Sterile processing departments are often called the invisible backbone of surgical care, but a recent investigation involving Penn State Health and Milton S. Hershey Medical Center highlights what can happen when those systems come under pressure. Reports of contaminated instrument trays, sterilization backlogs, staffing strain, and communication breakdowns are raising broader questions about patient safety, infection prevention infrastructure, and operational priorities across health care. ***Updated with an answer from Penn State Health.
***Update: This is a response from Penn State Health to this story:
Today’s Spotlight PA story about the Milton S. Hershey Medical Center provides an inaccurate and wildly sensational description of our processes and procedures, conflating different issues and unnecessarily raising concerns among patients needing surgical procedures.
We only perform procedures with instruments that meet our stringent standards, and any trays that don’t meet those standards get sent for reprocessing.
The existence of plastic particulate specks on some surgical instruments and in some instrument trays after sterilization is a common challenge in hospitals across the country and around the world. To date, this issue has affected a minute fraction of the instrument trays we sterilize. We have completed 99.8 percent of surgical procedures on schedule, always using the proper instruments, and maintained the highest standards for patient safety throughout.
What patients and their physicians need to know is that our quality control systems are working exactly as designed to protect patient safety.
Our closely monitored patient safety metrics and indicators have remained stable. Those metrics put us among the best healthcare institutions in the country. Our regulators at the state and federal levels have approved our efforts to manage the occasional identification of particulate specks.
These results are entirely attributable to our dedicated teams who work tirelessly for their patients. As we continue to take comprehensive steps toward a solution, patient safety remains the only consideration involved in every decision we make.
Original ICT article: Sterile processing departments (SPDs) are often called the invisible backbone of surgical care. Patients may never see these teams, but every surgical instrument used in an operating room depends on their ability to properly clean, inspect, assemble, sterilize, and distribute medical devices safely and consistently.
A recent investigation announced by Spotlight PA involving Penn State Health and its flagship Milton S. Hershey Medical Center has brought national attention to what can happen when sterile processing systems become strained. The investigation identified reports of contaminated instrument trays, sterilization backlogs, equipment concerns, staffing pressures, and communication breakdowns that alarmed employees and raised broader questions about patient safety, infection prevention infrastructure, and health care system priorities.
While the situation at Hershey Medical Center is still evolving, infection prevention and control (IPC) professionals say the issues highlighted in the report reflect challenges occurring in health care facilities nationwide.
Why Sterile Processing Matters
Every year, millions of surgical procedures are performed safely because sterile processing teams follow rigorous evidence-based practices designed to prevent contamination and infection.
When those systems fail, the consequences can be serious.
“Everything we do touches a patient,” Damien Berg, vice president of strategic initiatives at the Healthcare Sterile Processing Association (HSPA), told Spotlight PA. Sterile processing professionals often say they are the “heartbeat” of the hospital because no surgeries can be done without their work.
Unsterile instruments are among the most significant contributors to surgical site infections (SSIs), which remain one of the most common health care-associated infections (HAIs). According to the CDC, SSIs account for approximately 20% of HAIs among hospitalized patients.1 These infections can lead to prolonged hospitalization, repeat surgeries, sepsis, disability, and death.
The Penn State Health investigation described several troubling incidents, including black particulate matter repeatedly appearing on surgical instruments, delays in instrument reprocessing, and staff reportedly piecing together surgical sets because sterile instruments were unavailable. In one case, an emergency brain surgery reportedly proceeded using “contaminated” instruments because no alternative set could be located.
Perhaps most concerning, an internal review reportedly found that a heart surgery in January 2025 was performed using instruments later recognized as unsterile after a sterilization indicator strip was discovered to be red rather than the expected yellow.
Understanding Sterilization Indicators
For readers outside sterile processing or IPC, sterilization indicators are one of several safeguards used to confirm instruments have undergone proper sterilization conditions.
These indicators change color when specific time, temperature, and pressure conditions are met during sterilization cycles. A failed indicator may suggest that instruments did not meet the required sterilization parameters and should therefore not be used.
Health care systems build multiple layers of protection into the sterilization process specifically because no single safeguard is foolproof. Experts often describe this as the “Swiss cheese model” of patient safety: Errors become dangerous when multiple protective layers fail simultaneously.
Advertisement
According to the investigation, the internal review concluded that “safety behaviors and error prevention skills were not hard-wired as standard work” within several departments.
For IPC professionals, that language is significant. It suggests systemic vulnerabilities rather than isolated human error.
A Nationwide Problem
Although the Penn State Health case has received significant attention, experts say similar problems are occurring across the US.
Hospitals in Colorado, California, Missouri, Florida, and Texas have recently reported concerns about sterilization, particulate contamination, or disruptions to instrument processing that have forced surgical delays or temporary suspensions.
SPDs are frequently located physically separate from operating rooms, limiting communication and visibility between teams. At the same time, SPDs often operate with fewer financial resources because they are considered nonrevenue-generating departments.
That can create dangerous conditions when surgical demand increases but infrastructure investment does not keep pace.
The Human Cost of System Strain
One of the most striking aspects of the investigation was the emotional distress expressed by health care workers themselves.
A pregnant employee reportedly told administrators she was “scared to death” to undergo a cesarean section at her own workplace because of what staff members were witnessing daily.
Another employee described operating room staff “stealing instruments from other services” simply to keep surgeries moving.
These comments reflect a phenomenon increasingly recognized in health care: moral distress.
For IPC professionals, sterile processing failures are rarely about 1 person making 1 mistake. Instead, they often involve cascading operational pressures that gradually erode safety margins.
What Infection Preventionists Should Take Away
The Penn State Health situation offers several important lessons for IPC teams and health care leaders.
1. Sterile processing must be treated as a patient safety priority
SPDs are not merely operational departments. They are critical patient safety units directly linked to infection prevention outcomes.
2. Communication between departments is essential
IPC teams, operating room leaders, sterile processing professionals, facilities management, and executive leadership must collaborate consistently rather than operate in silos.
3. Near misses matter
Events that do not harm patients still provide vital warning signs. Experts emphasize that near misses should trigger aggressive system reviews before catastrophic events occur.
4. Environmental and equipment monitoring cannot be ignored
The repeated appearance of black particulate matter described in the investigation underscores the importance of equipment maintenance, water quality monitoring, environmental controls, and manufacturer guideline adherence.
5. Staffing and education remain central
Pennsylvania law requires sterile processing professionals to maintain certification and continuing education requirements, reflecting the complexity and importance of the work. However, education alone cannot compensate for chronic understaffing or unsustainable workloads.
Moving Forward
According to Spotlight PA, Penn State Health maintains that its quality systems are functioning appropriately and stated that affected trays were removed before use whenever identified. The organization also reported implementing corrective actions, equipment upgrades, additional monitoring, and process improvements.
Still, the investigation serves as a powerful reminder that infection prevention depends not only on policies and protocols, but also on culture, communication, staffing, infrastructure, and leadership investment.
For IPC professionals, the lesson may be simple but urgent: Sterile processing cannot remain invisible until something goes wrong.
References
Magill SS, O’Leary E, Janelle SJ, et al. Changes in prevalence of health care-associated infections in US hospitals. N Engl J Med. 2018;379(18):1732-1744. doi:10.1056/NEJMoa1801550. PMID: 30380384; PMCID: PMC7978499.
ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Association for the Advancement of Medical Instrumentation; 2023.
