FDA Actions: Needle Hazards, Antibody Testing for Immunity
Needlesticks result from malfunctioning safety syringe
Due to “needle safety device failures” — some of which led to needlesticks — the FDA is recommending healthcare providers stop using certain syringes and needles manufactured by Guangdong Haiou Medical Apparatus Co., Ltd. (HAIOU).
The FDA is recommending the action as it evaluates the products. So far, HAIOU has not initiated a voluntary recall.
On April 20, the FDA issued an import alert to block the devices from entering the United States. The FDA and federal partners are working to identify where these devices are in use to inform sites of the device failures.
The FDA reports incidents “where needles were reported to have detached from these HAIOU syringe and needle configurations and remained in the patient’s arm after injection, or the needle safety function failed — for example, did not activate or did not retract — and a small number of incidents involving accidental needlestick injuries to healthcare providers. The FDA is not aware of any instances where surgery was needed to remove a needle.”1
Risks of needle safety device failures and detachment in a person’s arm could include pain, infection, and surgery (if the needle breaks in a person’s arm). Healthcare workers also face risk of contracting bloodborne pathogens involving accidental needlestick injuries.
The device failures have been reported for these HAIOU syringe and needle configurations:
- 1 mL syringe with 25G × 1-inch needle;
- 1 mL syringe with 23G × 1-inch needle.
The FDA recommends providers:
- remove needle and syringe configurations manufactured by HAIOU from inventory until further notice. Facilities that decide to dispose of the unused products should follow facility processes for sharps disposal.
- do not purchase these HAIOU configurations until further notice.
- note the syringes and needle configurations might be available as individual units or part of a kit.
- report any issues with the quality or performance of these devices to the FDA.
There are no reports of concerns with other products (such as gloves, alcohol pads, etc.) that may be provided in kits with the needle and syringe configurations, but these devices should not be used.
Antibody Tests and COVID-19 Vaccine
The FDA issued a reminder to the public and healthcare providers that results of SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time — especially after receiving a COVID-19 vaccine.
Although positive antibody test results can help identify people who may have been infected, more research is needed in those who have taken a vaccine. SARS-CoV-2 antibody tests have not been evaluated to assess the level of protection provided by an immune response to COVID-19 vaccination. If antibody test results are interpreted incorrectly, people might be emboldened to take fewer precautions against exposure. Taking fewer steps to protect against COVID-19 can increase their risk of infection and result in the wider spread of the virus.
At this time, the FDA is recommending those vaccinated not use antibody tests to confirm immunity. “If the results of the antibody test are interpreted as an indication of a specific level of immunity or protection from SARS-CoV-2 infection, there is a potential risk that people may take fewer precautions,” the FDA warned.2 “Do not interpret the results of qualitative, semi-quantitative, or quantitative SARS-CoV-2 antibody tests as an indication of a specific level of immunity or protection from [infection after] a COVID-19 vaccination. While a positive antibody test can indicate an immune response has occurred, and failure to detect such a response may suggest a lack of immune response, more research is needed.”
People who received a COVID-19 vaccination can follow the CDC’s recommendations for fully vaccinated people, the FDA noted, adding that a positive test result on an antibody test could mean a previous SARS-CoV-2 infection.
“A COVID-19 vaccination may also cause a positive antibody test result for some but not all antibody tests,” the FDA stated. “You should not interpret the results of your SARS-CoV-2 antibody test as an indication of a specific level of immunity or protection from SARS-CoV-2 infection.”
For those unvaccinated, a positive antibody test does not necessarily indicate sufficient immunity and protection from infection.
“Antibodies are proteins created by your body’s immune system soon after you have been infected or vaccinated,” the FDA explained. “SARS-CoV-2 antibody or serology tests look for antibodies in a blood sample to determine if an individual has had a past infection with the virus that causes COVID-19. These types of tests cannot be used to diagnose a current infection.”
REFERENCES
- Food and Drug Administration. Stop using certain syringes and needles with needle safety devices manufactured by HAIOU. May 20, 2021.
- Food and Drug Administration. Antibody testing is not currently recommended to assess immunity after COVID-19 vaccination: FDA Safety Communication. May 19, 2021.
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