Orthopaedics firm DePuy has voluntarily recalled two of its hip replacement products, after post-market surveillance data showed a high risk of revision rates for patients implanted with the devices...
The Irish Medicines Board has issued a general advisory explaining the importance of establishing and managing effective traceability systems for medical devices in all healthcare settings 1 . The...
New Zealand's regulatory agency Medsafe is planning to deliver an updated version of its Uniform Recall Procedure for Medicines and Medical Devices (known as the Recall Code) by the end of September...
The US Food and Drug Administration should, as far as possible, rely on existing standards to achieve the objectives of its "home-use" initiative, which aims to assure the safe use of medical devices...
The US Supreme Court has agreed to review Matrixx Initiatives Inc v Siracusano, a case that has the potential to determine which adverse event reports drug and medical device companies must disclose...
It is “staggering” how many manufacturers fail to fully fulfil their legal responsibility to collect product data in the post-production phase, according to a senior official at the UK Medicines and...
Alex Denoon and Erik Vollebregt analyse the post-marketing surveillance obligations introduced in March. Post-marketing surveillance (PMS) obligations introduced in March 2010 for medical devices...
Critical biocompatibility tests that French regulatory agency Afssaps is conducting on the unauthorised silicone filler that was used in thousands of breast implants made by Poly Implant Prothèse...
Baxter Healthcare has been ordered by the US Food and Drug Administration to recall and destroy all of its Colleague infusion pumps in the US due to “a longstanding failure to correct many serious...
The UK Medicines and Healthcare products Regulatory Agency has issued a device alert requiring that all patients with metal-on-metal (MoM) hip replacements undergo a tighter follow-up regime 1 ....
The US Food and Drug Administration has warned the public that about 280,000 external defibrillators currently being used worldwide may malfunction during attempts to rescue people in sudden cardiac...
The Global Harmonization Task Force has expanded its focus on ethical considerations in the final version of its guidance on pre-market clinical investigations for medical devices 1 . It has also...
Reprocessing of single-use medical devices (SUDs) may pose several potential hazards and put patients at risk, the European Commission’s independent Scientific Committee on Emerging and Newly...
The American Academy of Orthopaedic Surgeons is on the “verge of making a US joint replacement registry a reality” 1 . The American Joint Replacement Registry, which was incorporated in 2009 2 , will...
The Swiss government has aligned its national laws with the European Union’s amending medical devices legislation (Directive 2007/47/EC) and has also introduced some country-specific measures, all of...
