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Evaluating Safety Product Criteria
By Michael Garvin
In 1991, the Occupational Safety and Health Administration (OSHA) issued itslong awaited standard on Bloodborne Pathogens. After years of investigation,OSHA concluded that a regulatory initiative was necessary to protect healthcareworkers. One of the major considerations in creating bloodborne pathogen safetyregulations was the growing concern of how the industry would manage patientswith AIDS. A prudent AIDS management plan is needed to address the issue ofprotecting the healthcare worker. OSHA felt compelled to require that employerssystematically design systems to ensure a high degree of safety for those staffwho care for patients.
As with most OSHA regulations, compliance strategy centered on three areas:
In November 1999, OSHA officials issued what is called a compliancedirective. This 178-page document serves as a set of guidelines for OSHAinspectors when conducting a safety survey. The Web site address for thisbloodborne pathogen compliance directive is www.osha.gov/bloodborne. TheNovember 1999 compliance directive is clear in its emphasis on having healthcarefacilities seriously consider purchasing safety devices that can reduce thepossibility of employee needlesticks. The compliance directive is anacknowledgement of the increasing body of evidence that protective medicaldevices have demonstrated the ability to reduce injuries significantly. Thecompliance directive encourages the OSHA inspector to investigate how thehealthcare facility has researched the effectiveness of a wide range of safetymedical devices. For a facility to be in compliance with the new emphasis of abloodborne pathogen standard survey, that facility needs to show evidence of awell designed and effective safety product clinical trial evaluation process. InOctober 2000, President Clinton signed the Needlestick Injury Prevention Act.This regulation will affect all hospitals that are surveyed by either a state orfederal OSHA office.
An effective medical product clinical evaluation system requires a variety ofcomponents. First, there must be a clearly defined purpose for the system.Secondly, the steps in the process must be well designed. The third componentinvolves having the staff completely understand both the purpose of the clinicalevaluation and each step of the process. A fourth stage for a successful medicalproduct evaluation process is providing sufficient training on the proper use ofthe product and adequate time for the clinical evaluation to be conducted. Thefinal essential element of an effective clinical evaluation process is having athorough collection of feedback information from the clinicians who used themedical product.
"We want to make sure that the staff who are going to use the productafter we purchase it are the people who are conducting the clinicaltrials," says Linda Fink, chairperson of the University of Iowa Hospitalsand Clinics' Nursing Product Evaluation Committee. "Our committee willscreen some products that we know will not be acceptable to staff. We select thesupplies that we think may be of benefit to our staff and operation and then weset up clinical trials in units that can give us the best trial information. Weoften review product usage rates to identify which units should be involved inthe evaluation." The experience at the University of Iowa Hospitals andClinics is fairly standard by industry standards. The OSHA Bloodborne standardis requiring a thorough process for clinical product evaluation for safetymedical products. This includes documentation of those trials.
"We use what we call the 'Green Sheet' for documenting the comments andevaluations from the staff," says Renee Gould, clinical trial specialist atthe University of Iowa Hospitals and Clinics and member of the Nursing ProductEvaluation Committee. "We take the comments noted on the 'Green Sheets' andcreate a clinical trial summary report that is then presented to the fullcommittee."
These kinds of reports are critical for a facility's compliance documentationfor the new emphasis of the Bloodborne Pathogen standard. (See sidebar titled Universityof Iowa Hospitals and Clinics' "Green Sheet" form.)
The foundation ofany clinical evaluation process is consistent, concise and well designed reviewcriteria. Such criteria provide the safety medical device evaluation processwith the basis of inquiry that can be used for various products. The emergingnational criteria standard is the Training for the Development of InnovativeControl Technology (TDICT) evaluation assessment criteria. Started in 1990, theTDICT project brings together healthcare workers, product design engineers, andindustrial hygienists who are dedicated to preventing exposure to bloodbornepathogens through better design and informed evaluation of medical devices. Theproject is directed by June Fisher, MD, associate clinical professor of medicineat the University of California-San Francisco and lecturer in the School ofEngineering at Sanford University.
By directly observing how products are used and by involving the users insystematic evaluations, TDICT has developed an effective system for evaluatingand, eventually, promoting medical safety devices. Although several devices havebeen invented as a result of this collaboration, the major focus of the projecthas been on the development of evaluation forms for selecting 10 devices. Theyhave helped both manufacturers and healthcare workers to be more critical indeveloping, selecting, and evaluating medical devices.
Professional medical product evaluation specialists support this set ofcriteria primarily because the set is thorough. The use of this set of criteriacan be defended during an OSHA Bloodborne Pathogen standard survey. The criteriaprovides a solid basis for safety medical products evaluation because itaddresses a wide range of inquiry such as:
The best way to see how the TDICT evaluation criteria work in practice is toassess 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 clinicaltrials on a safety blood collection needle called the Eclipse, manufactured byBecton-Dickinson (BD). The clinicians who used the product were asked 11questions. These questions were based on the TDICT criteria. The answersconstituted the following report summary:
The report accurately reflects the assessment of the staff who will be usingthe product. "We carefully assessed this product. We were most impressedwith the ease of activation. If activation is difficult then the staff are lesslikely to use the safety feature," says Kathy Eyres, MT (ASCP), the Managerof Specimen Collection at the University of Iowa Hospitals and Clinics.
With the issuing of theBloodborne Pathogen Compliance Directive in November 1999 and the signing of theNeedlestick Prevention Act of 2000, safety medical device evaluation process anddocumentation is essential to a facility's ability to comply with OSHAregulation. Product evaluation processes, like the one at the University of IowaHospitals and Clinics, need to be clearly defined and well documented.Identifying the appropriate staff to be involved in the clinical trial is justthe first step in the system. Product utilization reports can help in selectingstaff. The cornerstone of any clinical trial is the list of questions or theinformation collection tools that the facility uses. The set of questions orcriteria 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 Eclipseblood collection needle at the University of Iowa hospitals and Clinics. Theproduct rated high marks on every section of the criteria. Following theclinical trial report presentation to the Nursing Product Evaluation Committee,the Eclipse was recommended to be purchased on a facility-wide scale. TheUniversity of Iowa Hospitals and Clinics will now establish a baseline datapoint and use that point to determine what impact the use of the Eclipse productwill have on reducing needlestick injuries.
Michael Garvin is a Safety Engineer at University of Iowa Hospitals andClinics (North Liberty, IA).
Most of the discussion todayregarding safer medical devices centers on hollow bore needles. Newspaperarticles and professional journal reports often leave out any consideration ofthe dozens of other medical products that are both sharp and have been exposedto blood or body fluids. Even when healthcare safety professionals discusssharps injury prevention, the discussion usually focuses on syringes, venouscollection needles, and sutures. While each of these types of sharps docontribute to injuries, there are several more contaminated medical suppliesthat meet the criteria of being able to pierce the skin. Glass blood collectiontubes are a primary example. Any sharps injury prevention program shouldconsider all medical devices that can contribute to the transfer of disease frompatient to the healthcare worker.
"The safety of the employee was the primary reason for having ourhospital convert to plastic blood collection tubes," says Carol Staples,formerly a laboratory manager with New York Methodist Hospital. "Thebreakage factor with glass blood collection tubes was a real concern forus."
Every year, one and a half billion blood collection tubes are used throughoutthe US. The single purpose of these items is to collect and contain blood. Everyday, healthcare workers collect blood with any number of potentially infectiouspathogens into tubes that have the possibility of breaking. These tubes of bloodare then carried by hand or cart and shipped through pneumatic tube deliverysystems to laboratories. They may also be transported by courier to remotesites. There, the containers are once again handled and placed in centrifugesthat spin them at several thousands of revolutions per minute. After thenecessary sample has been retrieved and analyzed, these evacuated bloodcollection tubes are disposed of in medical waste containers and transported toan incinerator or an autoclave. The glass and blood waste may have to bere-packaged and sent to a processing facility several miles or even states away.Even though glass evacuated blood collection tubes have had an outstandingrecord of reliability, occasionally they do break.
Specimen container breakage has an effect on a hospital's operations in bothstaff safety and patient care. Plastic tubes could be the logical solution.
The one characteristic of blood collection tubes that concerns health caresafety professionals is the fact that nearly 75% of all of these supplies aremade of glass. Glass was the material of choice because it could withstand thepressures of a vacuum and it allowed the contents to be easily viewed. Thecontents needed to be viewed to determine volume and specimen quality. Thevacuum was necessary for the blood collection device to properly function. Glasswas the perfect selection and has served the healthcare industry well for morethan 50 years. Yet in the Nov. 5, 1999, OSHA Compliance Directive, evacuatedblood collection tubes were mentioned as a medical device that should beconsidered when planning a safe medical device program. OSHA calls on thehealthcare industry to consider using safety products, in this case plasticblood tubes. OSHA is recommending that consideration be given to the purchase ofbreak-resistant blood collection tubes.
How Can Collecting Blood Be Safer?
Plastic is the logical choice of a material for replacing glass collectiontubes. It is inexpensive. It provides acceptable material strength. Itsresiliency 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 encouragedto 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 workpractice controls that eliminate occupational exposure or reduce it to itslowest feasible extent. It is OSHA's view that preventing exposures requires acomprehensive 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 bloodcollection tubes as opposed to syringes. OSHA considers plastic tubes as havinga high level of reliability and safety. Since the OSHA Bloodborne PathogenCompliance Directive has been in effect since Nov. 5, OSHA compliance officersneed only to ask if a facility is currently using plastic blood collectiontubes. If the facility is not using plastic tubes, the compliance officer mustdetermine 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 plasticblood collection tubes.
The OSHA Compliance Directive also recommends that OSHA inspectors ask aboutthe possible problem of having blood collection tubes break in pneumaticsystems. If accident reports indicate that blood spills have occurred in thepneumatic, the compliance officer is expected to see that the facility hasaddressed this problem. Plastic blood collection tubes are an easy solution tothis often-messy problem.
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