Scheduling is not a workflow one normally associates with medical device connectivity. In some applications, scheduling is handled by software separate from the connectivity solution. Sometimes, scheduling is not done at all. In other applications, as we shall see, scheduling is so much a part of the broader workflow, that it’s hard to recognize as a scheduling task. Two illustrative aspects of scheduling will be discussed, scheduling for diagnostic modalities and scheduling for routine patient care tasks. Because it’s less understood (and frankly more interesting) we will look at scheduling for routine patient care tasks first.
Patient Care Task Scheduling
Patient care tasks encompass routine activities carried out by caregivers and/or aids. Examples of these routine tasks include vital signs collection, medication administration, bed turns (to avoid hospital acquired pressure ulcers, or HAPU), and respiratory circuit flushing (to avoid ventilator acquired pneumonia, VAP). These tasks must be completed at a predetermined frequency on a reliable basis or adverse events – including patient death – can result.Read More
Connectivity enabled medical devices send patient data right out of the medical device to a network, be it a body area network, cellular broadband network, home or enterprise network. The network then conveys this medical device data to databases and applications that store, display and manipulate the data. When a medical device is directly attached to a patient, there is no question as to which patient the device data belongs. As soon as the data leaves the actual medical device via the serial port or a network connection, the association of that data with a particular patient is no longer obvious.
Much of the data used in establishing and maintaining patient association or patient context comes from, or is stored in, the patient management database. Patient management workflow is an important enabling component in the overall connectivity solution and key to patient context management.
It is critical to reliably know that the data from a medical device belongs to a particular patient. If the data is not associated with any patient it’s worthless; should the data be associated with the wrong patient it could be deadly. When patient data from patient A is misidentified as belonging to patient B, patient A can miss out on a life saving clinical intervention that is mistakenly applied to patient B. In this example, patient A may die due to a lack of care, and patient B may be injured or die as a consequence of receiving some clinical intervention that is not needed and could be contraindicated. Consequently, safe and reliable patient association or patient context management is a foundational capability for virtually any medical device connectivity or interoperability solution.Read More
On April 8, 2013, the Joint Commission published a Sentinel Event Alert on medical device alarm safety in hospitals. Once again, alarm hazards tops the ECRI Institute’s 2013 Top 10 Health Technology Hazards. Alarm fatigue is unfortunately a topic that is evergreen because it has plagued hospitals for many years and shows little sign of abating. A search of the literature will show the most common consequence of alarm fatigue is a failure to rescue adverse event (in which
the vast majority 80% of patients die). A secondary consequence is on patient satisfaction; constant alarms audible throughout the unit make it difficult for patients to sleep.
A recent Class I recall (not pictured) of a medical monitor with a hospital network connected central station stimulates some generalities about software, “fixes”, and connectivity. (Class I recalls are defined by the FDA as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.)
The use of the product in question was given as:
- a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs
Curiously only one customer was identified as having received the product, or at least this particular version of the product. While the manufacturer and product in question is a matter of public record, and available at the link, I chose not to include it here because my objective is not to repeat the recall information, but to suggest the reasons for the recall, an associated labeling issue, and offer some general lessons.Read More
The issue of the EHR relative to safety and effectiveness has again made the news with the November 7, 2011 pre-publication (and downloadable) release of an Institute of Medicine report on EHR safety, commissioned by the U.S. Department of Health and Human Services (HHS). This report expands the discussion beyond the EHR (used henceforth for both EHR and EMR) to include other related electronic information tools collectively called health IT.
Health IT Risks
The potential for health IT to improve both the quality and efficiency of medical care has been much noted to include more complete and timely records, ready exchange of information between providers, clinical decision support, and in turn a reduction in errors associated with the quality and availability of patient information. Efficiencies may arise from electronic capture of data which would eliminate manual entry, and time savings in accessing and reviewing patient information, and perhaps in passing information to third party payers. Additional public health value might accrue from the enhanced searchability of electronic records with respects to trends, treatments and outcomes. These benefits assume well designed, user friendly, compatible systems not withstanding that the U.S. model is to allow for numerous independent products that may or may not be able to exchange information nor display it in a consistent manner. Not surprisingly the report notes that the IT imperative will likely not be fruitful without associated attention to the people and the clinical system they work in.Read More
On October 12 the NY Times headline read “Some Users May Lose Data On a T-Mobile Smartphone”. Those phones use software and support from Microsoft/Danger for their data applications. According to the article a “technical glitch” had resulted in customers losing personal information held on at least in part an associated cloud computer service. Another story here by Eric Savitz, led with the question: “So how sure are you that you want all of your data to live in the cloud?”
The precursor to the Times story had appeared earlier in a number of places including here on October 5th. At that time the issue was reported as a loss of data service as opposed to a loss of data, although it was noted that a reset could cause loss of the user’s contacts and calendar. On the 11th it was reported here that the data may be lost for good, but then on the 13th it was said here that maybe not all of the lost data was permanently lost. Apparently Microsoft/Danger was being run on a single server.
While there is no direct association of this situation with medical information (unless your doctor’s contact information was among the stored data), it should serve as yet another reminder that the connected world, and its operational software and hardware, is not without its own issues. When new medical applications are being discussed there seems too often to be a suspension of reality with respect to system functionality, data reliability, and data availability. Whether it is “just” an EMR/EHR, or it is more direct functionality (e.g. an alarm or communication system), or even a single device, it must be remembered that software anomalies (a nice word meaning it sometimes doesn’t work) are more common than rare, and that reliance on “the network” to perform as imagined can often be a false reliance.
In case there was any doubt of this, software is a fairly common cause of FDA mediated medical device recalls. The FDA’s recall datebase has a Simple Search function. Entering “software” without date limits brings up 500 hits, the systems maximum. Limiting the search to 2009 (through 10/21/09) on the Advanced Search produces 62 hits. The most recent of these involves a “software bug” cryptically reported as “The … flag is configured incorrectly. The flag is not generated according to system requirements.” A “software update” is said to be forthcoming.
As I have noted elsewhere, the software industry really needs to be congratulated for its use of the term “upgrade” to mean fixing something that was never right in the first place. The second most recent recall had an equally cryptic explanation: “There is a potential safety issue with … 3.0.x software where study split operations are not correctly replicated to a secondary ‘shadow’ archive”.Read More