Are Passive Safety Activation Medical Devices Best for Patients and Staff?
By Michael Garvin, MHA
When the Bloodborne Pathogen Standard was first being implemented in hospitals and doctors' offices, there were certain words and phrases used to describe desirable characteristics of safety medical devices. As the technology has changed, some of the terms and the use of those terms in both the general national discussion and the discussion involving the regulatory agencies also have changed. Some have become less relevant. Some have clouded the issue of ensuring staff safety. The goal of this article is to help identify those terms and concepts that are detracting from a productive discussion on healthcare worker (HCW) safety and recommend terms that better contribute to the goal of enhancing worker safety.
Passive vs. Active Safety Feature Activation
The terms "passive" and "active" have been used to describe how the safety feature of a particular medical device is activated. Generally speaking, the term "passive" is used to define a safety technology when no additional step in the use of the medical device is needed to activate the safety feature. When the clinician uses the device as it would normally 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 the shield that comes out to cover the needle tip. These types of devices have been well received in healthcare settings where management must ensure that the safety feature has been activated. Also, these products have been used in those procedures where staff cannot take the time to manually activate the safety feature. A good example of such a procedure is a psychiatric patient "take down" where a sedative is administered.
In contrast, active activation safety devices require the user to make a conscious effort and perform a triggering action for the safety feature to be activated. Active safety feature designs are most common in the safety medical devices that are available on the market. In these medical devices, the clinician must initiate a separate safety activation step. The clinician must push a button or apply pressure to the hinged needle tip cover in order to activate the safety feature of that device. It may better serve the national discussion on safety medical devices if we started referring active activation devices as "clinician-controlled" safety devices.
During the years that regulators, safety researchers and healthcare professionals have been discussing safety technology, there has been a general attitude that passive activation technology is preferred over active activation technology. Often times, proponents of this view point to the problems of clinicians failing to activate the safety feature of a medical device. A case can be made that the passive activation design for medical devices can eliminate this problem by taking away the choice factor. By the very use of the medical device the clinician will activate the safety feature of that device. Even communications from regulatory agencies indicate that passive activation device designs are considered safer than active activation products. Device manufacturers continue to seek new device designs that incorporate passive activation technology. Yet, in most cases, passive activation devices cost more to design and manufacture than active devices. The call for more passive activation designs seems to be driven by regulators and researchers rather than by clinician and healthcare organizations. It is hard to find scientific evidence that passive activation devices are better at providing safety to HCWs than active activation products. This may be due to the fact there are very few passive activation devices presently on the market. This may be a result of the fact that manufacturers do not believe the market will see the value of a passive activation device that will carry a higher price tag as compared to its active activation counterpart. Yet there may be a more compelling reason why there 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 of the use of the medical device is to provide healthcare services. The main reason that safety medical devices are rejected centers around the device negatively impacting the delivery of care. The safety feature somehow gets in the way of the clinician doing his or her job. "I cannot have a safety syringe get in the way of my job," says Marsha Watson, a nurse at St. Francis Medical Center in Peoria, Ill. "Safety is very important but I want a syringe that will 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 or patient. Early activation of the device may result in re-initiating the procedure causing inconvenience and additional discomfort to the patient and an increase in expense to the organization. "I want to have the additional level 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 completely finished 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 activation devices do provide a significant value in those situations where there is a high level of uncertainty that the clinical staff will activate the safety feature of the medical device. On the other hand, the question has to be raised of why the staff does not choose to activate the safety feature. Is there a problem with staff acceptance of the device? Is there a problem with the effectiveness of the training effort? Is the passive activation device employed simply because these other issues are not being addressed?
The other issue that involved trust is the relationship, however long or brief, that exists between patient and clinician. "We have to look at how the safety device protects our staff but how it affects our patients as well," says Dave Easler of Dahl Chase Pathology Associates in Bangor, Maine. "We have to take into consideration the comfort of the patient. When there are surprises in the delivery of treatment, the trust between the clinician and patient can be compromised. That trust relationship is very important to what we do. If an automatic safety feature is triggered early, both the clinician and the patient are surprised. The trust that the patient had in the clinician can be negatively affected. This is especially true in the care of children."
Getting staff to use and activate safety medical devices will never be an easy job. Healthcare has always gravitated to the status quo. Yet even the toughest critics of change must admit that these medical devices can provide a higher level of safety for all staff. The debate over passive and active activation technologies may be better served if the term "active" is changed to "clinician-controlled." There is a strong case for the benefits of clinician-controlled safety devices. One of those benefits may include maintaining the trust factors that exists between the clinician and the patient. We cannot afford to jeopardize that essential element of the healthcare delivery system.
Michael Garvin, MHA, is a safety consultant for the University of Iowa Hospitals and Clinics.