FDA Takes Step Backwards with New MDDS Guidance

We examined a few MDDS-related MAUDE reports, MEDSUN entries, and Recall Letters.  None of the defect descriptions contained anything surprising to someone with even a modicum of hands-on IT experience.  Four selected MDDS defect reports are described below.  We quote directly from the FDA databases (typos may be from the original documents) and provide a link to the original complete documents. Abbott Initiates Voluntary Recall of FreeStyle lnsulinx Blood Glucose Meters The company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle lnsulinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. For example, at a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL – 1024 mg/dL = 42 mg/dL). No other Abbott blood glucose meters are impacted by this issue. The functionality described in the recall included only the communication, storage, and display of a physiological value (blood glucose levels) from a medical device.  If those functions were compartmentalized they would be an MDDS.  In other words, Abbott found a defect in an MDDS serious enough that they issued a voluntary recall of that device.  Abbott is a large highly respected medical device manufacturer with vast experience in design controls and post-market surveillance.  We are concerned that had a similar MDDS been developed by a different company without d...
Source: Medical Connectivity Consulting - Category: Technology Consultants Authors: Tags: connectivity Healthcare IT Patient Safety Standards & Regulatory Source Type: blogs