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Year : 2023  |  Volume : 25  |  Issue : 1  |  Page : 29-31

Reason for medical devices recall in a hospital: An observation from a central sterile supply department at a cancer centre in eastern India

Central Sterile Supply Department, Tata Medical Center, Kolkata, West Bengal, India

Date of Submission10-Feb-2023
Date of Decision21-Apr-2023
Date of Acceptance24-Apr-2023
Date of Web Publication1-Jun-2023

Correspondence Address:
Debabrata Basu
Tata Medical Center, 14, Major Arterial Road (E-W), New Town, Kolkata - 700 156, West Bengal
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jacm.jacm_5_23

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Recall of medical devices is a very common phenomenon in every hospital due to several issues. A recall is an action taken on a medical device that violates standard procedure. This action is necessary when a device is found defective or a risk to health. It may happen by manual or mechanical error but ultimately a negative phenomenon that needs to control for unnecessary costs and save resources. A policy should be developed for recalling the items. Whenever the sterility of any product seems doubtful, the infection control committee and the quality team should be informed so that follow-up surveillance of patients can be conducted.

Keywords: Documentation system, recall, recall reasons, recall types, remedies

How to cite this article:
Roy S, Dutta J, Khatua S, Basu D. Reason for medical devices recall in a hospital: An observation from a central sterile supply department at a cancer centre in eastern India. J Acad Clin Microbiol 2023;25:29-31

How to cite this URL:
Roy S, Dutta J, Khatua S, Basu D. Reason for medical devices recall in a hospital: An observation from a central sterile supply department at a cancer centre in eastern India. J Acad Clin Microbiol [serial online] 2023 [cited 2023 Nov 30];25:29-31. Available from: https://www.jacmjournal.org/text.asp?2023/25/1/29/378071

  Introduction Top

Quality assurance is a systematic and ongoing procedure of checking whether a product or service is meeting specific requirements as per standard. It requires effort and participation from everyone in a facility, and to achieve optimal service to develop, implement and monitor processes. The aim of central processing is the orderly processing of medical and surgical instruments through a controlled environment to protect patients from infections while minimising risks to staff and preserving the value of the items that are being reprocessed. Ensuring consistency of sterilisation practices requires a comprehensive program that ensures operator competence and proper methods of cleaning and wrapping instruments, loading the steriliser, operating the steriliser and monitoring of the entire process. The objective of the article is to describe the 'reason for reusable medical device recall and their remedies' to reduce the unnecessary sterilisation cost and to save resources.[1],[2]

  Discussion Top

A recall is an action taken on a medical device that violates standard procedure. This action is necessary when a device is found defective or a risk to health. In a health care facility, a medical device can be recalled by many ways but in relation to the central sterile supply department (CSSD), frequent recalls happen due to failure of chemical indicators (CI) and biological indicators (BIs) or by internal wet pack occurrences in an entire load.

Failure of chemical or biological indicators

Improper loading or overloading of a steriliser cart is the major chance of this incident. As a result, sterilant cannot penetrate properly through the object that means it remains unsterile which is understandable by the internal CIs. Furthermore, inadequate vacuum, reduce pulsing, poor steam quality, wrong time and temperature setting are also added to the other causes. Because passing of a validated CI or BI is depending on the defined parameters of the steriliser. For BI failure, the items are asked from CSSD (as per batch/lot number) to the user department for reprocessing again. For implant load, the items cannot be issued until the BI result comes.

Reason for wet pack occurrences

The major wet pack occurrences in a steriliser happened due to poor vacuum, supersaturated (wet) steam, non-condensable gasses, leakage in valves and door seals and malfunctioning of steam trap.[2],[3] Condensation might occur during post-vacuum phase when maximum pressure drop to atmospheric pressure at the end of the sterilisation cycle. Illustrative example: (1) A reading (printout) of 25 kilopascals (KPa) on a pressure gauge in post-sterilisation, that means some moisture (25% of water in gas form) still remains inside the container that cannot be removed by the vacuum pump. (2) Temperature difference between the steriliser chamber and the inside container may create condensation inside the surgical set. Complete steam evacuation inside rigid containers at the drying phase is rarely possible and such residual steam is very challenging for the complete dryness of a sterilised product. During the drying phase, some percentage (for example: 25% moisture) of moisture present in the steriliser chamber implies that water vapour is present in the chamber and containers. When aeration takes place (the steriliser chamber returns to ambient pressure by filling air) at the end of the cycle, the remaining steam mixes with the influx of air and achieves a mixture (depending on the final load temperature [80°C–90°C] and the temperature of the incoming air [25°C–30°C]). As soon as the door of the autoclave is opened, the mixture inside the steriliser chamber escapes into the environment, but the mixture inside the container will be retained and condenses into water during the entire phase of cooling up to room temperature. Because warm air can hold considerably more water vapour than cold air during the cooling phase, the relative humidity inside the container will possibly increase. When 100% relative humidity is achieved, the steam will condense to the liquid because the air cannot hold it in vapour form. Hence, during the cooling phase, this mixture may cause severe condensation inside the container and the sterilised load becomes wet which is unacceptable for further use.[4]

  Remedies Top

Overloading the steriliser cart is to be strictly avoided and the items are to be loosely stacked on the baskets. The separate pack items are always placed vertically with paper-paper or plastic-plastic manner to avoid unnecessary condensation inside. The surgical sets (maximum weight: 12.5 kgs or 25 pounds) are all placed horizontally with a gap of 1–2 inches. Instrument boxes are all mesh type and packed by disposable non-woven fabric with good water repellency and tensile strength. All rigid containers have bottom drain valve to pull out the excess moisture easily. There are no packs inside the chamber that touches the chamber wall or ceiling during sterilisation. The steriliser vacuum levels should be good enough (i.e. 5 kpa for autoclave, 10 kpa for ethylene oxide steriliser and 0.05 kpa for vapourised H2O2/gas plasma steriliser) for successful penetration of sterilant. The leak test result is as per standard which is 0.5 kpa (1.3 kpa as per EN 285) for autoclave, 0.2 kpa and 1.2 kpa for ethylene oxide steriliser (low and high pressure), respectively and 0.06 kpa for plasma steriliser. For steam generator, optimal desalted water (demineralised) is used to avoid non-condensable gasses. The water's total dissolved solids should measure in a regular basis (below 10 ppm) for saturated steam preparation.[5] Every steriliser is monitored by all validated indicators for 'worst case loads' that interpret the results by their precise colour changing. The instruments which are packed for sterilisation should dry completely before sterilisation. Moreover, post-sterilised items should keep inside the steriliser for few minutes to acclimatise with room temperature. Finally, the preventive maintenance of sterilisers should be done periodically by inspecting valves, gaskets and filters. Sometimes, physical monitors are validated by third party with defined loads (i.e. surgical sets, linens, liquid and luminal implantable instruments) by the number of pulsing, sterilisation time and temperature and drying time.[4],[6]

  Conclusion Top

For the recall procedure, a written policy should be developed (in the user manual) for recalling the items where the reason for the recall, intimation, action taken and total turnaround time should be mentioned properly. The department head should decide based on the policies and procedures when a recall is activated. All the recalled items are treated as soiled items and reprocessing start from cleaning to sterilisation [Figure 1]. A form or register should filled properly with the name of recall sets, the reason for recall and method of reprocessing and their monitoring systems for documentation purposes [Table 1]. Whenever the sterility of any product seems doubtful, the infection prevention and control committee and the quality team should be notified so that follow-up surveillance of patients can be conducted.[2],[3]
Figure 1: Re-call process flow

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Table 1: A sample form of recall for documentation purposes

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Conflicts of interest

There are no conflicts of interest.

  References Top

Mohapatra S. Sterilization and Disinfection. Essentials of Neuroanesthesia. 2017:929–44. doi: 10.1016/B978-0-12-805299-0.00059-2. Epub 2017 Mar 31. PMCID: PMC7158362.  Back to cited text no. 1
Guideline for Disinfection and Sterilization in Healthcare Facilities; 2008. Available from: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/sterilizingpractices.html. [Last accessed on 2022 Nov 09].  Back to cited text no. 2
Ling ML, Ching P, Widitaputra A, Stewart A, Sirijindadirat N, Thu LT. APSIC guidelines for disinfection and sterilization of instruments in health care facilities. Antimicrob Resist Infect Control 2018;7:25.  Back to cited text no. 3
Das TK, Laha SK, Basu D. Potential problems of inadequate air removal and presence of non-condensable gasses in a steam sterilization process: A brief discussion. Infect Control Hosp Epidemiol 2020;41:739-40.  Back to cited text no. 4
Basu D. Reason behind wet pack after steam sterilization and its consequences: An overview from Central Sterile Supply Department of a cancer center in eastern India. J Infect Public Health. 2017 Mar-Apr;10(2):235-239. doi: 10.1016/j.jiph.2016.06.009. Epub 2016 Jul 19. PMID: 27450707.  Back to cited text no. 5
Basu D, Mondal P, Rafikul SK, Ghorai S. Benefits and limitations of external calibration required to validate the physical parameters of an autoclave: A brief discussion from an oncology centre in Eastern India. Acad Clin Microbiol 2022;24:32-4. Available from: https://www.jacmjournal.org/text.asp?2022/24/1/32/350318. [Last accessed on 2022 Dec 6].  Back to cited text no. 6


  [Figure 1]

  [Table 1]


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