Third party, hospital reprocessors of single-use devices subject to regulation
By Walter Gorski
Third party and hospital reprocessors of devices labeled or intended for single-use will now be subject to all the regulatory requirements applicable to original equipment manufacturers, including premarket submission requirements, according to a guidance issued by the Food and Drug Administration (FDA) in August .
The FDAs primary goal in issuing this new guidance document is to prevent device malfunctions, patient injuries and infections when reprocessed single-use devices are used.
Under the new guidance, 17 commonly reprocessed devices used in orthopaedics will now be subject to this guidance. These devices include: saw blades, surgical drills, arthroscopes, invasive traction components, scissors, reamers, orthopaedic knives, burrs, drill bits, rongeurs, trephines, countersinks, bone taps, staple drivers, needle holders, carpal tunnel blades and manual surgical instruments. Overall, more than 200 commonly reprocessed devices will fall under the jurisdiction of the FDAs new guidance.
The new guidance document differs substantially from a draft released earlier this year. The draft proposal was met with opposition from the physician community. In comments to the FDA, the AAOS voiced serious concern that the proposed guidance document had the potential to increase physicians liability when reprocessed devices labeled as single-use were used and that it could have a deleterious impact on the supply of these devices.
The AAOSs comments were critical of FDAs proposal to classify devices under a new scheme based on the risk a device poses to patients. The draft proposal would have classified devices into three categories (low, medium and high) and would have required physicians to visually inspect the device prior to use to determine whether reprocessing had affected the devices original characteristics.
The AAOS believed that inspection with the naked eye was insufficient to reveal damage, degradation or latent defects that may have occurred in the manufacturing or reprocessing of the device. The visual inspection criteria also would have resulted in some orthopaedic devices being grouped into a higher risk category, thus subjecting them to more stringent regulatory requirements.
In addition, the AAOS asserted that there was no scientific evidence that showed the use of reprocessed orthopaedic medical devices have resulted in adverse medical consequences. Therefore, exposing orthopaedic devices to new requirements would only increase regulatory burdens on physicians and other entities and could threaten access to devices that have never been shown to be unsafe.
The FDA opted to scuttle its draft scheme and settled on the use of the established device classification system listed in the Code of Federal Regulations (i.e., class I, class II and class III). This classification system will be used to determine enforcement priorities for premarket submission requirements as well as non-premarket requirements (i.e., registration and listing, medical device reporting, tracking, corrections and removals, quality system regulation and labeling.)
Under the new guidance, the FDA intends to enforce premarket submission requirements, if required, within six months of the issuance of the guidance document for all class III devices; within 12 months for class II devices and 18 months for class I devices. At a later date, the FDA intends to examine on a case-by-case basis the need to revoke exemptions from premarket requirements for class I and II exempt products based on the risks that may exist due to reprocessing. FDAs reexamination of the exemption status of devices could be a source of future controversy.
The impact of the final guidance document will be experienced primarily by hospitals and third parties that reprocess arthroscopes labeled for single-use and invasive traction components. Since these items are class II devices, the FDA will require premarket notification (510 (k)) submissions.
All other orthopaedic devices listed in the guidance document are exempt from premarket requirements. The FDA also has stated that while non-premarket requirements will be required for class I and II devices, it will use its discretion whether to enforce these requirements.
The new federal policies will not apply to permanently implantable pacemakers, opened-but-unused single-use devices, health care facilities that are not hospitals or hemodialyzers.
The FDA has asked parties affected by the guidance document to comment on its effectiveness. The FDA also will consider expanding the guidance document to other facilities as it deems necessary. In addition, the FDA may consider tackling single-use product labeling requirements in the future. The AAOS will continue to monitor the effects of the new guidance to ensure access to safe medical devices while not increasing the regulatory burden on physicians.