Related Experiment Video
Updated: Jan 14, 2026

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Published on: August 11, 2017
Breaking the seal: Defects in sterile processing.
Jessica A R Williams1, Soumyadipta Roy1, Joanna Veazey Brooks2
1Health Policy and Administration, The Pennsylvania State University, University Park, PA.
Over 90% of sterile processing departments (SPDs) reported defects weekly. Improving SPD performance requires standardized workflows, tracking systems, and staff certification to enhance patient safety.
Area of Science:
- Healthcare Quality
- Medical Device Reprocessing
- Patient Safety
Background:
- Sterile processing departments (SPDs) are critical for preventing surgical site infections.
- Defect measurement in SPDs is essential for quality improvement.
- National-level data on SPD defects were previously lacking.
Purpose of the Study:
- To provide the first national-level data on defect measurement in sterile processing departments (SPDs).
- To identify factors associated with higher defect rates in SPDs.
Main Methods:
- National survey of sterile processing departments (SPDs).
- Data collection on defect occurrence and quality management practices.
- Statistical analysis to correlate defects with facility characteristics.
Main Results:
- Over 90% of SPDs reported at least one defect in a single week.
- Higher defect rates were observed in facilities with inconsistent quality checklist usage, tracking systems, and lacking staff certification.
- Significant variation in defect rates across different facilities.
Conclusions:
- Systemic interventions are needed to improve sterile processing department (SPD) performance.
- Workflow standardization, integrated tracking systems, and uniform staff certification are recommended.
- Addressing identified factors can enhance patient safety through improved SPD practices.
Related Concept Videos
Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
Standard Precaution
Hand hygiene is the most crucial means to prevent the transmission of disease. Employers are legally required to provide their workers with personal protective equipment (PPE) to minimize exposure or contact with...
Asepsis
Key Techniques in Microbiology
Healthcare Associated Infections II: Preventive Measures
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...
Methods of Sterilization II: Chemical Methods
Using chemical sterilization rather than heat to clean out equipment is recommended. It eradicates and removes all bacteria,...

