Processing Devices

Standards are useful, and guidance based on evidence is often even more so.

Scope

This guidance provides recommendations regarding reuse instructions in labeling for reusable medical devices and the validation of the recommended reprocessing process in the instructions. The recommendations are applicable to the three device reprocessing situations below.

1. Reusable medical devices initially supplied as sterile to the end user and requiring the end user to process the device after initial use (i.e., cleaning and disinfection or sterilization) prior to the subsequent patient use.
2. Reusable medical devices initially supplied as non-sterile to the end user, and requiring the end user to disinfect or sterilize the initial packaged device and to subsequently reprocess the device after initial use (i.e., cleaning and disinfection or sterilization).
3. Single use medical devices initially supplied as non-sterile to the end user, and requiring the end user to sterilize the device prior to its use.

—Read More at Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

In particular of use to body artists and even more so to the providers of products to body artists are the seven criteria:

VI. FDA’s Seven Criteria for Reprocessing Instructions

Your labeling should address the seven criteria below for clear reprocessing instructions to help ensure users understand and correctly follow the instructions.

Criterion 1. Labeling should reflect the intended use of the device.

Your labeling should include instructions for a reprocessing method that reflects the physical design of the device, its intended use, and the soiling and contamination to which the device is subject during clinical use. Appropriate reprocessing instructions depend on whether the device will:

• contact only intact skin;
• contact intact mucosal surface;
• contact normally sterile tissues, blood, or bodily fluids such as cerebrospinal fluid, peritoneal fluid, etc;
• be subject to splatter or splash of body fluids or blood because of proximity to the patient, although it is not in direct contact with the patient;
• be subject to microbial contamination during use from contact with soiled hands of patient caregivers or patients (both unwashed and gloved hands can carry both organic soil and microorganisms to the surfaces they touch);
• be subjected to contamination by unexpected or accidental events (e.g., patient bleeding, incontinence, vomiting, wounds leaking through dressings);
• be subject to reprocessing with disinfectants or other chemicals that might leave harmful residues, or adversely affect device materials or performance, if inadequately rinsed; and
• present specific or unique risks to the patient or user.

When likely contamination may include human blood or body fluids capable of transmitting bloodborne pathogens, the requirements of the OSHA Standard 29 CFR 1910.1030 Occupational Exposure to Bloodborne Pathogens must be included in labeling.⁶

—Read More at FDA’s Seven criteria

A clear reference to Spaulding’s system in the third criteria

The crucial issues are in validation of these cleaning properties. That is what our ASTM F04-15 technical committee has been working on, “How clean is clean enough?”

• F2847-10 Standard Practice for Reporting and Assessment of Residues on Single Use Implants
• WK31799 New Guide for Designing Medical Devices for Cleanability
• WK32535 New Practice for Establishing Limit Values for Residues on Single use Implants
• WK33439 New Guide for Standard test soils for validation of cleaning methods for reusable medical devices
• WK33660 New Guide for Validating Cleaning Lines for Medical Devices

My hope is that our processing technologies can give validated results for questions raised about reuse of difficult to clean items.