510(k) SUMMARY. Epic s Blood Product Administration Module version 0.9

Transcription

1 510(k) SUMMARY Epic s Blood Product Administration Module version 0.9 Contact Person: Maggie Francis Phone: (608) Facsimile: (608) Date Prepared: January 30, 2014 Trade Name: Blood Product Administration Module version 0.9 Common Name: Blood Bank Software, Standalone Products Classification: Unclassified (Software, Stand Alone Products) Predicate Device: Korchek Technologies CareChek Patient Identification System Version 1.0 (BK040053) Intended Use / Indications for Use The Blood Product Administration Module is a software module intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion. The Module is based on a modular design allowing it to be used with a host electronic health record system. The Module can, through use of barcode technology, assist healthcare professionals in verifying patient identity at the bedside. The Module receives and manages information from orders placed from a host system and blood product information from an external blood bank system. The Module incorporates system controlled logic that can require a positive match of the patient, the blood product to be administered, and information received from the external blood bank system. The Module can also check a blood product s documented expiration date for appropriateness. Blood administration information entered in the Module is transmitted to the host system for storage. Device Description The Blood Product Administration Module is a software module that can assist clinicians in matching patients with ordered blood products. The Module receives and manages information from orders placed from an electronic health record system (a Host System ) and blood product information from an external blood bank system. In addition, the Module sends blood product administration information to the Host System for storage. The Module incorporates system controlled logic that can require a positive match between a patient s blood product order, identification information (e.g., a barcode on Epic Systems Corporation, 1979 Milky Way, Verona, Wisconsin 53593, (608) FAX: (608)

2 the patient s identification wristband) for a patient, and identification information (e.g., barcodes on the blood product) for a blood product to be administered to the patient. The Module also can check the expiration date identified on the blood product for appropriateness. The Module was designed such that in the future it may be available for use with other Host Systems; however, the Module is currently limited for use with the 2012 version of Epic s electronic health records software. Although the Module can display warning messages that may help inform a clinician of potential safety concerns (e.g., the blood product to be administered not matching the relevant order, or the blood product being expired), the clinician can also manually verify that he is administering the intended blood product and that the blood product hasn t expired. The Module is not intended to serve as a substitute for a clinician s professional judgment and decision making, and a clinician should not delay a needed blood transfusion because of documentation or software workflow issues. The Module s functionality is designed to be used in a client/server environment on a workstation (e.g., a desktop, laptop, or tablet computer) and/or Apple ios device, and can be used with or without barcode scanning technology. Information from the external blood bank system is transmitted via the Module s HL 7 interface. This information can be compared and combined with information entered into the Module, which may include a blood product s unit number, registration number, product code, blood type, and expiration date from an ISBT 128 or ABC CODABAR blood product label. Once the combined information has been collected and validated by the clinician, it is transmitted to the Host System for storage. Performance Data Epic conducted design validation, integrated testing, usability testing, regression testing, and beta testing of the Module as it operates when used with the required Host System. Per FDA s request, Epic also conducted electromagnetic compatibility and wireless testing of the handheld version of the Module. The assessment of this non clinical testing is that the software requirements have been met and that the Module functions as intended. During the design validation process, design requirements were reviewed by designated individuals and determined to be appropriate and consistent with the Module s intended use. Integrated testing took place at Epic, where mock hospital information systems were set up to serve as the test Host System and to test the interface functionality of receiving HL 7 interface messages from an external blood bank system. Test cases traceable to the requirements were run. The results of this integrated testing demonstrated that the requirements have been met and the Module functions as In usability testing conducted at Epic, nurses and other potential users evaluated the usability of the user interface for the Module in simulated representative tasks. The results of this usability testing also demonstrated that the Module functions as Regression testing confirmed that the requirements continued to be met and the Module functions as

3 In onsite beta testing conducted at a healthcare facility, nurses evaluated the usability of the user interface for the Module and trained Epic staff assessed the Module s functionality in simulated representative tasks. The results of this onsite beta testing confirmed that the Module functions as Finally, electromagnetic compatibility testing (emissions and immunity) of the handheld version Module resulted in a finding that the Module is compliant with the IEC standard, and wireless testing of the handheld version of the Module demonstrated that it can operate on the same network as other devices (medical or non medical). The conclusion drawn from Epic s testing of the Module is that, like the CareChek Patient Identification System Version 1.0, the Module functions as intended and results observed were as Substantial Equivalence The Module generally has the same intended use and similar indications for use as the CareChek Patient Identification System Version 1.0 (the Predicate Device ), and the minor differences between the two devices indications for use do not raise new types of safety or effectiveness questions. The intended uses and indications for use of the two systems are shown in the following table. Table 1: Intended Use/Indications for Use Comparison Blood Product Administration Module CareChek Patient Identification System Version 1.0 The Blood Product Administration Module is a software module intended for use by healthcare professionals to assist in the identification of patients and blood products for transfusion. The CareChek Patient Identification System is a computerized handheld system intended for use by hospital professionals to assist in the proper identification of patients, specimens, blood products for transfusion and medications to be administered. The Module is based on a modular design allowing it to be used with a host electronic health record system. The Module can, through use of barcode technology, assist healthcare professionals in verifying patient identity at the bedside. The Module receives and manages information from orders placed from a host system and blood product information from an external blood bank system. The Module incorporates system controlled logic that can require a positive match of the patient, the blood product to be administered, and information The CareChek System is based on a modular design: CareChek Blood Product Administration. The CareChek system offers solutions to enhance patient safety through the use of bar code technology to provide proper patient identification at the bedside. The system receives and manages orders placed from a remote system. The system incorporates system controlled logic that requires a positive scan of patient, blood products, and compares that information against that received from the remote host. The system documents patient identification. The system documents blood

4 received from the external blood bank system. The Module can also check a blood product s documented expiration date for appropriateness. Blood administration information entered in the Module is transmitted to the host system for storage. product identification, patient vitals taken during administration and AABB defined Transfusion Requirements. While there are minor differences in technological characteristics and principles of operation between the Module and the Predicate Device, none of these differences raise new types of safety or effectiveness questions. For example, the Module includes a narrower scope of functionality than the Predicate Device because the Module does not match or track specimens or medications. However, the two devices have the same general technological characteristics and principles of operation, and the minor differences between the two devices do not raise new types of safety or effectiveness questions. The following table outlines the technological characteristics of the two products. Table 2: Technological Characteristics Comparison Blood Product Administration Module CareChek Patient Identification System Version 1.0 User Population Healthcare professionals Hospital professionals Communication with External Systems Receives information from an external blood bank system via an HL 7 interface and order information from a Host System; the Module also communicates blood administration documentation to the Host System (an electronic health record system) for storage Receives information from a remote system via an HL 7 interface and communicates documentation to a remote host Barcode Scanning Can be used with a barcode scanner Must be used with a barcode scanner Blood Product Matching Incorporates system controlled logic that can require a positive scan of a patient and a blood product and compares that information against information received from the external blood bank system Incorporates system controlled logic that requires a positive scan of a patient and a blood product and compares that information against information received from the remote host

5 Specimen Management N/A Specimen tracking and matching Medication Administration N/A Medication tracking and matching Information Storage Transmits blood administration information back to the Host System for storage Stores blood administration and related information, and also transmits the information back to the remote host(s) for storage Hardware Handheld device, server, and workstation (e.g., desktop, laptop or tablet computer) Handheld device, server, and PC workstation Thus, because the Module and the Predicate Device have the same general intended use and similar indications for use, technological characteristics and principles of operation, and any minor differences do not raise new types of safety or effectiveness questions, Epic s Module is substantially equivalent to the Predicate Device.