Brandwood Biomedical Newsletter May 2008

We’ll see you at AusMedtech08!

 

The Inaugural AusMedtech conference will be held in Sydney 12-13 May. This event will bring together Australian Medical Device developers and manufacturers for a two day industry conference and exhibition covering all aspects of medical devices business. Brandwood Biomedical Principal Arthur Brandwood will Chair the main regulatory affairs session, which features a presentation from TGA’s Rita Maclachlan on the TGA’s new business models top manage the Post October 2007 regulatory system. Of particular importance is that TGA will now manage new conformity assessment applications as a separate “queue” to the large backlog of already marketed devices transitioning from the old “listing” rules. By doing this it’s aimed to speed up processing of new device applications to within target timeframes.  TGA is also placing much more emphasis on clinical evidence and post market monitoring of devices.

For those new to the regulation of medical devices, or needing an overview of how the whole system works, the session will feature ‘Regs to Riches?’ a hypothetical to both inform and entertain.  A panel of government and industry experts will explore regulatory requirements for a medical device – from invention through clinical trials, product approval and post market monitoring.   We look forward to meeting you there. Read full details in the conference program   Register for the event with Ausbiotech here.

CE Mark approval awarded for Nanosonics Ultrasound Disinfector

 

We are very proud to congratulate our longstanding client Nanosonics, on the award of the CE Mark for their Ultrasound Disinfector device. This advanced Australian designed and manufactured device replaces manual liquid disinfection methods and will bring new levels of safety and convenience to the disinfection of ultrasound probes in the clinic. Read the Nanosonics announcement here.

Ordered Apples and received Oranges – or Lemons?

 

Adequate control over subcontractors is an essential part of ISO 13485 quality systems. Outsourcing a process does not absolve a manufacturer from its responsibilities to meet the requirements of ISO 13485 or product regulatory requirements. Any process that the organisation has identified as being needed for its quality system but has decided, for whatever reason, to contract to an external party must be formally controlled. The extent of controls is dependent on the criticality of the process, the risk involved and the competence of the subcontractor. Subcontractors (“vendors”) need to be explicitly assessed, approved and monitored. Such controls can range from a simple questionnaire or telephone survey documenting satisfactory competence and internal controls at the subcontractor to a direct audit of the subcontractor, plus requirement for the supplier to maintain externally accredited quality systems. The importance of vendor controls has been illustrated in two recent well publicised cases.

• In early April the US FDA announced it is seeking US$ 2.2 million in civil penalties from Advanced Bionics, a US manufacturer of cochlear implants, over failure to comply with current GMP requirements, specifically those relating to supplier control. Advanced Bionic's alleged GMP violations include “the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the cochlear implant by testing lots under actual or simulated use when the unapproved vendor's component was used”. Advanced Bionics had previously been required to recall affected product.

• Also in April, there were recalls around the world of a range of medicines and devices containing heparin.  Here in Australia TGA recalled 5 batches of the anticoagulant Clexane.  FDA has received approximnately 80 reports of patient deaths following severe anaphylactic or allergic reactions related to contaminated heparin. The Heparin source was a Chinese sub contractor Scientific Protein Laboratories (SPL) of Changzhou, which provides heparin to a range of medicine and device manufacturers worldwide.  SPL in turn sourced raw materials from a number of suppliers and it is believed that the contamination was introduced by one of these suppliers.  Read the FDA notice to manufacturers for more detail on this event.
  

When deciding to outsource processes - particularly critical design or production activities, it's vital to understand the level of risk, and how the suppliers are to be assessed, approved and continuously monitored - and to factor those costs into the sub contracting decision.