Puritan-Bennett closes two plants – medical device manufacturer
Amajor U.S. manufacturer of ventilators and other medical devices was forced to shut two of its U.S. plants earlier this year, after agreeing to a corporate-wide injunction.
In a consent decree filed Jan. 13, 1994, Puritan-Bennett Corp. of Overland Park, Kan., agreed to a permanent injunction against itself and two of its principals, Burton A. Dole Jr., president and chief executive officer, and John H. Morrow III, vice president and chief operating officer. The injunction was filed in the U.S. District Court in Kansas. (See S.J. No. 21 in this issue’s Summaries of Court Actions.)
The injunction forced Puritan-Bennett to shut plants in Boulder, Colo., and in Carlsbad, Calif. Its other U.S. manufacturing facilities are subject to closure if they do not comply with FDA regulations.
The action was the first corporate-wide injunction against a medical device manufacturer for violating good manufacturing practice (GMP) and Medical Device Reporting regulations. It followed 34 product recalls and two safety alerts undertaken by the company between 1985 and 1993. Many of the violations involved inadequate manufacturing specifications and processes.
“We believed that the violations were corporate-wide,” said Bill Defibaugh, a consumer safety officer in FDA’s Center for Devices and Radiological Health. “So we looked at the corporation as a whole, not the individual plants separately.”
The corporate-wide regulatory approach toward noncomplying medical device firms that operate multiple facilities has since been used in similar actions against two other device manufacturers, National Medical Care Inc., Waltham, Mass., and Siemens Medical Systems, headquartered in Iselin, N.J. (See “Siemens Agrees to Correct Manufacturing Problems” in the September 1994 FDA Consumer.)
Puritan-Bennett makes resuscitators, ventilators for hospital and home use, and other respiratory therapy devices, as well as a blood gas monitoring system.
Resuscitators provide emergency respiratory support through a face mask. Ventilators control or assist the breathing of patients unable to breathe on their own, either permanently or for long periods. FDA considers the units “critical devices” because they support or sustain life.
In addition to the closed plants in Boulder and Carlsbad, Puritan-Bennett operates plants in Lenexa, Kan.; Wilmington and Marlborough, Mass.; and another in Carlsbad, Calif. The company also has plants in Mexico and Ireland, both of which ship finished devices to the company’s U.S. plants. Distribution of these devices also is bound by the terms of the injunction, Defibaugh said.
Between 1985 and 1993, FDA conducted about 36 inspections of various Puritan-Bennett plants. Many of those inspections resulted in recalls of ventilators, airway delivery systems, and humidifiers. At least two of the recalls had to be repeated because the original recall failed to correct the problem.
Recalls resulted from such problems as defective circuits, fluid leaks, and software problems.
The company also issued two safety alerts. One followed the discovery of a potential burn problem with a pulse oximetry monitoring option used with the company’s hospital ventilators. The other stemmed from a potential fire hazard due to possible development of high oxygen concentrations for various models of portable home-use ventilators.
According to Defibaugh, the company always responded to FDA’s warnings and notices of adverse findings with a willingness to correct the problems. “They would correct some things and make promises to correct others,” he said, “but then, upon reinspection, we would find some of the same GMP problems.”
FDA sought the permanent injunction after a series of inspections between September and November 1993 revealed continuing significant GMP violations at the Colorado plant, which made portable home ventilators, and the Carlsbad facility that produced a blood gas monitoring system.
For example, FDA found that Puritan-Bennett failed to:
* ensure that a critical device did not leave the manufacturer for distribution until the appropriate employee checked all acceptance records and test results
* validate software programs by adequate and documented testing, when computers were used as part of an automated production or quality assurance system
* maintain a device history record to show that a device was made according to the device master record
* receive, store and handle components used in manufacturing in a way that would prevent damage, mix-up, contamination, and other adverse effects and keep not-yet-accepted components separate from accepted components
* validate changes in the manufacturing process of a device
* provide complete information as required by FDA’s Medical Device Reporting system.
Under the consent decree, the company may not reopen its two closed plants until the GMP violations are corrected, as determined by FDA. As of June 1994, the Carlsbad, Calif., plant had not reopened, and the firm has permanently discontinued manufacturing at the Colorado facility.
FDA continues to monitor the company.
COPYRIGHT 1994 U.S. Government Printing Office
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