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A risk management approach to the design of contraceptive implants

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Rowlands, Sam, Sujan, Mark-Alexander and Cooke, Matthew, MB ChB. (2010) A risk management approach to the design of contraceptive implants. Journal of Family Planning and Reproductive Health Care, Vol.36 (No.4). pp. 191-195. ISSN 2045-2098

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Official URL: http://dx.doi.org/10.1783/147118910793048593

Abstract

Key message points - Appreciation of human factors can provide useful insights into the reduction of risks through intuitive device design and the management of contributory factors in the environment. - Risks of implants relate to the way in which devices are designed and used rather than to their pharmacological properties. - The risks associated with the use of contraceptive implants include non-insertion and deep insertion

Item Type: Journal Article
Subjects: R Medicine > RG Gynecology and obstetrics
Divisions: Faculty of Medicine > Warwick Medical School > Institute of Clinical Education (ICE)
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Contraceptive drug implants -- Design, Contraceptive drug implants -- Risk assessment
Journal or Publication Title: Journal of Family Planning and Reproductive Health Care
Publisher: B M J Group
ISSN: 2045-2098
Date: October 2010
Volume: Vol.36
Number: No.4
Number of Pages: 5
Page Range: pp. 191-195
Identification Number: 10.1783/147118910793048593
Status: Peer Reviewed
Access rights to Published version: Restricted or Subscription Access
References: (1) ISO 14971 Medical devices - application of risk management to medical devices. Geneva: International Organization for Standardization; 2007. (2) Tonks A. Patient safety: safer by design. BMJ 2008; 336:186-188. (3) Grout J, College B, Rome GA. Mistake-proofing the design of health care processes AHRQ publication 07-0020. Rockville MD: Agency for Healthcare Research and Quality; 2007. (4) Darney P. Implantable contraception. European Journal of Contraception & Reproductive Health Care 2000; 5 (Suppl 2):2-11. (5) National Collaborating Centre for Women's and Children's Health. Long-acting reversible contraception (NICE guideline). London: RCOG [http://www.nice.org.uk]; 2005. (6) Lader D. Contraception and sexual health, 2008/09. Newport: Information Centre; 2009. (7) Mansour D. Nexplanon® - what Implanon did next. J Fam Plann Reprod Health Care 2010; 36. (8) Summary of Product Characteristics for Implanon http://www.medicines.org.uk/EMC/medicine/5382/SPC/Implanon+68mg+implant+for+subdermal+use/. 2009. (9) Mascarenhas L. Insertion and removal of Implanon®. Contraception 1998; 58 (Suppl 6):79S-83S. (10) Rowlands S. Legal aspects of contraceptive implants. J Fam Plann Reprod Health Care 2010; 36. (11) Wenck BCA, Johnston PJ. Implanon and medical indemnity: a case study of risk management using the Australian standard. Med J Aust 2004; 181:117-119. (12) Mansour D, Fraser IS, Walling M, Glenn D, Graesslin O, Egarter C et al. Methods of accurate localisation of non-palpable subdermal contraceptive implants. J Fam Plann Reprod Health Care 2008; 34:9-12. (13) Good manufacturing practice guidelines. EuraLex Volume 4. Brussels: European Commission; 2009. (14) Edwards JE, Moore A. Implanon: a review of clinical studies. Br J Fam Planning 1999; 24 (Supplement):3-16. (15) Newton J, Newton P. Implanon® - the single-rod subdermal contraceptive implant. J Drug Eval 2003; 1:181-218. (16) Meirik O, Fraser IS, d'Arcangues C. Implantable contraceptives for women. Human Reproduction Update 2003; 9:49-59. (17) Darney P, Patel A, Rosen K, Shapiro LS, Kaunitz AM. Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials. Fertil Steril 2009; 91:1646-1653. (18) Reason J. Managing the risks of organizational accidents. London: Ashgate; 1997. (19) Norman DA. The psychology of everyday things. New York: Basic Books; 1987. (20) Vincent C, Taylor-Adams S, Stanhope N. Framework for analysing risk and safety in clinical medicine. BMJ 1998; 316:1154-1157. (21) BS EN 62366 Medical devices - application of usability engineering to medical devices. Bristol: British Standards Institution; 2008. (22) Walling M. How to remove impalpable Implanon® implants. J Fam Plann Reprod Health Care 2005; 31:320-321. (23) Mansour D, Mommers E, Teede H, Sollie-Eriksen B, Graesslin O, Ahrendt H-J et al. Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial. Contraception 2010; 82:243-249.
URI: http://wrap.warwick.ac.uk/id/eprint/36887

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