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"Every Load Monitoring" gains acceptance in the fight against infection.

In the past, a popular belief was that the safest place in the world to be when you were sick was in the hospital.

Today, this belief is being challenged by a multitude of sources. Disturbing stories of patients contracting deadly infections during hospital stays increasingly fill our newspapers, magazines, television reports and various online resources. According to the Association of peri-Operative Registered Nurses (AORN) Position Statement on Patient Safety, the surgical setting is one of the most potentially hazardous environments for patients. Infection, hemorrhage, and wrong patient/surgery/site are some of the most serious likely complications.1

Statistics from the Centers for Disease Control and Prevention (CDC) show that an estimated 1.7 million Healthcare-Associated Infections (HAIs) occurred in 2002 and were associated with approximately 99,000 deaths.2 According to some sources, approximately one in ten hospitalized patients will acquire an infection after admission. The CDC also estimates the annual cost of dealing with these infections to be 6.7 billion dollars, further contributing to the rising costs of healthcare within the United States.3

The costs associated with HAIs can be a crushing burden on hospital budgets. Effective October 2008, the Centers for Medicare and Medicaid Services will no longer  reimburse healthcare facilities for costs related to certain HAIs that could reasonably have been prevented through  the use of evidence-based guidelines.

Taking sterilization assurance to the highest level

Working to ensure the highest possible level of sterilization assurance for instruments, implantable devices and other surgical supplies that come in contact with patients' bodies is one of the best ways Sterile Processing Departments can do their parts to contribute toward reducing HAIs. The question is, what's the best way to ensure that each and every load you send to the operating room has been effectively sterilized?

It is generally accepted that biological indicators (BIs) offer today's surest and most realistic measurement of sterilization cycle lethality. In fact, according to ANSI/AAMI ST79:2006 ( biological indicators are the only sterilization process monitoring devices that provide a direct measure of the lethality of the process.

Current AAMI guidelines call for the use of BIs under certain situations: to monitor all loads containing implants; for routine sterilizer efficacy monitoring; sterilizer qualification testing; and periodic product quality assurance testing.4 Today, however, numerous SPD managers across the country are investigating the benefits of using a BI in every load – both as a means of improving patient safety, and to reduce the cost and disruption of potential recalls.

"We monitor every load with a BI to achieve the same standard of accountability for all instrumentation, not just implantables," says Diane Gantt, a former Consultant at the Detroit (Michigan) Medical Center. "Our primary goal in doing this is to achieve better patient outcomes.

Our second goal is to avoid disruption to physicians, patients and staff in the event of a recall." Diane explains that, with Every Load Monitoring, you usually only have  to go back one load to get to the last negative reading.  "If you used a BI just once a day, you might have to recall 10 or 20 loads."

Another reason more SPDs are turning to Every Load Monitoring with BIs is to reduce the chance of human oversight. "When every load gets a biological indicator, it serves to standardize the process and eliminates any second guessing about whether an implant load was monitored or not. It's one less thing the SPD has to consider or be concerned about. It takes standard practice to best practice, and aggressively pursues the highest standard of care for every patient. At the same time, it makes staff training on the process that much easier," states Martha Young, Senior Technical Service Specialist, 3M Sterilization Products.

Some SPDs have been reluctant to upgrade to every-load monitoring with BIs because of the increased cost. And yet, compared to the potential cost and disruption of multiple-load recalls the cost is often insignificant.

What's the real cost?

Consider the breadth and depth of a possible recall:

  1. Recall, re-pack and re-sterilize all items back to the last  negative biological indicator
  2. Possible delays and rescheduling of surgeries
  3. Informing surgeons who may have already used a pack item
  4. Numerous reporting and investigating actions across the facility involving Biomedical Engineering, Infection Control and Risk Management
  5. After major repairs are completed, qualification testing per AAMI and department policies
  6. Concerns over potential litigation should the patient contract an HAI

These were some of the considerations behind the move to monitor every load with BIs at Banner Health of Phoenix, Arizona. Al Cox, Manager, Sterile Processing at Banner, recalls that budget issues never even came up when he explained his decision to his Infection Control Committee.

"The Committee was very supportive; not one person challenged the new protocol, even from a budget standpoint." Al goes on to explain that this facility uses a  lot of loaner trays for many different surgeries; previously, if these loaners were not part of the first load of the day, they would not be monitored with a BI. "The Committee was very positive about knowing that loaner trays are all monitored with BIs, eliminating loaner instrumentation as the source in the event of deep wound or joint point infections."

Diane Gantt reports much the same reaction from the Infection Control Committee at Detroit Medical Center. "We told them it would cost more money to monitor every load with BIs, but that the benefits far outweighed the cost. We were completely supported. We talked about having the same standard of care for every site, and the advantage of only one load to pull, in the event of a recall, instead of an entire day's worth of work. The Committee indicated that they heartily approved of the same standard of care for all processing."

According to the CDC, healthcare associated infections are now the sixth leading cause of death in the U.S., killing almost twice as many people as breast cancer and HIV/ AIDS combined.5 With this in mind, it becomes the healthcare professional's responsibility to utilize the best practices and technology at their disposal, in order to safeguard the patients in their care. Monitoring every load with BIs gives those who are charged with ensuring the sterility of medical instruments and devices one more way to make an important contribution to that fight – and help preserve hospitals' reputations as places of healing.

For more information about Every Load Monitoring, please visit or call the 3M Health Care Customer Helpline at 1-800-228-3957.

1. Association of periOperative Registered Nurses (AORN), "AORN Position Statement, Statement on Patient Safety," PracticeResources/AORNPositionStatements/Position_PatientSafety
2. Centers for Disease Control and Prevention (CDC), "Estimates of Healthcare-Associated Infections,"
3. Graves N., "Economics and Preventing Hospital-Acquired Infection," Emerg Infect Dis [serial online], April 2004. Available from:
4. ANSI/AAMI ST79: 2006 Sections 10.5.3–10.7.2
5. Binder, Leah (The Leapfrog Group), "Infections Caused by Health Care," transcript of congressional testimony to the House Oversight and Government Reform Committee (April 16, 2008)

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