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Recalls are a necessary condition of healthcare in the U.S. Companies make hundreds of thousands of different healthcare products and any
number of them can be subject to a particular Class of recall (I, II, III). Unlike other types of products and equipment, tracking
implants and other patient-specific devices (e.g., infusion pumps, etc.) represents a particular |
challenge to clinical, bio-medical, and risk managers in hospitals given that -
- most hospitals maintain up to six different, largely manual and completely disconnected implant record repositories
- most hospitals have little to no connection between the supply chain process that made the product available and the patient record that documented who ultimately received the product
- most hospitals can't easily "bounce" recall notices against materials purchasing and inventory records (which would inform "what we use here"), making each recall notice a largely manual, tedious and time consuming investigation in and of itself
- most hospitals lack a meaningful way to document any steps taken by the staff to determine if a recall is applicable to their patients and what was done.
- Most hospitals (and vendors) use a manual process to send implant notices back to vendors as required by regulations
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(1) Document Implant - patient, physician, catalog and serial/lot number
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(2) Aggregate data from multiple departments, hospitals into one repository
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(3) Monitor recall notices; 3rd party services
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(4) Research implant data
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(5) Notify key parties as required
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(6) Automatically document efforts to research, notify to mitigate risk
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BlackTie's Utilization Management application is designed to address these issues and more.
- BlackTie is an extremely "light", web-based application that offers a single, uniform, simple data collection process for implant documentation across all departments in the hospital and all hospitals in the network.
- BlackTie offers all users access to a massive, pre-build database of typical implants - vendor, description, category, etc. - which greatly reduces the effort required to create a record while at the same time improving the quality of all records
- BlackTie offers JACHO compliant inventory management features that can be used for bone & tissue as well as for other key stock - like consigned orthopedics, for example.
- BlackTie offers automatic and real time conductivity to manufacturers so that implant information can be communicated in a HIPAA compliant manner.
- BlackTie's Recall Notice Log is an investigation documentation feature set that enables key users to record notes about their recall inquiries, steps taken to inform physicians and patients, etc., and may help mitigate any future liability - a liability that may last for years after the original recall.
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