Issues related to cleaning of medical devices made headlines last month, prompting the continuing recall of devices and other ramifications still unknown. In the first case, Johns Hopkins Hospital (Baltimore, Maryland) stirred the recall waters when it failed to receive an earlier notification concerning bronchoscopes made by Olympus (Tokyo, Japan). Johns Hopkins issued a statement on its web site concerning lung infections being carried by the instruments, which are used to examine lungs and remove tissue samples from airways and reportedly related to more than 400 cases of infections. Elsewhere, there were two deaths reported but no word yet concerning a definitive connection with the bronchoscopes. Olympus, whose U.S, headquarters is in Melville, New York, had issued a recall of the devices early last December, and a follow-up recall in February, but Johns Hopkins apparently did not receive them.
The problems were first seen in Tennessee, with that state's department of health being called in on Sept. 17 to investigate an abnormally high rate of infections at Skyline Hospital (Nashville, Tennessee). David Kirschke, MD, epidemic intelligence service officer with the Tennessee Department of Health, told The BBI Newsletter's sister publication, Medical Device Daily, that his office had received reports of "20 contaminated specimens out of 27 patients that had cultures done and one probable nosocomial [hospital-related] infection." There was no immediate identification of the problem, but a second outbreak then occurred "related to replacement scopes" the following month. After communicating with Olympus, "the company came out and told us that they had done some independent research and decided that defects in the 'scopes was responsible," Kirschke said. The company issued a recall letter Nov. 30, but that failed to provide closure to the issue. Kirsky's view is that "there may be a question as to whether the recall got out efficiently."
Johns Hopkins heard of the recalls only after it had begun its own effort to contact all of its patients who had been exposed "to bacteria due to defective bronchoscopes," it said in a statement. And it said that it raised the alert after "determined detective work by Hopkins Hospital pulmonologists and infection control experts before they learned of the manufacturer's recall." In its first recall letter, Olympus said it contacted more than 2,300 hospitals and health care centers. But the letter sent to Johns Hopkins apparently went to the wrong department, according to Phyllis Weller, a consumer affairs specialist with the FDA. Weller was answering questions when called at a number set up to respond to patient concerns about the recall. The agency also established a number for hospitals to call for information, primarily to help them in identifying the particular batches of bronchoscopes that may have been defective.
As a result of the news alert from Johns Hopkins, Olympus released a statement saying that it has been working closely with the FDA, the Centers for Disease Control and Prevention (CDC; Atlanta, Georgia) and hospitals to recall all remaining instruments. "We remain committed to ensuring that the recall of our bronchoscopes is completed expeditiously," it said in the statement. It also said, "At the time of the recall's commencement, Olympus America had received a report of bronchoalveolar lavage sample contamination and a single patient infection."
Thus far, there has been no indication from the FDA that any further action is required by the agency or that the company failed in its responsibilities. The company's explanation is that a part of the device in question was loose and this had prevented its proper sterilization. It said it also had sent out recall letters in Japan and that it had done everything possible it could, given the circumstances. It reported about half of the 4,418 devices imported to the U.S. and somewhat more than 80% of the devices used in Japan have been returned. A recall also has been launched in Europe, where more than 4,500 devices were distributed.
In a second recall effort, the FDA in mid-February issued an alert saying it was urging the recall of all products made by A&A Medical (Alpharetta, Georgia), specifying those products made by the company which have been labeled as "sterile or ethylene oxide processed." In a "talk paper," the agency said that the products, made and shipped from 1999 and after, "in fact may not have undergone" any sterilization. These devices have "the potential of causing death or serious injury such as infection, infertility and miscarriage," the agency said in a statement. A&A also does business as A&A Medical/Rocket USA and Lifequest.
The agency said that the company is recalling all of the products which were shipped to sites within the U.S. and to Canada, Egypt, Italy and Lebanon. A partial list of the products included in the proposed recall are: flexible and rigid curettes, uterine dilators, endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopic accessories, bone marrow needles, aspirations sets, biopsy pipettes and harvesting pumps used in in vitro fertilization. The agency said there may be additional unsterilized products in need of recall. The products are used during surgeries and gynecological procedures.
The agency sent notifications of the alert to hospital administrators and directors of hospitals' departments of obstetrics and gynecology and departments of surgery, in addition to the directors of central supply operations for ambulatory surgical centers. In a letter from David Feigal, MD, director of the Centers for Devices and Radiological Health, these administrators were encouraged to identify all distributors of these products, and on its web site the agency has supplied a list of those distributors it has identified, plus a list of the products being recalled. It also said it is encouraging the distributors to alert its costumers concerning the listed products.
In still another recall effort, this one in the pharmaceuticals sector, Bayer Corp. (Pittsburgh, Pennsylvania) reported that it had discovered an apparent tampering of vials of a drug, Gamimune N, Immune Globulin Intravenous, 10%, Solvent/Detergent Treate, used to treat some types of immune deficiencies. The product is distributed nationwide, but Bayer said it had received no reports of any adverse reactions related to the supposed tampering. Bayer said it notified federal authorities and initiated a voluntary recall of two lots containing these vials — lot 648X078, recalled Feb. 1, and lot 648X062, recalled March 14.
In a statement, however, it said, "use of the adulterated product poses a serious health risk to the patient." The company said that an analysis of the recalled vial indicates that after the product left the company's control, the overseals "of a small portion of the returned product" were tampered with. It said that the returned vials "have unexpectedly low protein concentration, an elevated chloride level, and the presence of bacteria."
Aragon says Sunrise technology 'won't die'
Sunrise Technologies International (Fremont, California), a refractive surgery company that last month announced it had laid off nearly all of its employees and is in a search for new financing, said it has adopted an out-of-court restructuring plan. David Brewer, managing partner of Aragon Ventures, said, "Aragon previously invested $10 million into Sunrise and I personally guaranteed the company's bank loan. We were great believers in the technology then, and we are great believers in the technology now. We are not going to let this important, valuable technology die."
Sunrise Technologies has developed holmium YAG laser-based systems that use a patented process for shrinking collagen developed by Dr. Bruce Sand for correcting ophthalmic refractive conditions.
Sunrise also reported that John Hendrick resigned as president, CEO and a director of the company, coincident with the layoff of all the remaining employees of the company on March 8. Anesti Management, an affiliate of Aragon Ventures, will run the company on an interim basis.