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EHR and Health IT Consulting
Technical Doctor's insights and information collated from various sources on EHR selection, EHR implementation, EMR relevance for providers and decision makers
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Lessons Learned from EHR Integration of Medical Devices 

Lessons Learned from EHR Integration of Medical Devices  | EHR and Health IT Consulting |

Human lives depend on how well a healthcare organization manages its EHR integration of medical devices.

As the assigned project manager spearheading numerous large health system enterprise-wise medical device integration programs for over a decade, I’ve learned an essential lesson about EHR integration of medical devices.

Data captured from thousands of heart monitors, ventilators, balloon pumps, and other bedside devices must be perfectly managed, seamlessly integrated, and standardized to each patient’s electronic health record (EHR) and then made accessible to multiple providers. Once synced properly across the care continuum, connected medical devices play a critical role in the transfer of near real-time, reliable data to EHRs that improve both the safety and quality of patient care.

Otherwise, failing to do so can prove fatal.

Lessons borne out of experience

My role in bringing together clinicians, IT experts and device vendor representatives is to achieve that goal through flawless organization of precise integration methods and over-communication. Sharing information among these three teams is paramount to our success — that is, we’re managing vital data used by physicians and nurses as analytics in making life-changing medical decisions as quickly as possible.

Additionally, I have learned other valuable lessons about EHR integration of medical devices.

Start with a clean inventory list of biomedical devices and equipment planned for the device integration project. This list should comprise the number counts of all devices and supporting equipment including firmware versions and serial ports in addition to Ethernet gateway connections.

At the project’s onset evaluate and identify devices lacking the capability to integrate. Identify older firmware versions and research feasibility of cost to update as opposed to replacement.

Conduct walkthroughs on clinical rounds to determine data points for integration in order to identify network cabling and power needs. At that time, initiate engaging device vendors and setting clear deadlines and key parameters for the EHR integration.

Ensure middleware vendors partnering with the medical facilities supply all security-related product information upfront.

Invite middleware vendors to an onsite visit to determine exactly how much hardware is needed to ensure connectivity with other devices. Also include them in weekly or biweekly team update meetings. They are oftentimes overlooked.

Be adaptable and versatile to make quick adjustments while also striving to deliver impeccable results. Since workflows are not usually established upfront, responsibilities get shuffled around and integration details quickly become overwhelming.

Find creative ways to facilitate communication among the different team members. For example, assign color-coded status levels — green, yellow and red — to flag a change in project progression to speed up problem resolution. When senior management tackles red status issues as a group, expect people to pay attention!

Organization translates to project acceleration

Finally, organization of every integration detail is imperative. Associated device hardware, such as installing mounting hardware and new monitors in each patient room, must be managed. Biomedical managers, hospital IT groups, and clinical administrators must work concurrently to coordinate every step. In my experience, managing all of these different teams is by far the most challenging aspect of device integration.

Our healthcare ecosystem is slowly but surely modernizing, and we must leverage our technologies every possible way to maximize delivery of patient care to improve outcomes and the patient-provider experience. Ultimately, the success of any enterprise-wide EHR integration of medical devices is founded on strong communication and organization in addition to data management.

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How to Adopt Unique Device Identifiers for Medical Devices |

How to Adopt Unique Device Identifiers for Medical Devices | | EHR and Health IT Consulting |
Unique device identifiers can improve tracking of medical devices for research and patient safety.
In response to new FDA requirements for all medical devices to have a unique device identifier (UDI) within the next few years, the Brookings Institute has helped to develop a roadmap for adopting and integrating UDI technology in order to improve patient safety and provide better data for research and analytics.  The roadmap includes a number of critical steps to help bring UDIs into provider systems, administrative transactions, and patient-directed tools.
“The benefits of UDI implementation across the health care system are significant and, while the path to full implementation is complex, there are relatively straightforward steps that can be done now to begin realizing many of them,” the document says.  “Recording UDIs at the point-of-care (POC) in electronic health records (EHRs) and in claims data could significantly enhance the nation’s ability to conduct medical device safety surveillance and manage recalls.”
“Other benefits include: efficient identification and communication of device safety concerns, active learning about the long-term quality and performance of devices, facilitation of premarket device approval/clearance and expanded indications for existing devices, data collection to support better value, increased reimbursement transparency, and more accurate and efficient supply chain processes.”
The recommendations include the following:
• Providers should incorporate UDIs into their EHR systems, and may consider adopting automatic identification and data capture (AIDC) technology to make the process more efficient.  Patient safety reporting should be automated.
• UDIs should be integrated across the entire healthcare ecosystem, including through the supply chain, clinical processes, and revenue cycle management to achieve the highest return on investment.
• UDIs should be incorporated into the criteria for Stage 3 meaningful use as well as the EHR certification criteria.
• The device identifier portion of the UDI should be included as a situational element at the claim detail level for high risk, implantable devices
• Patient advocacy groups, the FDA, and providers should work together to promote patient education on the subject of UDIs, and encourage patients to be aware of their devices and any potential recalls or issues related to their equipment
• UDIs should be integrated into personal health records to easily provide patients with appropriate device data.  Developers should collaborate with patient organizations to provide proper resources related to UDIs.
• Provider systems, payers, and other stakeholders should commission studies and pilots to highlight use cases for UDIs and demonstrate the benefits of integrating medical device data into the workflow.
The roadmap focuses primarily on the highest risk devices, which are typically implantable, but adds that all medical devices that impact a patient’s care, even transient equipment such as MRI machines, can significantly benefit from UDI labeling and tracking.  “The UDI system, which will be phased in over several years, represents a landmark step towards improving patient safety, modernizing device post-market surveillance, and facilitating device innovation,” the roadmap says. “These promised benefits will only be fully realized with the adoption and integration of UDIs into the health care delivery system.”

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How does medical device integration alter EHR adoption, use?

How does medical device integration alter EHR adoption, use? | EHR and Health IT Consulting |
Delivering care of the highest quality requires clinicians to have the most pertinent information about the patient available to them. In acute care environments, this information comes from a variety of sources, not all of them readily accessible such as medical devices.
“Devices obviously generate critical information at the patient bedside. Historically, a very small subset of that information would ever find its way to the electronic medical record because they didn’t need to archive every breath a patient took, for instance,” says Andrew Malcolmson, Director of Integrated Patient Intelligence at Covidien.
“If you’re doing clinical decision-making and trying to understand patient conditions, especially in a dynamically evolving situation, and you’re not at the bedside to look at the device firsthand, you want to be able to see everything — every loop, trend, waveform, alarm, and parameter,” he explains. “That’s the type, richness of information that just isn’t not possible to house in the EMR. That’s just too much.”
Malcolmson and his team are the driving force behind the company’s Vital Sync software, which allows clinicians to access beside medical devices from their own devices — from desktops to smartphones. “There’s an unmet need to have that bedside device information available to them wherever and whenever they needed it,” he adds.
Not only does the ability to access monitoring devices from their other devices, especially those that are mobile, extend the range of clinicians within the clinic, but it also makes possible the coordination of a patient’s care well beyond the four walls of the institution.

“A physician who isn’t in the unit and who may not necessarily be in the hospital can take a look at what’s being measured and what the devices associated with a given patient are telling them to help collaborate on improved decision-making,” Malcolmson notes.
According to Malcolmson, this shift toward medical device integration and remote monitoring is just beginning to emerge but its potential to change the way care is coordinated and collaboration among the care team takes place is clear.
“The whole paradigm of having to go to the patient bedside to get comprehensive information is something that is changing,” he continues. “Obviously, we would never encourage nor expect clinicians to not want to go to the patient’s bedside because there’s a whole universe of additional information that you can get beyond that which is just on the devices monitoring that patient.”

Tapping this potentially, however, requires device manufacturers to face the same challenges their counterparts in EHR development are currently encountering when trying to get information to flow seamlessly between data sources — that is, interoperability.
“We’re primarily exporting information to the EMR. We have an HL7 engine that is designed to handle just about any type of data requirements,” explains Malcolmson. “We’re on the cusp of releasing an ADT interface as well, which will be coming out with our next release. That will be the first element of our system that actually pulls information back from the electronic medical record system as well.”
If the EHR is to be a comprehensive record of a patient’s care, then it must comprise information from various sources not just those that are captured by clinicians. As with health information exchange at a more macroscopic level, moving information from one source to the next requires that standards and rules of the road are obeyed by all players.

David Greene's curator insight, December 9, 2014 3:12 PM

There are some great interoperable choices on the market - these tools not only can provide clinical support, but also can reduce some of the IT implementation costs...