Center for Devices and Radiological Health 2002
Warning Letter Issued to Manufacturer of TENS Leads/Electrodes
FDA Warns Firm For Serious Regulatory Problems
On August 15, 2002, FDA’s Cincinnati District Office issued a Warning Letter to the President of Selective Med Components, Inc., Mt. Vernon, Ohio, a medical device manufacturer. The firm manufactures electrode products such as transcutaneous electrical nerve stimulator (TENS) leads/electrodes.
FDA conducted an inspection of the firm July 8 - 16, 2002. The inspection revealed serious regulatory problems involving electrode products. The letter cited the firm for: failure to ensure that finished devices meet all specifications prior to distribution; failure to establish and maintain procedures to control product that does not conform to specified requirements, including failure to document the investigation of nonconforming products; and failure to establish and implement an adequate complaint handling program. In addition, the firm failed to adequately verify or validate corrective and preventive actions, to ensure that an adequate and effective quality system had been established, and to establish and implement adequate recordkeeping procedures.
Consent Decree of Permanent Injunction
Consent Decree Requires Firm to Recall Any Products “When FDA Deems Necessary”
United States v. Matrix Biokinetics, Inc., et al., (D. Nev.) On June 12, 2002, a U.S. District Judge signed a Consent Decree of Permanent Injunction entered because of defendants' violations of the device good manufacturing practice (CGMP) requirement. The Decree requires an up-front shutdown of Matrix Biokinetics, Inc., Las Vegas, Nevada, until the defendants hire an expert, the expert reports to FDA that the defendants' facility is in compliance with CGMP, FDA inspects and is satisfied that the facility appears to be in compliance, and the defendants reimburse FDA for its inspection. The Decree also requires that the defendants recall any products "as and when FDA deems necessary," pay for all inspections conducted under the Decree, immediately shut down and recall devices upon written order of FDA, and provides that any judicial review be decided under the arbitrary and capricious standard.
Previously, on July 21, 1998, FDA issued a Warning Letter to Matrix Biokinetics, Inc., following an FDA inspection in May and June 1998. The Warning Letter advised the firm of violations of the Quality System Regulation (QSR) for current good manufacturing practice in the manufacture and distribution of an electrical device, the ProElecDT2, used to treat pain. The firm received a second Warning Letter dated October 22, 1999, again citing violations of the QSR. Matrix’s failure to correct significant QSR deficiencies, led FDA to pursue the injunction.
Obstetrics and Gynecology
Seizure of Devices Labeled as Sterile
Obstetric and Gynecological Devices Seized Due to Concerns Regarding Sterility
On April 9, 2002, FDA investigators accompanied the U.S. Marshals Service in a seizure of all in-house sterile product inventory, consisting of approximately 40,000 units manufactured by A&A Medical, Inc. of Alpharetta, Georgia. The products consisted of many types of obstetric and gynecological surgical devices that are used only in a clinical setting. The products included, but were not limited to, curettes (flexible and rigid), uterine dilators, endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, harvesting pumps used in-vitro fertilization, and aspiration sets.
The products were seized because they were labeled as sterile or ethylene oxide processed but they may not have undergone sterilization. As a result, FDA determined that these devices could cause serious and possibly life-threatening infections that may result in infertility and miscarriage.
Previously, on March 15, 2002, and again on April 17, 2002, FDA issued a Safety Alert to notify healthcare professionals of a recall of all medical devices manufactured by A&A Medical, Inc.
On July 11, 2002, FDA announced that the products manufactured by A&A Medical/Rocket USA/LifeQuest Medical Ind., of Alphareta, Georgia were destroyed. The products were estimated to be valued at approximately $200,000.00.
A list of distributors of products manufactured by A&A Medical can be found on FDA’s web site at: http://www.fda.gov/cdrh/recalls/listaa.html.
Warning Letter Issued for Eye Care Solutions
Quality Assurance Failures Found at Manufacturer of Eye Care Products
On July 17, 2002, FDA’s Atlanta District Office issued a Warning Letter to the Chairman and CEO of Bausch & Lomb, Rochester, New York. The Warning Letter was issued based on conditions found during an inspection conducted between May 20 and June 10, 2002. The inspection was conducted at the firm’s Greenville, South Carolina eye care solutions plant. FDA inspection revealed that the firm had not validated all operations relevant to the manufacturing and packaging processes. The Warning Letter also noted that Quality Assurance failed to monitor and control environmental conditions upon discovering paint chips flaking from the ceiling grids.
In addition, the firm released partial lots of product with out-of-specification results in finished product testing for the appropriate amount of the preservative/disinfectant; the firm did not investigate or implement corrective action in response to viscosity failures in several finished lots; and the firm did not maintain appropriate procedures for the acceptance of incoming product to assure conformance to specified requirements.
Contact Lens Firm Receives Warning Letter
FDA’s Florida District Office issued a Warning Letter on January 29, 2002, to Optical Polymer Research, Inc., Gainesville, Florida, for Quality System Regulation (QSR) violations found during an inspection of the firm on December 6 and 7, 2001. The firm is a manufacturer and distributor of rigid, gas permeable contact lens and soft contact lens blanks.
The QSR violations included: failure to conduct quality audits at sufficient intervals as listed in their procedures to verify that the quality system is effective; failure to maintain complaint files; failure to analyze all sources of quality data to identify existing and potential causes of nonconforming product; failure to establish procedures covering documentation of corrective and preventive action; failure to establish design control procedures; failure to establish and maintain a design history file; and failure to develop, conduct, control and monitor production processes to ensure that the device conforms to its specifications.
Manufacturer of Dynamometers Receives Warning
FDA’s Florida District Office issued a Warning Letter on April 25, 2002, to Ametek, Inc., Paoli, Pennsylvania, a manufacturer of dynamometers, for violations of the Quality System Regulation. Dynamometers are medical devices if intended for medical purposes. They are used to assess neuromuscular function or degree of neuromuscular blockage, by measuring with a force transducer, the grip of a hand.
An FDA inspection at Ametek’s facility in Largo, Florida, conducted February 13 - 14, 2002, revealed the following violations: failure to establish, maintain, and implement a corrective and preventive action procedure; failure to establish and maintain procedures to control the design of device(s) in order to ensure that specified design requirements are met; failure to validate the results of processes that cannot be verified by a subsequent inspection or test; failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints; and failure to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned duties.
Defective Surgical Gloves Refused Entry
On May 15, 2002, FDA’s Chicago District Office witnessed the destruction of $1,575 worth of surgical gloves. Nine cartons of RFB Nitrile Surgical Gloves from India were refused entry for adulteration due to defects, failure to meet quality system regulations and failure of the device to be “listed” or to be covered by a premarket notification submission. The product originated from RFB Latex Limited of Noida, India, and was imported by Howard Medical Company of Chicago, Illinois.
Consent Decree of Permanent Injunction
Consent Decree Permits Letter Shut Down and Reinspection Authority
United States v. International Medical, Inc., M..D. Fla.). On June 3, 2002, a United States District Judge entered a Complaint for Injunctive Relief and a Consent Decree of Permanent Injunction ("the Decree") against International Medical, Inc. ("IMI"), Fort Myers, Florida, a medical device manufacturer. The Complaint alleges that IMI violated 21 U.S.C. § 331(a), by introducing adulterated devices into interstate commerce, as well as 21 U.S.C. § 331(k), by causing the adulteration of the devices while they were held for sale after shipment in interstate commerce. The devices were adulterated within the meaning of 21 U.S.C. § 351(h), in that they were not manufactured in conformity with the Quality Systems Regulation. The decree provides for IMI to correct its violation with the advice of an expert.
Court Orders Refunds to Customers
An FDA Consumer Safety Officer witnessed the destruction of tons of Stimulators, parts and accessories, being destroyed pursuant to the court case, United States v. Universal Management Services, 999 F. Supp. 974 (N.D. Ohio 1997), aff’d 191 F.3d 750 (6th Cir. 1999) cert. denied, 530 U.S. 1274 (2000). The firm, located in Akron, Ohio, began the destruction process on February 20, 2002, in Ohio, and concluded at a dumpsite in Michigan. The Stimulator is a gas grill igniter with handgrips, and was sold as a pain relief device through television infomercials and newspaper and magazine advertisements. In a decision, which the Sixth Circuit upheld, the district court ordered the manufacturer to offer refunds.
This case set a groundbreaking precedent as it represents the first time that consumers have received such an award under the Federal Food, Drug, and Cosmetic Act. This decision led to over $7 million in refunds to Stimulator customers and has also served as a basis for equitable awards of over $100 million in other FDA cases.
Baxter Recalls Dialyzers - Class I Recall
FDA Works With Firm To Identify Cause of Problems With Dialysis Machines
FDA announced on November 7, 2001, that the Agency was investigating reports of over 50 patient deaths worldwide, including four in the United States, that may have been caused by certain dialyzers made by Baxter Healthcare Corporation, Deerfield, Illinois. On October 18, 2001, Baxter announced an “Urgent Product Recall” of dialylzers. Baxter voluntarily recalled the dialyzers in mid-October 2001. The recall was initiated following reports of deaths associated with its product in kidney dialysis patients in Spain, Croatia, Italy, Germany, Taiwan, Colombia and the United States.
The U.S. deaths occurred at dialysis facilities in Austin, Texas, and Kearney, Nebraska. Most of the dialysis patients who died experienced shortness of breath, chest tightness, cardiac arrest or stroke symptoms within hours of being dialyzed. FDA worked closely with Baxter and with regulatory agencies abroad to identify the problems quickly, and protect the public health by recalling the dialyzers.
Preliminary tests have led Baxter to conclude that a perfluorohydrocarbon-based performance fluid used in a manufacturing step may have played a role in the deaths of these patients. Baxter reported that it had permanently ceased manufacturing these dialyzers. No dialyzer shortage is anticipated as a result of Baxter's decision.
The following dialyzers--labeled either Althane or Baxter--were recalled:
Series A11, A15, A18 and A22
Series AF150, AF180 and AF220
Series AX1500 and AX2200
The products were distributed from January 1998 to October 15, 2001, to dialysis facilities in more than 50 countries. The first reported deaths occurred in Spain in mid-August. In mid-October 2001, Baxter notified all of its customers to stop using these dialyzers immediately and return any inventory. FDA worked with Baxter to ensure that the recall was effective.
FDA Alerts Public of Problems with Dialysis Machines
On September 12, 2002, FDA announced that Baxter Healthcare Corporation had notified dialysis centers that certain blood tubing used with Baxter's Meridian dialysis machines may possibly be linked to five patient deaths and two injuries. These occurred at two kidney dialysis centers in late August 2002.
Although the cause of the deaths was not yet determined, on September 6, 2002, Baxter notified hemodialysis centers that it was exploring the possibility that the patients' hemodialysis treatments may have used the same model dialysis machine and bloodline set. Baxter told customers to immediately discontinue use of certain models of Medisystems blood tubing in conjunction with Meridian dialysis machines and use other Medisystems blood tubing instead.
FDA worked closely with both Baxter Healthcare of Roundtop, Illinois, and Medisystems Corporation of Seattle, to identify the exact cause of the problem.
FDA Deputy Commissioner, Dr. Lester M. Crawford stated, "FDA is alerting the public and the medical community to this problem in an effort to prevent other deaths and injuries. Although details are still sketchy, in the interest of patient safety, FDA wants to make certain that dialysis patients and the wider medical community are aware of these incidents."
Baxter's preliminary investigation found that the two hemodialysis centers where the incidents occurred may have been using the following:
Blood tubing--Medisystems Corp., Product Code D3-9694/9793 or K3-9694/9793, Baxter Product Code 5M9694 Hemodialysis Machine--Meridian
Alternate Medisystems blood tubing is available. The incidents occurred at Nephrology, Inc., in Mishawaka, Indiana, and Physicians Dialysis, Inc., in Grand Rapids, Michigan.
Warning Letter Issued to Manufacturer of Hemodialysis Access System
FDA Issues Warning Letter for Failure to File MDRs
FDA’s New England District issued a Warning Letter on November 29, 2001, to the President and CEO of Vasca, Inc. of Tewksbury, Massachusetts. The firm manufactures an implanted hemodialysis access system (marketed under the trade name LifeSite®) that was cleared for distribution in the United States in August 2000. FDA’s New England District Office conducted an inspection of the firm in July 2001.
Based on the findings from that inspection FDA issued a Warning Letter citing Quality System Regulation (QSR) deficiencies caused the device to be adulterated. The deviations related to complaint handling and a failure to provide a notice of a correction or removal under 21 C.F.R. Part 806. The firm was cited for failing to file Medical Device Reports (MDRs) within 30 days (in 14 instances) and for failure to file MDRs (in 6 specific instances).
The Warning Letter also stated that the device was misbranded and requested significant changes in the labeling. The Warning Letter stated that the firm should revise the labeling to incorporate important new post-market safety data. The labeling should also be revised to warn the user about the risks of such use and expected outcome in patients with a history of multiple access failures or access infections that are catheter dependent for dialysis access, and are not candidates for permanent access placement.
The Warning Letter stated, “With regard to this charge [misbranding] it is noted that your access device is currently intended for use in hemodialysis patients that are awaiting creation and/or maturation of a permanent access. Review of post-market adverse event data, however, indicated that the majority of reported deaths and many reported injuries occurred in patients that were not candidates for permanent access placement. Information provided on adverse events indicated that many affected patients had a history of multiple access failures and access infections and would not be candidates for further permanent access placement.”
“Moreover, several centers reported patient deaths for individuals that had been considered ‘last resort’ patients by their healthcare providers, in that they were not candidates for permanent access, were very ill, and had limited options for dialysis access.
Several reported deaths and many reported injuries occurred in patients that underwent access placement procedures (femoral or direct thoracotomy implantation) for which the device is not currently labeled.”