How Improper Sterilization of Medical Equipment Leads to Harm & Medical Malpractice

EvaluCare
May 22
5 min read

Updated: May 27

We often take proper sterilization of medical equipment and devices for granted. It is critical that Manufacturers Instructions for Use (IFUs) are followed to ensure proper sterilization occurs and bacteria isn't transported between patients between procedures. This problem is well known by regulatory bodies that have put standards in place to hold healthcare organizations accountable.

Manufacturer Instructions for Use (IFUs) are essential tools for ensuring the proper cleaning, disinfection, and sterilization of medical devices. The FDA mandates that manufacturers provide these instructions for all reusable devices, and compliance is critical for both safety and regulatory adherence.

Purpose of IFUs:

IFUs serve as the primary source of information for healthcare professionals on how to process a device correctly. There are many categories of problems below that can occur when IFUs are not followed. When breaches in manufacturer guidelines are not followed, it can result is significant harm and death to patients. Below is an overview of problems and medical malpractice cases.

1. Cleaning Procedures for Debris and Contaminants

AdventHealth Porter (Denver, CO): In 2018, a sterilization breach at this hospital led to infections among patients. Approximately 3,000 individuals filed lawsuits alleging harm due to improperly cleaned surgical instruments. The hospital settled these claims for $6.5 million. Wikipedia
Transvaginal Probe Infections (2016–2018): A U.S. healthcare facility faced a lawsuit from 67 patients who developed infections linked to inadequately cleaned transvaginal probes. The facility failed to adhere to proper cleaning protocols, resulting in significant legal and financial repercussions.

2. Disinfection Methods: Type, Concentration, and Contact Time

Saint Luke's Hospital (Kansas City, MO): A couple sued the hospital, alleging that insufficient disinfection practices led to a severe infection. The lawsuit claimed the hospital failed to implement and maintain adequate sterilization measures to protect patients. Kansas City Star
Duodenoscope-Related Infections: In Los Angeles, 11 patients were infected with a superbug due to inadequately disinfected duodenoscopes. The FDA acknowledged that existing cleaning procedures were insufficient and issued new guidelines to improve the sterilization of such complex devices. WIRED

3. Sterilization Protocols: Type of Sterilizer and Cycle Parameters

Porter Adventist Hospital (Denver, CO): The hospital faced scrutiny after it was revealed that surgical instruments were not properly sterilized, leading to patient infections. This incident was part of the broader issues that led to the $6.5 million settlement mentioned earlier. Live Science
Methodist Hospital (Houston, TX): In 2009, at least eight joint surgery patients developed infections due to improperly sterilized arthroscopic shavers. The FDA and CDC investigated, highlighting the challenges of cleaning complex reusable medical devices. Philly Injury Lawyers

4. Compatible Materials and Agents

Cosmed Group Inc.: This sterilization company filed for Chapter 11 bankruptcy in 2024 after facing over 300 lawsuits. Plaintiffs alleged injuries, including cancer, caused by inhalation of ethylene oxide, a sterilizing agent used by Cosmed. The company had previously settled a $1.5 million probe with the EPA over emissions at multiple facilities. Reuters

5. Storage and Handling Post-Processing

Wanaque Center for Nursing and Rehabilitation (New Jersey): In 2018, an adenovirus outbreak at this facility resulted in 11 child fatalities. A federal investigation found critical failings in infection-control practices, including improper storage and handling of medical equipment, contributing to the spread of the virus.

These cases underscore the critical importance of adhering to proper cleaning, disinfection, sterilization, and storage protocols to prevent infections and ensure patient safety. Healthcare facilities must remain vigilant and compliant with established guidelines to avoid legal repercussions and, more importantly, to protect patient health.

Importance of Compliance:

Following IFUs is not just best practice—it’s critical to preventing infections. Improper reprocessing of devices can result in the survival of pathogens that lead to HAIs such as MRSA, C. diff, and sepsis. Studies and outbreak investigations have repeatedly linked infections to non-compliance with manufacturer instructions.

Regulatory Citations and Oversight

The Joint Commission: Improper sterilization or high-level disinfection (HLD) of equipment continues to be a frequently cited noncompliant standard (IC.02.02.01). The Joint Commission emphasizes the need for healthcare organizations to ensure proper training and resources for staff to perform these critical functions. The Joint Commission+1The Joint Commission+1
Centers for Medicare & Medicaid Services (CMS): CMS mandates that Ambulatory Surgical Centers (ASCs) follow nationally recognized infection control guidelines. Failure to do so can result in deficiencies related to 42 CFR 416.51(b). CMS also requires ASCs to have a qualified professional directing the infection control program and to actively identify and document infections related to procedures performed. Centers for Medicare & Medicaid Services

Consequences of Non-Compliance:

Patient harm due to infection or cross-contamination
Device failure from incompatible cleaning agents or improper sterilization
Legal liability and regulatory fines from CMS, FDA, or The Joint Commission

IFU Challenges in Practice

Some IFUs can be highly technical, incomplete, or difficult to interpret. Hospitals and surgical centers must often develop supplemental protocols based on the IFU and consult with the manufacturer when unclear. However, this step is frequently skipped due to time pressures, staff shortages, or inadequate training.

Organizations like the FDA, AAMI, and CDC have urged manufacturers to simplify and clarify IFUs. In response, healthcare organizations are encouraged to:

Train staff regularly on IFUs
Keep IFUs easily accessible in digital or physical formats
Verify compliance during internal audits and infection prevention rounds

Legal Implications: When Non-Compliance Becomes Medical Malpractice

Neglecting IFUs can move beyond a safety issue into the realm of medical negligence and malpractice. Patients harmed due to improperly reprocessed devices may be eligible for compensation if the care team failed to follow IFUs.

Additional Notable Medical Malpractice Cases:

Reed v. Adventist Health System/West (CA, 2015): A patient developed sepsis following surgery. Expert testimony revealed that the hospital did not follow IFUs for cleaning arthroscopic equipment. The jury found in favor of the patient in this medical malpractice case.
Doe v. Hospital ABC (Confidential Settlement, 2020): A surgical center failed to sterilize endoscopic tools according to IFU guidelines. Multiple patients acquired infections, leading to a multi-million-dollar medical malpractice settlement.

Legal Basis: Failing to follow FDA-mandated IFUs can be used to demonstrate a deviation from the standard of care, a key element in proving medical malpractice.

Collaboration and Best Practices for IFU Compliance

Preventing HAIs through proper reprocessing requires collaboration:

Manufacturers must produce clear, actionable IFUs
Healthcare systems must implement consistent, IFU-based protocols
Regulators must enforce compliance through audits and penalties

Best practices include:

Establishing a centralized IFU library accessible to staff
Performing routine audits of reprocessing practices
Investing in competency-based training for all reprocessing personnel
Maintaining documentation of compliance for every sterilized device

How EvaluCare Can Help

If you or a loved one suffered from an infection that was disclosed to you that was believed to be due to improper device reprocessing, EvaluCare can help uncover the truth. Our team of quality professionals have worked to centralize IFU libraries, performed routine regulatory compliance audits, setup processes and procedures and trained hospital central sterile team members of best practices and manufacturer guidelines. We have disclosed to patients bacteria they were exposed to as a result of not following IFUs. We know the risks as healthcare insiders.

We provide:

Medical record reviews to determine if proper sterilization protocols were followed
Expert consultations to assess whether IFUs were ignored
Support in filing complaints or pursuing legal action
Guidance on next steps for resolution and recovery

EvaluCare bridges the gap between clinical detail and accountability for medical malpractice.

Our quality experts know the Joint Commission standards and know what questions to ask healthcare organization to establish a pattern of findings in this area that can be correlated with noncompliance with any guideline, like IFUs.

We ask the right questions, uncover the root causes, contributing factors and help ensure that hospitals are held responsible for lapses in safety.

We believe in change through accountability.

In Summary

If you or someone you love has experienced a preventable infection during a hospital stay, you deserve answers. EvaluCare is your trusted partner in uncovering whether negligence occurred and holding institutions accountable.

Learn more at www.EvaluCare.net or email info@EvaluCare.net

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