Blood Establishment Computer Software (BECS)

Blood Establishment Computer Software (BECS) Michael Gorman, BA, MT(ASCP)SBB Consumer Safety Officer, CBER, OBRR, DBA September 15, 2009

Outline • What is a BECS? • Regulations for Manufacturers • Manufacturers: Medical Device 510(k) Clearance • Regulations for Users • Validation • User Reporting of Implementation • CBER 510(k) Cleared BECS Website List • References

What is a BECS? • Medical Device: Defined under the Federal Food, Drug, and Cosmetic Act (FD&C Act) • FD&C Act applicability to BECS: • Device intended for use either in the: • Diagnosis of disease or other conditions OR • Cure, mitigation, treatment, or prevention of disease in man or other animals

What is BECS?(cont.) • Part of a computer system used by Blood and Source Plasma establishments, which also includes: • Hardware • SOPs and other documentation • Staff

BECS Examples Software Applications Used For: • Receiving and storing data for later use during the manufacturing process - examples: • Test results • Donor suitability/eligibility • Blood/blood component suitability – release for transfusion or manufacture into injectable or noninjectable products • Computer-assisted self-interview (CASI) donor questionnaires • Performing compatibility testing and other transfusion service related functions

Regulations for BECS Manufacturers • Medical Device Regulations: • 21 CFR 800 to 898 • Quality System Regulation (QSR) • 21 CFR 820 • Registration: Establishment Registration • 21 CFR 807 • Listing the Device: Medical Device Listing • 21 CFR 807 • Medical Device Reporting (MDRs) • 21 CFR 803 • Labeling • 21 CFR 801

BECS Manufacturers: Medical Device 510(k) Clearance • Premarket Notification (510k) required under the FD&C Act • Allows a medical device, BECS, to be introduced into interstate commerce: • Sold or given away (gratis) interstate • FDA also currently considers interstate data access or transmission to be interstate commerce

Regulations for BECS End Users • Blood Establishments • 21 CFR 211.68 • 21 CFR 606.100(b)(15) • 21 CFR 606.160(b)(5)(i) • 21 CFR 601.12 • Source Plasma Establishments • 21 CFR 606.100(b)(15) • 21 CFR 606.160(b)(5)(i) • 21 CFR 601.12 • Voluntary Medical Device Reporting

BECS End Users User Site Validation Overview • Done outside developer’s controlled environment • 21 CFR 211.68 (Blood Establishments Only) • 21 CFR 606.160(b)(5)(i) • 21 CFR 606.100(b)(15) • General Principles of Software Validation; Final Guidance for Industry and FDA Staff (1/11/2002) • Can be performed by: • End user • Third party (consultants) • Developer/manufacturer

BECS End Users User Site Validation Overview(cont.) • Perform at locations where the software is implemented (installed) • Follow a pre-defined written plan • Retain documented evidence of all testing and procedures

BECS End Users Validation SOPs Must be Developed • 21 CFR 606.160(b)(5)(i): Records shall be maintained for calibration and standardization • 21 CFR 606.100(b)(15): Equipment maintenance and calibration schedules and procedures

User Site Validation Should: * • Use actual hardware and software that will be part of the installed system • Be performed within the context in which the software is intended to be used • Take into account any site specific issues *General Principles of Software Validation; Final Guidance for Industry and FDA Staff (1/11/2002)

User Site Validation Should: *(cont.) • Ensure all system components are exercised and are the specified versions • Be done throughout the full range of operating conditions • Be carried out for sufficient time so the system encounters a wide range of conditions

User Site Validation Should: *(cont.) • Encompass: • High volumes of data • Heavy loads or stresses • Security • Error messages • Faults • etc.

Reporting of BECS Implementation to FDA • BECS: Annual Report - 21 CFR 601.12 • CASI: Discussed in CASI presentation

CBER 510(k) Cleared BECS Website List http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/SubstantiallyEquivalent510kDeviceInformation/ucm134987.htm

CBER 510(k) Cleared BECS Website List (cont.) • List of BECS is only for versions cleared by FDA • List does not include versions that did not require a new 510(k) submission • Not all software changes require a new 510(k) • List is not updated if a manufacturer discontinues distribution and support

References: General • FD&C ACT: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm • CFR on-line access - 1996 to 2009: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1

References: Reporting BECS Implementation to FDA • 21 CFR 601.12: Changes to an approved application • Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (8/07/2001)

References: User Site Validation • General Principles of Software Validation; Final Guidance for Industry and FDA Staff (1/11/2002) • Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility (10/26/2007) • Draft guidance comments to the docket are under review • Guidance Link: FDA website A to Z Subject Index - G Page; Click Guidance Documents – Biologics • http://www.fda.gov/SiteIndex/ucm148505.htm

Blood Establishment Computer Software (BECS)