| What were the "root causes" of the above adverse event? Were alarms inadequate? Was there insufficient vigilance on the part of the medical staff?
At its most basic level, the root cause of this woman's death must be understood as a system problem. How safe would a car be if key components, such as the brakes and cruise control, didn't work together? Imagine an airplane that didn't provide a warning if the landing gear didn't deploy.
The kinds of interoperable plug-and-play control and communication systems that are taken for granted in automobiles and aircraft are lacking in today's healthcare industry. Devices are essential to the practice of modern medicine and are typically used for routine procedures like physiologic measurements of blood pressure and temperature, x-ray and ultrasound imaging, administration of intravenous medications, and support of critical life functions. However, despite the dependency of healthcare professionals on these sophisticated medical devices, each one is designed to stand alone as an island. Developed without uniform communication standards, proprietary devices are not equipped to communicate with one another.
The high reliability and security of information systems, advisory alarms, and safety interlocks of commercial aircraft are good examples of what is needed in healthcare settings. Although intraoperative patient safety has improved significantly, the OR is still a complex and potentially hazardous environment, where clinicians depend on teamwork and a patchwork of systems to mitigate threats instead of using automated safety systems. Surprisingly, smart alarms and automated decision support tools are still generally absent from the clinical environment.
In 2004, Massachusetts General Hospital (MGH) and CIMIT (Center for Integration of Medicine and Innovative Technology) initiated the Medical Device Plug-and-Play (MDPnP) program to lead development and adoption of an open networking standard for communication and integration of medical devices. Networked device systems will ultimately support the widespread clinical use of medical device data and integration of devices to produce complete and accurate electronic health records, reduce medical errors, and reduce healthcare costs.
A multi-disciplinary, multi-institutional program, the MD PnP program led by Boston-based Partners Healthcare, now includes the participation of over 65 institutions, such as Kaiser Permanente, and over 500 experts - clinicians and engineers. One of the most crucial stakeholders in the initiative is the FDA; representatives from its Center for Devices and Radiological Health (CDRH) have participated in the discussion from the program's inception.
Initially, the PnP group convened three summits to begin the process of developing technical and clinical requirements for a networked medical device ecosystem for devices in the Operating Room of the Future (ORF) at Massachusetts General Hospital. The ORF is a "living laboratory" where clinicians explore new technology platforms and systems of care for performing minimally invasive surgery.
Inroads into establishing device interoperability have already been made. At this point, it is possible to bring multiple devices together into interconnected systems through the support of third-party data integration specialists. LiveData, Inc., which writes custom software to aggregate and display data from disparate systems, is participating in the newly-founded MD PnP laboratory.
In May 2006, the program opened the vendor-neutral lab to:
- evaluate the ability of candidate interoperability standards to meet clinical requirements
- model clinical use cases (in simulation environment)
- develop and test related network safety and security systems, especially to enhance the understanding of the technical issues at the intersection of biomedical engineering and information systems
- support interoperability and conformance testing
- serve as a resource for the medical device interoperability community
Currently, development of a closed-loop control system, a system that directly addresses the "root cause" of the adverse event in the opening scenario is near completion. The lab has coordinated x-ray equipment with Drager's anesthesia workstation, "Apollo." While the patient is ventilated, the system synchronizes or "gates" the x-ray to expose an image at the end of patient expiration or inspiration, thereby eliminating the necessity of completely turning off the ventilator in order to take an x-ray. As device interoperability is adopted to support this level of device integration, the adverse event described at the beginning is no longer a threat to patient safety.
The lab continues to develop new intermediary solutions toward achieving interoperability of medical devices, work that simultaneously serves in defining requirements for industry standards. Clinical interest in standardization of medical devices has been evinced since the mid-eighties, but earlier efforts sank in a morass of detail and proprietary interest. Today, there is a convergence of many factors that are key to success - improved technology, more open-sourcing, technically savvy clinicians, and a willingness on the part of regulatory authorities to consider new validation paradigms.
The opportunity for clinical engineers, biomedical engineers, operational managers, risk managers, and others in the medical community to participate in the definition of requirements for MD PnP systems is at hand. For example, the risk manager must evaluate systems for patient and clinician safety controls; with interoperability, one needs to understand how one integrated device's failure will affect the entire system. Each member in the healthcare technology management matrix has an experience or an idea that can be shared, and these ideas are highly sought after in the final definition of PnP standards for the operating room as well as for other areas of healthcare.
For more information on the MD PnP program, go to: http://mdpnp.org
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