Keep eye on infections following knee surgery
CDC reports on 5 infections, including 1 death
In the wake of five serious infections, including one Minnesota death, which may be linked to bone and tendon grafts used in knee surgery, the Centers for Disease Control and Prevention (CDC) is urging providers to consider possible clostridial infection in patients with evidence of infection following allograft implantation.
"Hospitals and surgery centers also can give prophylactic intravenous antibiotic therapy to patients as a precaution against infection," says Ellen O’Connor, membership chair of the Ambulatory Surgery Specialty Assembly of the Denver-based Association of periOperative Registered Nurses (AORN).
St. Alexius Same Day Surgery Center in Bis-marck, ND, puts knee surgery patients on prophylactic antibiotics, says Sandy Berreth, RN, director. "If it does grow anything, we are a whole step ahead," Berreth says. "We could catch it right away and prevent any cross-contamination."
O’Connor emphasizes education as well. "Com-plete discharge instructions with signs and symptoms to look for in case of infection are beneficial to the patients and their families," she says.
According to the CDC, symptoms and signs of sepsis include fever, hemodynamic compromise, and/or abdominal pain. However, in some patients, only local symptoms such as knee pain may be present during the early phase of infection, the CDC warns.1 "When septic arthritis occurs after use of an allograft, allograft contamination should be suspected, especially when the infection is polymicrobial or associated with gram-negative organisms," the CDC says.2
The CDC has closed the investigation into two other deaths in Minnesota after total knee replacement surgery because they don’t appear to have any connection to the allograft case. However, the CDC described four patients who acquired post-surgical septic arthritis that was probably associated with contaminated bone-tendon-bone allografts used for anterior cruciate ligament (ACL) reconstruction. These procedures were performed at ambulatory surgery centers in Florida and Louisiana. None of these patients died.
Tissue allografts frequently are used for ACL reconstruction, and septic arthritis is a rare complication of such procedures.2 The allografts used for two patients were supplied by a Texas tissue bank (tissue bank A) and were harvested from a common donor. Both patients’ initial ACL reconstruction procedures were performed on different days by different surgeons using different arthroscopic instruments, but at the same surgical center. The local health department conducted an on-site investigation of the center and found no lapses in infection-control procedures.2
Two other patients received allografts from the same Florida tissue bank (tissue bank B), and the allografts were from a common donor. When tissue bank B conducted a trace-back investigation and reviewed quality-control procedures, the implicated allografts had not received terminal sterilization with gamma irradiation.2
The investigation related to tissue bank A indicated that the allografts were the source of the infection, despite no apparent lapses in tissue processing. Cases related to tissue bank B were linked to allografts from a common donor that were released inadvertently before standard terminal sterilization procedures were conducted.2 The reports appeared in the Dec. 6 Morbidity and Mortality Weekly Report and are on line at www.cdc.gov/mmwr.
One way to avoid problems with infection is to use homografts, Berreth says. Consider these suggestions associated with allografts:
• Perform two sets of blood cultures for aerobes and anaerobes. These cultures should be incubated for seven days, the CDC advises. If appropriate, obtain other specimens (for example, knee aspirate or tissue) and culture them aerobically and anaerobically, the agency says. "If appropriate, health care providers should consider expanding empiric therapy to include anaerobic coverage," it says. Considering consulting with an infectious disease physician, the agency adds.1
• Use an accredited tissue bank. Hospitals and free-standing surgery centers need to be aware of the type of tissue graft banks with which they do business, O’Connor says. The Rockville, MD-based Food and Drug Administration (FDA), the McLean, VA-based American Association of Tissue Banks (AATB) and AORN have strict standards and guidelines for procurement and processing of allograft tissue, she says. "Not all tissue banks are certified by the AATB, nor is there a requirement that they become certified," O’Connor says.
In fact, in a report from the Office of the Inspec-tor General, approximately 44% of tissue banks identified were not accredited by the AATB or inspected by Florida or New York, the two states that require licensing and inspection of tissue banks,3 and this probably represents an underestimate of the tissue banks that are unaccredited or unlicensed.4 "Tissue banks that lack accreditation and licensure are not required to comply with external quality requirements beyond donor screening for HIV and hepatitis," the CDC reports.3
Completely read the literature that comes with the tissue, especially noting any test results performed on the tissue prior to or after processing, she advises. "Be concerned if there are no results of cultures taken during the procurement of the tissue," O’Connor emphasizes.
• Report contaminated allografts. Reporting infections resulting from contaminated allografts is not required; however, clinicians should report infections to the FDA’s MedWatch system (see "Sources and resource" at the end of this article) and through local and state health departments to the CDC’s Division of Healthcare Quality Promotion, National Center for Infectious Diseases.
• Examine your infection control practices. Effective sterilization methods that don’t functionally alter musculoskeletal tissue will prevent allograft-related infections, the CDC says.2 "Adhering to proper aseptic techniques during surgery is also beneficial," O’Connor says.
References
1. Centers for Disease Control and Prevention. MMWR 2001; 50:1,080.
2. Centers for Disease Control and Prevention. MMWR 2001; 50:1,081-1,083.
3. Office of the Inspector General. Oversight of Tissue Banking. Boston: U.S. Department of Health and Human Services; 2001: i-17.
4. Food and Drug Administration. Human cells, tissues, and cellular and tissue-based products: Established registration and listing. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, 2001. Fed Reg 2001; 66:5,447-5,469.
Sources and resource
For more information on post-surgical infection, contact:
• Sandy Berreth, RN, Director, St. Alexius Same Day Surgery Center, P.O. Box 4046, 810 E. Rosser Ave., Bismarck, ND 58502-4046. Telephone: (888) 495-5005 or (701) 530-5049 or -5000. E-mail: [email protected].
• Ellen O’Connor, 728 County Road 219, Scottsboro, AL 35768. E-mail: [email protected].
To report an infection to the MedWatch system, you can download a copy of the form at www.fda.gov/medwatch/safety/3500.pdf. Fax to (800) FDA-0178 or mail it back using the postage-paid addressed form. Telephone: (800) FDA-1088.
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