EXECUTIVE SUMMARY

Patients have sued a Colorado hospital over infections that occurred after surgery. The lawsuit follows public notification of an earlier infection breach in surgical instrument sterilization and cleaning.

  • It is unknown whether the infections were directly related to the surgery or infection breach.
  • Typically, infection breaches in ambulatory surgery centers (ASCs) are related to the facility’s culture of safety.
  • ASCs must prioritize infection prevention from leadership on down.

As a recent lawsuit shows, any infection breach can be risky to patient health and amplify the appearance of infection control problems.

More than 65 patients and spouses recently sued Porter Adventist Hospital in Denver over infections, including sepsis that developed after hip and knee surgeries. It is unknown whether these infection cases are connected to the hospital’s earlier infection breach in surgical instrument sterilization and cleaning.

When patients hear about an infection breach at any surgery center, they will believe the surgery center’s practices were the cause, even when there is no evidence of a direct connection. “The problems patients developed may or may not be related to that sterilization failure,” says Emily K. Shuman, MD, assistant professor of internal medicine, division of infectious diseases, at the University of Michigan. “A certain percentage of patients will get an infection anyway, and it’s not always related to sterilization of instruments. There are many other factors involved in developing infection after surgery.”

In general, ambulatory surgery centers (ASCs) report low infection rates, she notes. “There are a few reasons for that,” Shuman says. “Generally, we’re doing more minor surgical procedures, shorter surgeries, and a little selection bias because patients eligible for surgeries in those settings are healthier.”

But as lawsuits over infections in surgery centers demonstrate, any breach or failure in infection control can sow doubt among patients. “People will point to that failure and say that is what caused Grandma to get sick, and it may not be, but it’s hard to prove that,” Shuman explains. “It puts negative attention on this facility, and it’s hard to overcome that.”

In 2018, Porter Adventist Hospital sent orthopedic and spine surgery patients a letter notifying them of an infection control breach involving surgical instruments. The letter said there was an extremely low risk of surgical site infections. The Colorado Department of Public Health and Environment (CDPHE) investigated the situation. The 2019 lawsuit is connected to the 2018 announcement of an infection breach.

“We acknowledge the concern of these patients and are aware of existing lawsuits stemming from a review by CDPHE of the precleaning process of surgical instruments prior to sterilization, which was identified in February 2018,” Joel R. Malecka, communications advisor with Porter Adventist Hospital, said in an email sent to Same-Day Surgery. “To protect the privacy of all involved, we will be addressing this matter through the legal process, which is underway. As an outcome of the CDPHE investigation, we continue to provide reports to CDPHE that confirm Porter Adventist Hospital continues to meet the sterilization process guidelines of CDPHE.”

Some research shows that operating rooms across the world continue to experience outbreaks of infectious agents. The infections are associated with inadequate instrument reprocessing and sterilization.1

“Stainless steel instruments are reused until their functionality is lost,” says Karen Vickery, BVSc, MVSc, PhD, MASM, on the faculty of medicine and health sciences, Macquarie University in Sydney, Australia. “Some instruments can be reused for years and years. The dried-on patient secretions and biofilms have ample opportunity to grow in size. There is also ample opportunity for incorrect processing due to human error.”

Vickery’s research has shown that biofilm of Staphylococcus aureus can survive autoclaving, and these can be found on instruments.2 On the rare occasions when infection breaches occur in surgery centers, they probably are related to deficits in the organization’s culture of safety, suggests Michael Brenner, MD, FACS, associate professor, department of otolaryngology-head and neck surgery at the University of Michigan. When surgical center infection breaches occur, it highlights the imperative for professional societies to maintain readily accessible guidelines and best practices, Brenner says.

Brenner co-authored a paper on reprocessing standards for medical devices and equipment. The authors reviewed guidance on disinfection and sterilization of equipment used in otolaryngology.3 They found that modern disinfection and sterilization standards have evolved from Earle Spaulding’s 1957 classification system and that the preferred sterilization processes include high-pressure steam. The FDA is the chief regulator of reprocessing standards. The authors advised otolaryngologists to adhere to approved practices for endoscopes and other reusable devices and to follow a rigorous, FDA-approved procedure when recycling single-use devices.

Reprocessing has been recognized by federal regulators since 2000, and regulatory oversight has greatly increased since then.4 “There is a moral imperative for individuals and healthcare systems and providers to establish a culture of safety that involves every person in patient care,” Brenner says.

Sometimes, surgery center staff lack knowledge or the skills needed to adhere to infection prevention standards; sometimes, they flagrantly disregard the rules, Brenner says. “Often, the key element is having an environment conducive to safe practices.”

There are two ways surgery centers can improve infection prevention in the operating room:

Focus on a culture of safety. An ASC that demonstrates safety and infection prevention from the top down will succeed. “It runs from the leadership down, but it’s also grassroots up,” Brenner says. “Make it a place where everyone agrees the patient is at the center of everything you do so no one would ever think it’s reasonable to bypass some critical step in sterilization of instruments.”

An ASC’s culture of safety will include appropriate checks and double-checks to ensure all procedures are followed appropriately, he adds. Reprocessing staff who are underpaid and never interact with patients might not be as invested in a culture of safety as is necessary, Brenner says. “Engagement is very important.”

This culture also requires organizations to reprocess tools and sterilize instruments according to manufacturer’s instructions for use and state and federal laws. “An organization’s culture is very important because when that starts to slide, you will see the practices start sliding,” Shuman says. “The idea is causing zero harm and emphasizing that these little things we do every day are so important in terms of outcomes for our patients. That comes from the top down.”

If those leading an organization are not modeling that zero-harm behavior and culture, then employees will not carry out their jobs with safety as a priority. “There needs to be an expectation at the highest level that the primary emphasis is on the patient, we’re doing all we can for this patient, and we have to get it right every single time,” Shuman adds.

Use only well-trained reprocessing. “Reprocessing is one of the most important jobs in any surgery center,” says Kerri Ubaldi, RN, MBA, CPHRM, vice president of operations, Merritt Healthcare in Ridgefield, CT. “If you don’t have someone who pays meticulous attention to details in how they reprocess your instruments, it can absolutely lead to infections.”

ASCs should ensure reprocessing employees are well trained. Employees should be tested on competencies frequently and observed regularly to ensure they are reprocessing equipment properly, Ubaldi adds.

When ASCs plan to reprocess single-use items that are approved for reprocessing, they probably should not carry out that reprocessing task in their own facility, says David Chang, MD, FACS, associate professor of otolaryngology-head and neck surgery at the University of Missouri. Chang also is the co-chair of the patient safety quality improvement committee of The American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS), which advises surgery centers to not put single-use items through their own cleansers.

“You are not an approved reprocessor, and you haven’t had reprocessing methods sanctioned by the FDA, so those items should go to an official reprocessor,” Chang says.

Some surgical tool manufacturers have begun to offer reprocessing services. “There are very strict standards on the process that companies have to use to reprocess items,” Ubaldi says. “Over the years, the standards for reprocessing have been very high, and instrument reprocessing is such a huge learning curve.”

REFERENCES

  1. Lopes LKO, Costa DM, Tipple AFV, et al. Complex design of surgical instruments as barrier for cleaning effectiveness, favouring biofilm formation. J Hosp Infect 2018; Nov 10. pii: S0195-6701(18)30587-5. doi: 10.1016/j.jhin.2018.11.001. [Epub ahead of print].
  2. Costa DM, Lopes LKO, Tipple AFV, et al. Evaluation of stainless steel surgical instruments subjected to multiple use/processing. Infect Dis Health 2018;23:3-9.
  3. Chang CWD, Brenner MJ, Shuman EK, Kokoska MS. Reprocessing standards for medical devices and equipment in otolaryngology. Otolaryngol Clin North Am 2019;52:173-183.
  4. Ubaldi K. Reprocessing single-use devices in the ambulatory surgery environment. AORN J 2019;109:452-462.