DATA LOGGING / PROPER USAGE VALIDATION
Like many complex pieces of equipment, it is often advantageous to log medical device data. The logged data could include: the identification of the operator and/or patient; the settings for various controls: the time, date and duration of treatments; output levels; the date of last calibration, and so on.
The main reason for logging this data is usually to ensure that the medical equipment is being used properly. Logging and analyzing this data can also be used to develop new and improved treatment plans and could even be used as evidence in litigation cases.
Proper usage of a medical device is especially a concern when a patient is operating the equipment in their home without the direct supervision of medical personnel.
Problem: How can medical device OEMs add data logging capabilities to their equipment and make it easy for both medical personnel and patients to deliver the logged data for analysis?
Solution: Add a high cycle-life receptacle to the medical device and use a rugged memory key or token to log the data.
Details: In some cases, where data logging is desired, the medical device can log data to (non-removable) non-volatile memory that is internal to the device. In these cases, the OEM design team must determine how the logged data will be transferred off of the medical device (typically to a PC) for analysis.
Using a network, whether wired (e.g. Ethernet) or wireless (e.g. Wi-Fi or Bluetooth), may be an option for some applications, but is not desirable, practical or even allowable in many other cases. When networking is not used, a portable memory device is usually the best solution.
For data logging applications, Datakey Electronics' offers:
UNIQUE FORM FACTOR
The unique form factor of Datakey Electronics' data carriers provides several benefits in medical data logging applications.
- SECURITY - The fact that Datakey Electronics' keys and tokens cannot plug directly into a PC, provides a basic, yet effective barrier against data spillage of private patient data (or other logged data). Additional security features or measures can be used to more fully protect the logged data to meet design requirements or other regulations (e.g. HIPAA).
- DETERS THEFT - Because of the unique form factor, people who come into contact with Datakey Electronics' memory keys and tokens instantly recognize that these are not consumer memory products like USB flash drives or SD cards. Because they do not directly plug into a PC, digital camera or other consumer products they are not targets for theft.
- EASE OF USE - Especially in cases where patients are self-administering treatments from their homes, it is important for all aspects of the treatment to be as simple and straight-forward as possible.
 Patients of nearly all ages and backgrounds intuitively know how to use a key, which is one of the reasons why OEMs choose Datakey Electronics' key form factor. Also, Datakey Electronics' keys and tokens both have redundant contacts. That means that you can't insert the key/token the wrong way. When it is time to remove the logged data some OEMs elect to have their patients mail their keys or tokens in. This eliminates potential frustration and support costs due to users not being comfortable with using technology like personal computers.
- ONLY QUALIFIED PRODUCTS FIT - Using Datakey Electronics' unique receptacles ensures that only qualified, tested memory products will fit. Contrast that with a consumer memory interface, like USB or Secure Digital (SD), where it is virtually impossible to test all of the devices that could fit into the connector.
LONG TERM AVAILABILITY
It is also important for OEMs to select a portable memory solution that will be available for the medical device's full product life cycle. Datakey Electronics' products deliver long term availability. We have data carrier solutions that have been around for over 20-years and are still in production today, unchanged! Long term availability is critical for medical devices as it may take years just to get from concept to design through FDA approval. Then, once the product is released, a long production run is desired.
Although consumer memory products like USB thumb drives and SD cards may initially seem like good options for data logging applications in medical devices, it is important for medical device manufacturers to closely look at the potential problems that using these consumer-focused "standards" bring. We touched on just a few of the considerations on this page. For more information, check out our web page on consumer memory products and our information sheet that compares Datakey Electronics products to consumer memory products. You can also download our white paper, Transferring Data In Non-Networked Applications or contact Datakey Electronics for a no-cost, no-obligation consultation with one of our engineers.
Email: info@datakey.com
Phone: 1-800-328-8828
Phone: 1-952-746-4066
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