Accreditation lays down standards for management of reuse of single use device
By Deepak Agarkhed
The single use device means a device that is intended for one use, or on single patient during a single procedure. The label displayed on device package clearly indicates item as disposable after single usage. It does not provide instruction for re-processing. The term reuse of any medical device is usage on same or different patient with applicable reprocessing between uses like octopus being used in cardiac surgery.
In one the hospital, the staff used to term cardiac catheters and guide wires with ‘Oxford’ as reusable and ‘New York’ as brand new!
We come across single use devices at various clinical areas in different hospitals like ambubag at emergency crash cart to octopus used in cardiac surgeries. Most of the healthcare manufacturers bring out various medical devices instead of using it multiple times, looking at patient safety and enhancing the recurring business of product. As per the WHO report on health at India, total expenditure on health per capital for Indian is 267 dollar which is much lower than 3453 dollar on average for 35 OECD countries. The percentage of out of pocket spent in India on health is 62.4%.
The natural question that arises among everyone is that can India afford to spend more money on healthcare when the total expenditure on health per capital in public is only 25%. The medical devices and consumables form substantial share in patient bill especially for surgical patients, the care full adoption of re-usage of single use device will help patient to afford for our of pocket expenditure to some extent.
The sterility, integrity and functionality of device play a major parameter to decide on how to use single use device multiple times. Both NABH & JCI accreditation have standards for identification, implementation of process of management of reusage of single use device. The single use medical devices can be grouped as:
⊲ Open and unused wherein there is breach of sterility or sterile package has been opened.
⊲ Open and used like dialyser
⊲ Unopened and expired.
The risk are associated with re-usage of single use device are primarily the potential of increased risk of infection, unacceptable performance of post reprocessing. The hospitals should follow the state policy as guidelines before adopting practice in their respective hospital.
The following are the practical challenges the hospitals faces while adopting any single use device for re-usage.
⊲ Methodology to identify the frequency of usage to be considered as median value for tracking number of usages.
⊲ Methodology to track the number of actual usages of devices either at user level or at central sterilisation supply department level.
⊲ The billing of patient on particular device whenever the device loses its efficacy before the defined frequency.
⊲ Protocol on cleaning, disinfection and sterilization of each of these devices.
⊲ The tracking of patients on whom the device is being used whenever any adverse event occurs and preventive, corrective action initiation.
The single use devices will be recalled from clinical usage if repetitive incidents or reporting from within or hospitals are noticed. The hospital team should carefully evaluate medical devices for each procedure and come with action plan with fine trade of cost to patient and quality/ safety of patient before deciding to include any device in this group.