BECL backing off on non-510(k) cleared clients. (Medical devices).

A Feb. 25-March 5 inspection of Biological and Environmental Control Laboratories (BECL) by FDA uncovered cleaning and sterilization validation deficiencies for the firm's reprocessed, single-use limb compression sleeve devices.

However, it was not until a June 20 warning letter (Doc. 11794W) that the agency stated the Toledo, OH-based firm was marketing the reprocessed devices without a cleared 510(k).

According to documents released by the agency, BECL reprocessed single-use compressible limb sleeves from two firms. One was Millennium Reprocessing Services, Inc., which received June 14 510(k) clearance for the devices to be reprocessed, FDA stated.

The other limb sleeve firm only was identified as "MDR," but it did not have a 510(k), according to FDA. BECL Quality Assurance Manager John Blair stated in a July 8 letter to the agency that the firm would discontinue working with companies that do not have 510(k) clearance for their products.

Until the firm in question received a 510(k), BECL would not "participate in any reprocessing activities associated with this firm," the exec told the agency.

Investigator Phillip Pontikos of the Cincinnati District noted in his three-page 483 that the validation protocol for ethylene oxide (EO) sterilization dated Aug. 31, 2001, had not been signed as completed, adding that the validation had not been fully completed and documented.

Cincinnati District Director Henry Fielden continued in the warning letter that BECL's sterilization process had "not been fully completed and documented" nor were bioburden studies performed or specific load configurations during sterilization cycles established or defined.

Pontikos continued that specific load configurations had not been established or defined, that there was no documentation showing that testing was conducted for pyrogenicity of for determining the bioburden levels for all types of reprocessed medical devices. He added that BECL did not have documentation showing that packaging materials and operations "provide a microbial barrier and maintains package closure and seal integrity after sterilization, handling, shipping, and storage."

Blair noted the firm would address the issues of EO sterilization when the unnamed firm in question obtained 510(k) clearance.

Pontikos also cited BECL for not having documentation to demonstrate that cleaning process for each type of compression garment had been validated, records stated.

Specifically, Pontikos cited a lack of documentation defining specifications prior to conduction testing. Also, the inspector noted that subjective assessments were used to determine cleanliness and dryness of devices.

Blair defended the cleaning process, stating this was validated and attached a copy of the protocol with his response. In a cleaning evaluation using the protocol, Blair noted "a percent reduction in bacterial counts of 99.36%."

Noting management had not ensured that the quality system was fully implemented and maintained, Pontikos also noted lack of a written quality plan for the reprocessing of single-use devices, no review of reprocessing medical devices in management review meetings, and that quality audits were not being done "with sufficient frequency to detect quality system defects."

Blair responded that BECL's reprocessing of sleeves began in 1999 before the company's ISO 9001 certification in December 2000 and that this was the reason a quality plan was not available for these devices. According to the letter, the firm attached a copy of the quality plan in the response.

Concerning management reviews, Blair again noted the predating of sleeve reprocessing to ISO 9001 certification and responded that management review meetings occurred every six months and that there would be "a section dedicated to the reprocessing of compressible sleeves" in July 2002.

FDA stated the FIR was not being released as it "could reasonably be expected to interfere with enforcement proceedings." Calls into BECL requesting comment were not returned as of deadline.

Biological and Environmental Control Laboratories, Toledo, OH, 2/25, 27-28, 3/1, 4, 5/02, Doc. 109316M, $5.50 plus retrieval.

[check] The Checklist--BECL

[check] cleaning and sterilization validation

[check] validation protocol incomplete/ undocumented

[check] documentation specifications

[check] quality system