Sunday, December 16, 2018

Should dialysers be reused?

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

No comments:

Post a Comment