Originally Published MDDI January 2005
January 1, 2005
Originally Published MDDI January 2005
Device Misuse
Addressing the Problem of Medical Device Misuse
Medical device misuse is unavoidable. But how much responsibility should device manufacturers bear for creating safer products?
Michael E. Wiklund
Manufacturers must consider many factors during a product's |
For ethical, legal, and economic reasons, medical device manufacturers need to pay close attention to the many ways their products can be misused. Misuse sometimes exposes people to serious hazards that can lead to injury, death, or property damage. Such adverse outcomes can jeopardize a manufacturer's reputation and provoke lawsuits.
Of course, not all misuses are necessarily dangerous, and they may even be desirable. As used in this article, the word misuse is a product development term of art that has sparked considerable semantic debate. To many design professionals, it encompasses not just operating a device in an erroneous, and even malevolent, manner, but also beneficial and widely accepted but off-label uses.
Understanding the full range of possible misuses will allow manufacturers to make fully informed choices about how to prepare for these misuses. They may even be prompted to reassess whether they have correctly identified all the appropriate uses of their products.
Some manufacturers will take great care to prevent or mitigate foreseeable misuses. Others will take a more-limited approach that focuses only on uses described in the product's labeling, even when they may be directly or indirectly promoting the product's off-label uses. Logically, most will seek ways to limit their responsibility for egregious misuses.
Whether a given approach is regarded as reasonable or not depends in part on the work of a joint IEC-ISO standards committee, called IEC-ISO JWG4, which is currently addressing the issue of misuse. It also depends on how particular manufacturers manage their risks and on their assumed responsibility to protect people from design-induced and self-inflicted harm.
Preventing Misuse
Prudent manufacturers engineer their products to reduce the chance of misuse or abuse. For example, a manufacturer may choose to permanently seal a device's case rather than screw it together. That way, people cannot dismantle it easily. Such a solution may complicate repairs or even make them impossible. Still, it reduces the chance that someone will open the device and possibly receive an electrical shock. It also reduces the chance of tampering. As another example, a monitor manufacturer may customize its sensor leads to prevent users from inserting the leads into the wrong ports or outlets.
Other protective strategies in lieu of eliminating a hazard altogether include adding safety features, training people to use products properly, and placing warnings on the products. The last option is especially popular with manufacturers because it represents a simple, low-cost fix that also offers an essential measure of legal protection, since liability lawsuits often focus on a manufacturer's failure to warn users about hazards.
Persistent Forms of Misuse
Still, despite measures to encourage proper use, the misuse of seemingly well-designed products is a relatively common event. In fact, some misuses, often called off-label uses, have actually emerged over time as accepted practice.
For example, it has become routine to send patients home with intravenous (IV) infusion pumps. These pumps were originally designed for use in hospitals by trained medical professionals. IV pump manufacturers may not have anticipated such use or formally sanction it, despite the fact that it may be good for their business. Still, it is happening, and the situation raises concerns about laypeople using the product incorrectly. Matthew Weinger, MD, professor of anesthesiology at the University of California, San Diego, director of the San Diego Center for Patient Safety at the San Diego VA Healthcare, and cochair of AAMI's Human Factors Committee, says such misuses are common. “You have situations where patients and their family members are operating infusion pumps at home,” Weinger says. “For instance, a mother may be caring for a sick child. Should the manufacturer be held responsible if the mom turns off the alarms and there is a problem?”
Another form of common off-label use occurs with single-use syringes. Even though these syringes should be thrown away after just one injection, people may use them repeatedly. Is it enough for the manufacturer to label the syringes as single use? Or should manufacturers be held responsible for somehow disabling the syringe after its first use—a measure that can increase product cost? Some companies have already engineered single-use syringes that become inoperable after one use. Does this place companies that have not taken this step at risk? These questions do not have clear answers at this time.
Ventilators and warmers are also often misused, in the sense of the term of art. Although originally designed for use in operating rooms and ICUs only, Weinger says, “they have migrated into emergency rooms, step-down units, and even people's homes.” He adds, “These devices were intended to be used by individuals with special training but are now being used in less-acute domains by people who may have less skill. This misuse can lead to problems. For example, forced-air warmers can cause burns if you do not use them properly.”
Some manufacturers have treated common off-label uses as an opportunity to develop new products to meet those needs, properly accounting for the intended users' knowledge and abilities. However, this by itself has not eliminated the persistent problem of mismatched devices and users, a problem that must be addressed by both manufacturers and healthcare institutions.
Drawing the Line
As one might imagine, manufacturers want to take a number of steps to protect themselves. Such steps include:
• Drawing a clear line between misuses that are reasonably likely and those that are not.
• Differentiating misuses that are well intentioned from those that are not.
• Limiting their risk-management efforts to misuses associated with the product's intended purposes, which one might define as use error, rather than misuse, which seems to suggest flaws in the user's intent.
Manufacturers wonder how they can protect themselves against somebody using their device for an unintended purpose or to deliberately cause harm. They reason that a deranged individual could always find a bizarre way to hurt someone with a medical device. They suggest that designing a device to prevent such criminal acts while also maintaining the device's effectiveness and usability might be impossible.
Meanwhile, regulators and human factors specialists have been encouraging manufacturers to take a closer look at misuses before dismissing them as unlikely, unrelated to the product's established purposes, or outright aberrant. The proponents of a more-expansive analysis believe that some manufacturers ignore a large number of likely misuses, including the aforementioned off-label uses. Instead, those manufacturers take the logical stance that no one should use a medical device without having the proper qualifications and training to use the device in accordance with the instructions for use.
Weinger is a proponent of intensive human factors analysis of potential misuses. “If you are going to design a device with a certain set of intended uses, doesn't it make sense to ask the customer if those uses are reasonable or not?” he asks. Weinger's proposition assumes that manufacturers will discover differences between their intentions and the users' expectations.
So, the medical device industry is caught in a debate on misuse and the manufacturer's level of responsibility. It seems headed toward a compromise solution in which manufacturers perform more-intensive analyses of potential misuses. This compromise also may establish a cutoff point for misuses falling outside the manufacturer's responsibility.
Categorizing Misuse
During its 2004 meetings in Vancouver and London, the IEC-ISO JWG4 committee addressed the issue of medical device misuse. Specifically, they discussed how device misuse (alternately described as use error) factors into the overall risk-management process, as defined in IEC/CD Standard 62366, Medical Devices—General Requirements for Safety and Essential Performance—Usability.
One issue facing the committee as well as others concerned with incidence of medical device–related injuries is how to reliably differentiate reasonably foreseeable misuses from those that are not reasonably foreseeable. Another issue is where to draw the line in terms of the manufacturer's responsibility to protect against such misuse. To complicate matters, two analysts could independently evaluate the same potential misuses and draw different conclusions about the reasonableness of a particular user action, never mind the limits of manufacturer responsibility. The second issue introduces all kinds of economic and political issues that are beyond this article's scope.
Currently, failure modes and effects analyses (FMEAs) and fault tree analyses (FTAs) can focus on reasonably foreseeable misuses, but one has to depend on professional judgment supported by available historical data to determine the likelihood of a particular event.
Meanwhile, there is the matter of off-label uses. Although such uses are technically considered misuses, off-label uses may be so common that they become standard operational procedure—the established standard of care. This poses challenges to manufacturers that may have focused their design efforts on the needs of a particular user population, only to see the device serve broader needs. It is these kinds of complexities that have motivated ISO-IEC to take up the issue and work toward a common framework for dealing with misuses.
Most product developers would agree that some misuses (what some developers would term use errors) could be predicted by applying human factors engineering principles. For instance, it is well-known that people often bump into medical devices in corridors and procedure rooms. Such collisions might inadvertently change a critical control setting if the control were not guarded. Product designers can use this knowledge to develop devices that can withstand casual impact.
Also consider the case of a digital thermometer with a pointed tip. One could predict that someone might someday stick the thermometer's tip in an ac power outlet and receive an electrical shock. Such an outcome could be extrapolated from documented cases of people sticking a medical device's leads into an ac outlet and causing burns and electrocution.1 Therefore, some manufacturers may address these kinds of predictable misuses in their risk management efforts. At the same time, some manufacturers might feel this goes beyond their risk-management responsibilities.
There seems to be a strong consensus among manufacturers, regulators, and patient safety advocates that manufacturers should not be held responsible for malevolent acts, such as using a surgical instrument deliberately as a weapon. Gerald Panitz, an anesthesia equipment developer with Draeger Medical (Lubeck, Germany) and an IEC committee member, concurs. “Some theoretical possibilities, such as throwing a device at somebody, should be dismissed,” he says. He thinks that reasonable people would agree that such acts qualify as abuse and should be outside the manufacturer's responsibility.
One possible scheme for characterizing product uses as proper or improper included the following categories:
• Normal use: Using the device as the manufacturer intended, as described in the device's user manual.
• Common use: Using the device in ways that the manufacturer did not intend but that fall within the established standards of care.
• Misuse subject to mitigation: Using the device in ways that could be predicted by a thorough human factors analysis that considers the user population, the task, and the use environment.
• Misuse not subject to mitigation: Using the device in ways that could not be predicted by a thorough human factors analysis.
• Abuse: Using a device in ways intended to cause damage and personal harm.
However, this approach could be viewed as expanding the manufacturer's risk management responsibilities beyond reason, particularly because of the complexities of predicting human behavior.
Another possible scheme for characterizing product uses includes the following categories:
• Correct use: Using the device as intended by the manufacturer and as described in the device's instructions for use.
• Use error: Using the device in a well-intentioned but
incorrect manner.