FDA regulates reprocessed single-use medical devices
June 1, 2001
FDA regulates reprocessed single-use medical devices
On April 23, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) sent a letter to all U.S. hospitals regarding the FDA’s intention to enforce requirements regarding the reprocessing of single-use medical devices (SUDs) for later use on patients. The letter provides a timetable and specifies actions that may be taken against hospitals that do not comply with the FDA’s requirements.
Although many SUDs are not handled directly by pharmacy staff, some are, such as syringes. For pharmacy staff who may not have received the guidance information directly, the following information may prove useful.
In short, the letter states that hospitals will be regulated in the same manner — held to the same regulatory guidelines — as are device manufacturers regarding the reprocessing of SUDs.
Seven compliance requirements
As a device manufacturer, a hospital that reprocesses SUDs is required to comply with seven requirements of the Federal Food, Drug and Cosmetic Act:
1. Establishment registration and device listing. A hospital that reprocesses SUDs must register with the FDA and list every type of device that is reprocessed at that facility.
2. Good manufacturing practice under the quality system regulation. Hospitals must have a quality assurance program or quality system that is appropriate for the reprocessed devices. The FDA monitors quality compliance during facility inspections. All registered hospitals that reprocess SUDs will be subject to periodic FDA inspection.
3. Device labeling. The FDA requires that all SUDs bear the name and place of manufacture and adequate directions for use.
4. Submission of adverse events reporting under Medical Device Reporting regulations. In addition to user facility reporting requirements, hospitals that reprocess SUDs are subject to manufacturer reporting requirements.
5. Medical Device Tracking regulations. A hospital that reprocesses SUDs is not subjected to Medical Device Tracking regulations unless the FDA issues a direct order to track a specific reprocessed device.
6. Corrections and removals. A hospital that reprocesses devices must report to the FDA certain types of device corrections and approvals.
7. Premarket requirements. The FDA is phasing in active enforcement of regulations for reprocessed devices, depending on the device class status. Class III devices, considered to pose the greatest potential health risk, require a premarket approval application. Enforcement of class III device requirements went into effect on Feb. 14, 2001. Class II and I devices generally pose less risk of harm and, depending upon the device, may require premarket notification to the FDA. Of those devices requiring notification, class II and I device requirements will be enforced beginning Aug. 14, 2001, and Feb. 14, 2002, respectively.
FDA enforcement actions
It is essential that hospitals wishing to continue the reprocessing of SUDs comply with these regulations to avoid the following FDA enforcement actions:
• Public health alerts and notifications. The FDA has the authority to require a hospital to directly notify health care providers, consumers, and other relevant parties of devices that pose actual or potential health risk. In addition, the FDA has the authority to issue alerts and notifications on issues that are of a public health concern.
• Warning letters. A warning letter informs an individual hospital of serious violation. The FDA may initiate action without further notice if the violation is not corrected promptly. However, the FDA is not legally obligated to send a warning letter prior to initiating action.
• Mandatory recall. The FDA can require a hospital to recall a reprocessed SUD if it could cause serious, adverse health consequences or death.
• Seizure. The FDA may seize a medical device it considers adulterated (e.g., determined not to be in compliance with the quality system requirements) or misbranded (e.g., labeled with an incorrect device description, such as size).
• Injunction. The FDA may seek an injunction against a hospital to prevent manufacturing or distributing a device that is in violation of the requirements.
• Civil money penalties. The FDA may initiate an administrative proceeding to impose civil money penalties of up to $1 million (per proceeding) against people responsible for violations.
• Prosecution. The FDA has the authority to initiate action to criminally prosecute people responsible for violations.
The FDA recommends that health care professionals planning to engage in or continue manufacturing activities become familiar with FDA’s reprocessing and reuse policy. More information, including FDA guidances, may be found at www.fda.gov/cdrh/reuse/index.shtml. Or, you may contact the FDA’s Division of Small Manufacturers Assistance by phone at (800) 638-2041 or by e-mail at [email protected]. Copies of the SUD enforcement guidance are available at CDRH Facts on Demand (800) 899-0381 or (301) 827-0111; specify number 1168 when prompted for the document shelf number.
The FDA realizes that these regulations are not familiar to most hospitals, and that compliance with them will not be easy, but is enforcing them for the sake of patient safety. The FDA’s goal is to see that patients who receive reprocessed SUDs are afforded the same level of safety and effectiveness as those who receive new ones.
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