Are you using sterile equipment on your patients? How can you be sure?

2 recent events raise questions about infections

Two bronchoscopy patients die of pneumonia after a scope, which was later recalled, was used on them at The Johns Hopkins Hospital in Baltimore. Johns Hopkins alerted 415 patients that they might have received a life-threatening lung infection from the devices. At press time, fewer than 10 of those patients have tested positive for the pseudomonas bacteria. Hospital officials say the device may be at fault. Pseudomonas bacteria can cause pneumonia in patients already suffering from critical illnesses.

The recall notice was mailed to a loading dock across the street from the department using the bronchoscope, and it took at least a month to reach the physicians. No one knows how many of the recalled scopes are being used every day because many hospitals are unaware of the potential danger for infection from the recalled bronchoscope.

Recalled Models and Modified Serial Numbers
Recalled models: BF-40, BF-P40, BF-IT40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160.

Beginning with and including the serial number listed next to each bronchoscope model, all of these scopes with higher serial numbers already have been modified with the corrective action and do not need to be returned: 
BF-P40, 1132479; BF-1T40, 1121288; BF-3C40, 1110611; BF-XP40, 1100458; BF-XT40, 1120321; BF-40, 1130472; BF-P160, 1100535; BF-XT160, 1100084; BF-160, 1111266; BF-3C160, 1100149; BF-1T160, 1110960; BF-P240, 1141022; BF-1T240, 1130880; BF-240, 1140791; and BF-6C240, 1110201.
Source: Olympus America, Melville, NY.

In early March, officials with Melville, NY-based Olympus America, which manufactured the bronchoscope, said that fewer than 40% of the recalled scopes had been sent back to the company for inspection and repair. The company sent second notices to institutions that did not answer the first notice. Is your facility one of them?

Before the recall was discovered, Johns Hopkins had recognized the rise in infection rates and determined that the bronchoscope was the probable cause. Would your facility recognize such an increase and be able to determine why? To answer these questions, Same-Day Surgery analyzes what happened and offers suggestions from experts in the field. Here’s a summary:

On Nov. 30, 2001, Olympus America recalled 15 models of bronchoscopes because a loose port was trapping bacteria in a spot that was not reached during the usual disinfecting process. Although the Johns Hopkins physicians didn’t immediately receive the recall notice, they noticed a two- to threefold increase in the number of patients with pseudomonas in December. By early February, they determined the devices were the probable cause. Johns Hopkins officials mailed certified letters in which they asked patients to call their doctors if they experienced symptoms such as fever, coughing, phlegm, or shortness of breath. (Editor’s note: To see the letter, go to www.hopkinsmedicine.org/press/2002/MARCH/patientletter.htm.) Physicians also called all of their bronchoscopy patients since June 1, 2001, a month before the period when the infection rate increased. They cancelled all elective bronchoscopies for about two weeks, and the defective scopes were removed. Designated telephone lines were set up so that the patients could arrange for free appointments to be evaluated or to obtain more information.

Johns Hopkins physicians say that even though patients may have been exposed to the bacteria during the procedures, not all will become infected. Also, because some of these patients have illnesses such as cystic fibrosis, HIV/AIDS, lung transplants, and cancer, some probably carried the bacteria before they came to the facility for bronchoscopies.

John Hopkins’ press releases indicated that they believe the cause of the infection problem may be related to the loose port, says Wally Pellerite, assistant to the director of the Food and Drug Administration’s (FDA’s) Office of Compliance in Rockville, MD. "But there is not direct evidence to establish that, as far as information we have," he says. "There’s an ongoing investigation, and more work needs to be done."

Pellerite says he isn’t aware of other hospitals that have reported "spikes" in infection rates that may be related to the recalled bronchoscope or any other reason. "I have a lot of people, such as risk managers, contacting me about whether they should be contacting patients who have had infections," he says. "The bottom line is that hospitals need to assess their own problems and make independent determinations."

Shortly after the Olympus America recall was announced, the FDA released an alert saying A&A of Alpharetta, GA, may have shipped unsterilized obstetrics and gynecological medical devices and labeled them as sterile or ethylene oxide processed. Some of the products may not have undergone any sterilization, which raises the threat of infection, infertility, and miscarriage. The problem potentially affects products shipped since 1999.

List of Known A&A Medical OB/GYN & Surgical Devices*
• Curette (flexible and rigid, all sizes)
• Collection set tubing
• Aspiration sets
• Laminaria
• IUD removal instruments
• Mucus samplers
• Biopsy pipettes/endometrial sampling sets
• Uterine sounds
• Pratt dilator set
• Ovum forceps
• Tenaculum forceps
• Needle extenders and guide
• Fetal bladder drain
• Fetal blood sampler
• Harvesting pump and accessories
• Loop/ball electrodes
• Laparoscopy accessories

* This is a partial list; as known at the time of the alert.
Source: Food and Drug Administration’s Center for Devices and Radiological Health, Rockville, MD.

Former company employees said that sterile and nonsterile devices had been shipped in the same batches. Agency inspectors who visited the company facilities found evidence that supported those allegations, an FDA official says. The FDA has urged the company to recall these products. A list of distributors and the products they receive from A&A Medical is being placed on FDA’s web site at www.fda.gov/cdrh/recalls/recall31402.html. The firm also does business under the name A&A Medical/Rocket USA and LifeQuest.

If you are using these products, immediately discontinue such use, the FDA advises. For more information, you can contact the FDA Center for Devices and Radiological Health at (800) 638-2041.

To avoid using medical equipment that may be nonsterile or recalled, consider these suggestions:

Make sure your infection control processes are in order. Use infection control teams to monitor rates of diseases in your facilities, suggests Daniel B. Jernigan, MD, medical epidemiologist at the Centers for Disease Control and Prevention (CDC) in Atlanta. For hospitals, this team would include a hospital epidemiologist and infection control professionals. Having such a team and monitoring infections may be challenging for freestanding surgery centers, he acknowledges.

"Many may not have the resources or staff to have an involved infection control process," he says. However, all outpatient surgery providers can follow the guidelines outlined in the documents from the Healthcare Infection Control Practices Advisory Committee (HICPAC). These documents are available on the CDC web site (www.cdc.gov) by searching for "HICPAC."

When questions are raised concerning infection related to the use of any device, undertake an investigation, advises William Schaffner, MD, the chairman of preventive medicine and chairman of the Infection Control Committee at Vanderbilt University Medical Center in Nashville, TN. "In my experience, to be quite frank, ambulatory surgery centers and the like do not have the expertise to do these type of investigations," Schaffner says. "They don’t have the background, the training, the resources, etc." What’s the answer? Contact infection control professionals, or call the local health department, he suggests.

Also, many surgery centers survey surgeons to ask about postoperative infections, so increases may show up in those surveys, sources say.

Use recall notification services. Recall notification services are available through ECRI and the FDA. Recall notices from manufacturer are not always correct, says Eric Sacks, Internet services manager at ECRI, a nonprofit health care technology research organization in Plymouth Meeting, PA. Sacks points to the original recall notice from Olympus America, which didn’t specify which models and serial numbers were affected. (For information on subscribing to the ECRI or FDA recall notification service, see the resources listed at the end of this article.)

Clarify interfacility communication over recalls. Events such as one at Johns Hopkins where the recall notice went to the wrong area should be a "wake-up call" for surgery providers, experts say. "Large institutions, my own included, are often decentralized," Schaffner says. "If a recall of this type is received by [staff] within large institutions, they probably shouldn’t deal with that just locally, within their own shop. They need to bring it to the attention of the infection control program."

Clearly communicate who within your facility should receive recall notices, Sacks advises. This person could be the risk manager or the patient safety officer, he says. "The fact that manufacturers send recall notices to the wrong location or nonexistent personnel will persist," Sacks says. Manufacturers frequently don’t know who to send recall notifications to, so they’ll send them to a standard list of titles, such as chief executive officer or risk manager, or they’ll send them to the department that ordered the device, such as the purchasing department.

You should have procedures to ensure all the appropriate people have been informed, Pellerite advises. The notice can be stamped or initialed, he says.

Jernigan adds, "The take-home message is that institutions should have guidance for staff on which scopes are used for which particular procedure, who is responsible for marking sure repairs are made, and any information sent to facility is centralized to be sure not to miss anything."

Sources and resources

For more information, contact:

David L. Lewis, PhD, Research Microbiologist, Environmental Protection Agency’s National Exposure Research Laboratory, Athens, GA. E-mail: lewisdavel@aol.com.

Wally Pellerite, Assistant to the Director of the Office of Compliance, Food and Drug Administration, 2098 Gaither Road, Rockville, MD 20850. Telephone: (301) 594-4692, ext. 159. Fax: (301) 594-4610. E-mail: wap@cdrh.fda.gov.

Eric Sacks, Internet Services Manager, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000, ext. 5317. Fax: (610) 834-1275. E-mail: esacks@ecri.org.

For more information on A&A, contact: Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, Rockville, MD. Telephone: (800) 638-2041. Additional information also can be found on the FDA’s MedWatch web site at www.fda.gov/bbs/topics/NEWS/2002/NEW00799.html.

For additional information on the Olympus America recall, you can access the firm’s web site at: www.olympusamerica.com/innards/h_endoscopy.asp?s=11&p=15. Or contact: Laura Storms-Tyler, Director, Regulatory Affairs and Quality Assurance, Olympus America, Two Corporate Center Drive, Melville, NY 11747-3157. Telephone: (631) 844-5688.

Health Devices Alerts is a database of medical equipment-related problems, hazards, and recalls. The print version of Health Devices Alerts includes Action Items, which is published every Friday. Action Items contains reports of ongoing medical device problems, hazards, and recalls that have been verified by ECRI and has specific recommendations for quick follow-up action to prevent harm. A subscription includes Hazard Bulletins when there are urgent reports of life-threatening or injury-causing incidents. The cost is $3,045 per year. For ordering information, contact: ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000, ext. 5547. Fax: (610) 834-1275. E-mail: info@ecri.org.

• FDA medical device postmarket safety notifications can be found at www.fda.gov/cdrh/safety.html. Postmarket safety notifications also can be obtained through e-mail on the day they are released by subscribing to a list server. You may subscribe at list.nih.gov/archives/dev-alert.html.

The FDA Enforcement Report is published weekly and contains information on actions such as recalls, medical device notification, and safety alerts. Web: www.fda.gov/opacom/Enforce.html.

• With the FDA’s e-mail lists, MedWatch, you can receive immediate notification of safety alerts on drugs, medical devices, and dietary supplements regulated by the FDA. Subscribe at www.fda.gov/medwatch/index.html. To receive immediate e-mail notification of new material on the MedWatch web site, send an e-mail to medwatch@listmanager.fda.gov. Enter subscribe in the subject field. You may leave the body of the message blank. To remove your name from the list, send an e-mail to the above address and enter "unsubscribe" in the subject field.