Handling Single-Use Devices in the SPD
In
February The Joint Commission issued a safety advisory addressing special circumstances for single-use devices ( SUDs ).
The advisory details how most SUDs are not designed for reprocessing and do not allow for thorough decontamination after use , including that some are made of lower quality metals or components that will not withstand cleaning and sterilization processes and may deform , rust , pit , chip , or crack if subjected to reprocessing methods .
According to background in The Joint Commission ’ s advisory , the Food and Drug Administration ( FDA ) considers
There are special circumstances under which third parties , usually through a contracted service with healthcare organizations that use SUDs , may reprocess medical devices and instruments labeled for single use .”
reprocessing instructions part of labeling and in 2015 provided guidance to ensure that the appropriate level of reprocessing is addressed based on the intended use of the device . The FDA also provided guidance for manufacturers to assist in the formulation and scientific validation of reprocessing instructions for reusable medical devices . Manufacturers of medical devices must submit evidence to the FDA to demonstrate that the device to be marketed is safe and effective . Reprocessing instructions for medical devices should be validated . However , because of the greater risks to the public health posed by some devices , 510 ( k ) submissions for those devices , but not all , must include protocols and complete test reports of the validation of the reprocessing instructions . Manufacturers of devices intended to be used as a critical device and sterilized are required to provide instructions for decontamination , cleaning , and sterilization . Sterilization instructions for medical devices provide the critical parameters that must be followed to achieve sterility of that device – sterilization method , time , temperature , pressure , and dry times . Instructions for reprocessing are not provided for SUDs and may include instruments or devices .
While a SUD is intended for use on one patient during a single procedure and is not intended to be reprocessed and used on another patient , there are special circumstances under which third parties only may reprocess .
In the U . S ., the advisory explains , “ There are special circumstances under which third parties , usually through a contracted service with healthcare organizations that use SUDs , may reprocess medical devices and instruments labeled for single use . These third parties have been approved by the FDA to reprocess specific medical devices labeled for single use and must abide by strict rules that may be even more strict than those applicable to the original manufacturers of the SUD . Other countries have similar guidance or laws that prohibit reprocessing single-use or expired items . Contracting with an FDA-approved third party to reprocess opened but unused devices , high-cost or high-volume SUDs ( such as blades , bits and burs ) or with a sterilization service , are other ways organizations can mitigate costs associated with providing safe sterile devices .”
Importantly , SUDs do not have validated instructions for reprocessing and may not be designed to allow for thorough decontamination after use . Reprocessing an SUD may alter its physical characteristics and functionality so that it no longer complies with the original manufacturer ’ s specifications , therefore compromising instrument or device performance and patient safety . For example , a device designed to remove tissue or bone within very tight parameters may remove more or less tissue or bone as a result of wear during reuse or undergoing unvalidated reprocessing . This also applies to sterile , single-use items that have expired and were never used for patient care . The result could have serious consequences for the patient as well as the organization .
It is essential that SPDs understand that only a miniscule number of SUDs may be appropriate to be reprocessed by a third-party reprocessor for reuse on another patient . As The Joint Commission cautions , “ SUDs that have not undergone the extensive testing , validation and documentation required by the FDA cannot be guaranteed to be safe for reuse . For this reason , the FDA prohibits reprocessing of SUDs by anyone other than an FDA validated reprocessor . Healthcare organizations should note that resterilizing a SUD is considered reprocessing by the FDA and SUD reprocessors are subject to all the regulatory requirements currently applicable to the original device manufacturer , including premarket submission requirements .”
The Joint Commission says it expects accredited healthcare institutions to ensure that critical instruments and devices that are being reprocessed are not labeled as SUDs and have validated reprocessing instructions for decontamination , cleaning , and sterilization : “ Organizations must maintain reusable instruments in a condition to ensure safe and effective use . Instruments and