Clinical Evidence for Customised Procedure Packs

Senior Validation Officer - Biological Therapies

May 2015

< 1 min reading time

My company is a manufacturer of Customised Procedure Packs (CPP’s) and we need to prepare clinical evidence in regard to these packs. Apart from literature reviews, does anyone have any suggestions on how to obtain the appropriate evidence to meet TGA requirements for a Technical File? Any help would be greatly appreciated. If anyone is interested in preparing such a report, my company would be prepared to pay a reasonable price for preparation of the report.
Thanking you all in advance.
Rodney Button.

source: https://www.linkedin.com/groups/78665/78665-6004720397562494977

Marked as spam

Posted by Rodney Button

Asked on May 14, 2015 8:00 am

60 views

	Private answer In addition to literature reviews copies of successful, and electronically available submissions, would be worth seriously looking for. Marked as spam Report spam
	Private answer Not sure what the definition of 'clinical evidence' is, but you could try interviews with hospitals who have experience using the packs. It's anecdotal but better than nothing, and might lead to opportunities to collect data. Marked as spam Report spam
	Private answer Duncan Dando Rodney, Who has specified the content of the packs and their intended use? Are the devices in the pack CE marked? Duncan Marked as spam Report spam
	Private answer Conduct a research trial, organizing the study goals to determine hospital efficiency outcomes rather than the traditional patient outcomes. This strategy will help you achieve evidence-based clinical value. If I can be of any help please do not hesitate to reach out. Godspeed Marked as spam Report spam
	Private answer Rodney Button Thank you all for your comments. In answer to Duncan's questions, the customer (usually a hospital) specifies the contents and their intended use. My company only packs and sterilises the individual medical devices requested by the customer. The devices in the pack are either CE marked or have an Australian ARTG number, or both. Marked as spam Report spam
	Private answer Duncan Dando If your customer specifies the contents and intended use, could they not be consider a procedure pack under MDD article 12? No specific clinical evaluation would be required. Not sure how this would affected Australian Competent Body requirements. Marked as spam Report spam
	Private answer Rodney - I suggest you prepare a brief clinical assessment declaration and have it signed by one (or more) representative clinical experts from your pool of customers. This declaration should simply get the message across that the procedure pack has been supplied in accordance with clinical requirements, and that clinical experience so far in using the procedure pack has indicated that it fulfills the intended clinical purpose effectively and safely. You should prepare (at least) one separate declaration for each logical 'group' of your procedure packs - and also make sure you keep a CV on file for each of your signing clinical experts (indicating that they are indeed relevant clinical experts). PM me with your phone/e-mail if you want to chat more... Cheers, Tim Marked as spam Report spam

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