FDA Presents a List of 510(k) Cleared Sterilants and High Level Disinfectants

By Lisa Nadile

The FDA has released a list of sterilants and high level disinfectants that have cleared a 510(k) for reusable medical and dental devices. The Center for Devices and Radiological Health (CDRH) classifies these solutions as medical devices themselves, and requires manufacturers to meet specifications for safety and quality.

The eleven companies with products on the 510(k) list are:

  • Advanced Sterilization Products
  • Sporicidin International
  • Johnson & Johnson Medical Products, Inc.
  • Metrex Research, Inc.
  • Cottrell Limited
  • Wave Energy Systems
  • Steris Corp.
  • Minntech Corp.
  • Reckitt & Colman, Inc.
  • MedSci, Inc.
  • Cetylite Industries, Inc.

“The 510(k) shows your products have met FDA requirements for toxicity levels, efficacy testing, and [compatibility],” says Harry Plank D.D.S., Sporicidin's technical director. “The [manufacturers] of the product must also show they used good manufacturing practices (GMPs),” says Plank.

The FDA must also clear unique qualities or advances to products classified as medical devices. For example, when Sporicidin sought 510(k) clearance for its product, the company had to prove the efficacy of their solution that contains 1.64 percent phenol/phenate and 0.95 percent glutaraldehyde, a toxic ingredient present in similar products at levels of over 2 percent.

In addition, the company has to prove the duration of their product’s effectiveness with quantified results. In this case the testing of Sporicidin's solution shows that it is effective as a sterilant for 12 hours at 25°C with a maximum reuse of seven days. Data also shows the product is effective as a high level disinfectant for 20 minutes at 25°C with a maximum reuse of seven days. Other products on the FDA 510(k) clearance list show similar duration results.

According to Sporicidin officials, a company seeking FDA 510(k) clearance can expect to spend about $750,000 to complete the testing and ensure products meet government requirements.

The list of 510(k) cleared sterilants and high level disinfectants is available on the FDA website at: http://www.fda.gov/cdrh/ode/germlab.html

Information and requirements for meeting 510(k) clearance is available on the FDA website at: http://www.fda.gov/cdrh/manual/510kprt1.html

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