The U.S. FDA said that Medtronic plc, of Dublin, is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk that the delivery system could fracture during stent placement. Fractured pieces could be left inside the patient’s brain bloodstream. If this happens, or if a surgeon attempts to retrieve the pieces, the patient’s condition could worsen. If a clinician already has implanted successfully, there is no increased risk to patients due to this issue. The agency received 50 medical device reports, with 10 injuries and one death, from Nov. 1, 2019, to March 1.
Regarding the COVID-19 pandemic, the U.S. FDA updated its FAQs on Diagnostic Testing for SARS-CoV-2 regarding specimen collection. To that end, for symptomatic patients, nasal swabs can be used that access just the front of the nose rather than the depth of the nasal cavity. Such testing could result in increased comfort for patients, as well as self-collection at collection sites. The agency also has issued guidance to provide a policy to help expand the availability of surgical apparel for health care professionals, including gowns, hoods and surgeon’s and patient examination gloves during the pandemic. A separate guidance is intended to provide a policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers.
Health Canada has issued an interim order related to the importation and sale of medical devices for use in relation to COVID-19. It allows for the expedited authorization of the importation or sale of medical devices used in the diagnosis, treatment, mitigation or prevention of the disease.
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released guidance on medical devices clinical investigations during the COVID-19 outbreak. It advises, among other things, that if a clinical investigation must be paused, MHRA should be notified as soon as possible. It also should be informed when the interested party can restart the trial. Also, if there are any actions required to take in response to COVID-19 that are considered an amendment, sponsors should contact email@example.com, and the organization will expedite the review. Sponsors must disclose about any changes made to:
- The device under investigation;
- Study documentation, including the clinical investigation plan;
- Investigators or investigating institutions; and
- Changes requested by an ethics committee.
MHRA will assess any amendments that are not related to COVID-19 within normal processing times. In addition, the organization unveiled “Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak.” It relates to devices that are most likely to confer therapeutic benefit on a patient requiring CPAP because of respiratory failure caused by the virus, used in the initial care of patients requiring support.