Last week, the Food and Drug Administration (“FDA”) published a notice in the Federal Register implementing additional requirements for medical devices under the 21st Century Cures Act (“Cures Act”).
Section 3059 of the Cures Act requires FDA to publish a list of reusable device types that must include validated instructions for use, in addition to validation data regarding cleaning, disinfection, and sterilization in their 510(k) submissions. Manufacturers of reusable medical devices are required to have labeling that bears adequate directions for use, including instructions on preparing a device. FDA cites significant changes in knowledge and technology involved in reprocessing reusable medical devices and more complex reusable device designs making it more difficult to clean. The requirement to provide cleaning instructions and validation data will assist FDA to assure such devices are designed for adequate reprocessing and safe reuse, and have comprehensive and clear instructions for effective reprocessing procedures for use by health care facilities that reprocess the devices.
Accordingly, today’s notice provides a list of reusable devices that are now required to include in their 510(k) submission instructions for use, which have been validated, and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. FDA provides two lists, or tables, in the notice. Table 1 identifies those reusable medical devices that FDA has determined pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed. Table 1 includes specific product codes under the following device types that require validation data and validated reprocessing instructions included in a 510(k) submission:
- Bronchoscopes (flexible or rigid) and accessories;
- Ear, Nose, and Throat endoscopes and accessories;
- Gastroenterology and Urology Endoscopes that have elevator channels (not including accessories) [e.g., duodenoscopes used for endoscopic retrograde cholangiopancreatography];
- Automated Reprocessors for Reusable Devices;
- Other Flexible Gastroenterology and Urology Endoscopes 1 (not including accessories);
- Neurological endoscopes (not including accessories);
- Water-based heater-cooler systems for use in operating rooms;
- System, Surgical, Computer Controlled Instrument;
- Arthroscopes and accessories;
- Laparoscopic instruments and accessories; and
- Electrosurgical instruments and accessories.
Table 2 includes specific design features that may pose a challenge to adequate reprocessing for arthroscopes, laparoscopic instruments, and electrosurgical instruments. Accordingly, arthroscopes, laparoscopic instruments, and electrosurgical instruments that have any of the following design features must include validated reprocessing instructions and reprocessing validation data reports in a 510(k) submission:
- Lumens (especially lumens of flexible design, multiple internal lumens, lumens that are not freely accessible, bifurcated lumens, 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, depressions, joints with gaps, overlapping or butted joints that result in acute angles, or ribbed or otherwise “roughened” surfaces (e.g., jaws);
- Interior device channels;
- Sleeves surrounding rods, blades, activators, inserters, etc.;
- Shafts within lumens;
- Adjacent device surfaces between which debris can be forced or caught during use·
- Fittings with very close tolerances;
- Clamps that cannot be fully opened for cleaning;
- Small internal parts (e.g., springs, magnets, etc.) that may become soiled;
- Ridges, articulations or grooves;
- Rough, irregular, discontinuous surfaces that can entrap or retain soil;
- Capillary gaps;
- Luer locks;
- Porous materials (smooth surfaces are desirable, where possible);
- Junctions between insulating sheaths and activating mechanisms (as in certain laparoscopic instruments);
- Dead-ended chambers;
- Internal movable device components such as multiple cables;
- Device features that may entrap debris that can later become aerosolized (e.g., through application of power, etc.); and
- Devices with these or other design features that cannot be disassembled for reprocessing.
The notice states that these premarket requirements are effective on August 8, 2017. The Agency’s notice is silent on submitting comments on these additional requirements.