Medical Device Daily Washington Editor

It’s always amusing to poke fun at government agencies for the torpid pace at which they seem to work, unless you work for a company getting a warning letter from FDA. Two companies found warning letters from November 2006 on the FDA site yesterday, including one to a long-time industry presence.

The Nov. 29, 2006, warning letter to Steris (Mentor, Ohio) said that the maker of the Amsco sonic energy cleaner (for surgical instruments) failed to submit medical device reports for 16 units that experienced electrical failures.

FDA said that the earliest complaint, dated May 25, 2004, involved an Amsco unit that was observed by a hospital employee to have “visible flame coming from the right side of the unit at the lid switch actuator opening.” The model number was identical to all the other complaints described in the warning letter.

Two reports from August 2004 addressed “interior wires, which melted and caught fire.” Steris received a report in September 2004 that was reported to have been “sparking and smoking.”

The warning letter stated that Steris had responded to the 483 to the effect that it would “review procedures and processes relating to complaint administration and medical device reporting” and that the company would review all complaints back as far as Nov. 2000 “to identify any additional instances requiring reporting.” The agency said it would “evaluate the adequacy of this response during the next FDA inspection of your facility.

The letter also cited Steris for failure to notify the agency of a correction to the Amsco cleaners that advised service personnel to inspect lid switch wiring at a subsequent service call and to “make corrections as required” on units that were not the subjects of preventive maintenance agreements.

A representative of Steris speaking on condition of anonymity told Medical Device Daily that FDA conducted a follow-up inspection in March, and the company and FDA have “closed all the findings.” He said the wiring problem was caused by location of wires in an area subject to saturation.

The second of the fine-aged warnings, a November 8, 2006, warning letter to UCA (Nashville, Tennessee), said that the company’s forms for corrective and preventive actions (CAPAs) were “limited to two incomplete ... forms” and that UCA could not document analysis of returned materials. For this latter finding, FDA noted that between February and August 2006, the company became aware of broken latches on 13 of 51 sterilization containers and could not document any investigation into the broken latches. The letter also said that UCA had no device history records indicating that sterlilizer containers were “manufactured in accordance with your firm’s device master record.”

Attempts to contact UCA for comment were unsuccessful.

In a much more recent vintage, FDA’s Aug. 1, 2007, warning letter to Sunoptic Technologies (Jacksonville, Florida), informed the company that it had misfired on a couple of basics regarding regulatory clearance for devices. The letter said that Sunoptic had not filed a PMA or a 510(k) for a dental probe prior to marketing and did not include information on the manufacturer on product labels.

The warning letter led with a citation for failure to validate the cleaning/sterilization process used for surgical fiberoptic cables. The letter also noted that the company “did not perform a validation of the fiberoptic manufacturing process after equipment critical to the process was moved” from one part of the facility to another, a finding usually characterized as an equipment installation/operation qualification issue rather than as a validation issue.

Janice Lee, director of quality and regulator affairs, told MDD that “We responded appropriately to all the items” in the warning letter and that the company validated the fiberoptic cleaning/sterilization procedure in May. She said the company “responded to everything else” in correspondence dated Aug. 17.

Also in more recent actions, a July 18, 2007, warning letter addressed to Louisville APL Diagnostics (Seabrook, Texas), maker of ELISA (enzyme-linked immunosorbent assay) diagnostics noted that the company had moved its facility from Doraville, Georgia to Seabrook in March 2006 and that Louisville failed to contact the agency’s Atlanta district office for recalls undertaken in 2004 and 2005 to ask if those were reportable to the agency. The company is also alleged to have failed to make a similar inquiry at the Dallas district office in connection with a recall undertaken in July 2006.

The warning letter said that Louisville did not “identify a value error in the positive control range” in a quality control fact sheet that was shipped with one lot of ELISA kits designed to detect a specific anti-phospholipid (aPL) in October 2005. FDA said that consequently, “your firm received a customer complaint of aberrant laboratory test results” and that Louisville instructed the customer “to discard the incorrect QC fact sheets” and then sent the customer the correct sheets.

The warning letter said that the company mixed conjugates for two types of ELISA diagnostic kits in 2004 and dealt with the resulting customer complaint by sending out replacement conjugates and instructing the customer to discard the mislabeled conjugates.

FDA cited the firm for failure to adjust a refrigerator’s operating temperature despite readings that indicated that the temperature exceeded the threshold for storage of ELISA components and for failure to document an evaluation of the effect of that thermal excursion on the products.

Louisville was cited for two validation lapses, including one for lack of procedures determining how “design changes are to be verified or validated, approved and documented.” The second part of this citation stated that the company failed to “create a design change record” describing the rationale behind issuance of a new “flyer” that addressed the subject of cut-off values for aPL antibody filters. These filters were shipped with ELISA kits and the company evidently told FDA at the time of the inspection that the reappraisal study behind the flyer was designed to “clarify the meaning of the ‘low positive aPL titers’” and enhance the safety of the kit.

At press time, Louisville had not responded to a call for comment.