Creating Adequate Reprocessing Instructions

This white paper discusses the reasons for requiring validated reusable medical device reprocessing instructions.

Adequate Reprocessing Instructions.

Help Reduce Healthcare-Acquired Infections

According to the CDC, “on any given day about one in 25 hospital patients has at least one healthcare-associated infection.”1,2

Statistically, about 6-7% of all procedures/hospital visits in the U.S. result in an HAI (Healthcare Acquired/Associated Infection).2

In other, less-developed countries, the infection rate can be as high as 40%.

This may lead you to question what causes these infections?

The answer can sometimes be difficult to trace, but numerous studies have identified caregiver hand hygiene as one of the major sources of infection.Catheters, central lines and surgical sites also are major sources of infection.

HAI Categories.Another player is reusable medical devices:

Surgical equipment, dental hand pieces, nebulizers, flexible and rigid endoscopes, ultrasound probes and transducers.

And less obvious equipment:

Monitors, overhead lights in a surgical suite, bed rails in a hospital room, stethoscopes, blood pressure cuffs, ventilators, and pulsometers used to test oxygen levels.3,4

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Best Practices

According to the U.S. Food and Drug Administration (FDA), 21 Code of Federal Regulations (CFR) 801, the labeling for medical devices shall provide adequate directions for preparation for use.

FDA Reprocessing Criteria.In March 2015, FDA provided a guidance document titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.”

This document is intended to guide device manufacturers in the complex process of writing instructions for reprocessing and for validating those instructions.

For a successful validation process, the best practice is to design the device for effective cleaning and decontamination. The more complex the device, the more difficult these processes can become. Areas of complexity are lumens, seams, buttons, mated surfaces, etc.

Often decontamination is overlooked in the design stage, and since the reprocessing validation is one of the final steps in the project progression before an FDA submission, failure to consider this can lead to submission delays, or may even require a redesign of the device.

If the reprocessing is taken into consideration during early design stages, it can alleviate a lot of headaches later and even speed your time to market.

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More in the White Paper

Cleaning Agents — Common cleaning agents are enzymatic detergents; however, nonenzymatic (surfactant based) detergents also can be effective cleaning agents.

Cleaning & Sterilization Validation Criteria.

FDA Decontamination Classification — According to the CDC, the following levels of decontamination are required:

  • Critical Items: sterilization
  • Semicritical Items: when in contact with mucosal membranes, minimally high-level disinfection; when a device that may contact nonintact skin for a brief period or blood may contact the device, intermediate-level disinfection.
  • Noncritical Items: low-level disinfection

CDC Decontamination Levels — The CDC recognizes four levels of decontamination: Sterilization, high-level disinfection, intermediate-level disinfection, and low-level disinfection.

Other Cleaning Factors — The type of water to be used for cleaning, rinsing, and final rinsing after disinfection needs to be considered and listed in the IFU.

Items to Consider in a Cleaning Validation

  • Test soil
  • Dry times of the soils
  • Test markers (using validated assay methods)
  • Inoculation sites
  • Simulated use conditions
  • Worst-case processing (using minimum processing conditions)
  • Visual inspection methods

Items to Consider in Disinfection or Sterilization Validation Testing

  • Test organism
  • Inorganic and organic soils
  • Disinfection/Sterilization method
  • Sterilization packaging


With the HAI rate being on average 6-7% of all procedures, any additional measures to reduce this rate are monumental as patients’ lives are at the mercy of healthcare workers and the medical devices being used. In the end, a better reprocessing procedure equals a safer device.


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  1. Center for Disease Control, Healthcare-associated Infections, April 24, 2017.
  2. Center for Disease Control, HAI Data and Statistics, October 25, 2016.
  3. Otter, JA., Yezli, S. and GL French. The role played by contaminated surfaces in the transmission of nosocomial pathogens. Infection Control Hosp. Epidemiol., 2011 July, 32(7):687-99.
  4. O’Flaherty, N., and L. Fenelon. The stethoscope and healthcare-associated
    infection: a snake in the grass or innocent bystander? J. Hosp. Infect., 2015
    Sep. 91(1):1-7. https://www.ncbi/