Risks Point-of-Use Filter Reprocessing

In the pursuit of sustainability and cost-effectiveness, some have ventured into the realm of reprocessing point-of-use filters. However, a closer examination reveals a host of challenges and risks that make this approach less than ideal.

Manual reprocessing of POU filters has yielded disappointing results, with a significant failure in bacterial retention performance^1,2. The gamble of relying on manual processes jeopardizes the hygienic integrity of these critical devices.

While automatic reprocessing using advanced technologies like Miele washer-disinfectors at high temperatures (92-115°C) shows promise, it’s not foolproof. Fine bacterial retention performance is observed, but exceptions exist^1. Bacterial breakthrough, even after successful integrity tests, underscores the precarious nature of reprocessing^1-4.

Surface pores, a vital part of the filtration process, may impede successful disinfection and sterilization⁵. Reprocessing introduces various risks, from membrane damage due to drying and cleaning agent residues to clogged pores hindering cleaning agent access. Membrane degradation, hard to model accurately, poses a significant challenge for proper integrity validation⁴. Standard integrity tests may not catch thinning areas in the membrane caused by reprocessing, allowing bacteria to sneak through⁴.

Reprocessing of other devices

Further insight can be gained from looking at the reprocessing of other devices, such as dialyzers and endoscopes. Dialyzers, which filters blood to remove wastes and salt in case of kidney failure, are often made with the same type of membrane as POU filters. The discontinuation of reprocessing dialyzers by major manufacturers in Western countries therefore speaks volumes⁶.

Endoscopes, which are medical devices used to look inside the body has historically been reused. However, reprocessed endoscopes, regardless of type, age, or use frequency exhibit contamination issues^7,8. Manual cleaning is crucial, but reports show that up to 92% of endoscopes aren’t cleaned properly⁹. Reprocessing failures, especially related to improper cleaning, highlight the difficulty of achieving reliable results^10,11.

Environmental impact

The environmental impact of reprocessing is substantial due to the required personal protective equipment used during handling of devices. Double the energy consumption and carbon footprint for one endoscope reprocessing cycle compared to single-use endoscopes raises questions about the sustainability of reprocessing practices when it comes to medical devices¹².

Regulatory Perspectives

Regulatory bodies, including the FDA, express concerns about reusing sterilization-grade filters⁴ General Electric and Medela discourage the reuse of sterilization-grade filters for sterile drug production, emphasizing the potential risks associated with reprocessing⁴.

Conclusion

Reprocessing POU filters, despite well-intentioned motives, presents a hygienic and logistical minefield. The challenges in inspection and validation, coupled with the significant risk of contamination, we believe, make it clear that the gamble of reprocessing POU filters is an unwise choice in the pursuit of sustainability and cost savings.

References

1. 1. Daeschlein G, Krüger WH, Selepko C, Rochow M, Dölken G, Kramer A. Hygienic safety of reusable tap water filters (Germlyser) with an operating time of 4 or 8 weeks in a haematological oncology transplantation unit. BMC infect Dis, 7, 2007,
2. 2. Vonberg RP, Sohr D, Bruderek J, Gastmeier P. Impact of a silver layer on the membrane of tap water filters on the microbiological quality of filtered water. BMC Infect Dis, 8, 2008, 133.
3. 3. Wendt C, Weist K, Schlattmann P, Rüden H. Field study to obtain Legionella-free water from showers and sinks of a transplantation unit by a system of water filters. Zentralbl Hyg Umweltmed, 196 (6) 1995, pp. 515-531.
4. 4. Pall Life Sciences. Considerations on Re-Use of Sterilizing-Grade Filters. Scientific report, Pall Life Sciences, Port Washington, NY, USA, 2009.
5. 5. Vearncombe M et al. Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment+Devices In All Health Care Settings, 3rd edition. Technical guideline, Public Health Ontario, Toronto, Canada, 2013.
6. 6. Golper TA, Schwab SJ, Berns JS, Taylor EN. Reuse of dialyzers. Scientific report, University of Vermont, Burlington, VT, USA, 2022.
7. 7. Rauwers AW, Voor in’t Holt AF, Buijs JG, de Groot W, Hansen BE, Bruno MJ, Vos MC. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut, 67 (9) 2018, pp. 1637-1645.
8. 8 Rauwers AW, Voor in’t Holt AF, Buijs JG, de Groot W, Erler NS, Bruno MJ, Vos MC. Nationwide risk analysis of duodenoscope and linear echoendoscope contamination. Gastrointest Endosc, 92 (3) 2020, pp. 681-691.
9. 9. Ofstead CI, Quick MR, Eiland JE, Adams SJ. A Glimpse at the True Cost of Reprocessing Endoscopes: Results of a pilot project. Scientific report, International Association of Healthcare Central Service Materiel Management, Chicago, IL, USA, 2017.
10. 10. Beilenhoff U, Neumann CS, Rey JF, Biering H, Blum R, Schmidt V. ESGE–ESGENA guideline for quality assurance in reprocessing – Microbiological surveillance testing in endoscopy. Endoscopy, 39 (2) 2007, pp. 175-181.
11. 11. Pyrek KM. Best Practices for High-Level Disinfection and Sterilization of Endoscopes. Infection Control Today, Mar 2012. Retrieved from https://www.mdrao.ca/wp-content/uploads/2012/04/asset-best-practices-for-high-level-disinfection-and-sterilization-of-endoscopes.pdf
12. 12. Sørensen BL, Grüttner H. Comparative Study on Environmental Impacts of Reusable and single-use bronchoscopes. Am J Environ Prot, 7 (4) 2018, pp. 55-62.

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