Blood community professionals and vendors met with officials from the Food and Drug Administration in a first-of-its-kind conference examining the impact of federal regulations on the development of donor and transfusion information technology (IT) systems.
The Blood Establishment Computer Software (BECS) Conference, held at the Hilton in Silver Spring, Maryland on July 10-11, attracted 170 participants, including more than a dozen presenters from blood centers, national organizations such as the American Red Cross (ARC), regulators, and software manufacturers.
The conference was organized by America's Blood Centers (ABC) under the auspices of the international Alliance of Blood Operators (of which ABC and ARC are the US members). The conference was also co-sponsored by FDA's Center for Biologics Evaluation and Research (CBER). ABO, ARC, AABB and AdvaMed also supported the conference and participated in the planning along with ABC and CBER.
Changes Proposed. The purpose of the conference was to examine the reasons behind the BECS regulatory paradigm and how it might be changed to ensure the continued safety of the blood supply while keeping blood centers abreast of the latest software improvements. Presenters also discussed ways to make the IT market more attractive to vendors by streamlining the regulatory process, decreasing their risk, and developing more open software platforms and architectures.
Opening the conference, ABC CEO Jim MacPherson noted that only in the US are BECS regulated as medical devices; there is no similar regulation anywhere in the world that applies to pharmaceutical or medical device manufacturers. "The value of such regulation is not clear, but the unintended consequence is that worldwide blood establishments are served by a niche industry of poorly capitalized software houses. Also, available software is usually years behind in technology and changes are slow and expensive," Mr. MacPherson said. He asked whether there were alternative ways to both assure the confidence of the regulators and the needs of blood establishments.
In the end, Jeffrey McCullough, MD, a professor at the University of Minnesota who served as the conference reporter, suggested that an IT forum should be established involving IT, quality assurance and operations professionals from blood centers as well as BECS vendors and officials from the FDA. He also noted that there appeared to be a consensus to explore some form of partnership with the International Society for Blood Transfusion (ISBT) Task Force to develop a universal data interface standard that will allow blood center core IT systems to plug into more third-party software and other systems. Participants urged the FDA to cut down on the number of unnecessary documents that applicants submit, clarify validation requirements, and reduce the number of changes to requirements during active 510(k) reviews.
Jay Epstein, MD, director of the Office of Blood Research and Review, said the FDA will look for ways to streamline the 510(k) process, clarify expectations, and consider a "modular approach" of clearing the core system software and peripheral software differently, perhaps even developing "white box vs. black box" regulations. He said a common misconception among vendors is that "you can't talk to the FDA or argue with the FDA," before or during a submission clearance, whereas the agency tries to practice "interactive reviews" to head off problems early. He also noted a "paucity of data" on the vendor experience with the 510(k) process, asking "What about the vendors who dropped out?"
Some discussion at the workshop centered on ways to lure more of the IT giants, such as Microsoft, into the BECS market by decreasing the business risk involved. But Dr. McCullough asked whether it actually would benefit blood centers to entice the "big guys" into what is a small market now dominated by a few players who have invested greatly to obtain 510(k) clearance.
Level Playing Field. One BECS vendor who sat on a panel that discussed possible alternatives to the current regulatory scheme said that a standard interface and a more open architecture would "level the playing field" for all vendors. But, noting that vendors in a small market tend to be more protective of their proprietary systems, he said America's Blood Centers and other large organizations are in the best position to "force vendors to cooperate on open interfaces." In the hospital market, by contrast, a vendor cannot enter without conforming to the HL7 (Health Level 7) interface.
FDA initially regulated BECS as equipment. But during the 1980s, blood centers increased the number of donor questions asked and tests performed on blood, and Congress grew more concerned about blood safety during the AIDS crisis. The FDA responded by initiating inspections of all blood establishments. In 1993, the agency issued a Draft Guideline and held a workshop on the validation of BECS and in 1994 began to regulate BECS as a medical device. The following year, FDA announced a deadline to submit BECS applications for 510(k) clearance.
Tamara Poling of Sunquest Information Systems, who was attending as a member of the AABB Information Systems Committee, gave the results of a survey of independent blood centers, transfusion centers and hospital blood centers. Results showed a consistent opinion that BECS regulation does improve safety but also slows down time to market IT improvements and increases costs to the vendor that are passed along to the consumer.
While most presenters stopped short of calling for the end of 510(k) regulation, a few questioned the underlying reasons for its existence and several spoke of the mountains of paperwork and staff time involved in preparing for and undergoing a 510(k) clearance. BECS Planning Committee Co-chair Rodeina Davis, who is vice president and CIO, Information Services, Blood Center of Wisconsin, showed a photo of a several-foot-long set of documents required by the FDA, though the agency's reviewers seemed to focus more on the hazards analysis report than anything else. FDA officials said that the hazards analysis report is a "pathway" that leads evaluators to problem areas, but that all reports requested are reviewed at some point.
The FDA considers BECS a Class II medical device, which is defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article including any component, part, or accessory which is ...intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease." The agency also determines whether the BECS "contrivance" is intended for interstate commerce/commercial distribution and whether the data are transmitted or accessed across state lines in its classification.
Pointing out that a number of large blood centers have service areas that cross state lines, Ms. Davis asked "If there is no commerce involved and the data stays within the blood center, should it be a Class II device?"
One vendor recounted ordeals her company endured to get clearance for software because of changed requirements and seemingly unneeded paperwork requests. "We believed that we knew exactly what FDA expected, and I was 100 percent confident that the submission would be cleared in less than 90 days," she said.
Though the company had received 510(k) clearance in 1999 and 2002, other submissions were fraught with delays, despite no significant changes to personnel, development methodology or BECS guidelines. One clearance was delayed by FDA's "wireless hysteria" over how RF signal interference would impact other devices, she said. FDA officials responded that signal interference was indeed a major concern (a recent study showed it can cause medical devices to malfunction), and that requirement changes were a response to the sloppiness and missing information in documents submitted by some vendors.
This story originally appeared in the July 18, 2008 issue of the ABC Newsletter, the flagship publication of America's Blood Centers. Reprinted in an abridged form with permission.
Video Case Study: Blood/Biologics: Community Blood Center of the Carolinas
America's Blood Centers: Blood Establishment Computer Software (BECS) Conference http://www.fda.gov/Cber/meetings/becs0710081.htm
The Changing Regulatory Climate for Blood Establishments and Their Vendors http://www.devicelink.com/ivdt/archive/97/11/007.html