A colleague in California reports that his hospital's transfusion service has a computer system that has functioned well for several years without the need for any vendor assistance. The hospital's 'in-house' computer staff is well versed in the computer system and can address the various issues that come up from time to time. The software vendor has indicated that they are terminating support of the system due to a business decision, and the software (and support for it) will no longer be available 'at any price'. The hospital is in the process of acquiring a replacement computer system for the transfusion service, but anticipates a period of time without vendor support. The laboratory and the in-house computer support staff feel comfortable in continuing normal operations until a replacement system is implemented. However, they wonder if they are at risk of violating any accreditation or regulatory requirements during the time period that they are 'on their own'?

The following comments have been received.

ADDENDA June 6, 2006

1. A transfusion medicine physician in California who is very familiar with computer system operations believes that the inquiring colleague's institution is "not alone" in being without a vendor supported computer system. He is of the opinion that so long as the inquiring colleague's current computer system is fully validated, functional, and maintained by internal staff, the unexpected loss of external vendor support should not preclude the facility from continuing to use their computer system. However, the inquiring facility should have a plan to transition to a supported system as soon as possible, and have a backup system (as required by AABB 3.9.2) so that a breakdown will not be catastrophic.

2. A colleague who works for the California Department of Health Services/Laboratory Field Services comments that from a regulatory standpoint, a transfusion service computer system must already have a backup process which includes operating within the foreseeable disaster mode. Power, funding, loss of personnel, and lack of vendor support, should all be part of the disaster planning process. Looking to the future for the newer system, vendor qualification is an extremely crucial issue. Future support, ancillary support, ability to obtain source code if the vendor is no longer available, internal support for both the application and hardware are just a few of the points to consider. The responding colleague would question, however, the vendor terminating support. He believes that they are required to provide support for the current system version and two previous versions. Thus, the facility must have been informed (or had clues along the way) of the pending termination of support in a time frame to have replaced the system before support was terminated. Sensitivity to these issues should be uppermost for those responsible for these systems.

ADDENDA June 7, 2006

3. Sheryl A. Kochman of CBER/OBRR/DBA, Chief, Devices Review Branch (attribution used with permission) reports that the FDA has no requirements that a manufacturer continue to support a medical device beyond its expected life. The FDA also has no requirement that a previously-cleared medical device cannot be used if the vendor is no longer supporting it. That said, Ms. Kochman would agree with the other commenters to this discussion regarding having back-up procedures in place and moving to validation and implementation of a new, cleared system ASAP. Perhaps most importantly, the inquiring facility needs to understand that they are still the ones ultimately responsible for the safety of their patients whether the vendor is supporting them or not. As an aside, everyone needs to understand that just because a system was cleared and is listed on CBER's website as being cleared, this does not mean that it is still a viable choice for use. This list does not include any information regarding recalls of the listed devices, which could provide significant information regarding their suitability for use, nor does it provide information about the status of distribution and/or service. Cleared medical devices are listed indefinitely, even when there has been a recall(s) and/or there is a newer version available, unless there is a significant hazard to health which results in the rescission of the clearance. Recall alone does not lead to a determination that there is a significant hazard to health and clearances are rarely rescinded.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator