| Device |
interim reprocessing cleaning and intermediate-level disinfection wipe |
| Definition |
An interim reprocessing cleaning and intermediate-level disinfection wipe is intended for use by a health care provider to clean and intermediate-level disinfect medical device types indicated on the labeling as an interim step prior to sterilization or high-level disinfection. This is intended as a non-terminal disinfection step compatible with subsequent terminal reprocessing such as sterilization or high-level disinfection and renders the device safe to handle by the user compared to unprocessed, clinically soiled devices. “Safe to handle” is limited in scope to mean the device has been appropriately intermediate-level disinfected. |
| Physical State |
Wet wipes in germicide solution in a container. |
| Technical Method |
The wipes are intended to be used, through manual cleaning actions, to remove any visible soil and chemically disinfect (to an intermediate level) applicable critical and semi-critical medical devices. Following disinfection, the residual germicide is rinsed away prior to high level disinfection or sterilization. |
| Target Area |
Nonsubmersible and/or heat-sensitive critical and semicritical medical device. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | SHM |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6891
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
