Systems that facilitate medical data are marketplace standouts
By ARTHUR GASCH
Healthcare InfoTech Contributing Editor
The key to healthcare IT is getting medical data into information systems. Datex-Ohmeda (Tewksbury, MA), the newly merged conglomerate of Finland’s Instrumentarium, recently announced an oximeter with a built-in RS-232 serial port to facilitate telecommunication of oximetry values. The device has FDA clearance and is available immediately. It may be of most interest to IT suppliers serving the home healthcare, skilled nursing facility, and physician office markets.
Spacelabs (Redmond, WA) announced its new CPR product for emergency departments. It is based on the ORCA product, which the company recently acquired. We saw this product at the Philadelphia regional American College of Emergency Physicians (ACEP) conference in December. Features like QuickSheets (templates), and its ProblemEditor utility made it one of the more functional systems shown there.
The systems from Nine Rivers (Raleigh, NC) also were standouts. Indeed, the Nine Rivers applications were the only ones on the floor we tested that did not accept bad data input by users. For each system we had demonstrators attempt to key in bogus blood pressure values as part of their patient assessment. We had them input systolic and diastolic values of 120/800 instead of 120/80. This is a real issue because the keyboard rep rate can easily add an extra number, as any typist on PCs can attest, if it is set a little too high, and what is OK for one user is slow for another. In every system except the Nine Rivers software, the bogus values were accepted without even a "reality check" message warning the user that the data was impossible. Such sloppy programming and system design beg for FDA involvement in regulating these systems, something that, when it occurs, will be loudly decried as unnecessary by the very vendors whose oversight in the area of reality checks made it necessary in the first place.
The problem of reality checks is not new and in addition to the newcomers offering their first PC-based systems, there were just as many big and established players at the ACEP gathering, companies that have been in healthcare IT or patient monitoring markets for decades, who should have known better but apparently didn’t submit these critical applications to the same scrutiny that they do for other products they produce that are subject to FDA review. What this says is that the industry continues to be comfortable selling software of poor quality, as long as there is no regulatory agency to force it to do better. The shabby design of these systems has convin ced us that the FDA has a needed role to play in the medical software industry, just as it has in the medical device industry.
The amazing part of this is that many of these systems were developed by doctors, who clearly know the importance of valid data, but made no efforts to put reality checks into their software.
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