BK241081 · Epic Systems Corporation Verona, WI · MMH · Aug 21, 2024 · Hematology
Device Facts
Record ID
BK241081
Device Name
Blood Product Administration Module (BPAM 4-2023)
Applicant
Epic Systems Corporation Verona, WI
Product Code
MMH · Hematology
Decision Date
Aug 21, 2024
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
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 product and order information from a host system and a blood bank. The Module incorporates system-controlled logic that can require a positive match of the patient, the product to be administered, and information from the blood bank. The Module can also check a product's documented expiration date for appropriateness. Administration information entered in the Module is transmitted to the host system for storage.
Device Story
Software module integrated with electronic health record (EHR) and blood bank systems; assists clinicians in bedside blood transfusion verification. Inputs: patient identification (barcode/manual), blood product data (ISBT-128/ABC Codabar barcodes). Operation: system-controlled logic compares patient/product identifiers against EHR/blood bank orders; checks expiration dates. Output: visual alerts for mismatches/expired products; documentation of administration transmitted to EHR. Used in clinical settings by healthcare professionals on workstations or mobile devices (iOS/Android). Benefits: reduces transfusion errors by enforcing positive patient-product matching; supports emergency massive transfusion protocols (MTP). Clinician retains final professional judgment.
Clinical Evidence
Bench testing only. Verification and validation testing performed using mock hospital information systems. Testing included design validation, unit, integration, and regression testing, and human factors/usability testing. Results confirmed requirements met and device functions as expected.
Technological Characteristics
Software-only device; client/server architecture. Operates on workstations, tablets, and mobile devices (iOS/Android). Supports ISBT-128, Codabar, and ISBT-Compound 2D barcodes. Integrates with EHR and blood bank systems via network. Logic-based matching and expiration checking. No hardware components; optional barcode scanner accessory.
Indications for Use
Indicated for healthcare professionals to assist in patient and blood product identification during transfusion. Used in clinical environments to verify patient identity, match products to orders, and check expiration dates via barcode scanning or manual entry.
Regulatory Classification
Identification
Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.
Special Controls
*Classification.* Class II (special controls). The special controls for these devices are:(1) Software performance and functional requirements including detailed design specifications (
*e.g.,* algorithms or control characteristics, alarms, device limitations, and safety requirements).(2) Verification and validation testing and hazard analysis must be performed.
(3) Labeling must include:
(i) Software limitations;
(ii) Unresolved anomalies, annotated with an explanation of the impact on safety or effectiveness;
(iii) Revision history; and
(iv) Hardware and peripheral specifications.
(4) Traceability matrix must be performed.
(5) Performance testing to ensure the safety and effectiveness of the system must be performed, including when adding new functional requirements (
*e.g.,* electrical safety, electromagnetic compatibility, or wireless coexistence).
Predicate Devices
Blood Product Administration Module Version 3-2020 (BK200482)
Submission Summary (Full Text)
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# 510(k) SUMMARY
## Epic's Blood Product Administration Module Version 4-2023
Contact Person: Brian Jacobson
Phone: (608) 271-9000
Fax: (608) 271-7237
Date Prepared: 08/08/2024
**Trade Name:** Blood Product Administration Module Version 4-2023
**Common Name:** Blood Bank Software, Standalone Products
**Classification Regulation:** 21 CFR 864.9165 – Blood Establishment Computer Software and Accessories
**Classification:** Class II
**Product Code:** MMH
**Predicate Device:** Blood Product Administration Module Version 3-2020 (BK200482)
### 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 product and order information from a host system and a blood bank. The Module incorporates system-controlled logic that can require a positive match of the patient, the product to be administered, and information from the blood bank. The Module can also check a product's documented expiration date for appropriateness. Administration information entered in the Module is transmitted to the host system for storage.
### Device Description
The Blood Product Administration Module Version 4-2023 ('BPAM 4-2023') is a software module that can assist clinicians in matching patients with ordered blood products. BPAM 4-2023 receives and manages product and order information from an electronic health
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record system (a “Host System”) and a blood bank. In addition, BPAM 4-2023 sends product administration information to the Host System for storage. BPAM 4-2023 incorporates system-controlled logic that can require a positive match between a patient’s product order, identification information (e.g., a barcode on the patient’s identification wristband) for a patient, and identification information (e.g., barcodes on a blood product) for a product to be administered to the patient. BPAM 4-2023 also can check the expiration date identified on the product for appropriateness.
Healthcare organizations can choose whether to enable BPAM 4-2023’s product matching functionality or use BPAM 4-2023 without its matching functionality (e.g., to use only the BPAM 4-2023’s documentation workflow). Healthcare organizations that enable BPAM 4-2023’s matching functionality can also choose to enable BPAM 4-2023’s flexible matching functionality for massive transfusion protocols (MTP) and similar emergency protocols. These options allow healthcare organizations that implement BPAM 4-2023 to choose the administration and matching workflows that work best in their clinical environments.
Although BPAM 4-2023 can display user-facing messages that may help inform a clinician of certain potential safety concerns (e.g., the product to be administered not matching the relevant order, or the product being expired), the clinician can also manually verify that he is administering the intended product, and that the product has not expired. BPAM 4-2023 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 transfusion because of documentation or software workflow issues.
BPAM 4-2023’s functionality is designed to be used on a workstation (e.g., a desktop, laptop, or tablet computer) or an Android or Apple iOS mobile device and can be used with or without barcode scanning technology.
Information from the blood bank can be compared and combined with information entered into BPAM 4-2023, which may include a product’s unit number, registration number, product code, blood type, and expiration date from an ISBT-128 or ABC Codabar product label. Once the combined information has been collected and validated by the clinician, it is transmitted to the Host System for storage.
## Performance Summary
Like the Predicate Device, BPAM 4-2023 was designed, developed, and is maintained using well-established methods from Epic’s software lifecycle procedures, from design through testing and product release, including updates and change control. Verification and validation testing, including design validation, unit testing, integration testing, regression testing, and human factors/usability testing, were performed to ensure that BPAM 4-2023’s requirements are met. The assessment of this non-clinical testing is that the software requirements have been met and that BPAM 4-2023 functions as intended.
Verification testing took place at Epic, where mock hospital information systems were set up to serve as the test Host System. Test cases traceable to the requirements were run.
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The results of this testing demonstrated that the requirements have been met and BPAM 4-2023 functions as expected.
Verification and validation testing confirmed that BPAM 4-2023 meets its requirements and functions as expected.
The conclusion drawn from Epic's testing of BPAM 4-2023 is that the device functions as intended and results observed were as expected.
### **Substantial Equivalence**
BPAM 4-2023 and the Predicate Device have the same general intended use. Although minor wording changes have been made for clarity, those minor differences do not change the intended therapeutic effect of BPAM 4-2023 as compared to the Predicate Device. The wording of the indications for use statement has been minorly updated to reflect minor editorial modifications and clarifications regarding the scope of the device. Those updates do not represent significant differences in functionality and do not raise different questions of safety or effectiveness.
In addition, the two products have very similar technological characteristics. The purpose of this submission is to describe certain modifications associated with: flexible matching functionality for use in massive transfusion protocols (MTP) and similar emergency protocols; modified user-facing messages; fixes to unresolved anomalies; labeling for use with additional hardware and off-the-shelf software; support for ISBT-128 product codes beginning with S; and updated labeling to make the device easier to configure and use.
The following table outlines the technological characteristics of BPAM 4-2023 and the Predicate Device.
**Table 1: Technological Characteristics Comparison**
| | BPAM 4-2023 | Predicate Device |
| --- | --- | --- |
| **Communication with External Systems** | Receives information from a blood bank system and a Host System (an electronic health record system); communicates administration documentation to the Host System for storage. | SAME |
| **Product Administration** | Patient and product matching functionality; expiration date checking functionality. Incorporates system-controlled logic that can require a positive scan of a patient and a product and compares that information | SAME |
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| | against information from the external system. | |
| --- | --- | --- |
| **Technological Makeup** | Software-only device. | SAME |
| **Environment** | The clinician can use the device in a client/server environment on a workstation (e.g., a desktop, laptop, or tablet computer) and/or Apple iOS or Android device | SAME |
| **Accessories** | Designed to be used with a blood bank system and a Host System (an electronic health record system). Limited for use with versions of Epic's electronic health records software beginning with the February 2024 version. Designed to be used with a barcode scanner as an optional accessory. | SAME, except limited for use with versions of Epic's electronic health records software beginning with the November 2020 version. |
| **Hardware** | Mobile device (Apple and Android), server, and workstation (e.g., desktop, laptop, or tablet computer). Barcode scanner (optional) | SAME |
| **Barcode Types** | ISBT-Compound ('2D') barcodes, ISBT-128 and Codabar barcodes. Supports ISBT-128 product codes with prefixes A-D (including those with the Belgium-specific identifier &<), E, F, N (Netherlands-specific), S, and plasma derivatives labeled X0001000-0999000. | SAME, except ISBT-128 product codes with prefix S are not supported. |
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BPAM 4-2023 has identical or similar technological characteristics to those of the Predicate Device. No new safety or effectiveness issues are introduced as a result of minor differences in technological characteristics, and the device's fundamental scientific technology is unchanged. Based on the comparison of the technological characteristics, BPAM 4-2023 is substantially equivalent to the Predicate Device.
