Incidents raise a red flag on risks from improper sterilization

An employee at the St. Louis VA Medical Center identified spots on surgical trays prior to surgeries on Feb. 2, 2011. No single source was identified for the reason trays were pitted with metallic corrosion after completing wash cycles. Surgeries were suspended until thousands of replacement instruments were brought in. On March 8, the VA awarded a $6.8 million contract for the modernization and expansion of the Sterile Processing Department (SPD).

At Lawrence Hospital Center in Bronxville, NY, staff determined earlier this year that nine surgical trays did not go through the complete sterilization cycle. Lawrence officials voluntarily notified the state department of health. An internal investigation identified 10 patients who might have been exposed to the trays. Nurses contacted the patients by telephone and letter, and the hospital offered to test them free of charge. The hospital proactively established a hotline to answer questions from the general public. After its review, hospital officials independently decided to reinforce patient safety protocols with additional staff training.

"Recently incidents in the news involving inadequately sterilized instruments have created concern on the part of patients and healthcare workers alike," says Sue Barnes, RN, CIC, national leader of infection prevention and control, Quality and Safety Department, Program Office, at Kaiser Permanente in Oakland, CA, and a board member for the Association for Professionals in Infection Control and Epidemiology (APIC).

Barnes says there is good news, however: Due to transparency, the errors were shared. "This sharing is critical in improving healthcare systems to continue making them safer," she says. "In the recent reported events, no patient infections or injury was reported, and it appears that redundancy and other human factors engineering strategies built into the systems resulted in prompt identification and remediation of the problems."

Such problems have gotten the attention of state officials, legislators, and others. Illinois is preparing to roll out an adverse event reporting requirement for hospitals and ambulatory surgery centers (ASCs). The state is setting up a reporting system for serious reportable events ("never events"), as defined by the National Quality Forum, according to a staff person at the Illinois Department of Public Health in Chicago who asked not to be identified. One of the never events is "patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility."

In the wake of possible hepatitis outbreaks at two New York medical facilities, State Assemblyman Ken Zebrowski of New York City recently introduced Bill A05576 to create "the crime of reckless infection of a patient with a communicable disease by a health care provider." One of the New York incidents involved improper sterile processing of surgical tools. According to a statement on his web site, the subject is personal for Zebrowski because his late father (former Assemblyman Kenneth Peter Zebrowski) contracted HCV from blood transfused during a brain operation.

In particular, the bill targets the reuse of a syringes and needles, but specifies that it is "not limited to" that breach in basic infection control. The bill requires the state department of health to notify patients who have been potentially infected and allows the state medical board to revoke licenses, according to Chris Bresnan, Zebrowski's chief of staff. It also amends the statute of limitations so that it begins when the patient finds out, not when the infection occurred, Bresnan says.

Barnes says, "The focus being applied to infection prevention by media, legislators, and consumers is proving to be extremely helpful in increasing the recognition of complex expert work done by sterile processing departments and raising the bar for all physicians and healthcare workers in preventing infection."

Complete these steps

What should your outpatient surgery program be doing in terms of sterilizing surgical trays?

"Surgical instrument reprocessing from point of use collection — where spray enzymatic foam is applied to prevent drying of body fluids on instruments and spillage of the detergent in the halls — through decontamination, wrapping, sterilization, and storage involves both automated processes and manual processes," Barnes says.

The goal? Zero sterilization failures, she says, "and more importantly, zero patient exposures to contaminated instruments."

Human factors can lead to errors, however, Barnes points out. For that reason, "redundancy and other safety mechanisms are built into the system," she says. "Sterilization procedures are monitored through a combination of mechanical, chemical, and biological techniques designed to evaluate the sterilizing conditions and the procedure's effectiveness." Consider these suggestions from Barnes and others:

• For items in storage, apply a "first in, first out" process. Always check expiration dates.

• Before opening the OR, check the basic integrity of the sterile wrapped tray (including water marks and tears or holds in the sterile wrap, the integrity of the instruments (no rust or pitting), and the appropriate change of indicators/integrators.

"These are all examples of human factors engineering strategies that are designed to make the complex task of sterilization safer for patients and employees alike," Barnes says.

• Machine design (washers and sterilizers) can provide an alert when there are technical failures and, in some cases, reduce the need for manual calculations.

• After decontamination and before wrapping, staff should make visual inspections and use checklists. "This inspection includes functionality, cleanliness, and integrity of instrument surface, ensuring there is no pitting or rust," Barnes says. "Checklists can reduce reliance on memory and often can simplify tasks." [See checklist from APIC.] A diagram or picture of what the tray should look like can help avoid problems with missing instruments or parts from a tray.

• Quality tests can be applied such as a test designed to monitor the cleaning function of an automated instrument washer.

At the Griffin Road campus of Lakeland (FL) Surgical & Diagnostic Center (LSDC), validation testing is done on all equipment including performing tray validation testing, an ultrasonic cleaner check, an evaluation of the automated instrument washers along with daily biological indicator (BI) and a chemical indicator (CI) on every load, says Emily Duncan, RN, CASC, executive director at the Griffin Road campus. "All implants get BI and CI in every load," Duncan says. (For more suggestions from Duncan, see story below.)

Keys to success with sterilization

At the core of surgical infection prevention is sterile surgical instrument reprocessing, says Sue Barnes, RN, CIC, national leader of infection prevention and control, Quality and Safety Department, Program Office, Kaiser Permanente, and a board member for the Association for Professionals in Infection Control and Epidemiology (APIC).

"Consequently, sterile processing department managers and staff are key strategic partners of infection preventionists in working to reduce the risk of surgical infections in hospital and ambulatory surgery centers," Barnes says.

At the Griffin Road campus of Lakeland (FL) Surgical & Diagnostic Center (LSDC), "we try to make sure everyone is properly oriented on every new piece of SPD [Sterile Processing Department] equipment before we put it in operation, which is often very difficult to arrange with our busy OR schedules and shift demands, says Emily Duncan, RN, CASC, executive director at the Griffin Road campus.

The center now requires all techs to be SPD certified from groups such as the International Association of Healthcare Central Service Material Management ( The facility has one person certified by the Certification Board for Sterile Processing and Distribution ( "The facility invests in making sure we attend conferences and financially help us acquire certification and ongoing CEU requirement to support this," Duncan says.

Consider these other suggestions from Duncan:

• Use outside expertise.

Leaders at the Griffin Road campus have used consultants from 3M and SPSmedical Supply Corp. to evaluate the facility's processes and make recommendations for improvement. They also consulted with the Association of periOperative Registered Nurses (AORN) and went by their recommended standards for processing ophthalmic instruments to avoid Toxic Anterior Segment Syndrome (TASS). The facility had one case in 2007.

Also, staff members stay updated on the latest standards from the Association for the Advancement of Medical Instrumentation (AAAMI. Web: and American National Standards Institute (ANSI. Web: as new updates and revisions are introduced.

• Learn from your mistakes.

"We had an issue with our autoclave chamber getting rusted on the inside, and we discovered during a troubleshooting exercise with the service rep that we were using a chamber cleaner that was too corrosive in nature," Duncan says. The facility had been instructed that the cleaner was recommended; however, it didn't work well with their particularly model.

"We have all learned by past costly mistakes, believe me," Duncan says.

• Maintain documentation.

A notebook catalog holds an alphabetical listing of instrument cleaning and disinfection instructions. "We had to work with the autoclave vendor to get multiple settings on our autoclave for the various settings, which are not just the 4 minutes and 30 dry time anymore," Duncan says.

The facility uses recommended or suggested enzymatic and detergent cleaners, per the manufacturers. Cleaning equipment includes printouts that are required to be checked and signed by the processing person and the user, Duncan says.

"I think we probably are not doing anything out of the ordinary except to say we have some very conscientious employees who are stickler for details in performing their SPD duties on a daily basis, and not afraid to bring any issues to the attention of the supervisor for immediate correction," she says.