Instructions for Use

The manufacturer's IFU should include specific info on the:

-Specific cleaning and disinfecting agents -Cleaning implements -Methods to be used -Instructions on disassembly

The FDA has developed a guidance document on

IFUs (FDA, 2015)

Surveyors have been reported to request the manufacturer's instructions for the

SPD staff and to ask them to demonstrate and describe the process that they use.

Info obtained in a phone call or from a sales representative should be followed by

a written statement; verbal instructions should not be accepted.

The importance of the cleaning process has been

acknowledged by the JC

Depending on the complexity of the device

an annual competency assessment might be nescessary.

After initial training, there should be a written verification

at a later date of the staff's ability to perform the task.

If the instructions provided are unclear, inadequate or contraindicated by

best practice, the manufacturer should be contacted for more info.

There must be a record of each staff member's training in the process and

compliance with the procedure

Importance of obtaining and complying with manufacturer's IFU can't be

emphasized enough

Additional chemicals (alcohol, hydrogen peroxide, disinfectant wipes) should never be used to

enhance the cleaning unless the device manufacturer has specified their use.

There should be a written plan for the routine verification and documentation of the ability of the

facility's cleaning equipment to clean and verify the cleanliness of instrumentation surfaces after manual cleaning.

The device manufacturer's IFU should be kept on

file and be readily available to the decontamination staff for reference.

Manufacturers IFUs must be available for

loaned instrumentation

An IFU should never be

modified

This info should appear in the facility's written decontamination procedure, which

must comply with the IFU

You are responsible for complying with the manufacturer's IFU

noncompliance could void the manufacturer's expressed or implied warranty and could result in sterilization failures

The HCF must develop written procedures that identify the step by step process described in the IFUs and

that are based on published and validated recommended practices and guidelines

If cleaning is performed exactly as the manufacturer specifies, even if the cleaning is done manually

the device will be safe to handle without PPE in the perparation and packing area.

Before a medical device is cleaned

the manufacturer's instructions for use must be obtained

To ensure that the facility is able to perform the cleaning process prescribed by the manufacturer

these instructions should be reviewed before an item is purchased or at least before the item is used for the first time.

Purpose of document is to provide medical device manufacturers with guidance on creating and

validating reprocessing instructions that if followed, will ensure that a device can be safely used for the purpose for which it was intended.

In addition to having manufacturer's IFUs, the end user must be able to

verify the cleaning process.