Have there been any Food and Drug Administration (FDA) recalls or safety concerns regarding XPERIENCE Advanced Surgical Irrigation?

XPERIENCE Advanced Surgical Irrigation: FDA Recalls and Safety Concerns

Direct Answer

No FDA recalls or safety concerns specific to "XPERIENCE Advanced Surgical Irrigation" were identified in the available evidence. The provided evidence focuses on general surgical irrigation practices, FDA device approval processes, and device recall patterns, but does not mention this specific product by name.

Important Context About Medical Device Oversight

FDA 510(k) Clearance Process Concerns

The majority of medical devices, including surgical irrigation systems, typically enter the market through the FDA's 510(k) pathway rather than the more rigorous premarket approval (PMA) process:

• 78% of high-risk device recalls (those causing serious health problems or death) from 2005-2009 involved devices cleared through the 510(k) process or were exempt from FDA review 1

• Devices using recalled predicates as their basis for 510(k) clearance have a 6.4-fold higher risk of subsequent Class I recalls compared to matched controls 2

• Only 17.8% of devices cleared through 510(k) from 2013-2014 had any published research examining their safety or effectiveness 3

How to Verify Product Safety Status

To determine if XPERIENCE Advanced Surgical Irrigation has any recalls or safety alerts:

1. Check the FDA's Device Recall Database directly at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm 1

2. Review MedWatch (www.fda.gov/medwatch), the FDA's Safety Information and Adverse Event Reporting Program for medical products 4

3. Search the Devices@FDA database for the specific product's 510(k) number and regulatory history [@12@]

General Surgical Irrigation Safety Principles

While no specific concerns about XPERIENCE Advanced Surgical Irrigation were found, evidence-based irrigation practices include:

Recommended Irrigation Solutions

• Use sterile saline or sterile water as coolant/irrigant for surgical procedures, delivered through devices specifically designed for sterile irrigating fluids [@1@]

• Povidone-iodine irrigation has been associated with lower surgical site infection rates compared to saline-only irrigation, though recent data suggest this should be reconsidered [4, @7@]

• Antibiotic irrigation is NOT recommended due to lack of benefit and contribution to antimicrobial resistance [@2@, 4,5]

Critical Equipment Requirements

• Single-use devices should be used for one patient only and disposed of appropriately [@1@]

• Sterile water quality meeting EPA standards (<500 CFU/mL heterotrophic plate count) should be used [@6@]

Common Pitfalls to Avoid

• Do not assume device safety based solely on FDA 510(k) clearance, as this pathway requires less rigorous evidence than PMA [@10@, 1]

• Verify the specific product has not been subject to recall by checking FDA databases directly, as recall information may not be widely disseminated [@11@, 2]

• Ensure proper sterile technique regardless of the irrigation system used, as contamination can occur with any device [4, @6