Guideline Development for Medical Device Technology: Issues for Consideration

Author:

Battelino Tadej1ORCID,Brosius Frank2,Ceriello Antonio3,Cosentino Francesco4,Green Jennifer5,Kellerer Monika6,Koob Susan7,Kosiborod Mikhail89,Lalic Nebojsa10,Marx Nikolaus11,Nedungadi T. Prashant12,Rydén Lars13,Rodbard Helena W.14,Ji Linong15ORCID,Sheu Wayne Huey-Herng16,Standl Eberhard17,Parkin Christopher G.18ORCID,Schnell Oliver17ORCID

Affiliation:

1. University Medical Center Ljubljana, University of Ljubljana, Ljubljana, Slovenia

2. University of Arizona College of Medicine–Tucson, AZ, USA

3. IRCCS MultiMedica, Milan, Italy

4. Cardiology Unit, Department of Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden

5. Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA

6. Marienhospital Stuttgart, Stuttgart, Germany

7. PCNA National Office, Madison, WI, USA

8. Saint Luke’s Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA

9. The George Institute for Global Health, University of New South Wales, Sydney, Australia

10. Clinic for Endocrinology, Diabetes and Metabolic Diseases, University Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia

11. Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany

12. American Heart Association, Dallas, TX, USA

13. Department of Medicine K2, Karolinska Institute, Stockholm, Sweden

14. Endocrine and Metabolic Consultants, Rockville, MD, USA

15. Peking University People’s Hospital, Beijing, China

16. Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung City

17. Forschergruppe Diabetes e.V., Munich, Germany

18. CGParkin Communications Inc., Henderson, NV, USA

Abstract

Advances in the development of innovative medical devices and telehealth technologies create the potential to improve the quality and efficiency of diabetes care through collecting, aggregating, and interpreting relevant health data in ways that facilitate more informed decisions among all stakeholder groups. Although many medical societies publish guidelines for utilizing these technologies in clinical practice, we believe that the methodologies used for the selection and grading of the evidence should be revised. In this article, we discuss the strengths and limitations of the various types of research commonly used for evidence selection and grading and present recommendations for modifying the process to more effectively address the rapid pace of device and technology innovation and new product development.

Publisher

SAGE Publications

Subject

Biomedical Engineering,Bioengineering,Endocrinology, Diabetes and Metabolism,Internal Medicine

Reference153 articles.

1. International Diabetes Federation. IDF Diabetes Atlas, 10th ed. Brussels, Belgium: International Diabetes Federation. https://diabetesatlas.org/atlas/tenth-edition/. Published 2021. Accessed January 31, 2022.

2. Gaps and barriers in the control of blood glucose in people with type 2 diabetes

3. World Health Organization (WHO). Draft global strategy on human resources for health: workforce 2030. Geneva, Switzerland: World Health Organization. https://www.who.int/health-topics/health-workforce#tab=tab_1. Published 2016. Accessed March 3, 2020.

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