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Are Passive Safety Activation Medical Devices Best for Patientsand Staff?
By Michael Garvin, MHA
When the Bloodborne Pathogen Standard was first being implemented inhospitals and doctors' offices, there were certain words and phrases used todescribe desirable characteristics of safety medical devices. As the technologyhas changed, some of the terms and the use of those terms in both the generalnational discussion and the discussion involving the regulatory agencies alsohave changed. Some have become less relevant. Some have clouded the issue ofensuring staff safety. The goal of this article is to help identify those termsand concepts that are detracting from a productive discussion on healthcareworker (HCW) safety and recommend terms that better contribute to the goal ofenhancing worker safety.
Passive vs. Active Safety Feature Activation
The terms "passive" and "active" have been used todescribe how the safety feature of a particular medical device is activated.Generally speaking, the term "passive" is used to define a safetytechnology when no additional step in the use of the medical device is needed toactivate the safety feature. When the clinician uses the device as it wouldnormally be used in the delivery of healthcare, the safety feature is activated.The very steps involved in the normal use of the medical device activate theshield that comes out to cover the needle tip. These types of devices have beenwell received in healthcare settings where management must ensure that thesafety feature has been activated. Also, these products have been used in thoseprocedures where staff cannot take the time to manually activate the safetyfeature. A good example of such a procedure is a psychiatric patient "takedown" where a sedative is administered.
In contrast, active activation safety devices require the user to make aconscious effort and perform a triggering action for the safety feature to beactivated. Active safety feature designs are most common in the safety medicaldevices that are available on the market. In these medical devices, theclinician must initiate a separate safety activation step. The clinician mustpush a button or apply pressure to the hinged needle tip cover in order toactivate the safety feature of that device. It may better serve the nationaldiscussion on safety medical devices if we started referring active activationdevices as "clinician-controlled" safety devices.
During the years that regulators, safety researchers and healthcareprofessionals have been discussing safety technology, there has been a generalattitude that passive activation technology is preferred over active activationtechnology. Often times, proponents of this view point to the problems ofclinicians failing to activate the safety feature of a medical device. A casecan be made that the passive activation design for medical devices can eliminatethis problem by taking away the choice factor. By the very use of the medicaldevice the clinician will activate the safety feature of that device. Evencommunications from regulatory agencies indicate that passive activation devicedesigns are considered safer than active activation products. Devicemanufacturers continue to seek new device designs that incorporate passiveactivation technology. Yet, in most cases, passive activation devices cost moreto design and manufacture than active devices. The call for more passiveactivation designs seems to be driven by regulators and researchers rather thanby clinician and healthcare organizations. It is hard to find scientificevidence that passive activation devices are better at providing safety to HCWsthan active activation products. This may be due to the fact there are very fewpassive activation devices presently on the market. This may be a result of thefact that manufacturers do not believe the market will see the value of apassive activation device that will carry a higher price tag as compared to itsactive activation counterpart. Yet there may be a more compelling reason whythere are not more passive designed devices available.
Clinicians Weigh in on the Passive vs. Active Discussion
What regulators sometimes forget to consider is that the primary objective ofthe use of the medical device is to provide healthcare services. The main reasonthat safety medical devices are rejected centers around the device negativelyimpacting the delivery of care. The safety feature somehow gets in the way ofthe clinician doing his or her job. "I cannot have a safety syringe get inthe way of my job," says Marsha Watson, a nurse at St. Francis MedicalCenter in Peoria, Ill. "Safety is very important but I want a syringe thatwill provide safety but not compromise my work."
Passive activation devices do take the choice factor away from the clinician.Regulators and program managers may view this as a positive. Clinicians may not.The automatic activation of the safety feature may surprise the clinician orpatient. Early activation of the device may result in re-initiating theprocedure causing inconvenience and additional discomfort to the patient and anincrease in expense to the organization. "I want to have the additionallevel of safety," says Alice Carpenter of Northern Maine Medical Center."I also want to be able to control when the safety feature is activated.What if the safety feature automatically activates and I am not completelyfinished giving the medication?"
It's a Matter of Trust Between Staff and Patient
The balance seems to be pivoting on the issue of trust. Passive activationdevices do provide a significant value in those situations where there is a highlevel of uncertainty that the clinical staff will activate the safety feature ofthe medical device. On the other hand, the question has to be raised of why thestaff does not choose to activate the safety feature. Is there a problem withstaff acceptance of the device? Is there a problem with the effectiveness of thetraining effort? Is the passive activation device employed simply because theseother issues are not being addressed?
The other issue that involved trust is the relationship, however long orbrief, that exists between patient and clinician. "We have to look at howthe safety device protects our staff but how it affects our patients aswell," says Dave Easler of Dahl Chase Pathology Associates in Bangor,Maine. "We have to take into consideration the comfort of the patient. Whenthere are surprises in the delivery of treatment, the trust between theclinician and patient can be compromised. That trust relationship is veryimportant to what we do. If an automatic safety feature is triggered early, boththe clinician and the patient are surprised. The trust that the patient had inthe clinician can be negatively affected. This is especially true in the care ofchildren."
Getting staff to use and activate safety medical devices will never be aneasy job. Healthcare has always gravitated to the status quo. Yet even thetoughest critics of change must admit that these medical devices can provide ahigher level of safety for all staff. The debate over passive and activeactivation technologies may be better served if the term "active" ischanged to "clinician-controlled." There is a strong case for thebenefits of clinician-controlled safety devices. One of those benefits mayinclude maintaining the trust factors that exists between the clinician and thepatient. We cannot afford to jeopardize that essential element of the healthcaredelivery system.
Michael Garvin, MHA, is a safety consultant for the University of IowaHospitals and Clinics.