TGA and Philips Sign MOU Over Defibrillator Supply
Australia’s Therapeutic Goods Administration and Philips Electronics have entered into a memorandum of understanding under which Philips has agreed to notify the agency of any anticipated shortage of parts associated with its HeartStart MRx defibrillator and to provide service as needed.
Philips advised the TGA in May 2017 that the HeartStart MRx would no longer be supplied, but it continues to be used and supported in hospitals, clinics and ambulances across Australia.
Under the agreement, Philips has agreed to continue service until Dec 31, 2022, and it will meet with the TGA twice yearly and report adverse events as required under normal operations.
TGA Issues Guidance on Regulation of Menstrual Cups
Australia’s TGA advised sponsors that menstrual cups no longer need to be included on the Australian Register of Therapeutic Goods (ARTG).
Prior to July 1, menstrual cups were required to be listed on the register, but listing is no longer required for these products. However, menstrual cups are required to comply with Therapeutic Goods Order No. 99 — Standards for Menstrual Cups 2018 before they can be supplied in Australia.
The TGA advised sponsors that they should notify the TGA to de-list the products from the registry or they will need to pay applicable fees.
Under the regulatory requirements, manufacturers should be able to demonstrate that the materials are in compliance with relevant standards, the agency says.
The guidance lists requirements for design, packaging, labeling on both the package and the information leaflet. Reporting adverse events associated with the device remains mandatory.
India Recalls Allergan’s Ozurdex Intravitreal Implant
India’s Central Drugs Standard Control Organization (CDSCO) recalled Allergan’s Ozurdex 700 mg intravitreal implant because a single loose silicone particle may become detached from the needle sleeve during administration of the implant and may be delivered into the eye.
The defect was discovered during a routine manufacturing inspection. The 300 micron silicone particle originated from the needle sleeve. Additional testing by Allergan found two to four percent of defective units, but defect rates as high as 22 percent have been reported.
Although the root cause of the defect has not yet been determined, Allergan identified a corrective action that eliminates creation of the particle and is implementing the correction before releasing additional stock.
Allergan said the silicone particle “is not expected to degrade, and it will remain permanently in the vitreous cavity unless removed.” The company warned that a corneal adverse reaction could not be ruled out (IDDM, Oct. 15).
Allergan said that for some patients the benefit of the product might outweigh the risk.
CDSCO directed Allergan India to recall all defective lots imported into India, which included seven batches manufactured between 2016 and 2018.