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The Perils of Improper Sterilization in Sterile Processing


Healthcare-associated infections (HAIs) remain a significant concern in healthcare facilities, often linked to lapses in sterile processing protocols. One notable case involved the use of improperly sterilized arthroscopic shavers, leading to severe infections in patients. This incident highlights the critical need for stringent sterilization processes and thorough training for sterile processing department (SPD) personnel.

The Case of Contaminated Arthroscopic Shavers

In 2009, a Texas hospital faced a severe outbreak of bacterial infections among post-operative patients, traced back to dirty arthroscopic shavers. These instruments were found to retain tissue and bacteria even after supposed sterilization, leading to infections and severe complications in patients who underwent surgery with these tools. The investigation revealed that the cleaning and sterilization protocols were insufficient, failing to adequately remove biological material from the complex internal structures of the shavers.



Seven organ/space surgical site infections (SSIs) that occurred after arthroscopic procedures and were due to Pseudomonas aeruginosa of indistinguishable pulsed-field gel electrophoresis (PFGE) patterns occurred at hospital X in Texas from April 22, 2009, through May 7, 2009.


To determine the source of the outbreak and prevent future infections.


Infection control observations and a case-control study.


Laboratory records were reviewed for case finding. A case-control study was conducted. A case patient was defined as someone who underwent knee or shoulder arthroscopy at hospital X during the outbreak period and subsequently developed organ/space SSI due toP. aeruginosa. Cultures of environmental and surgical equipment samples were performed, and selected isolates were analyzed by PFGE. Surgical instrument reprocessing practices were reviewed, and surgical instrument lumens were inspected with a borescope after reprocessing to assess cleanliness.


The case-control study did not identify any significant patient-related or operator-related risk factors. P. aeruginosa grew from 62 of 388 environmental samples. An isolate from the gross decontamination sink had a PFGE pattern that was indistinguishable from that of the case patient isolates. All surgical instrument cultures showed no growth. Endoscopic evaluation of reprocessed arthroscopic equipment revealed retained tissue in the lumen of both the inflow/outflow cannulae and arthroscopic shaver handpiece. No additional cases occurred after changes in instrument reprocessing protocols were implemented. After this outbreak, the US Food and Drug Administration released a safety alert about the concern regarding retained tissue within arthroscopic shavers.


These SSIs were likely related to surgical instrument contamination with P. aeruginosa during instrument reprocessing. Retained tissue in inflow/outflow cannulae and shaver handpieces could have allowed bacteria to survive sterilization procedures.


The Case of Contaminated Arthroscopic Shavers

Legal and Health Implications

News: An appeals court affirmed a $3.5 million verdict in favor of a patient whose left eye was removed following an infection caused by improper sterilization of surgical tools. The patient alleged that the surgical staff failed to follow proper sterilization procedures, introducing two species of bacteria to her eye. A jury found in favor of the patient and her husband and awarded $2.7 million to the patient and $470,000 to the patient’s husband.

The hospital sought a new trial after the verdict, but the court found that the patient’s expert sufficiently supported the finding of negligence. An appellate court affirmed the verdict and finding.

Background: A patient was diagnosed with a macular hole in her left eye, which caused her to suffer some vision impairment. In 2011, she underwent surgery to repair the eye; however, her eyesight worsened. The day after surgery, the patient could see only light with her left eye, although previously she could distinguish shapes and see clearly enough to count fingers. Testing revealed elevated blood pressure and a collection of white cells, referred to as hypopyon, in her eye. These white cells indicated that the patient was suffering from endophthalmitis. Although an antibiotic injection was administered directly into the woman’s eye, her condition continued to worsen. As the infection progressed, the patient’s eye sustained significant damage and was removed.

The patient and her husband sued the hospital, alleging that the hospital failed to adhere to proper sterilization procedures led to the patient’s eye infection. During trial, the patient’s expert witness testified as to the type of organisms that caused the infection, explaining that they were not “common” and should not be found in an operating room. This expert testimony supported the allegations that the hospital’s staff had not followed procedure and had failed to adequately sterilize all surgical instruments. The patient argued that the sterile technique during the preparation, and use of a bottle of balanced salt solution (BSS), had not been followed adequately. This caused two bacteria species, Pseudomonas aeruginosa and Serratia marcescens, to enter the patient’s eye and cause the infection. The hospital contended that it followed the proper procedures and argued that the patient had not shown sufficient evidence linking the physician’s conduct to the patient’s injury. The hospital specifically claimed that there was insufficient evidence and expert testimony pertaining to causation and that the trial court erred by permitting evidence about the bottle of BSS.

A jury found in favor of the patient, awarding $2.7 million to the patient and $470,000 to the patient’s husband. The defendant hospital challenged the jury’s finding by bringing two different legal procedures: a motion for judgment as a matter of law and a motion for a new trial. The trial court denied both and found that the patient’s expert sufficiently supported the finding of negligence. The defendant hospital appealed the verdict and trial court’s decisions. In its ruling, the appellate court explained that the expert’s testimony was sufficient. The expert stated that it was his opinion, to a reasonable medical certainty, that the bacteria must have been introduced due to a breach of the surgical procedure because such bacteria do not live in eye drops or makeup and because the rate at which the infection progressed suggested that the bacteria had been introduced directly into the patient’s eye during surgery. The appellate court did not find that the trial court abused its discretion or that its rulings were based on an erroneous legal standard. (Relias Media)​​ (RN.com)

Contributing Factors

Several factors contribute to the recurring issues in sterile processing:

  1. Inadequate Training: Many SPD technicians receive minimal training, leading to errors in instrument cleaning and sterilization. Establishing mandatory certification and ongoing education programs could significantly improve compliance with sterilization standards​ (RN.com)​.
  2. Complex Instrumentation: Modern surgical tools are often complex and difficult to clean. Inadequate decontamination of these instruments can leave behind biological material that poses a risk of infection. Developing more effective cleaning protocols and using advanced sterilization technologies can help address these challenges​ (Relias Media)​.
  3. Resource Limitations: Budget constraints often lead to understaffing and outdated equipment in SPDs. Investing in modern sterilization equipment and adequate staffing is essential for maintaining high standards of cleanliness and safety​ (RN.com)​.

Proposed Remedies

To mitigate the risks associated with improper sterilization, healthcare facilities can implement several measures:

  1. Enhanced Training and Certification: Establishing mandatory certification for SPD technicians through organizations like the Certification Board for Sterile Processing and Distribution (CBSPD) or the International Association of Healthcare Central Service Material Management (IAHCSMM) ensures that personnel are adequately trained and knowledgeable about the latest sterilization techniques​ (RN.com)​.
  2. Investment in Advanced Technologies: Upgrading to more advanced sterilization technologies, such as automated cleaning systems and real-time monitoring tools, can enhance the effectiveness of sterilization processes and reduce human error​ (Relias Media)​.
  3. Regular Audits and Quality Assurance: Implementing robust quality assurance programs that include regular audits and inspections can help identify and address gaps in sterilization protocols before they lead to patient harm​ (Relias Media)​.
  4. Interdepartmental Collaboration: Encouraging collaboration between OR staff and SPD personnel can improve the handling and decontamination of surgical instruments, ensuring that all parties are aligned in maintaining high standards of patient care​ (RN.com)​.


The persistent issue of HAIs linked to improper sterilization underscores the need for systemic improvements in SPD practices. By investing in training, advanced technologies, and rigorous quality assurance programs, healthcare facilities can enhance patient safety and reduce the incidence of infections related to dirty surgical instruments.


May 22, 2024

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