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Improving Medical Device Cleaning: Validated Cleanroom Wipers for Enhanced Bioburden Control, Cost Efficiency, and Patient Safety

by | Mar 7, 2024

Maintaining stringent control over bioburden levels within medical device facilities is paramount, particularly given their operation in non-sterile environments. Although many medical devices undergo terminal sterilization processes such as gamma irradiation, e-beam, or EtO to achieve the necessary sterility for patient safety, effectively managing microbial contamination on these devices before sterilization is critical.

Beyond Bioburden: Addressing Particle Shedding Concerns

Conventional “lint-free” cleanroom wipers often fall short in adequately addressing particle shedding, which significantly contributes to bioburden issues. It’s imperative to assess wipers for their propensity to shed particles during use, as nonviable particles can harbor and transport microorganisms, thus escalating overall bioburden levels on medical devices.

Validated Cleanroom Wipers: A Solution for Enhanced Bioburden Control and Reduced Particle Shedding

Validated cleanroom wipers present a promising solution to traditional cleaning methods. These wipers are specifically engineered for controlled environments and undergo rigorous testing to ensure:
  • Material suitability: They are compatible with delicate medical device surfaces.
  • Low extractables: They release minimal particle or chemical residue.
  • Microbial reduction: They effectively reduce bioburden in accordance with industry standards.
  • Low particle shedding: They contribute minimally to overall particle levels.
Independent laboratories like Foamtec demonstrate the efficacy of specific validated cleanroom wipers through rigorous testing. For example, their MRT17-024 report showcases the effectiveness of their CleanWIPE product in reducing Staphylococcus aureus levels on stainless steel coupons. The report confirms that CleanWIPE meets stringent microbiological standards, achieving significant reductions in bacterial contamination when compared to a solution of 70% IPA/water.

Validated for Superior Bioburden Control, Cost Efficiency, and Patient Safety

Consistently maintaining low bioburden levels is not just good practice; it’s a regulatory requirement to ensure device sterility when employing terminal sterilization methods. Validated cleanroom wipers play a crucial role in removing and controlling bioburden on medical devices. Failing to maintain bioburden levels below those specified by your facility’s sterilization validation document can have severe repercussions, including:
  • Costly Retesting and Reprocessing: Exceeding bioburden limits can render the entire sterilization batch invalid, necessitating retesting and reprocessing, resulting in delays, material wastage, and increased labor costs.
  • Product Recalls and Reputation Damage: Inadequate bioburden control may lead to product recalls, resulting in financial losses, damage to reputation, and potential legal consequences.

The Benefits of Validated Wipers
  • Enhanced Sterility Assurance: By ensuring superior bioburden control, validated cleanroom wipers contribute to a higher level of sterility assurance before terminal sterilization, thereby reducing the risk of costly reprocessing and potential product recalls.
  • Reduced Particle Shedding: The low particle shedding properties of these wipers further mitigate the risk of bioburden contamination from personnel and cleaning materials.
  • Potential Cost Savings: While not intended to entirely replace 70% IPA, validated wipers offer a cost-effective alternative for specific tasks, potentially leading to savings through reduced reprocessing and recall management.
  • Device Compatibility: They are often compatible with various medical device materials.
Choosing the Right Solution

Selecting the appropriate cleaning method necessitates careful consideration of multiple factors, including specific protocols, regulatory requirements, and device compatibility. Consulting with qualified professionals is imperative to ensure the chosen solution is compliant and minimizes the risk of bioburden and particle contamination.
Incorporating validated cleanroom wipers with superior bioburden control and low particle shedding capabilities enables medical device facilities to bolster sterility assurance, mitigate the risk of costly corrective measures, and ultimately enhance patient safety.
See our Microbiology Analysis Report on CleanWIPE Wipes:

Learn more about CleanWIPE Foam Wipes: