Medical Device Daily Washington Editor

The expression "too late smart" can sound uncomfortably apropos when dealing with warning letters FDA waits seven months or more to post to its web site, and the Feb. 2 warning letter to Biomed Devices (Front Royal, Virginia), was one of those. Addressed to a firm said to have been out of business for several years, the warning letter names optometrist Robert Breece as the company's president and CEO. However, the representative for the successor firm to Biomed, known as Medlens Innovations (also Front Royal, Virginia), told Medical Device Daily that Breece passed away earlier this year. Medlens uses the same address and phone number as Biomed.

According to the warning letter, the October 2008 inspection of the maker of soft and rigid contact lenses lacked a quality system, specifically lacking provisions for management responsibility, corrective and preventative actions, and production and process controls. According to FDA, the firm's Dec. 22, 2008, response to this finding on the 483 was that the procedures were under development and would be in place by Dec. 31, 2008. FDA found the response lacking due to lack of documentation of the procedures in question.

As has long been the case, FDA cites firms for failure to follow their own standard operating procedures and in this instance, the citation dealt with monthly quality audits. The warning letter states that two of the company's SOPs required "monthly quality assurance reviews of changes and additions to" a number of records, including device master records, raw materials logs, equipment and facilities maintenance logs, returned product and complaint logs, and lens fabrication logs. FDA did not mention any response by the firm to this finding on the 483, noting only that Biomed offered no records indicating "that these monthly reviews have been performed."

FDA also states that the firm could not document the sterilization of soft lenses as required by SOPs. The warning letter indicates that the company's SOPs require that biological indicators for each lot of the sterilized lenses should be "allowed to incubate for [redacted] hours" and that the results be logged. However, "at least 20 of the approximately 100 sterilization records" reviewed between January 2007 and October 2008 lacked such information. FDA states further that the lenses in question were shipped "with no documentation that they were sterilized."

The firm's response to this finding was grouped generically with the remaining five others. According to the warning letter, Biomed informed FDA that it would revise procedures as necessary and have them in place by last Dec. 31, but the agency decreed the response inadequate due to lack of documentation.

In a finding said to be a repeat finding from an inspection that took place in July 2003 (no warning letter is listed for Biomedical in association with that or any other inspection), FDA asserted that Biomed failed to document calibration of equipment used to cut contact lenses, a finding extended to equipment used to "verify the lens base curve and front curve" as well as equipment used "to verify the lens power."

Also cited as a repeat finding from 2003 was a citation for lack of procedures for review of logs for non-conforming lenses and for investigations into the non-conformances.

In a separate citation, FDA alleges in the warning that the company failed to follow its own SOP for complaint evaluation and handling, stating that not only did Biomed not document weekly review of complaint files, but that the company also had no procedures for determining whether an investigation is necessary for a complaint.

Biomed's response to the 483 apparently included the note that it had hired a regulatory consultant, which recommended the company hire "a person whose primary job is to direct and oversee regulatory compliance," but FDA noted that while Biomed had asserted it had made the hire, no documentation was provided for the hire. A similar note regarding a lack of documentation was provided in regard to the firm's promise to "purchase software specific to contact lens firms, which has quality system modules."

At press time, the company had not returned calls for comment on the substance of the warning letter.

FDA publishes revised standards list

Materials and performance standards are some of the essential ingredients in any device application, so a revision of those standards by FDA is big news for any applications in the works.

Biocompatibility of medical devices seems to have rung in as the biggest concern where materials standards are concerned. Among the 35 new or revised standards for this category is a joint standard by the American National Standards Institute (ANSI; Washington), the Association for the Advancement of Medical Instrumentation (AAMI; Arlington, Virginia) and the International Organization for Standardization (ISO; Geneva) dealing with tests for in vitro cytotoxicity, which has been tweaked for changes to the "extent of recognition and relevant guidance."

FDA has withdrawn and replaced a portion of ISO 8536 dealing with "caps made of aluminum-plastics combinations for infusion bottles." This was the first of a total of 24 items in the category of general hospital/general plastic surgery standards listed in yesterday's Federal Register announcement.

Coming in third with a total of 23 items is "materials," a series of standards dealing with various alloys often used in implantable devices, of special concern to those in the cardiac and orthopedic spaces. All 23 items listed in this section are withdrawn and replaced, including at least two standard each for various alloys forged for use as surgical implants and surgical fixation wires, which had been developed by ASTM (formerly the American Society for Testing and Materials; West Conshohocken, Pennsylvania). Despite a separate listing for orthopedic devices, this group includes ASTM F451-08, which addresses acrylic bone cement.

Only seven items, all ASTM standards, appear in the orthopedic list, including ASTM F1440-92, which the FR notice states had been reapproved last year. This standard deals with cyclic fatigue testing for metallic stemmed hip arthroplasty femoral components. Standards for radiological applications, which numbered 16, include a standard promulgated by the National Electrical Manufacturers Association (Rosslyn, Virginia) for characterization of specific absorption rates for MRI systems. FDA indicated it will accept comments on an ongoing basis. n

Mark MCcarty, 703-268-5690;
mark.mccarty@ahcmedia.com