Abstract
A number of groups have published their positions on reuse of hemodialyzers and concerned physicians, nurses, technicians, and patients have developed advisory guidelines to promote safe and effective reprocessing methods. Some patients have complained of situations where they perceived evidence of improper reuse techniques (P. Lundin, personal communication). A representative of the National Association for Patients on Hemodialysis and Transplant (NAPHT) has urged external controls on the grounds that vested interests may undermine the medical profession’s concern for the welfare of the patients (M. Klavins, unpublished). Certain governmental bodies agree that mandatory regulations on reuse of hemodialyzers are required to assure the public health and have promulgated mandatory standards. This chapter presents a general discussion of regulatory and standards activities followed by an analysis of the specific provisions of proposed and finalized regulations and standards (table 12-1).
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Department of Health and Human Services, Health Care Financing Administration: Medicare program; end-stage renal disease program; prospective reimbursement for dialysis services and approval of special purpose facilities; final rule, 1983. Fed Register 48: 2 1272, 1983.
National Kidney Foundation: Revised standards for reuse of hemodialyzers, December 2, 1983. Contemp Dial 5(2):29 and 37, 1984.
Food Drug Administration (FDA): Compliance policy guide 7124.16: reuse of medical disposable devices, chapter 24, devices, July 1, 1981. Contemp Dial 3 (6): 32, 1982.
Alabama reverses itself and allows reuse. Contemp Dial 3 (6): 40, 1982.
Colorado Department of Public Health: 6C.C.R. 1011–1 chapter 11: Licensure, 7.0: single use of disposable medical devices. Contemp Dial 3(7):21, 1982.
California reuse delay continues. Contemp Dial 5 (2): 10, 1984.
Illinois reuse ban delayed. Contemp Dial 5 (9): 13, 1984.
Zom TS: Study of the reuse of renal dialyzers. Contemp Dial 3 (10): 34–40, 1982.
JCAH: Accreditation manual of hosptials. Joint Commission on the Accreditation of Hospitals, Chicago, 1983.
Barnes A: Reuse and JCAH accreditation. AAMI Technical Assessment Report 6-83: reuse of disposables. Association for the Advancement of Medical Instrumentation, Arlington VA, 1983.
Easterling RE: Introduction, commentary and direction for the future. AAMI Technical Assessment Report 6-83: reuse of disposables. Association for the Advancement of Medical Instrumentation, Arlington VA, 1983.
Ogden DA: If carefully observed, new National Kidney Foundation dialyzer reuse standards offer assurance of safe, effective dialysis. Contemp Dial 5 (2): 5, 1984.
Taylor JD: Dialyzer reuse: industry concerns regarding the practice or remanufacture and reuse of single-use hemodialyzers. Contemp Dial 3(7):52–56, 1982, and 3 (8): 47–50, 1982.
Deane N, Bemis JA: Multiple use of hemodialyzers: final report to the National Institute of Arthritis, Diabetes and Digestive and Kidney Diseases. Contract NO1-AM-9-2214. June 1981, pp 53–64.
Epilogue. AAMI Technical Assessment Report 6-83: reuse of disposables. Association for the Advancement of Medical Instrumentation, Arlington VA, 1983, pp 88–94.
Favero MS, Deane N, Leger RT, Sosin HE: Effect of multiple use of dialyzers on hepatitis B incidence in patients and staff. JAMA 245: 166–167, 1981.
American National Standard for First Use Hemodialyzers. Association for the Advancement of Medical Instrumentation, Arlington VA, 1984.
Pizzaconi VB: QA and QC aspects of reuse. AAMI Technical Assessment Report 6-83: reuse of disposables. Association for the Advancement of Medical Instrumentation, Arlington VA, 1983, pp 76–82.
Gotch FA: Quality control tests for validation of dialyzer performance. AAMI Technical Assessment Report: hemodialyzer reuse: issues and solutions. Association for the Advancement of Medical Instrumentation, Arlington VA, 1985, pp 37–41.
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1986 Martinus Nijhoff Publishing
About this chapter
Cite this chapter
Easterling, R.E. (1986). Regulations and Standards. In: Deane, N., Wineman, R.J., Bemis, J.A. (eds) Guide to Reprocessing of Hemodialyzers. Developments in Nephrology, vol 15. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-2313-6_12
Download citation
DOI: https://doi.org/10.1007/978-1-4613-2313-6_12
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4612-9423-8
Online ISBN: 978-1-4613-2313-6
eBook Packages: Springer Book Archive