Evaluating Safety Product Criteria
By Michael Garvin
Electron microscope image of needle piercing glove surface.
In 1991, the Occupational Safety and Health Administration (OSHA) issued its long awaited standard on Bloodborne Pathogens. After years of investigation, OSHA concluded that a regulatory initiative was necessary to protect healthcare workers. One of the major considerations in creating bloodborne pathogen safety regulations was the growing concern of how the industry would manage patients with AIDS. A prudent AIDS management plan is needed to address the issue of protecting the healthcare worker. OSHA felt compelled to require that employers systematically design systems to ensure a high degree of safety for those staff who care for patients.
The Bloodborne Pathogen Standard and the Compliance Directive
As with most OSHA regulations, compliance strategy centered on three areas:
- Procedures, instituted by the facility, to see that staff use precautions when caring for patients.
- Engineering controls which provide safety products that have demonstrated an ability to reduce accident risk.
- Training systems that ensure that staff know about established safety procedures and safety products.
In November 1999, OSHA officials issued what is called a compliance directive. This 178-page document serves as a set of guidelines for OSHA inspectors when conducting a safety survey. The Web site address for this bloodborne pathogen compliance directive is www.osha.gov/bloodborne. The November 1999 compliance directive is clear in its emphasis on having healthcare facilities seriously consider purchasing safety devices that can reduce the possibility of employee needlesticks. The compliance directive is an acknowledgement of the increasing body of evidence that protective medical devices have demonstrated the ability to reduce injuries significantly. The compliance directive encourages the OSHA inspector to investigate how the healthcare facility has researched the effectiveness of a wide range of safety medical devices. For a facility to be in compliance with the new emphasis of a bloodborne pathogen standard survey, that facility needs to show evidence of a well designed and effective safety product clinical trial evaluation process. In October 2000, President Clinton signed the Needlestick Injury Prevention Act. This regulation will affect all hospitals that are surveyed by either a state or federal OSHA office.
Clinical Evaluation Process
An effective medical product clinical evaluation system requires a variety of components. First, there must be a clearly defined purpose for the system. Secondly, the steps in the process must be well designed. The third component involves having the staff completely understand both the purpose of the clinical evaluation and each step of the process. A fourth stage for a successful medical product evaluation process is providing sufficient training on the proper use of the product and adequate time for the clinical evaluation to be conducted. The final essential element of an effective clinical evaluation process is having a thorough collection of feedback information from the clinicians who used the medical product.
"We want to make sure that the staff who are going to use the product after we purchase it are the people who are conducting the clinical trials," says Linda Fink, chairperson of the University of Iowa Hospitals and Clinics' Nursing Product Evaluation Committee. "Our committee will screen some products that we know will not be acceptable to staff. We select the supplies that we think may be of benefit to our staff and operation and then we set up clinical trials in units that can give us the best trial information. We often review product usage rates to identify which units should be involved in the evaluation." The experience at the University of Iowa Hospitals and Clinics is fairly standard by industry standards. The OSHA Bloodborne standard is requiring a thorough process for clinical product evaluation for safety medical products. This includes documentation of those trials.
"We use what we call the 'Green Sheet' for documenting the comments and evaluations from the staff," says Renee Gould, clinical trial specialist at the University of Iowa Hospitals and Clinics and member of the Nursing Product Evaluation Committee. "We take the comments noted on the 'Green Sheets' and create a clinical trial summary report that is then presented to the full committee."
These kinds of reports are critical for a facility's compliance documentation for the new emphasis of the Bloodborne Pathogen standard. (See sidebar titled University of Iowa Hospitals and Clinics' "Green Sheet" form.)
Criteria for Evaluating Safety Products
The foundation of any clinical evaluation process is consistent, concise and well designed review criteria. Such criteria provide the safety medical device evaluation process with the basis of inquiry that can be used for various products. The emerging national criteria standard is the Training for the Development of Innovative Control Technology (TDICT) evaluation assessment criteria. Started in 1990, the TDICT project brings together healthcare workers, product design engineers, and industrial hygienists who are dedicated to preventing exposure to bloodborne pathogens through better design and informed evaluation of medical devices. The project is directed by June Fisher, MD, associate clinical professor of medicine at the University of California-San Francisco and lecturer in the School of Engineering at Sanford University.
By directly observing how products are used and by involving the users in systematic evaluations, TDICT has developed an effective system for evaluating and, eventually, promoting medical safety devices. Although several devices have been invented as a result of this collaboration, the major focus of the project has been on the development of evaluation forms for selecting 10 devices. They have helped both manufacturers and healthcare workers to be more critical in developing, selecting, and evaluating medical devices.
Professional medical product evaluation specialists support this set of criteria primarily because the set is thorough. The use of this set of criteria can be defended during an OSHA Bloodborne Pathogen standard survey. The criteria provides a solid basis for safety medical products evaluation because it addresses a wide range of inquiry such as:
- The effect of the product on clinical technique.
- The security of the locking mechanism.
- How easy it is to lock the safety mechanism.
- The reliability of the safety locking mechanism.
- The level of safety provided by the safety mechanism.
- The ease of teaching how the product should be used.
Clinical Evaluation Process Applied to a Safety Medical Product
The best way to see how the TDICT evaluation criteria work in practice is to assess a safety product. The TDICT Safety Feature Evaluation Form for I.V. Access Devices contains the following criteria:
1. The safety feature can be activated using a one-handed technique.
2. The safety feature does not interfere with normal use of this product.
3. Use of this product requires use of the safety feature.
4. This device does not require more time to use than a non-safety device.
5. The safety feature works well with a wide variety of hand sizes.
6. The device allows for rapid visualization of flashback in the catheter or chamber.
7. Use of this product does not increase the number of sticks to the patient.
8. The product stops the flow of blood after the needle is removed from the catheter (or after the butterfly is inserted) and just prior to line connections or hep-lock capping.
9. A clear and unmistakable change (either audible or visible) occurs when the safety feature is activated.
10. The safety feature operates reliably.
11. The exposed sharp is blunted or covered after use and prior to disposal.
12. The product does not need extensive training to be operated correctly.
Recently, the University of Iowa Hospitals and Clinics conducted clinical trials on a safety blood collection needle called the Eclipse, manufactured by Becton-Dickinson (BD). The clinicians who used the product were asked 11 questions. These questions were based on the TDICT criteria. The answers constituted the following report summary:
- My phlebotomy technique feels the same. This trial question relates to criterion 2 on the TDICT survey. This question ensures that the clinical technique of the users is not compromised. The product scored 4.7 out of a possible 5.0.
- It is easy to engage the safety shield. This trial question relates to criterion 4 on the TDICT survey. This question assesses the product's ease of use. The product scored 4.8 out of 5.0.
- The safety shield locks securely. This trial question relates to criteria 4 and 10 on the TDICT survey. This question provides inquiries about the product being able to maintain protection. The product scored 5.0 out of a possible 5.0.
- The safety feature can be easily activated using a one-handed technique. This trial question relates to criterion 1 on the TDICT survey. A one-handed technique is considered a safe method of activating a safety medical device simply because there is little chance of getting the second hand in front of the needle tip where an injury could happen. The product scored 4.8 out of a possible 5.0.
- The safety feature does not interfere with the ability to penetrate the skin. This trial question relates to criteria 2 and 4 on the TDICT survey. This criteria attempts to reconfirm that the clinical technique of the user is not negatively affected. There was some initial concern about the Eclipse product in this regard. Yet the product has the needle bevel oriented in a direct line with the hinged cover so that clinicians could identify the bevel in an easier fashion than with a conventional device. The product scored 5.0 out of 5.0.
- The patient reports no increase in pain with this product. This trial question relates to criterion 8 on the TDICT survey. Safety medical devices should never increase the discomfort to the patient. This product scored 5.0 out of 5.0.
- The safety feature does not impair the blood draw procedure. This trial question relates to criteria 6 and 8 on the TDICT survey. This question again reconfirms that the product does not affect clinical technique. The product scored 4.8 out of 5.0.
- I can tell when the safety device has been activated. This trial question relates to criteria 9, 10, and 11 on the TDICT survey. This question ensures that staff will not inadvertently receive an injury because they thought that the safety feature was activated. The product scored 4.7 out of a possible 5.0.
- The safety feature operates reliably. This trial question relates to criterion 10 on the TDICT survey. Safety features should have a very low rate of failure to activate. The product rated 5.0 out of 5.0.
- The safety shield provides increased protection at the point of venipuncture. This trial question relates to criteria 9, 10, 11, and 12 on the TDICT survey. These criteria ensure that the protective benefit is activated as early in the procedure as possible to maximize the safety benefit. The product rated a 5.0 out of a possible 5.0.
The report accurately reflects the assessment of the staff who will be using the product. "We carefully assessed this product. We were most impressed with the ease of activation. If activation is difficult then the staff are less likely to use the safety feature," says Kathy Eyres, MT (ASCP), the Manager of Specimen Collection at the University of Iowa Hospitals and Clinics.
With the issuing of the Bloodborne Pathogen Compliance Directive in November 1999 and the signing of the Needlestick Prevention Act of 2000, safety medical device evaluation process and documentation is essential to a facility's ability to comply with OSHA regulation. Product evaluation processes, like the one at the University of Iowa Hospitals and Clinics, need to be clearly defined and well documented. Identifying the appropriate staff to be involved in the clinical trial is just the first step in the system. Product utilization reports can help in selecting staff. The cornerstone of any clinical trial is the list of questions or the information collection tools that the facility uses. The set of questions or criteria that is most often used is the TDICT evaluation assessment document.
That set of criteria was used in the recent clinical trial of the BD Eclipse blood collection needle at the University of Iowa hospitals and Clinics. The product rated high marks on every section of the criteria. Following the clinical trial report presentation to the Nursing Product Evaluation Committee, the Eclipse was recommended to be purchased on a facility-wide scale. The University of Iowa Hospitals and Clinics will now establish a baseline data point and use that point to determine what impact the use of the Eclipse product will have on reducing needlestick injuries.
Michael Garvin is a Safety Engineer at University of Iowa Hospitals and Clinics (North Liberty, IA).
Can Plastic Tubes Make a Difference?
Most of the discussion today regarding safer medical devices centers on hollow bore needles. Newspaper articles and professional journal reports often leave out any consideration of the dozens of other medical products that are both sharp and have been exposed to blood or body fluids. Even when healthcare safety professionals discuss sharps injury prevention, the discussion usually focuses on syringes, venous collection needles, and sutures. While each of these types of sharps do contribute to injuries, there are several more contaminated medical supplies that meet the criteria of being able to pierce the skin. Glass blood collection tubes are a primary example. Any sharps injury prevention program should consider all medical devices that can contribute to the transfer of disease from patient to the healthcare worker.
"The safety of the employee was the primary reason for having our hospital convert to plastic blood collection tubes," says Carol Staples, formerly a laboratory manager with New York Methodist Hospital. "The breakage factor with glass blood collection tubes was a real concern for us."
Every year, one and a half billion blood collection tubes are used throughout the US. The single purpose of these items is to collect and contain blood. Every day, healthcare workers collect blood with any number of potentially infectious pathogens into tubes that have the possibility of breaking. These tubes of blood are then carried by hand or cart and shipped through pneumatic tube delivery systems to laboratories. They may also be transported by courier to remote sites. There, the containers are once again handled and placed in centrifuges that spin them at several thousands of revolutions per minute. After the necessary sample has been retrieved and analyzed, these evacuated blood collection tubes are disposed of in medical waste containers and transported to an incinerator or an autoclave. The glass and blood waste may have to be re-packaged and sent to a processing facility several miles or even states away. Even though glass evacuated blood collection tubes have had an outstanding record of reliability, occasionally they do break.
Specimen container breakage has an effect on a hospital's operations in both staff safety and patient care. Plastic tubes could be the logical solution.
The one characteristic of blood collection tubes that concerns health care safety professionals is the fact that nearly 75% of all of these supplies are made of glass. Glass was the material of choice because it could withstand the pressures of a vacuum and it allowed the contents to be easily viewed. The contents needed to be viewed to determine volume and specimen quality. The vacuum was necessary for the blood collection device to properly function. Glass was the perfect selection and has served the healthcare industry well for more than 50 years. Yet in the Nov. 5, 1999, OSHA Compliance Directive, evacuated blood collection tubes were mentioned as a medical device that should be considered when planning a safe medical device program. OSHA calls on the healthcare industry to consider using safety products, in this case plastic blood tubes. OSHA is recommending that consideration be given to the purchase of break-resistant blood collection tubes.
How Can Collecting Blood Be Safer?
Plastic is the logical choice of a material for replacing glass collection tubes. It is inexpensive. It provides acceptable material strength. Its resiliency is much greater than glass, allowing it to break less. It is clear, so the contents can be viewed.
In the following OSHA Compliance Directive excerpt, hospitals are encouraged to consider the purchase of break-resistant blood collection tubes. OSHA's Nov. 5,1999, Compliance Directive states:
"OSHA has required that employers must use engineering and work practice controls that eliminate occupational exposure or reduce it to its lowest feasible extent. It is OSHA's view that preventing exposures requires a comprehensive program, including engineering controls (e.g., needleless devices, shielded needle devices, and plastic capillary tubes) . . . "
The task of the OSHA compliance is much easier when assessing blood collection tubes as opposed to syringes. OSHA considers plastic tubes as having a high level of reliability and safety. Since the OSHA Bloodborne Pathogen Compliance Directive has been in effect since Nov. 5, OSHA compliance officers need only to ask if a facility is currently using plastic blood collection tubes. If the facility is not using plastic tubes, the compliance officer must determine if the facility has a good reason for that decision. In a word, hospitals will be asked to explain why they are not using the safer plastic blood collection tubes.
The OSHA Compliance Directive also recommends that OSHA inspectors ask about the possible problem of having blood collection tubes break in pneumatic systems. If accident reports indicate that blood spills have occurred in the pneumatic, the compliance officer is expected to see that the facility has addressed this problem. Plastic blood collection tubes are an easy solution to this often-messy problem.
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