The FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed. This identification was based on knowledge gleaned through MDRs; recalls; periodic outbreaks of microbial transmission or patient infections reported in the literature or media; reports provided by the
Centers for Disease Control (CDC)
, the Veterans Administration (VA), and other health care settings; and manufacturer-initiated surveillance studies.
Reprocessing instructions for medical devices should be validated. However, because of the greater risks to the public health posed by the devices listed below, 510(k) submissions for these devices should include protocols and complete test reports of the validation of the reprocessing instructions so that FDA has the information it needs to evaluate substantial equivalence. This includes validation of the cleaning instructions as well as the disinfection or sterilization instructions. The reprocessing validation data should demonstrate that the proposed reprocessing instructions will reprocess the subject device at least as well as the reprocessing instructions for the predicate device. The devices identified by FDA as within this subset are listed as follows:
Bronchoscopes (flexible and rigid) and accessories
| Product Code | Device Name | Regulation Number |
|---|
| EOQ | Bronchoscope (flexible or rigid) | 874.4680 |
| KTI | Bronchoscope accessory | 874.4680 |
| BTG | Brush, biopsy, bronchoscope (non-rigid) | 874.4680 |
| JEI | Claw, foreign body, bronchoscope (non-rigid) | 874.4680 |
| JEL | Curette, biopsy, bronchoscope (rigid) | 874.4680 |
| BST | Curette, biopsy, bronchoscope (non-rigid) | 874.4680 |
| BWH | Forceps, biopsy, bronchoscope (non-rigid) | 874.4680 |
| JEK | Forceps, biopsy, bronchoscope (rigid) | 874.4680 |
| ENZ | Telescope, laryngeal-bronchial | 874.4680 |
| KTR | Tube, aspirating, bronchoscope (rigid) | 874.4680 |
| JEJ | Tubing, Instrumentation, bronchoscope (brush sheath A/O aspirating) | 874.4680 |
Ear, Nose, and Throat (ENT) endoscopes and accessories
| Product Code | Device Name | Regulation Number |
|---|
| EOX | Esophagoscope (flexible or rigid) | 874.4710 |
| GCL | Esophagoscope, general & plastic surgery | 876.1500 |
| FDW | Esophagoscope, rigid, gastro-urology | 876.1500 |
| EOB | Nasopharyngoscope (flexible or rigid) | 874.4760 |
| EQN | Laryngoscope, nasopharyngoscope | 874.4760 |
| EWY | Mediastinoscope, surgical, and accessories | 874.4720 |
Gastroenterology and Urology Endoscopes* that have elevator channels (not including accessories) [e.g., duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP)]
| Product Code | Device Name | Regulation Number |
|---|
| FDT | Duodenoscope and accessories, flexible/rigid | 876.1500 |
| FAK | Panendoscope (gastroduodenoscope) | 876.1500 |
| FTK | Pancreatoscope, biliary | 876.1500 |
| ODF | Mini endoscope, gastroenterology-urology | 876.1500 |
| FBN | Choledochoscope and accessories, flexible/rigid | 876.1500 |
| ODG | Endoscopic ultrasound system, gastroenterology-urology | 876.1500 |
* For endoscopes that fall under the product codes above, 510(k) submissions should include reprocessing validation data for those endoscopes designed with elevator channels.
Automated Endoscope Reprocessors (AERs)
| Product Code | Device Name | Regulation Number |
|---|
| FEB | Accessories, cleaning, for endoscopes | 21 CFR 876.1500 |
| NZA | Accessories, germicide, cleaning, for endoscopes | 21 CFR 876.1500 |
| KOG | Endoscope and/or accessories | 21 CFR 876.1500 |
| OUJ | High level disinfection reprocessing instrument for ultrasonic transducers | 21 CFR 892.1570 |
Colonoscopes (not including accessories)
| Product Code | Device Name | Regulation Number |
|---|
| FDF | Colonoscope and accessories, flexible/rigid | 876.1500 |
| FDA | Enteroscope and accessories | 876.1500 |
Neurological endoscopes (not including accessories)
| Product Code | Device Name | Regulation Number |
|---|
| GWG | Endoscope, neurological | 882.1480 |
Arthroscopes and accessories
| Product Code | Device Name | Regulation Number |
|---|
| HRX | Arthroscope | 888.1100 |
Laparoscopic instruments and accessories**
| Product Code | Device Name | Regulation Number |
|---|
| GCJ | Laparoscope, general & plastic surgery | 876.1500 |
| GEI | Electrosurgical, cutting & coagulation & accessories | 878.4400 |
**For laparoscopic instruments and accessories that fall under the product codes above, premarket review of reprocessing validation data is only necessary for those with design features given in Table 1 below.
Laparoscopic instruments and accessories**
Table 1
510(k) Submissions Should Include Reprocessing Validation Data for Laparoscopic Instruments and Accessories with Any of the Following Design Features
|
| Lumens (with internal surfaces that are not smooth, have internal ridges or sharp angles, or are too small to permit a brush to pass through) |
| Hinges |
| Interior device channels |
| Sleeves surrounding rods, blades, activators, inserters, etc. |
| Adjacent device surfaces between which debris can be forced or caught during use |
| O-rings |
| Devices with these or other design features that cannot be disassembled for reprocessing |
| Stopcocks |
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