Pandemics and Single Use Devices

In this article, we’ll try to explain to you Pandemics and Single Use Devices.

Click here for World Health Organization page about Coronavirus.

What is a Virus?

A virus is the smallest of infectious microbes, smaller than bacteria or fungi. A virus consists of a small piece of genetic material (DNA or RNA) surrounded by a protein shell.

What is a Prion (Proteinaceous Infectious Particles)?

Infectious agents, smaller than viruses. Unlike other pathogens, prions contain no DNA or RNA. Their only known component is a protein.

What is a Single Use Device?

According to the Food and Drug Administration a single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed.

What is a Reusable Device?

Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients.

Can viruses or prions be inactivated?

The ability of a process to inactivate or remove viruses should take into account: 

– the reduction in virus titre achieved;

– for inactivation processes, the rate of inactivation and the shape of the inactivation curves; for removal, mass balance;

– how robust the step is in response to changes in process conditions; and

– the selectivity of the process for viruses of different classes.

Most of viruses and bacterias can be inactivated when validated methods are applied, there should be some
abilities to inactivate viruses as shown above. There are some methods to inactivate viruses.

Prions, the abnormal proteins associated with prion diseases (e.g. Creutzfeldt-Jacob disease [CJD] and variant Creutzfeldt-Jacob disease [vCJD]) are very resistant to all conventional methods of decontamination. In order to reduce the risk of transmission of abnormal prion proteins during surgical procedures, the devices designated for single episodes of use must not be reused under any circumstances. Prion is an important pathogen in terms of inactivation because it is the most difficult pathogen to inactivate.

Can viruses or prions be inactivated?

Reprocessing single-use devices may compromise their intended function. Single-use devices may not be designed to allow thorough decontamination and (if applicable) re-sterilization processes. Reprocessing a single-use device may alter its characteristics so that it no longer complies with the original manufacturer’s specifications and, therefore, the performance may be compromised. Single-use devices have not undergone extensive testing, validation and documentation to ensure the devices are safe to reuse.

Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with Supranational Articles. But many single-use devices are also reused without adequate evaluation of the increased risks to patients.

The further development of methods to sterilize microorganisms including prions is more important with increasing emphasis of reducing microorganism-related iatrogenic risks recognized in terms of public health. Recent developments have also suggested the importance of confirming the efficacy of each method with a reliable standardized system.

Read the article Post Operative Medical Device Disinfection.

References

  1. Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products ( Link: https://www.who.int/bloodproducts/publications/WHO_TRS_924_A4.pdf )
  2. Rutala, W. A. & Weber, D. J. (1999) Infection control: the role of disinfection and sterilization.
  3. Single Use medical Devices : Implications and Consequences of Reuse ( Link: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/842614/Single-use_medical_devices_v2.3_Oct-19.pdf )
  4. Onodera, Takashi (2010) Inactivation of Viruses
  5. What are reusable devices?
    ( Link: https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/what-are-reusable-medical-devices )