In 2016, the Food and Drug Administration (FDA) will be taking a stronger stance on reporting medical device complications and deaths. The agency’s newly published draft guidance will allow it to report early warnings signs associated with medical devices before the reports have been fully analyzed.
The FDA currently releases safety warnings and recalls on its website. That said, prior to this guidance the agency was unable to release any information on possible complications and injuries related to said warnings until after the all reports had been fully analyzed. The issue was that the agency receives hundreds of thousands of device safety reports in need of vetting each year.
The Boston Scientific Corp. issued an urgent medical device recall of its RotaWire “Elite” core wires and wireClip Torquer guidewires on November 27. The company said the guidewires may crack and detach from the Rotablator Rotational Atherectomy System (RRAS). The RRAS is used to open narrow arteries and cut away at plaque, improving blood flow to the heart. When the guidewires crack, the pieces can be left inside the artery causing tamponade or heart attacks. Boston Medical has learned of three incidents of guidewires cracking so far, with one case resulting in a patient’s death.
The recall comes in the wake of a FDA safety communication on intravascular devices. Since 2014, the FDA has received 500 medical device reports on peeling hydrophilic and/or hydrophobic coatings on intravascular devices, with the majority of reports submitted for vascular guidewires.
The FDA encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Facilities still using these guidewires are told to stop using them immediately. All affected products should be returned to Boston Scientific and distributors should notify any customer who may have received the product.
Hi blog readers,
Although this posting isn’t specifically accreditation-related, I thought you might find the ECRI’s list of top 10 medical device hazards of 2008. The list is as follows:
- Alarm hazards
- Needlesticks and other sharps injuries
- Air embolism from contrast media injectors
- Retained devices and fragments left in patients
- Surgical fires
- Anesthesia hazards related to poor equipment inspection prior to use
- Misleading displays on equipment
- High radiation levels associated with CT scan
- MRI burns
- Fiberoptic light-source burns, usually from endoscopes, retractors, and head lamps
This year’s list differed from last years in that five new hazards were added. The ECRI institute does not want hospital staff members to think that those hazards left off the list this year are no longer problems–instead the institute felt that they should highlight some new concerns this year. Last year’s list also included burns during electrosurgery, caster failures, infusion pump programming errors, misconnection of blood pressure monitors to IV lines, and radiation therapy errors.
Do you see these hazards occurring in your facilities? How have you tried to make sure they don’t occur?
To read the ECRI Institute’s full report, click here.