How can we best protect patients while making progress?
The pace of development in new surgical procedures and technologies continues to accelerate, driven in part by manufacturers, surgeons and community expectations. Despite regulatory bodies such as the Therapeutic Goods Administration (TGA), new devices can enter the market with little or no evidence of their effectiveness, and even their safety can be poorly evaluated. The withdrawal of the DePuy Orthopaedics articular surface replacement hip prosthesis illustrates the difficulty in anticipating the unintended problems with a joint prosthesis that superficially appeared to be little different from hundreds of others already available on the market.1
- 1. Australian Government, Department of Health, Therapeutic Goods Administration. Recall of DePuy Orthopaedics ASR hip replacement device. Behind the News; 16 May 2011. https://www.tga.gov.au/behind-news/recall-depuy-orthopaedics-asr-hip-replacement-device (accessed Mar 2015).
- 2. Medical Services Advisory Committee. Guidelines for the assessment of diagnostic technologies. Aug 2005. http://www.health.gov.au/internet/msac/publishing.nsf/Content/D81BE529B98B3DB6CA2575AD0082FD1B/$File/Guidelines%20for%20the%20assessment%20of%20diagnostic%20technologies%20Sept%202005.pdf (accessed Mar 2015).
- 3. Maddern G. The Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S) assesses new surgeries. Aust Health Rev 2004; 28: 143-144.
- 4. Chen D, Barber C, McLoughlin P, et al. Systematic review of endoscopic treatments for gastro-oesophageal reflux disease. Br J Surg 2009; 96: 128-136.
- 5. Thavaneswaran P, Richardson C, Humphreys K, Maddern G. ASERNIP-S Report No. 75. Robotic-assisted surgery for urological, cardiac and gynaecological procedures. Adelaide: ASERNIP-S, May 2009. http://www.surgeons.org/media/299238/RPT_2009-12-09_Robotic-assisted_Surgery.pdf (accessed Apr 2015).
- 6. Australia and New Zealand Horizon Scanning Network. Horizon scanning technology prioritising summary. Robotic-assisted endoscopic thyroidectomy. Nov 2009. http://www.horizonscanning.gov.au/internet/horizon/publishing.nsf/Content/A21BB57C2AA8FA71CA2575AD0080F3DF/$File/PS%20robot%20assisted%20thyroidectomy.pdf (accessed Mar 2015).
- 7. McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009; 374: 1105-1112.
- 8. McCulloch P, Cook JA, Altman DG, et al. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ 2013; 346: f3012.
- 9. Barkun JS, Aronson JK, Feldman LS, et al. Evaluation and stages of surgical innovations. Lancet 2009; 374: 1089-1096.
- 10. Koehestanie P, de Jonge C, Berends FJ, et al. The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicentre randomized controlled trial. Ann Surg 2014; 260: 984-992.
- 11. Weber T, Roitman M, Link KH. Current status of cytoreductive surgery with hyperthermic intraperitoneal chemotherapy in patients with peritoneal carcinomatosis from colorectal cancer. Clin Colorectal Cancer 2012; 11: 167-176.
- 12. Boekstegers P, Hausleiter J, Baldus S, et al; Germany Society of Cardiology Working Group on Interventional Cardiology Focus Group on Interventional Mitral Valve Therapy. Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system. Clin Res Cardiol 2014; 103: 85-96.
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