Hospitals Reuse of Single Use Medical Devices Presents Patient Safety Questions
As reported in a series of articles published in December, 2005, by Alec Klein of the Washington Post, eight major hospitals in the Washington area are reusing medical devices that are designated by the manufacturer as single-use device only. In most cases, patients and their families are unaware of this practice and are not given the opportunity to make an informed decision about whether they agree with this practice. According to the recent series in the Washington Post, while hospital administrators and reprocessors argue that this practice is safe and results in significant cost savings, there have been cases with adverse outcomes where questions have arisen regarding the role the reprocessing played in the failure of the device.
According to one device manufacturer, 71% of surgeons and 82% of nurses queried in an informal survey would not consent to use a reprocessed single-use device on themselves or a family member.
The attorneys at Regan, Halperin & Long have experience investigating incidents involving medical devices and reprocessed devices. If you are planning a surgery or a hospital admission, we strongly recommend that you ask your surgeon about whether any of the devices that may be used in your surgery will be reprocessed. If so, find out what the hospital’s quality assurance process is, and how the hospital will guarantee the safety of that equipment.
While the U.S. Food and Drug Administration regulates the practice, often the surgeons themselves do not know that the device was reconditioned. According to Alec Klein, of the 4800 hospitals in the United States, approximately 3,370 of the hospitals have established accounts with one or more of the three largest U.S. reprocessors. Last year, the reproccessors estimate they refurbished approximately 4.6 million single use devices for reuse in another medical procedure.
If you have specific questions about reprocessing of specific devices, you can visit the FDA website for further guidance.
By federal law, hospitals are required to tell the FDA about incidents involving patient injury. Recent changes require hospitals to specifically to designate whether the device involved in the incident was reprocessed. Also, according to federal law, each hospital maintains the responsibility to establish and make changes to the facility's quality policy. The implementation of the quality system may be delegated; however, it is up to the highest level of hospital management to establish quality policy and ensure implementation.