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Review Article

The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review

ORCID Icon, , , , ORCID Icon & ORCID Icon
Pages 2458-2465 | Received 24 Oct 2016, Accepted 24 May 2017, Published online: 20 Jun 2017

References

  • International Standards Organisation. Business plan ISO/TC 168 prosthetics and orthotics. Geneva: International Standards Organisation; 2004.
  • Klasson B, Jones D. ISPO workshop on quality management in prosthetics and orthotics. Prosthet Orthot Int. 2000;24:188–195.
  • Council of the European Communities. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Luxembourg: Council of the European Communities; 1993.
  • Sorenson C, Drummond M. Improving medical device regulation: the United States and Europe in perspective. Milbank Q. 2014;92:114–150.
  • Centres for Medicare and Medicaid Services. Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) quality standards. Baltimore: Centres for Medicare and Medicaid Services; 2008.
  • International Society for Prosthetics and Orthotics, Campbell JN, Martina J. Report of a consensus conference on the orthotics management of stroke patients: held at Avegoor Conference Centre, Ellecom, Netherlands, 21st-26th September 2003. Condie E, editor. Ellecom, Netherlands: International Society for Prosthetics and Orthotics; 2004.
  • Ramstrand N, Jacobs NA. ISPO consensus conference on appropriate lower limb orthotics for developing countries: conclusions and recommendations. Prosthet Orthot Int. 2007;31:214–216.
  • Morris C, Condie D, Fisk J. ISPO cerebral palsy consensus conference report (available free at www.ispoweb.org). Prosthet Orthot Int. 2009;33:401–402.
  • Bowers R. Use of ankle-foot orthoses following stroke. Glasgow: NHS Quality Improvement in Scotland; 2009.
  • Churchill N, Regan C. Improving the quality of orthotics services in England. London: NHS England; 2015.
  • Group TRoLLAW. VA/DoD clinical practice guideline for rehabilitation of lower limb amputation. Washington: Department of Veterans Affairs, Department of Defence; 2007.
  • Ankle-Foot & Knee-Ankle-Foot Orthotics (Braces): Anthem; 2015 [cited 2016 Feb 13]. Available from: https://www.anthem.com/medicalpolicies/guidelines/gl_pw_a053659.htm
  • Therapeutic Shoes, Inserts or Modifications for Individuals with Diabetes: Anthem; 2015 [cited 2016 Feb 13]. Available from: https://www.anthem.com/medicalpolicies/guidelines/gl_pw_a053655.htm
  • Prefabricated and Prophylactic Knee Braces: Anthem; 2015 [cited 2016 Feb 13]. Available from: https://www.anthem.com/medicalpolicies/guidelines/gl_pw_a047994.htm
  • Custom-made Knee Braces: Anthem; 2015 [cited 2016 Feb 13]. Available from: https://www.anthem.com/medicalpolicies/guidelines/gl_pw_b088536.htm
  • Jarvis V, Verrall T. Prosthetic best practice guidelines. Leeds: RSL Steeper; 2011.
  • International Committee of the Red Cross. Manufacturing guidelines: patellar tendon bearing orthosis. Geneva: International Committee of the Red Cross; 2006.
  • International Committee of the Red Cross. Manufacturing guidelines: knee ankle foot orthosis. Geneva: International Committee of the Red Cross; 2006.
  • International Committee of the Red Cross. Manufacturing guidelines: partial foot prosthesis. Geneva: International Committee of the Red Cross; 2006.
  • International Committee of the Red Cross. Manufacturing guidelines: trans-tibial prosthesis. Geneva: International Committee of the Red Cross; 2006.
  • International Committee of the Red Cross. Manufacturing guidelines: trans-femoral prosthesis. Geneva: International Committee of the Red Cross; 2006.
  • Department of Health and Human Services – Centre for Medicare and Medicaid Services. Manufacturing guidelines: ankle foot orthosis. Geneva: International Committee of the Red Cross; 2010.
  • International Committee of the Red Cross. Manufacturing guidelines: Push fit Syme prosthesis. Geneva: International Committee of the Red Cross; 2013.
  • International Committee of the Red Cross. Manufacturing guidelines: Syme prosthesis with medial window. Geneva: International Committee of the Red Cross; 2013.
  • British Association of Prosthetists and Orthotists. Standards for best practice. Paisley: British Association of Prosthetists and Orthotists; 2013.
  • Jarrett B. Prescription custom foot orthoses practice guidelines. Bethesda (MD): American College of Foot and Ankle Orthopedics and Medicine; 2006.
  • Kilbride C. Splinting for the prevention and correction of contractures in adults with neurological dysfunction: practice guideline for occupational therapists and physiotherapists. London: College of Occupational Therapists, Association of Chartered Physiotherapists in Neurology; 2015.
  • Saint M. Hand and wrist orthoses for adults with rheumatological conditions. London: College of Occupational Therapists; 2015.
  • Geertzen J, van der Linde H, Rosenbrand K, et al. Dutch evidence-based guidelines for amputation and prosthetics of the lower extremity: rehabilitation process and prosthetics. Part 2. Prosthet Orthot Int. 2015;39:361–371.
  • Geertzen J, van der Linde H, Rosenbrand K, et al. Dutch evidence-based guidelines for amputation and prosthetics of the lower extremity: amputation surgery and postoperative management. Part 1. Prosthet Orthot Int. 2015;39:351–360.
  • Eagle M. Guidelines for exercise and orthoses in children with neuromuscular disorders. London: Muscular Dystrophy UK; 2003.
  • Smith TO, Drew BT, Meek TH, et al. Knee orthoses for treating patellofemoral pain syndrome. Cochrane Database Syst Rev. 2015;12:CD010513.
  • Beaudreuil J, Bendaya S, Faucher M, et al. Clinical practice guidelines for rest orthosis, knee sleeves, and unloading knee braces in knee osteoarthritis. Joint Bone Spine. 2009;76:629–636.
  • Van Der Linde H, Hofstad CJ, Van Limbeek J, et al. Use of the Delphi technique for developing national clinical guidelines for prescription of lower-limb prostheses. JRRD. 2005;42:693–704.
  • Armstrong R, Hall BJ, Doyle J, Cochrane Update, et al. 'Scoping the scope' of a Cochrane review. J Public Health (Oxf). 2011;33:147–150.
  • Pratt DJ. British standard (BS) 5750-quality assurance? Prosthet Orthot Int. 1995;19:31–36.
  • Condie DN. In: Hsu JD, Michael JW, Fisk JR, editors. AAOS Atlas of Orthoses and Assistive Devices. International Organization for Standardization (ISO) terminology. 4th ed. Philadelphia: Mosby-Elsevier; 2008. p. 3–8.
  • Condie DN. The modern era of orthotics. Prosthet Orthot Int. 2008;32:313–323.
  • Coombes R. Europe's plan to tighten regulation of devices will not reach US standards. BMJ (Clinical Research Ed). 2012;345:e6303.
  • Moore R. Standardising. New medical technologies, Part II. Med Technol. 2002;13:30–31.
  • Moore R. Standards in the 21st century. Standardising new medical technologies, Part I. Med Technol. 2002;13:44–45.
  • Resnik L, Klinger SL, Krauthamer V, et al. U.S. food and drug administration regulation of prosthetic research, development, and testing. J Prosthet Orthot. 2010;22:121–126.
  • Gingerich BS. CMS durable medical equipment prosthetics, orthotics, and supplies (DMEPOS) quality standards. Home Health Care Manag Pract. 2009;21:430–431.
  • Joint Commission on Accreditation of Healthcare Organizations. CMS recognizes Joint Commission accreditation for durable medical equipment, prosthetics, orthotics, and supplies. Joint Commission Perspectives 2007;27:1–5.
  • Parver C, O'Connor B. DMEPOS (Durable Medical Equipment, Prosthetics, Orthotics and Supply) model compliance program: does the OIG have it right? Caring. 1999;18:20–23.
  • Stover Gingerich B. Durable medical equipment prosthetics, orthotics, and supplies (DMEPOS) accreditation. Home Health Care Manag Pract. 2008;20:495–497.
  • Gingerich BS. Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) accreditation options. Home Health Care Manag Pract. 2007;19:317–318.
  • Jacobs BC, Lee JA. Durable medical equipment: types and indications. Med Clin North Am. 2014;98:881–893.
  • Buzatu M, Gheorghe G, Dontu O, et al. The lower limb prosthetic devices quality management. Romanian Rev Precision Mechanics Optics Mechatronics. 2013;44:135–139.
  • Cutler T, Cpo F. An orthotist's concern about research findings and recommendations. J Prosthet Orthot. 2015;27:118–119.
  • Fraser AG, Krucoff MW, Brindis RG, et al. Commentary: international collaboration needed on device clinical standards. BMJ 2011;342:d2952–d2952.
  • Morris C, Condie D. Aiming to improve the health care of people with cerebral palsy worldwide: a report of an International Society for Prosthetics and Orthotics conference. Dev Med Child Neurol. 2009;51:689.
  • Bowers R, Ross K. Development of a best practice statement on the use of ankle-foot orthoses following stroke in Scotland. Prosthet Orthot Int. 2010;34:245–253.
  • Hijmans JM, Geertzen JH. Development of clinical guidelines for the prescription of orthoses in patients with neurological disorders in the Netherlands. Prosthet Orthot Int. 2006;30:35–43.
  • Sedki I, Fisher K. Developing prescribing guidelines for microprocessor-controlled prosthetic knees in the South East England. Prosthet Orthot Int. 2015;39:250–254.
  • Sneed RC, May WL, Stencel C. Policy versus practice: comparison of prescribing therapy and durable medical equipment in medical and educational settings. Pediatrics. 2004;114:e612–ee25.
  • Williams AE, Graham AS, Davies S, et al. Guidelines for the management of people with foot health problems related to rheumatoid arthritis: a survey of their use in podiatry practice. J Foot Ankle Res. 2013;6:23.
  • Colombo C, Marchesin EG, Vergani L, Boccafogli E, et al. Study of an ankle prosthesis for children: adaptation of ISO 10328 and experimental tests. Procedia Eng. 2011;10:3510–3517.
  • Mason ZD, Pearlman J, Cooper RA, et al. Comparison of prosthetic feet prescribed to active individuals using ISO standards. Prosthet Orthot Int. 2011;35:418–424.
  • Suvapan D, Sorachaimetha P, Junsa-ard T, et al. The evaluation of Sirindhorn National Medical Rehabilitation Centre guideline for prosthetic knee testing. Bangkok, Thailand: In Proceedings of the 5th International Conference on Rehabilitation Engineering & Assistive Technology; 2011. p. 46.
  • Ikeda AJ, Grabowski AM, Lindsley A, et al. A scoping literature review of the provision of orthoses and prostheses in resource-limited environments 2000–2010. Part one: considerations for success. Prosthet Orthot Int. 2013;38:269–286.
  • Ikeda AJ, Grabowski AM, Lindsley A, et al. A scoping literature review of the provision of orthoses and prostheses in resource-limited environments 2000–2010. Part two: research and outcomes. Prosthet Orthot Int. 2014;38:343–362.
  • Forghany S, Sadeghi-Demneh E, Trinler UK, et al. The influence of staff training and education on prosthetic and orthotic service quality. Prosthet Orthot Int. Forthcoming. 2017.
  • Banwell HA, Mackintosh S, Thewlis D, et al. Consensus-based recommendations of Australian podiatrists for the prescription of foot orthoses for symptomatic flexible pes planus in adults. J Foot Ankle Res. 2014;7:49.
  • Morris C, Bowers R, Ross K, et al. Orthotic management of cerebral palsy: recommendations from a consensus conference. NeuroRehabilitation. 2011;28:37–46.

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