Safety Needles

New Requirements of the OSHA Bloodborne Pathogens Rule

Eve J. Cuny, RDA, BA; Richard Fredekind, DMD, MA; and Alan W. Budenz, MS, DDS

Copyright 1999 Journal of the California Dental Association.

In September 1998, a California assembly bill was signed into law that requires significant changes to the Cal/OSHA Bloodborne Pathogens Standard. As of July 1, 1999, all health care employers in the state must begin providing sharps safety devices. For dentistry, this means a shift from the traditional needles to safety needles with engineered, built-in safety mechanisms. Some exceptions are provided in this new regulatory change. There is no reliable data on the safety and efficacy of the available devices. This article explores the regulatory changes and begins to provide information on the devices available. Design features, usability by the practitioner, and safety to the patient are important issues to consider when deciding whether these devices are appropriate for dental anesthesia. Most practitioners will find it difficult to conduct an independent evaluation and must rely on information in the professional literature to help guide their decisions.

On Sept. 29, 1998, Gov. Pete Wilson signed Assembly Bill 1208 into law. This bill, which adds section 144.7 to the California Labor Code, requires the California Occupational Safety and Health Administration to adopt several revisions to the Bloodborne Pathogens Standard. These changes are the first significant changes to the state Bloodborne Pathogens Standard since its required enforcement began in 1992.

Assemblywoman Carol Migden introduced the legislation requiring Cal/OSHA to make these changes in response to a general outcry by health care workers and the media. Beginning in April 1998, the San Francisco Chronicle published a series of articles and follow-up stories titled "Deadly Needles." These articles explored the issue of occupationally acquired HIV and hepatitis among healthcare workers. In spite of universal precautions, including the use of gloves and other protective attire, health care workers continue to be infected with HIV and hepatitis on the job. According to the Centers for Disease Control and Prevention HIV/ AIDS Surveillance Report, 54 health care workers have been infected with HIV on the job, none of them dental health care workers. Another 133, including six dentists, are classified as possibly having been infected occupationally.¹ These numbers represent only those cases that are reported to the Public Health Services. Controversy remains regarding the true number of health care workers occupationally infected with bloodborne diseases. The reports in the San Francisco Chronicle placed the numbers as high as 60,000 infectious disease transmissions in the past decade with one health care worker each week contracting HIV.² The reporters for the Chronicle list as their sources for these numbers the International Health Care Worker Safety Center. However, the center estimates that there may be from 18 to 35 occupationally acquired HIV infections occurring each year. There is a clear need for more reliable information regarding occupationally related disease transmission to assist public health officials and regulatory agencies in making science-based recommendations and regulations.

At the center of the highly emotional issue is the charge by health care worker unions and other groups and individuals that hospitals were not consistently providing adequate protective devices that are readily available in the medical market.³ Hospitals were charged, and in some instances found guilty, of failing to provide safety devices that were readily available in favor of the less expensive nonsafety needles. Manufacturers of needles were accused of continuing to supply standard needles in an effort to ensure profits when safer devices were available. There were also charges that agencies such as OSHA were not responsive to the needs of these employees.

By signing the Migden Bill, Wilson set into motion a series of events that promises eventually to impact every health practitioner in the United States that uses needles, including dentists.

Summary of the Regulatory Changes

In California, an emergency rule is in effect with provisions that must be met by July 1, 1999. The emergency standard requires employers to provide devices with "engineered sharps protection." Cal/OSHA defines this as "a physical attribute built into a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, which effectively reduces the risk of an exposure incident by a mechanism such as barrier creation, blunting, encapsulation, withdrawal or other effective mechanism." This means that if a safety needle is available for a given procedure, such as dental anesthetic administration, it must be used. Four situations allow for exceptions. The engineering control is not required if:

* It is not available in the marketplace;

* It will jeopardize the patients safety or the success of the medical, dental or nursing procedure (this must be specifically documented);

* The employer can demonstrate by means of objective evaluation criteria that the engineering control is not more effective in preventing exposure incidents; or

* Reasonably specific and reliable information is not available about the safety performance. The employer must then be actively determining by means of objective evaluation criteria whether use of the engineering control will reduce risk of exposure incidents.

Additional requirements of the emergency provisions call for the keeping of a written sharps injury log. This log must record the date and time of each sharps injury resulting in an exposure incident, as well as the type and brand of device involved. Additionally, the revised Bloodborne Pathogens Standard requires a procedure for:

* Gathering the information required in the log;

* Determining the frequency of use of the types and brands of sharps involved in exposure incidents;

* Identifying and selecting currently available engineering controls;

* Documenting circumstances in which engineering controls are not used because of patient safety determinations; and

* Obtaining the active involvement of employees in reviewing and updating the exposure control plan.

This information should be written in to the exposure control plan currently required by the Bloodborne Pathogens Standards.

The problem the emergency regulation is intended to address is that the existing Bloodborne Pathogen Standard does not adequately prevent occupational sharps injuries. According to a survey of the health care industry, it is estimated that health care workers suffer 96,000 needlestick injuries per year in California.⁴

The figures on needlestick injuries provided by the scientific literature, regulatory agencies, government service agencies, and affected business associations vary considerably, and reference to underreporting of sharps injuries is common in nearly every report attempting to analyze needlestick injuries. This has led to a common view that needlesticks and other occupational exposure incidents to bloodborne pathogens such as sharps injuries are significantly underreported in the health care industry.^5-7 This underreporting has led to speculation that bloodborne disease transmissions among healthcare workers are occurring unnoticed and remaining undocumented.

Beyond California

Last year, Federal OSHA asked for information from interested parties on the issue of safety for health care workers exposed to blood and other body fluids. They are currently in the process of reviewing the more than 400 responses received as result of their request for information. It is uncertain at this time what the outcome will be on the federal level.

It is more immediately apparent that the states are not going to wait for a federal rule to act on this issue. Iowa, Illinois, Indiana, Maryland, Massachusetts, Minnesota, Montana, New Jersey, Texas, and Washington all have bills that have been introduced to their state legislatures that would require similar regulation. As of this writing, Connecticut, the District of Columbia, Florida, Georgia, Maine, Michigan, New York, Oregon, Pennsylvania, and Wisconsin all have bills in the process of being drafted or introduced.

Many practitioners and organized dental groups have expressed concern over the effect such requirements will have on dental practices. Of particular concern is the lack of independent data to verify the safety and efficacy of the currently available devices. The California regulation requires the use of objective evaluation criteria, but unfortunately, no resource for such criteria exists for the thousands of dental practitioners.

Uncovering information that provides meaningful results in safety device evaluation is extremely difficult. To determine if a device reduces injuries, one must first look at previous injury rates as a baseline and compare that to injury rates after implementation of a new device. A sufficient sample size is needed to ensure the data is significant. Because needle injuries are relatively rare in dentistry, conclusions should not be drawn on injury rate changes alone.^8-10

Safety Devices

In an effort to comply with the Cal/OSHA requirements, the University of the Pacific School of Dentistry undertook an evaluation of the products for their usefulness in the dental setting. The authors were able to identify four devices that are currently available to dentists.

Figure 1. UltraSafe Syringe

One system was not evaluated in the clinical setting because of problems with getting it to work in the manner it is intended during the preliminary "bench" evaluation (Figure 1). Upon resheathing, the needle poked through a vented area in the side if the sheath on more than one occasion, placing the operator’s finger at risk of puncture. This same device also required numerous steps for replacing the anesthetic carpule, and after inserting a new carpule it was necessary to leave the needle unsheathed in order to give a subsequent injection. Leaving an unsheathed needle at chairside between injections was deemed unacceptable because of the hazard of unintentional needlestick to the dental team.

Figure 2. HypoSafety Syringe Figure 3. One-handed scoop technique

Another safety syringe was not tested because it was not identified as available until after the evaluation had commenced (Figure 2). A few design problems were identified in a preliminary evaluation of the device that did not involve administering injections to live subjects. The syringe employs a passive aspiration mechanism that does not allow the operator to control the aspiration. The safety mechanism is unique in that it retracts the needle into the syringe shaft when the handle is pulled back after injection. However, all anesthetic must be expressed from the carpule before activation of the safety mechanism. It is not reasonable to express unused solution into the patients mouth. Therefore, it is necessary to remove the syringe from the mouth and transfer to a location where the solution can be released before the safety device is activated. This scenario of handling an unsheathed dental needle outside the patient’ mouth does not appear to be an improvement over the one-handed sheathing techniques currently employed by most dentists (Figure 3).

The UOP School of Dentistry evaluated the two remaining devices. The study involved 156 senior dental students who were divided into two groups, each of which was trained in the use of one of the safety needle systems. Each group used one type of safety needle exclusively in the treatment of all patients in the comprehensive care clinic.

During the eight-week evaluation period, each group completed six sets of questionnaires on the usability of the needle. The questionnaire had 11 items covering such topics as visibility of the carpule contents, ease of needle and carpule removal from the syringe, and reliability of the safety feature. The number and nature of needlesticks in each group was also evaluated and compared to the same period in previous years.

Figure 4. Safety Plus

The first system evaluated, SafetyPlus is a system that incorporates a sterilizable plastic syringe with a one-use safety needle (Figure 4). It is lighter in weight than a traditional needle and syringe, a design issue that the students found more difficult to accommodate.

Overall, it was found to be significantly more difficult and time-consuming to operate. Carpule removal was much more difficult than a traditional syringe. The carpule contents were more difficult to visualize due to the translucent nature of the needle sheath. The device was also more difficult to use for workers with a smaller hand size. The amount of force required to expel the carpule contents varied significantly from one carpule to the next. If the sheath were not pulled down properly, as was often the case, the needle assembly would separate from the syringe handle during injection.

Figure 5. SafeMate Needle

The second device tested, the SafeMate (Figure 5), incorporates a clear plastic sheath and needle system that is adaptable to traditional metal syringes. This makes accommodation easier because its "feel" is no different from a traditional needle and syringe. Because the sheath is clear and shorter than the sheath on the SafetyPlus, it was easier to visualize the contents of the carpule while aspirating. However, because it is not vented, this sheath did tend to fog once it was placed inside the mouth.

As with the SafetyPlus, the SafeMate needle could not be reused after it was bent. In nine out of the 11 criteria that were evaluated, this system received more favorable scores than the SafetyPlus. The only criteria in which it was found to be less effective was needle removal from the syringe. This is illustrated by the large number of times the needle was overtightened on the syringe, requiring time-consuming and dangerous breakdown of the device to allow removal from the syringe.

All four systems, plus the traditional needle system, are listed in Table 1 according to their manufacturer and approximate cost per unit.

Needlestick Injuries

An important aspect of this study was to determine if the devices do reduce the risk of accidental needlestick injury. During the eight-week preliminary trial, SafeMate had three needlesticks reported in the senior class, while SafetyPlus had two. Of these five exposures, four occurred in the first two weeks of the project and the fifth occurred in the sixth week. An additional exposure occurred to a dental assistant using the SafeMate.

All four SafeMate exposures happened during needle removal when the operator had his or her hand in front of the needle sheath and engaged the locking mechanism, allowing the needle to move forward into the operators hand. All injured health care workers identified lack of experience as a factor that contributed to the injury. They felt that additional experience with each system and following directions for its use were the best preventive strategies.

The overall exposure rate for both safety needle systems (0.625 exposures per week) was three times greater than it had been in the same academic quarter over the past five years among the senior students (an average of 0.2 exposures per week). From this result, it cannot be stated that either of these safety needle systems was necessarily safer than traditional needle systems.


Clinical Trial Results

The results of this study indicate that SafeMate was less expensive and scored higher in acceptance by the students, but had one more needlestick injury than SafetyPlus. SafeMate seems easier to adapt to and allows use of the standard metal syringe. Specific recommendations for use of SafeMate and improvement in design are listed below.

Operator Issues

* Never place a hand in front of the needle sheath.

* Avoid over-tightening the needle on the syringe.

* Recognize the differences in use between SafeMate and the traditional needle.

* Practice repeatedly all steps in the safe use of the product before using it during a procedure.

* Allow for a learning curve to accommodate to the changes required to efficiently and safely use the product.

Manufacturer Issues

* Vent the sheath to reduce fogging.

* Redesign the needle attachment to the syringe to reduce the chance of overtightening.

* If the needle has been overtightened, redesign the needle sheath to allow easy and safe removal.

* Redesign the sheath locking mechanism to reduce the chances of accidentally engaging it during needle removal.

Conclusions

The results of the product evaluation at UOP do not provide sufficient information to declare that any of the devices are superior in safety to traditional dental needles. It is clear that the health care worker is not removed from risk of needlestick when these self-sheathing needles are employed. Collecting enough data to use statistical models to determine whether injury rates may be reduced does not appear feasible.

The most reasonable approach is to continue engineering and clinical evaluations of the devices. The drawback to clinical trials is that the only means by which to judge efficacy requires health care workers be placed at risk by using untested devices. Engineering evaluations alone do not give valuable clinical information such as whether the device sufficiently aspirates, whether there is fogging when the patient breathes, and any other information related to patient comfort and safety.

Authors/

Eve Cuny, RDA, BA, is the director of Environmental Health and Safety at the University of the Pacific School of Dentistry in San Francisco.

Richard Fredekind, DMD, MA, is an associate professor in the Department of Diagnosis and Management and a group practice administrator at UOP School of Dentistry.

Alan Budenz, MS, DDS, is an assistant professor in the Department of Anatomical Sciences and chairperson of the Department of Diagnosis and Management at UOP School of Dentistry.

References/

1. Centers for Disease Control and Prevention, HIV/AIDS Surveillance Report, 10(1):24, 1998.

2. Holding R, Carlsen W, Epidemic ravages caregivers. San Francisco Chronicle, April 13, 1998, p A1.

3. Holding R, Carlsen W, High profits -- at what cost? San Francisco Chronicle, April 14, 1998, p A1.

4. IPINet, Uniform Needlestick and Sharps Injury Reports, 77 Hospitals, 1993-1995, International Health Care Worker Safety Center, University of Virginia.

5. Culver J, Preventing transmission of blood-borne pathogens: A compelling argument for effective device-selection strategies. Am J Infect Control 25:430-3, 1997.

6. Gershon RM, Byrns GE, Dunleavy ML, Occupationally acquired HIV in health care workers, nurse practitioner. Am J Primary Health Care 21(9), Sept 1996.

7. Patel N, Tignor GH, Device-specific sharps injury and usage rates: An analysis by hospital department. Am J Infect Control 25:77-84, 1997.

8. Cleveland JL, Lockwood SA, et al, Percutaneous injuries in dentistry: an observational study. J Am Dent Assoc 126:745-50, 1995.

9. Ramos-Gomez F, Ellison J, et al, Accidental exposures to blood and body fluids among health care workers in dental teaching clinics: a prospective study. J Am Dent Assoc 128(9):1253-61.

10. Panagakos FS, Silverstein J, Incidence of percutaneous injuries at a dental school: a 4-year retrospective study. Am J Infect Control 25(4):330-4, 1997.

To request a printed copy of this article, please contact/Eve J. Cuny, RDA, BA, 2155 Webster St., San Francisco, CA 94115.