Medical Devices - Critical Disposables cited for design control faults.

FDA's review of Critical Disposables of Sanford, FL, handled by investigator Kevin Vogel of the Florida District Office in August 1999, netted the maker of catheterization manifolds and high-pressure lines several citations for design problems. FDA wasted little time in punching up a Sept. 24 warning letter (Doc. 8131W) which arrived at the firm just under a month after the inspection.

According to the EIR, Critical was formerly known as L.O.N. Research, which DeRoyal Industries of Powell, TN, bought out in 1991.

Vogel hit the firm for failure to "directly" obtain design inputs from actual users in their manufacture of ultra-high pressure (UHP) lines. This observation was likely based on several Medical Device Reporting events that FDA said the firm failed to file. Vogel also wrote in the EIR that Critical had received "numerous complaints of high-pressure lines bursting at pressures below their specifications." He cited the firm up for not implementing corrective action in these instances as well.

According to the EIR, plant engineer Tim Rowen stated that Critical had commenced production of the UHPs in order to crack the market in

Europe and to compete with another firm's products. Vogel wrote that the company based its design of the UHP lines, intended to withstand 1200 psi versus 1000 for the standard lines, on an increase in wall thickness and increased Durometer.

In the EIR, Vogel noted that the production of the UHP was intended to "meet what they perceived as changing user needs" and inquired of Rowen whether Critical had obtained input from users regarding design. Rowen responded that DeRoyal Europe had provided the input, which he assumed was culled from end users.

Vogel commented further in the 483 that the design plan failed to include information regarding review, verification and transfer of designs as well as "interaction between groups involved in the design process."

Vogel criticized the company's design work in the EIR because it only documented "the product performance qualification and the risk analysis." He added that "design validation was performed as product peformance qualification and thus failed to determine if [the] product actually meets the user's needs."

The Checklist Critical Disposables, Florida district

Design controls Process validation In the warning letter, FDA repeated the charge leveled by Vogel regarding design review, transfer, verification and group interaction in no further detail. Later in the warning letter, FDA also complained that performance qualification did not "indicate how user needs are considered and assessed."

Lisa Perkins, the firm's director of regulatory affairs co-signed an Oct. 18 letter with plant manager Henry Richardson and President/CEO Tracy Thompson, which stated that Critical was "in the process of revising design control procedures to address this observation," which was promised for implementation by Nov. 1, 1999. The company also offered to revise its engineering change orders to call for regulatory review of the process in the interim.

Company officials noted their intention to conduct a series of on-site visits in order to review actual device use and that Critical would assemble a questionnaire for end users. At press time, DeRoyal had not responded to calls for comment.

Critical Disposables, Sanford, FL, 8/16-20, 23-24, 27/99, Doc. 108872M, $31.50 plus retrieval.