Hemo-dialyzer reuse is the practice of using the dialyzer
multiple times for a single patient. The basic procedure for dialyzer
reprocessing involves four steps: rinsing, cleaning, performance testing,
and disinfection/sterilization. The process of reprocessing is done
by automated or manual methods. Meticulous adherence to an established
protocol is essential to ensure safety of the procedure.
Reuse is largely used as a cost containment measure in
areas of limited resources such as in our country. In the United
States, reuse is rarely practiced.
Three main areas of concern with reuse of dialyzer are:
·
Risk of infection to patients or staff
·
Exposure of patients or staff to germicide
·
Loss of performance with impairment in
clearance and/or ultrafiltration
Failure to strictly adhere to guidelines increases the
risk of transmission of HIV or hepatitis B/C virus to patients or staff
involved in the dialysis process. Exposing patients to reused dialyzers
increases the risk for bloodstream infections (Am J Kidney Dis. 2017
Jun;69(6):726-33). Great care has to be taken to prevent cross usage of
dialyzers.
In the Clinical journal of the American Society of
Nephrology, Upadhyay et al write: “The potential of inadequate germicide
concentration use raises the possibilities of pyrogen reactions and bacteremia
outbreaks. Changes in the membrane integrity with reuse can also affect
membrane polarity as well as the clearance of small and middle molecules. The
issue of increased environmental contamination with reuse is also of potential
concern”.
Reuse also increases the relative risk of hospitalization
and death for patients.
The number of times that the dialyzer is reused is
associated with loss of performance. The rate
at which this happens depends on the type of cleaning agents used for
reprocessing, the membrane type and dialyzer. Hence, when dialyzers are being
reused, the performance of the dialyzer should be closely
monitored.
The two most commonly used germicides are peracetic acid
and formaldehyde, both of which are harmful to human health.
Peracetic acid can be potentially destructive to mucous
membranes (especially respiratory mucosa) and to the skin and eyes. Among
staff, allergic reactions to formaldehyde may occur. Formaldehyde
is a known carcinogen; its inhalation can impair lung function. When bleach is
used together with peracetic acid or formaldehyde, hypochloric acid / formic
acid vapors are released, which if not properly drained, can potentially
pollute the working and patient spaces (Murthy B, Molony D: Reprocessing of
hemodialyzers, In: Chronic Kidney Disease, Dialysis & Transplantation, 2nd
Ed., Pereira BJ, Sayegh M, Blake P (Eds), Philadelphia, Elsevier, 2005, pp 388–
404; Semin Nephrol.1997;17:321-30)
Cracks in the threaded portion of dialyzer headers may
occur due to repeated exposure to chemicals during reprocessing of dialyzer.
Failure of timely detection may result in significant blood loss (ECRI
Institute, 1995).
Single use of dialyzers reduces chances of infection and
contamination and the probability of errors and accidents, and risks associated
with exposure to germicides and denatured blood products. A favorable immune
response and a better clearance of small and middle molecules are also more
likely with single use.
Single dialyzer use should be implemented whenever
possible to reduce infection risk. A study investigating an outbreak of bloodstream infections (BSIs) caused by Burkholderia
cepacia and Stenotrophomonas maltophilia among hemodialysis patients
in clinics of a dialysis organization found
that each additional use of the dialyzer
significantly increased the risk for BSI by 7%, and higher dialyzer use count
(>6) was associated with 7-fold increased risk for becoming a case. Dialyzer
reuse, reprocessing, and a specific dialyzer model were found to be predictors
of increased risk for infection. (Am J Kidney Dis. 2017
Jun;69(6):726-33).
In addition, we cannot go against the manufacturer’s
recommendation or the Drug Controller General of India (DCGI) approved
indication.
Two companies (ev3 and Covidien LP) now owned by
Medtronic will pay $31 million to resolve US Department of Justice (DOJ)
charges involving marketing violations and kickback schemes. The company ev3
has pled guilty to charges related to its neurovascular medical device Onyx
Liquid Embolic System. The US FDA approved the Onyx Liquid Embolic
System in 2005 for use in the presurgical treatment of arteriovenous
malformations but sales representatives encouraged surgeons to use Onyx in
large quantities for unproven and potentially dangerous surgical uses outside
the brain.
Covidien LP, another company will pay to resolve
allegations of violations of the False Claims Act resulting from its alleged
payment of kickbacks to hospitals to encourage use of its Solitaire mechanical
thrombectomy device.
The highest compensation
in medical practice, awarded by the Hon’ble Supreme Court in the matter of
Balram Prasad vs Kunal Saha & Ors on 24 October, 2013 in the Supreme
Court of India: Civil Appellate Jurisdiction: Civil Appeal No.2867 of 2012 also
provides an answer to this conundrum. “…This Court has categorically held
that the injection Depomedrol used at the rate of 80 mg twice daily by Dr.
Sukumar Mukherjee was in clear violation of the manufacturer’s warning and
recommendation and admittedly, the instruction regarding direction for use of
the medicine had not been followed in the instant case. This Court has also made
it clear that the excessive use of the medicine by the doctor was out of sheer
ignorance of basic hazards relating to the use of steroids as also lack of
judgment. No doctor has the right to use the drug beyond the maximum
recommended dose...”
Reuse is cost reduction, to be read with harm reduction.
But, when done has to be with consent of the patient.
Dr KK Aggarwal
Padma
Shri Awardee
President Elect Confederation of Medical Associations in Asia and
Oceania (CMAAO)
Group
Editor-in-Chief IJCP Publications
President
Heart Care Foundation of India
Immediate Past National President IMA
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