Center for Devices and Radiological Health continued 2001
Chapter 2
Last Update: August 07, 2003
Lasers
Civil Money Penalties for LaserVision Centers, Inc.
Corporation Agrees to $1 Million Civil Money Penalty - the Maximum Permitted Under Statute
In the Matter of LaserVision Centers, Inc. et al (FDA Docket No. 00H-1242) On January 12, 2001, LaserVisions Centers, Inc. and four of its executives agreed to settle an administrative action for civil money penalties filed by FDA in April 2000. FDA had charged the respondents with multiple violations of 21 U.S.C. Sections 331(a), 331(c), and 331(k) related to interstate shipments of unapproved medical devices. FDA's evidence showed that the firm had made arrangements with a firm in Bermuda to make unapproved changes to the software of its approved excimer lasers which permitted them to be used to treat nearsightedness beyond FDA-approved limits.
The lasers were approved by FDA for use with "key cards" that contained a software "lock out" feature that prohibited their use beyond the FDA approved treatment ranges. LaserVision had arranged for a firm in Bermuda to remove the lock-out feature from the software and then sold them to physicians in the United States. The corporation agreed to the maximum penalty permitted under the statute of $1,000,000. The four individuals, including the corporate President and its General Counsel, agreed to a total penalty of $500,000 with joint and several liability.
Mammography
Congress enacted the Mammography Quality Standards of 1992 (MQSA) to ensure that all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages. In the fall of 1998, Congress reauthorized the MQSA extending the program to 2002.
Florida District Issues Warning Letters to Mammography Facilities
The FDA's Florida District Office issued Warning Letters to mammography facilities for failure to meet the requirements of the Mammography Quality Standards Act (MQSA). On March 6, 2001, a Warning Letter was issued to Baptist Medical Plaza at Coral Gables, Coral Gables, Florida. A State inspection conducted on February 6, 2001, found both level 1 and 2 deficiencies in that mammograms were processed in the Kodak room processor when it was out of limits for 7 days. In addition, the radiology technologist did not meet the continuing education requirement of having completed a minimum of 15 CEUs in mammography in a 36-month period.
On March 6, 2001, Florida District issued a Warning Letter to the Assistant Hospital Administrator, Edward H. White Hospital, St. Petersburg, Florida. An inspection conducted by the State of Florida on February 6, 2001, found a repeat level 2 violation in that there was no documentation for any corrective action taken before further exams, for a failing image score, or a phantom background optical density, or density difference outside the allowable regulatory limits. The inspection also found a new level 2 violation in that the phantom quality control was not adequate for unit 1, mammo room.
Serious Regulatory Problems Found at Breast Evaluation Center
On February 2, 2001, the FDA's New England District Office issued a Warning Letter to the South Shore Breast Evaluation Center located in Scituate, Massachusetts. An inspection conducted by the Commonwealth of Massachusetts acting on behalf of the FDA revealed serious regulatory problems involving mammography at this facility. The Warning Letter cited one (1) Level 1 finding and four Level 2 findings.
The inspection disclosed that the Phantom Quality Control records were missing for 7 weeks for unit 3, in Mammo Room (R) - a Level 1 finding. The following Level 2 (or repeated Level 3) violations were also found: there were no written procedures for handling consumer complaints; processor Quality Control records were missing 2 consecutive days for processor 9, in the darkroom; mammograms were processed in processor 1, in the darkroom when it was out of limits on 2 days; and finally, the fixer retention Quality Control was not adequate for processor 1 in that the fixer retention Quality Control records were not done at the required frequency.
Warning Issued for Failure to Provide Timely Summaries to Patients
On May 22, 2001, the FDA's Minneapolis District Office issued a Warning Letter to Edina Family Physicians, Edina, Minnesota. An inspection conducted on May 2, 2001, by the State of Minnesota, acting on behalf of the FDA, found Level 1 and Level 2 compliance problems. The inspection disclosed that the firm did not provide timely lay summaries to all patients (Level 1). In addition, a mammography equipment evaluation was not done when a major component of either the mammography unit or processor equipment was changed or repaired, and the facility had not specified adequate written procedures for collecting and resolving mammography consumer complaints ( both Level 2 findings).
Failure to Report Complaints Results in Warning Letter
On May 15, 2001, the FDA's Minneapolis District Office issued a Warning Letter to Allina Medical Clinic, a.k.a. Oak Point Clinic, Eagan, Minnesota, for MQSA violations. The State of Minnesota inspected the firm on April 12, 2001, on behalf of the FDA. The State inspection revealed the firm's complaint system was deficient because it did not report unresolved serious complaints to the accreditation body in the manner and time frame specified by the accreditation body. This was a repeat Level 2 non-compliance. Additional citations included: time period between previous and current physics surveys for their mammography unit exceeded 14 months; and failure to produce documents that a Radiology Technologist met continuing education requirements. The Radiology Technologist has since re-qualified.
Inspection Finds Serious Problems at New York City Facility
On March 20, 2001, the FDA's New York District Office issued a Warning Letter to Queens Open MRI, Flushing, New York, a mammography facility. An inspection conducted by the New York City Department of Health, Bureau of Radiological Health, acting on behalf of FDA, disclosed both Level 1 and Level 2 violations of the MQSA. A Level 1 noncompliance observation was noted concerning the fact that Phantom Quality Control records were missing for at least 4 weeks for unit #1 in room #1.
Level 2 noncompliance noted in the Warning Letter included: processor Quality Control records in the month of December 2000, were missing for at least 10 percent, but less that 30 percent of the operating days for one of the processors; processor Quality Control records were missing at least 2 but less than 5 consecutive days for a processor. In addition, the facility failed to produce documents verifying that three of the interpreting physicians met the continuing education and/or experience requirements of the MQSA; and finally, two of ten random reports reviewed did not contain an acceptable assessment category.
Inspection Discloses Repeat Level 2 Violation
The FDA's Cincinnati District Office issued a Warning Letter on June 18, 2001, to Lake Cumberland Medical Associates, Somerset, Kentucky. The Warning Letter was based on a repeat Level 2 violation observed during an inspection conducted by the Commonwealth of Kentucky, acting on behalf of the FDA, on July 6, 2001. The inspection found that five of ten random interpreting physician mammography reports did not contain the required overall final assessment of findings. The five mammography reports each appeared to be negative impression, however, these reports were without any of the required final assessment languages.
Inspection Finds Phantom Quality Control Records Missing
The FDA's New Orleans District Office issued a Warning Letter to the CEO of Christus Coushatta Health Care Center, Coushatta, Louisiana, on June 22, 2001. An inspection conducted by the State of Louisiana on June 5, 2001, disclosed a Level 1 MQSA violation. The Warning Letter noted that phantom quality control records were missing for at least four weeks for unit 1, Lorad Medical Systems, Inc.
Inspection by State of Texas Finds Level 1 Noncompliance
On April 24, 2001, the FDA's Southwest Regional Office issued a Warning Letter to the Director of Clinical Services, Marshall Regional Medical Center, Marshall, Texas. The Warning Letter was based on findings of a Level 1 noncompliance with the MQSA. An inspection on April 17, 2001, conducted by the State of Texas, on behalf of the FDA, disclosed that the mammography facility failed to provide timely medical reports. In addition, there was no system in place to provide timely lay summaries.
Obstetrics and Gynecology
Latex Contraceptives Detained
FDA Lab Finds Defects and Holes in Condoms
The FDA's Atlanta District Office detained 20,000 gross latex contraceptives on March 13, 2001, from M/S J. K. Ansell, India, with a value of $95,000. FDA analysis by the Southeast Regional Laboratory disclosed that the condoms contained defects/holes. Therefore, they were detained at the Port of Savannah, Georgia.
Ophthalmology
Contact Lens Materials Recalled
Unapproved Color Found in Gas Permeable Contact Lens
The FDA's New York District Office was notified by Bausch and Lomb, Inc., Rochester, of the firm's plans to initiate a recall involving 15 lots of rigid gas permeable (RGP) lens materials known as buttons. The recalled buttons included five products (Boston II Green, Boston Equalens II Green, Boston ES Green, Boston ES Gray, Boston XO Green and Boston EO Green).
The 15 lots subject to recall were manufactured using an unapproved color, D&C Yellow #11, instead of the approved color D&C Yellow #10. D&C Yellow #11 is approved for topical drugs and cosmetics. The manufacturer of the buttons is Polymer Technologies, Wilmington, Massachusetts. Over 92,000 buttons were distributed between December 1999 and January 2001 to 57 United States and 49 foreign lens laboratories (manufacturers). The recall was to the lens laboratory level.
Warning Issued to Manufacturer of Intraocular Lenses
FDA Inspection Finds CGMP Violations of Quality System Regulation
The FDA's Florida District Office issued a Warning Letter on June 6, 2001, to Medical Developmental Research, Inc., Clearwater, Florida, for CGMP violations of the Quality System Regulation. These violations were found during an inspection of the firm on March 5 - 9, 2001, covering the firm’s manufacture and distribution of Intraocular lenses. The QSR violations included the following: failure to establish a quality policy and objectives; failure to validate its deionized water system; failure to develop, conduct, and monitor production processes; and failure to validate the steam sterilization system.
Orthopaedic
FDA Announces Recall of Hip Implants
Device Recalled Due to High Fracture Rate
On September 14, 2001, FDA announced that eight U.S. firms that make hip implants were voluntarily recalling certain of their hip implants due to a potential problem with a component. The component, a zirconia ceramic femoral head, was recalled by its French manufacturer, St. Gobain Desmarquest, on August 14, 2001, because it was fracturing at a higher rate than expected in some patients 13 to 27 months after being implanted.
The component is the ball portion of the hip prosthesis that connects the femoral stem to the pelvis. St. Gobain Desmarquest distributes zirconia and alumina ceramic femoral heads worldwide to most of the orthopaedic industry. The French recall applied to nine batches of zirconia ceramic femoral heads manufactured since early 1998. The affected batches have the prefix "TH" before the batch number. All these potentially defective batches were manufactured after the beginning of 1998 when St. Gobain Desmarquest changed part of its manufacturing process. No metal or alumina femoral heads were involved in the recall.
U.S. companies estimated that hip implants with zirconia ceramic femoral heads were used in less than six percent of hip implant procedures in the United States. An estimated 150,000 to 200,0000 hip implants are performed annually in the United States. Surgeons should not continue to implant artificial hips with zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest since early 1998.
Patients who already have these hip implants should contact their surgeons with any questions or concerns. Not all zirconia ceramic femoral heads are expected to fail, and not all patients will experience a problem; therefore, FDA is not recommending surgery to replace hip implants that have not fractured or are not causing problems. Physicians will likely choose to monitor the performance of the implant more closely as a result of the potential problem.
Fracture of implants with this component is usually signaled by a sudden pain in the implanted hip joint, sometimes preceded by an audible "pop" from the hip just before the onset of pain. If a hip implant fractures, surgery to replace it will be necessary. No tests exist that can predict which patients will experience failure of their hip implants because of defective zirconia ceramic femoral heads.
The U.S. companies that use the St. Gobain Desmarquest zirconia femoral heads are: Apex Surgical, LLC, Lakeville, Mass.; Biomet, Inc., Warsaw, Ind.; DePuy Orthopaedics, Inc., Warsaw, Ind.; Encore Orthopedics, Inc., Austin, Tex.; Osteoimplant Technology Inc. (OTI), Hunt Valley, Md.; Smith & Nephew, Inc., Memphis, Tenn.; Stryker Howmedica Osteonics, Allendale, N.J.; and Zimmer, Inc., Warsaw, Ind.
The recall of hip implants was the second major hip implant recall in the past year. Sulzer Medica announced a voluntary recall of certain of its Inter-Op hip implants in December 2000, due to a lubricant residue on the implant that prevented it from bonding with the hipbone. Like Desmarquest, Sulzer's problem was traced to a change in a manufacturing process.
Improperly Sterilized Hip Stem Recalled
On October 3, 2000, the manufacturer of hip implants, Howmedica Osteonics Corporation, Allendale, New Jersey, recalled a product labeled as sterile when it was not properly sterilized. Howmedica Osteoncs recalled the following product: Omnifit Normalized Hip Stem, for use in bipolar and total hip arthroplasty in either a cemented or cementless: a) Omnifit Normalized Hip Stem (Collarless), Catalog No. 6033-0625; b) Omnifit Normalized Hip Stem (Collared), Catalog No. 6034-0625. Recall #Z-106/107-1. CODE a) Lot Code S00L303; b) Lot Code S00L269. The recall was initiated by the manufacturer, by letter on October 3, 2000. Distribution was to the following states: California, Florida, Germany, Korea, United Kingdom, Canada, Peru. Twenty-two units were distributed.
Potential Fracture Problem Results in Recall of Hip Implant
On September 14, 2001, FDA announced that eight U.S. Firms that make hip implants were voluntarily recalling certain of their hip implants due to a potential problem with a component. [See FDA Talk Paper T01-41]. The component, a zirconia ceramic femoral head, was recalled by its French manufacturer St. Gobain Desmarquest on August 14, 2001, because it was fracturing at a higher rate than expected in some patients 13 to 27 months after being implanted. The component is the ball portion of the hip prosthesis that connects the femoral stem to the pelvis. St. Gobain Desmarquest distributes zirconia and alumina ceramic femoral heads worldwide to most of the orthopedic industry.
The French recall applied to nine batches of zirconia ceramic femoral heads manufactured since early 1998. The affected batches have the prefix “TH” before the batch number. All these potentially defective batches were manufactured after the beginning of 1998 when St. Gobain Desmarquest changed part of its manufacturing process. No metal or alumina femoral heads were involved in the recall.
U.S. companies estimated that hip implants with zirconia ceramic femoral heads were used in less that six percent of hip implant procedures in the United States. An estimated 150,000 to 200,000 hip implants are performed annually in the United States.
FDA advised that surgeons should not continue to implant artificial hips with zirconia ceramic femoral heads manufactured by St. Gobain Desmarquest since early 1998. Patients who already have these implants should contact their surgeons with any questions or concerns. Not all zirconia ceramic femoral heads are expected to fail, and not all patients will experience a problem; therefore, FDA does not recommend surgery to replace hip implants that have not fractured or are not causing problems. Physicians will likely choose to monitor the performance of the implant more closely as a result of this potential problem.
X-Ray
X-Ray Devices Recalled
Potential Injury from X-Ray Device Results in Recall
On October 26, 2000, FDA approved the correction action plan letter for the recall of the product Mobile Digital Imaging Systems, C-Arm fluoroscopic x-rays: a) Series 7700; b) Compact 7700. Recall #Z-005/006-1. The manufacturer of the product was GE OEC Medical Systems, Inc., Salt Lake City, Utah. The distribution was both nationwide and international with 218 units distributed.
The diagnostic x-ray devices were found defective and failed to comply with the performance standard detailed in FDA regulations for x-ray devices. The defect occurred as a result of the emission of electronic product radiation that is unnecessary to the accomplishment of its primary purpose and which creates a risk of injury to the operator and patient. The system also failed to meet the fluoroscopic performance standard, "X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure."
Seizure at Wuestec Medical, Inc.
In January 2001, the FDA's New Orleans District Office conducted a seizure of at least $1 million worth of products manufactured by Wuestec Medical, Inc., Mobile, Alabama. Wuestec is an importer, manufacturer, and assembler of diagnostic x-ray products. Previously, on February 23, 2001, CDRH issued a Program Disapproval Letter to Wuestec notifying the firm that its testing and quality control programs for product certification were not approved. Until the disapproval is lifted, Wuestec may not legally introduce any of the cited products into commerce.
Consent Decree of Condemnation
On May 1, 2001, a Consent Decree of Condemnation against articles of device manufactured by Wuestec Medical, Inc. (Wuestec), Mobile, Alabama, was filed in the U.S. District Court for the Southern District of Alabama. Wuestec agreed to destroy all products seized valued at over $1 million, cease all device manufacturing until a qualified expert is retained and certifies CGMP compliance, conduct regularly scheduled audits and report the results to the FDA's New Orleans District, and FDA inspection finds the firm in compliance.
Radiation
Radiation Seeds Recalled
Complaints Report Lower Activity Level in Radiation Seeds by 15 - 50 Percent
The FDA's New England District Office reported that Uromed Corp., Norwood, Massachusetts, conducted a voluntary recall by fax on January 30, 2001. The recall involved 17 patient lots of Symmetra I-125 Brachytherapy Sources (sealed source, Radio nuclide) distributed to 5 Hospitals. The recall was initiated because the seeds were labeled with the wrong activity levels. The product is implanted and used in the treatment of localized tumors. The firm received two complaints on January 25, 2001, that the radiation activity levels were found to be lower than the stated labeled claim by 15-50%.
The product was returned from the two hospitals and a failure analysis was conducted. Investigation at the manufacturer determined that during receipt of inventory from Germany on November 22, 2000, and November 30, 2000, inventory switching occurred. Upon receipt the manufacturing lot vials received an internal Nuclide Inventory Control Number. The control number was placed on the internal label, over the existing labeled activity placed on the vials in Germany. The labels placed over the existing labels contained the incorrect activity ranges for the lots. The health risk is that patients may require additional treatment due to the lower activity level.
Unapproved Devices
Warning Letter Issued for “Love Magnets”
On July 20, 2001, the FDA's Denver District Office issued a Warning Letter to FeelGood for Life, Lakewood, Colorado. The firm is an own-label distributor for magnetic products, including neck wraps, love magnets, and magnetic headbands, which make unapproved claims. The products are sold in the firm's retail store in Denver, Colorado, by the Internet, and via catalog, including the catalogs found in United Airlines Skymail. Claims made for the magnetic products include: cancer, viral infections, bacterial infections, heart disease, multiple sclerosis, polio, cerebral palsy, and "all the other crippling and killer diseases know to man."
Warning Letter Issued for “Fertility Awareness Kit”
The FDA's Center for Devices and Radiological Health issued a Warning Letter on April 23, 2001, to the President and CEO of HealthCrest, Fair Oaks, California. The FDA issued the letter for the product labeled as “HealthCrest Fertility Awareness Kit". The device was marketed as a fertility awareness kit that contained a device referred to as “the Lens,” an Instruction Booklet, a HealthCrest Warranty, a booklet entitled “A Cooperative Method of Natural Birth Control” by Margaret Nofzinger, a Fertility Awareness Book, a Tracking Chart, and a pocket size tracking chart. The promotional brochure for the kit stated that “...the Lens is a fertility awareness tool that allows women to become their own fertility experts...pinpointing ovulation.”
This product is considered a medical device under the FD&C Act. A medical device is defined as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. The Warning Letter noted that medical devices are required to obtain marketing clearance for their product from the FDA before they may offer it for sale. FDA records did not show that the firm had obtained marketing clearance before they began offering the product for sale.
Court Orders Refund To Customers
Court Orders Firm to Pay a Refund to Customers for Purchase of Fraudulent Device
On November 30, 2000, a United States District Court judge ordered the maker and distributor of gas grill igniters marketed for pain relief to begin refunding approximately $82.00 to each purchaser of the fraudulent medical device. Judge Solomon Oliver, Jr., of the U.S. District Court for the Northern District of Ohio, ordered Universal Management Services, Inc., Natural Choice, Inc., Paul M. Monea and his son, Paul A. Monea, of Akron, Ohio, to send out refund notices within 45 days to purchasers of the Stimulator.
The device was manufactured and sold through Universal Management Services, owned by the Moneas, and through Natural Choice, a distributor managed by Universal Management. Some 800,000 of the devices were sold between 1994 and 1997.Universal Management Services made the Stimulators by outfitting gas grill igniters with finger grips. Users were instructed to apply the tip of the Stimulator to so-called acupressure points on the body and press a plunger to send an electric current into the body. The companies also sold an accessory cord called the Xtender to help consumers reach hard-to-reach areas of the body, such as the spine.
The U.S. Food and Drug Administration's interest in the devices was sparked in 1994 when disappointed consumers began complaining to the agency that the device did not work. In May 1995, at FDA's request, U.S. Marshals seized about 16,000 Stimulators, worth more than $1.2 million, from the companies' offices. However, the Moneas continued to sell the devices.
In December 1997, the U.S. District Court for the Northern District of Ohio ordered a permanent halt to the sale of the products and ordered a refund to customers. In September 1999, the U.S. Court of Appeals for the Sixth Circuit upheld the lower court's decision, and this June the U.S. Supreme Court refused to hear the case. This is the first case brought under the Federal Food, Drug, and Cosmetic Act in which a company has been ordered to pay restitution to consumers.
Under the order, the companies must notify customers within 45 days by mail that if they purchased a Stimulator or Xtender between May 4, 1995, and December 22, 1997, they are entitled to receive their money back. The refund program is being administered by Gilardi & Co., 1116 Magnolia Avenue, Larkspur, California 94131. The refund notice will provide instructions for requesting a refund as well as a toll-free telephone number consumers can call for additional information.