What About the Inherent Risks of all These New Diagnostic and Treatment Technologies?
The medical errors studies cited in Part One of this series also list equipment and operator errors or failures as contributing factors to untimely and unnecessary patient deaths. Searching the web with key words such as “medical devices failures” and “litigation” yields a plethora of media articles where technologies have killed patients and law firms who specialize in litigating medical equipment failure cases. Unquestionably, today’s medical devices and equipment are highly technical and complex which must operate safely, accurately, and reliably under every circumstance. Providers have a clear and undeniable responsibility to ensure that these devices are properly accounted, quality assurance tasks performed and maintained to OEM and/or FDA specifications no matter what the cost to sustain these systems safely. The lack of oversight for these key activities would have devastating results to the safety of patients who are on the receiving end of these diagnostic and treatment tools and could possibly place operators at risk as well. If a linear accelerator does not receive periodic quality assurance checks, this could result in the radiation beam intensity not being uniformly administered with the potential to under or over treat a patient. Not adhering to an OEM recall or modification on an IV pump may result in overdosing a patient.
For hospitals and physician medical groups the capital outlay involved is almost eclipsed by the operational life cycle costs to properly account and maintain these devices. Moreover, as the sophistication and cost of medical equipment continues to escalate so too is the complexity and cost of maintaining these devices. According to a Canadian study of US acute hospitals, each hospital acquired about 15–20 items of medical equipment for each staffed bed, costing a capital investment of around $200,000–$400,000 per staffed bed. For a 100 bed hospital that ranges from 1,500 to 2,000 devices. That is a significant amount of monitors, infusion pumps, ventilators, mammography units, CTs, linear accelerators, etc. that must be accounted, maintained and quality assured.
Connectivity of Devices Complicates Safety Even More
I spent 11 years as an artillery officer in the US Army and I thought this institution led the world in developing acronyms that is until I got into the healthcare industry which I have been a part of for 24 years. This industry sure has its fair share of contractions. Now I am in the software industry and I must admit, they are gunning for supremacy. Take the acronym IoT. The internet of things also known as ‘connected devices” and “smart devices” where seemingly anything can be embedded with electronics, software, sensors, actuators, and network connectivity so that it can be tracked and/or controlled remotely across a network infrastructure.
In the healthcare industry, the number of connected devices is increasing with the goal to improve patient care and create efficiency in the healthcare system. However, this is primed for unauthorized intrusion. Hackers are going beyond hacking EHRs, they are increasing going after medical devices that are on healthcare networks for monitoring and for automatic transmitting information to EHRs. This leaves such devices as patient monitors, infusion pumps, imaging devices, diagnostic equipment and even linear accelerators vulnerable to hacking. It is hard to imagine someone seeking ransom for threatening to harm or kill a patient, however, we do live in a vicious and cunning world, therefore, it just might happen.
However, a Modern Healthcare survey of providers found that 31% respondents didn’t have an accurate, complete record of all their web-connected devices, whether medical or non-medical. Moreover, there are companies developing software that scans provider networks for connected medical devices and to detect and fix any security vulnerabilities. However, these programs cannot defeat all intruders when a healthcare entity doesn’t even know what they have on hand. Furthermore, they don’t even have a proper process for notifying IT departments about newly connected devices that have been obtained.
How Can Crux Quality Solutions Help Thwart Medical Device Errors?
Equate™ is a cloud-based tool whose key features are uniquely designed with clinical efficiency and safety in mind. This software is a must for healthcare resource & materials managers, radiation safety officers, medical physicists, information technology professionals or any other manager involved in the product life cycle of a medical device and clinical software.
The feature Inventory Management provides inventory control and management of medical devices, clinical software, and radioactive sources including calibration dates and certifications. Notifications are sent to appropriate staff to account for the device in the system. For instance, when a network connectable device is listed in Equate™, notifications are sent to IT so that the anti-hacking software can account for it, and thus, defend against intruders.
The Quality Assurance Data System feature allows for the performance of routine, scheduled quality assurance tasks in accordance with approved regulatory and industry protocols. This feature captures approvals, peer review, date of service, due dates and reminders to ensure that all devices are operating at OEM and/or FDA specifications and even flags overdue QA tasks. For major medical devices, real time status notifications are made to key staff and visual dashboards track device operational statuses as well as up and down time reports.
QA Scheduler creates calendars for device maintenance and QA tasks allowing healthcare facilities to adequately plan personnel for coverage at different locations while managing communications and avoiding double booking.
The QA Document Management feature manages all machine, device, and software related documents securely and in one place where pertinent staff can review, approve, archive and filter. This also allows staff to manage audit and accreditation compliance. Additionally, this feature manages all medical device and software policies and procedures in one place, keeping track of versions and staff training.
SafetyNet™ ensures organizations and healthcare professionals are meeting their legal and moral responsibilities to maintain a safe workplace. Delivered by a team of highly qualified professionals, SafetyNet™ is a consultative service provided by Crux Quality Solutions for managing the standards of care and safeguarding the wellbeing of patients that is crucial in radiation oncology by conducting:
• Staffing model analysis
• Policy and procedure review
• Safety culture statement
• Throughput analysis
• Technology choice & use
• Treatment plan quality reporting
• Quality metric review
• Treatment machines & planning system-technical accuracy and performance
In the new value based healthcare paradigm, faulty, defective and unaccounted for equipment is a safety risk, which may impact patient satisfaction and facility up time. This can cause significant procedure delays and cancellations further infringing on the patient experience. Equate™ and SafetyNet™ can significantly mitigate these risks to the patient, while enhancing the quality of their care while greatly assisting providers attain those Merit Based Incentive Payment System (MIPS) measures that safeguard the patient.