 52 weeks.

Results. The survey results indicated increasing user dissatisfaction with nine of the safety device features evaluated over the 52 weeks. At eight weeks, use of one of the two devices was discontinued owing to poor clinical performance. A review of the blood exposure incident reports that routinely are collected following an exposure incident revealed a small increase in exposures involving anesthetic needles. The sample size was too small to determine statistical significance of the change in injury rate, but it did show that needlesticks continue to occur in spite of the use of safety devices.

Conclusions. None of the safety devices tested successfully passed the clinical evaluation. Continued evaluation is necessary to ensure that effective safety devices are available to dental practitioners.

Clinical Implications. Evaluators had significant concerns about the usability of dental safety needles and their ability to adapt to using them effectively. Results of a review and bench tests indicate that the devices tested are no safer than traditional anesthetic needles.

Occupational exposure to pathogenic organisms is a concern among health care workers. Over the years, the means of reducing the risk of infectious disease transmission in dental offices have included adopting aseptic techniques such as sterilization and disinfection, as well as wearing protective attire. More recently, safety devices in the form of safety needles and syringes have entered the dental market. Little information exists as to the efficacy of these devices, which may be one reason that they are not widely used.

Currently, the Occupational Safety and Health Administration, or OSHA, and Congress are placing pressure on health care employers to use safety-enhanced devices.

In this article, we explore the proposed regulatory requirements and current OSHA compliance directives, as well as present the results of a year-long safety needle evaluation conducted at a dental school.

	OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION REQUIREMENTS

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Many state governments recently have required that health care employers provide safety needles and other safety devices to employees by mandating revisions of the OSHA Bloodborne Pathogens Rule.¹ These revisions include a requirement for employers to implement the use of devices specifically engineered to prevent injuries with contaminated sharp instruments and other objects. Congress now has before it two bills that would require all states to adopt such changes.^2,3

Several states have implemented OSHA Bloodborne Pathogens Rule revisions on their own; if OSHA adopts its own revisions, all states must comply by having requirements that are at least as strict as the OSHA revisions. The proposed requirements for revision present a number of challenges to the dental practitioner. One is that little evidence exists supporting the claim that safety needles provide better protection than regular needles. Other than a study of three devices conducted by the Dental Investigative Services of the U.S. Air Force,⁴ and a preliminary article by us,⁵ dentists must rely on opinion pieces, manufacturer’s claims or anecdotal evidence as to the efficacy and appropriateness of safety needle systems. Another challenge is that there are no established evaluation criteria to help dentists and dental hygienists select the appropriate device for their practices. Finally, availability of training to use these needle systems safely is inadequate to reach all potential users.

Although Congress has not passed a safety device bill, OSHA already has taken steps to enforce the use of engineered safety devices. In 1999, OSHA issued a compliance directive concerning the Bloodborne Pathogens Rule.⁶ This directive describes a federal program change and applies only to states that do not have a state OSHA plan. The directive replaces previous guidelines issued by OSHA, includes instructions to help compliance officers conduct inspections of work sites that may be in violation of the Bloodborne Pathogens Rule and requires most employers to initiate potentially significant changes.⁷

The OSHA directive concedes that U.S. Food and Drug Administration, or FDA, clearance of a safety device alone does not guarantee that the device will be effective in the workplace. OSHA states, "(T)he employer must rely on further evidence to ensure its effectiveness in the situation it will be used."⁶ In other words, FDA premarket 510(K) clearance of a product as a safety device alone does not indicate that a device necessarily is safer than devices currently in use, and employers are not required to provide the device if other evidence does not support its effectiveness.

OSHA requires that employers conduct ongoing evaluations safety needles and syringes through review of studies, pilot tests and published data. If employers actively review current data and maintain an awareness of the available devices, it appears that they would be in compliance with OSHA requirements as long as devices found to be effective are provided to employees with occupational exposure.

Unfortunately, it is difficult to evaluate the efficacy of dental safety needles. The FDA states, "Since needlestick injuries are relatively rare, the sample size needed to achieve statistical confidence that a device measurably decreases the incidence of needlestick injuries is prohibitively large."⁸ The FDA further states that "lower sample sizes increase the chance of accepting a device that has a potentially higher injury rate even if no failures in the test are reported."

When longitudinal control test results using traditional needles are available, large clinics or dental schools seem the most appropriate location for device evaluations, as the large number of practitioners allow for the collection of large amounts of data over a short period. We chose a dental school as our test location because we could ensure standardization of operator training, observe practices and centralize the collection of surveys.

	MATERIALS AND METHODS

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Our evaluation took place in the clinics of the 175-chair University of the Pacific, or UOP School of Dentistry. A total of 273 students who used the dental needle safety devices completed surveys at regular intervals.

Four safety-engineered needles were available for dental use in the United States when we conducted the study. Preliminary evaluation at the UOP, School of Dentistry revealed the following details regarding each device.

Safe-Mate needle system. Safe-Mate (Septodont Inc.) is a needle system that is adaptable to conventional metal syringes. The system has a clear plastic sheath that retracts over the metal syringe barrel when the needle is exposed for use. This system uses a traditional dental anesthetic syringe and needle combination and, therefore, should require the least user adaptation. The clear plastic sheath lets the user view the carpule contents during aspiration.

Safety Plus syringe. The Safety Plus syringe (Septodont Inc.) consists of a lightweight, autoclavable syringe handle and a disposable barrel with an attached needle. It weighs less than a typical syringe/needle combination, which may take some time to get used to. The carpule barrel is constructed from translucent plastic and has a translucent sheath that slides back over the barrel to expose the needle.

UltraSafe syringe. The UltraSafe syringe (Safety Syringes Inc.) is a disposable syringe and needle combination with a transparent, hard-plastic syringe barrel and a transparent hard-plastic, vented, retractable needle sheath. The user can view the carpule contents through the clear plastic syringe barrel.

Hypo Safety syringe. The Hypo Safety syringe (Dentsply MPL Technologies) is a translucent disposable plastic syringe and needle combination. The needle is retracted into the barrel of the syringe after the anesthetic solution has been injected.

With all of these safety-engineered systems, the user is not able to reactivate the safety sheath to administer a second injection if a bent-needle technique is used.

Criteria. As safety devices enter the dental market, it will be important for practitioners to evaluate them for use in their practice. Inferior products may affect quality of care and potentially could increase risk of injury to the practitioner. Therefore, an evaluation before clinical use is prudent.

We determined the criteria used in this evaluation before the study began and developed them to identify desirable characteristics and determine how well each device measured against the criteria.

Bench criteria. Ideally, a set of bench criteria should be used by clinicians to assess devices before they are introduced into clinical use. We identified the following criteria during the evaluation of devices discussed in this article: – The device provides a better alternative than traditional needle recapping.

– The device is no more difficult to breakdown than a traditional syringe.

– The design of the device allows for easy removal and changing of the needle in the syringe or disposal of the needle with the syringe barrel.

– The design of the device allows for easy removal of the carpule from the device.

– Removal of the needle from the syringe does not expose the worker to unnecessary risk.

– The needle or syringe is easy to insert into the sharps container.

Once the device has met the bench criteria, a clinical evaluation may be undertaken.

Clinical criteria. Clinical evaluation by the user should identify desirable aspects of the device being evaluated. We included the following criteria in the evaluation of the safety devices discussed in this article:

– The view of the tip of the needle is not obstructed during use.

– The visibility of the carpule contents is not obstructed during use.

– The device does not require more time to use than a standard needle.

– The device is easy to use for different hand sizes—extra small, small, medium, large and extra large.

– The engineered safety feature operates reliably.

User evaluation. We used an 11-statement questionnaire to determine the usability of the Safe-Mate needle; the Safety Plus, UltraSafe and Hypo Safety syringes were deemed unacceptable owing to inherent features identified during a clinical trial (Safety Plus) and the bench test (UltraSafe and Hypo Safety). We asked respondents to grade the device on a scale of 1 to 5, with 1 indicating agreement with a statement and 5 indicating disagreement with a statement. We also encouraged them to provide written comments.

Respondents completed the questionnaire at one, two, four, five, six, eight and 52 weeks after initiation of use to gauge the change in usability, if any, over time. The table describes each statement and whether the dissatisfaction level decreased or increased over the 52-week use period.

View this table: [in this window] [in a new window]   TABLE USER SURVEY RESULTS.

 

	RESULTS

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During our evaluation of four dental safety needles and syringes, we eliminated the UltraSafe syringe during bench testing owing to problems with manipulating it; problems were especially prevalent when changing carpules.

Through our bench tests, we found that during normal use, it was possible for the needle to protrude through the sheath vents during resheathing, presenting a puncture hazard to the user.

We eliminated the Hypo Safety syringe, as it was difficult to retract the needle if anesthetic solution was left in the carpule. If an entire carpule of solution is not required for the injection being administered, handling of the unsheathed needle outside the patient’s mouth is required, which largely defeats the purpose of safety-engineered needles. This system also requires disposal of the syringe at the completion of each carpule of anesthetic. With the nature of dental anesthesia being that multiple injections often are necessary, the practicality of a single-use device is questionable.

We eliminated the Safety Plus syringe after a three-month clinical trial when it was found to have unacceptable problems during the delivery of the dental anesthetic. Problems included the carpule barrel separating from the syringe handle under injection pressure, difficulty seeing aspiration results and inconsistent pressure needed to express solution.

Only the Safe-Mate needle system was used during the entire 52-week evaluation period.

Figure 1 provides the average dissatisfaction score for each of the 11 statements asked in the survey. Response rates to the surveys ranged from 14 to 39 percent. The results indicate that the users had significant concerns in four areas:

View larger version (66K): [in this window] [in a new window]   Figure 1. Combined average score for all surveys of the Safe-Mate (Septodont Inc.) needle system. The dissatisfaction scores are on a scale of 1 to 5, with 1 indicating agreement with the statement and 5 indicating disagreement with the statement.

 

– needle tip visibility;

– carpule visibility;

– ease of breakdown after use;

– ease of needle removal from syringe.

Although the average dissatisfaction level was the same for two statements, user dissatisfaction for statement 1 increased over time, while it did not change for statement 7.

The usability of the Safe-Mate needle system did not improve over time in these four areas. Owing to the increased bulk of the sheath (compared with a traditional needle), the users often had difficulty visualizing the tip of the needle. The sheath tended to fog intra-orally, making the contents of the carpule after aspiration difficult to visualize. If the sheath was overtightened, the user had to exert more pressure on it to remove it from the syringe. Occasionally, the unsheathing mechanism was activated during this process, causing the sheath to move down the barrel of the syringe and exposing the user’s hand to the contaminated needle tip.

The three statements found to have the highest level of user satisfaction were ease of use related to hand size, ease of carpule removal from syringe and the ease of insertion into a sharps container. Only the latter two statements showed an increase in agreement over the course of the survey. This is not surprising, as the Safe-Mate needle system does not require a change from the traditional carpule and syringe, and the relatively small size of the Safe-Mate needle system made its insertion into the sharps containers a little different than that of a traditional needle.

There was either an increase or no change in the users’ dissatisfaction with the device over time in nine of the 11 areas, indicating users were not able to adapt to the Safe-Mate needle system. This is a significant finding, since any new device or instrument requires a certain period of accommodation by the user, as well as repeated use. That accommodation did not occur in these nine areas.

An ideally engineered dental safety needle would take into account a number of factors. At a minimum, they would include the following:

– passivity (for example, the device requires little or no user manipulation to activate the safety feature) and reliability of the engineered safety feature;

– ability for carpules to be changed efficiently;

– visibility of the needle tip and carpule contents at all times;

– adaptability to any hand size;

– easy, safe breakdown and insertion into a sharps container;

– cost-effectiveness.

We found no safety needle system on the market that meets these criteria.

	BLOODBORNE EXPOSURE INCIDENTS

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UOP has been tracking blood-borne exposures in the school of dentistry’s dental clinics for more than a decade. Since 1995, a bloodborne exposure reporting protocol and a questionnaire have enabled UOP researchers to collect specific information on the nature of the exposures.

Each year, approximately 80,000 needles are used in UOP clinics, providing a relatively large sample size. Not all clinics, however, used the Safe-Mate needle system for the entire 1999 calendar year. The dental school has two student clinics: the junior clinic and the senior clinic. From January through June of 1999, one-half of the senior class used the Safe-Mate needle, and one-half used a combination of the Safety Plus syringe and the traditional needle. None of the junior class used safety needles. Certain specialty clinics within the school also were exempt from using safety needles during this time. From July through December 1999, all junior and senior dental students in all clinics used the Safe-Mate needle system.

Exposure incident results and discussion. To determine the influence of the Safe-Mate needle on exposure rates in UOP clinics, we examined total injury and needle injury rates from July through December 1999 with the same period during the previous four years (Figure 2). The population from which these data are derived includes 273 clinical students, 50 clinical faculty members and 24 clinical staff members. The injury rate for each of the six-month periods from the five years injury data were collected remained constant at 0.09 injuries per dental health care worker. The figures for 1995 through 1998 represent traditional dental needles, with the exception of one safety needle injury in 1997 during a brief period of use that year. All injuries from needles during July through December 1999 involved the use of the Safe-Mate needles.

View larger version (62K): [in this window] [in a new window]   Figure 2. Exposure injuries, July through December.

 
Combining a detailed examination of the usability study with the fact that there was no change in exposure rate using Safe-Mate needles indicates that this is not a safer system when used in this environment. A truly safe system would eliminate injuries altogether or significantly reduce the needle exposure rate. Comparison of the Safe-Mate needle with our ideal characteristics of a safety needle indicates further variance between what is available and what is needed.

	CONCLUSION

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Our experience using the FDA-approved devices being evaluated resulted in an initial increase in needlestick injuries. Hands-on training, monitoring and follow-up reminders appeared to be effective in reducing the injuries associated with the change from traditional to safety needles. We strongly urge practitioners and institutions undertaking an evaluation to become thoroughly familiar with the new product, review and closely follow the manufacturer’s use instructions, and manipulate the device until they become familiar with its characteristics.

None of the FDA-approved devices tested at UOP dental school clinics had a significant impact on injury rates after the initial increase and when we looked at data over six months aggregate. We found neither a significant increase nor decrease in exposures related to needlesticks. The majority of users found that several attributes of each device interfered in the delivery of dental anesthetic, rendering the devices unacceptable for continued clinical use in our setting.

The relatively small sample of injuries created a barrier to applying a statistical model to the evaluation of the safety needles and syringes. As new devices enter the market, it will be important for dental organizations, institutions and researchers to provide clinical evaluations to help clinicians select an appropriate and safe device. Development of standardized evaluation criteria that does not place the clinician or patient at risk will provide much needed assistance to the dental practitioner.

	FOOTNOTES

Dr. Fredekind is acting assistant dean for clinical services, University of the Pacific School of Dentistry, San Francisco.

Dr. Budenz is an associate professor, Department of Anatomical Sciences, and the chair, Department of Diagnosis and Management, University of the Pacific School of Dentistry, San Francisco.

The information presented in this article is limited to devices that were FDA-approved at the time of the evaluation. The authors do not intend this information to be interpreted as research results, but rather as potential guidelines for device selection and evaluation by other institutions and practitioners.

The authors would like to acknowledge Dr. June Fisher and the Training for Development of Innovative Control Technologies Project for their safety feature evaluation tool that provided guidance in development of the 11-item survey used in this safety needle assessment.

	REFERENCES

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1. Kennedy G. Massachusetts passes needle-safety law. Available at: "www.icanprevent.com/main/contentmain.jhtml?ag_nav_path=A1x1x1y1x7d0x1y3x1a27x2729x1". Accessed Aug. 25, 2000.
   
   
2. HR1899. 106th Cong., 1st Sess. (1999).
   
   
3. S1140. 106th Cong., 1st Sess. (1999).
   
   
4. Bartoloni J. Synopsis of local anesthetic safety syringes (project 99–43). Available at: "www.brooks.af.mil/dis/DIS59/sec6b.htm#DIS59027". Accessed Aug. 22, 2000.
   
   
5. Cuny EJ, Fredekind R, Budenz AW. Safety needles: new requirements of the Occupational Safety and Health Administration bloodborne pathogens rule. J Calif Dent Assoc 1999;27(7):525–30.
   
   
6. United States Occupational Safety and Health Administration. Enforcement procedures for the occupational exposure to blood-borne pathogens. Washington: U.S. Department of Labor, Occupational Safety and Health Administration; 1999. OSHA CPL 2-2.44D.
   
   
7. OSHA Revised Bloodborne Pathogens Compliance Directive. U.S. Department of Labor. OSHA National News Release. Nov. 5, 1999.
   
   
8. Supplementary guidance on the content of premarket notification [510(K)] submissions for medical devices with sharps injury prevention features. U.S. Food and Drug Administration. Draft. March 1995.
   
   

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by CUNY, E. Articles by BUDENZ, A. W. Search for Related Content PubMed PubMed Citation Articles by CUNY, E. Articles by BUDENZ, A. W. Related Collections Dental Equipment/Instruments