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Doing it by the numbers

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Reassuring equipment users about the level of patient safety associated with their equipment and what we are doing to ensure that it is maintained at an acceptable level

(This material was published as a document titled "Final Word: Doing it by the numbers" BI&T; 48:72; Jan/ Feb 2014 by Malcolm Ridgway and Alan Lipschultz. This version of that original document was last modified on 6-11-15)

When our clinical colleagues ask us: “How do I know that all of my equipment is safe to use on my patients”, and we respond by saying; “Well, all of our PMs are always done on time”; wouldn’t it be more reassuring if we could give them a response something like this:

“Well, there are some pieces of equipment like the knee exerciser over there that are not very complicated and which couldn’t possibly injure a patient, even if they failed completely. These kinds of items are classified as non-critical and they only need very simple maintenance to keep them functional. A lot of the equipment on the hospital’s inventory falls into this non-critical category.
There are some other items, such as this critical care ventilator and this transport incubator that have non-durable parts that need periodic restoration as well as being critical in the sense that if they fail completely a patient could be injured. These kinds of devices are classified as maintenance-critical or PM-critical and we take a number of steps to make sure that the possibility of them failing completely is very rare. For devices in this category we follow all of the manufacturer’s recommendations for periodic preventive maintenance and we carefully analyze every instance when any of these types of device fail. These kinds of device are specially designed to be very reliable. We also monitor the statistics from our national database to confirm that each specific make and model of the devices that we have classified as maintenance-critical is demonstrating an average mean time between failures (MTBF) of at least several hundred years.
There are some other types of devices such as this apnea monitoring system and this infant incubator which can, in theory, cause some kind of patient injury if they fail in such a way that they are either misleading the clinical staff by providing incorrect or substantially inaccurate information, or in such a way that they are no longer meeting the relevant safety specifications. All of the different ways that these kinds of devices (which we classify as performance/ safety-critical or PM-critical devices) could fail in this way have been identified as potentially critical failures. These kinds of failures are called hidden failures because, usually, they can be discovered only by periodically performing some kind of performance verification or safety testing. These kinds of device are also designed to be very reliable and, oftentimes, to warn the operator of the onset of any hidden failures. We have been collecting and aggregating the results of these performance and safety tests in our nationwide database and, again, we have confirmed that each specific make and model that we have of these performance/safety-critical devices develop potentially critical failures only very, very infrequently. Our database shows that these kinds of hidden failures occur, on the average, no more frequently than once every 500 years.”


The statement above is, of course, meant only to illustrate the principle. The underlined statements will need to be customized to each specific facility and adjusted to reflect the levels of safety that can be substantiated by actual test data.

If you agree that this is the kind of response that we should aim to provide, then you are invited to join us in exploring how we could assemble just such a database.

After you have reviewed this material, which is completely tentative at this point, please e-mail your comments on the concept of the project and on the preliminary material to the address for the current Task Force, which is htmc.mptf@gmail.com.


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