• Looking at underreported close-call incidents

• Redefining semantics to improve reporting

• Establishing pathways for rigorous reporting

The Center for Devices and Radiological Health (CDRH) receives approximately 100,000 medical device reports in a given year, about one-third of which mention errors on the part of the device users. Most are adverse events resulting in physical harm or death to the patient; however, the number and nature of close calls is unknown. A conservative estimate—based on the everyday use of hundreds of clinical devices (some inadequately designed)—could put these close-call incidents in the hundreds of thousands per year in the US alone, and perhaps millions worldwide.

Due to clinical underreporting, close calls are not well documented, making it difficult for a product development team to analyze and potentially correct a problem related to such events. Close calls are device-use errors that have the potential to result in serious hazards, those that the International Electrotechnical Commission (IEC) standards call “slips, lapses, and mistakes” (Annex C, IEC 62366:2007). While device manufacturers are obligated to identify, analyze, and mitigate foreseeable use-related hazards during premarket development, the current clinical culture does not consistently report user feedback postmarket.

Standardized reporting in hospitals has been shown to improve patient safety, but implementation of these protocols remains a challenge. If the system is difficult to access, cumbersome to implement, nonintuitive, and time-consuming, it isn’t likely that many clinicians will want to take the time to report close calls. Moreover, with the punitive nature of the clinical culture, the litigious nature of the US healthcare system, and the existing postmarket surveillance reporting processes, clinicians seriously question the value of reporting hazardous events.

Redefining semantics

The first step in redressing this data gap has already been implemented by the standards community. It was to advance postmarket reporting by redefining industry semantics (the distinction between User Error and Use Error was first coined by William A. Hyman, “The Issue Is ‘Use,’ Not ‘User,’ Error,” MD&DI, 17(5), May 1995). In IEC 62366:2007, which FDA recognizes as a consensus standard, use error is defined as “an act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user.”

The term use error precludes the assignment of cause (i.e., user’s fault) by providing only the identification of what happened, not why it happened. Essentially, it takes the onus off the user; no longer is it the user’s fault if the device causes the user to commit an error. The intention is to minimize or eliminate the ability of the user to commit an error despite device design and instructions for use (including labeling and training).

The next step is to educate the clinical community on the impact of the terminology in their punitive culture of postmarket reporting. A new Technical Information Report (TIR), Surveillance and Complaint Analysis of Use Error is under development by the Association for the Advancement of Medical Instrumentation (AAMI) and will address the subject and provide the clinical community with guidance.

Adding robustness

The human factors community views these recommended guidelines as having the potential to create a paradigm shift in the institutional healthcare culture. If adopted by the Joint Commission, this TIR could mandate more rigorous reporting within the healthcare community to ensure that close-call data are shared with medical device manufacturers. The report is expected to provide clinicians and manufacturers with a high-level process to leverage postmarket use-error data in the management of existing devices and in the development of next-generation product designs.

The value to the manufacturer in implementing such a robust process is the qualification of potential use-error conditions to best optimize a device design. From the manufacture’s perspective, the results of the postmarket use-error data analysis will result in the development of ease-of-use and safety features that are ultimately a competitive advantage. This will be perceived as added value by customers.

In addition, the report will provide guidance for recognizing, collecting, evaluating, and communicating postmarket use-error data from the clinical, manufacturer, and standards compliance perspectives. This high-level guidance describes process flow, training, scalability, and includes sample questions for data collection. The intended audience includes the users and associated colleagues that would be reporting the events:

• technician (biomed engineer, scrub tech, etc.)

• layperson (patients, family members, care givers, etc.)

• clinician (nurse, physician, therapist, etc.)

• human factors engineer/clinician (site staff)

• stakeholders collecting and analyzing the data

Such stakeholders would come from the clinical and industrial side, inclusive of the following:

• healthcare professionals

• safety officers

• complaint handlers

• technical support

• customer-facing personnel

• product quality management (risk managers and quality engineers)

• post-market quality organizations

• pharmacy vigilance groups

• patient-safety organizations

• medical affairs

• service organizations (internal, subcontractors)

• product development support/maintenance teams

• all manufacturer employees receiving complaints from customers

• manufacturer-usability practitioners

In order to comply with the usability engineering process outlined by IEC62366, postmarket surveillance and vigilance reporting are considered important inputs to ensure the continued safe use of a medical device in identifying its strengths and shortcomings. The report describes potential sources of postmarket feedback. These include (but are not limited to):

• relevant vigilance reports

• Joint Commission sentinel event alerts

• incident reports

• adverse event reports

• customer complaints

• MedWatch data

• closed claim data

• post-market surveillance data

• precursor analysis

• use of critical incident analysis techniques

• structured interviews with users who have experienced problems with the device

• performance evaluations performed by independent laboratories

• feedback from sales, marketing, or training staff

Collecting, analyzing, and investigating complaints filed by customers is the responsibility of the device manufacturers. It is a rigorous process with mechanisms in place to capture, triage, and investigate various types of quality control issues. Use error is a challenging category to define and execute in an existing system. In many cases, there is no one cause but a multitude of issues that result in a complaint. Use error is often part of larger categories identified from known or potential issues defined by risk management.

Postmarket data are commonly used to determine trends associated with a medical device being used by clinicians. As trends develop, these data can be used for future design changes to improve the device. Additionally, as new devices are developed, which could be similar to existing ones, such data can be invaluable for identifying potential use errors that would be used in the risk-management process. A process that would determine acceptable risk levels and possible mitigations would later be designed into the medical device and validated.

The goal of this high-level process recommendation is to leverage the efforts spent on use-related risk assessment, integrate those efforts with a rigorous quality reporting system, and provide insight and guidance to the design team on use errors that exceed acceptable levels. The AAMI TIR provides the framework to close the loop between R&D and postmarket usage in order to improve outcomes. The challenge remains for the device- manufacturing community to educate the clinical community on the implication of this process—the health and safety of their patients are at stake.