In the recent months, there has been increasing focus on Reuse of Single Use Devices. The ever-increasing costs of healthcare delivery, shrinking margins due to government health schemes and increasing insurance disallowances, increasing cost of manpower are all making it essential for Healthcare providers to cut costs to remain profitable. This effort to make it viable to function in the current market scenario is further made challenging with increasing manufacturers labelling their devices as “Single-Use”, leaving smaller hospitals with little option but to reprocess and use these devices multiple times to reduce healthcare delivery costs. But this reprocessing is fraught with many risks, both to the patient and the healthcare provider, predominantly due to partial or incorrect information on the correct methods of reprocessing and the lack of government regulations around it.
Very few countries in the world have regulations around the reuse of SUDs, while research into the subject has shown practice of re-use in most countries, including the United States, Canada, UK, Germany among others. The United States has regulated the re-use of SUDs with the Food and Drug Administration (FDA) issuing regulations to which all third party reprocessors and reprocessing hospitals are required to conform. European Union, Canada, Australia and New Zealand do not recommend re-use, though evidence points otherwise.
The risk of a deregulated re-use is –
- Lack of clarity on what can be reused
- Lack of understanding on how to reprocess the SUDs to ensure it is safe for reuse, including the number of times it can be reused.
- Lack of monitoring to ensure the reprocessed SUDs meets the desired criteria.
In India, where access to technology, resources and skills vary largely with every few kilometers, it is very essential to have government regulations and monitoring to ensure safe re-use of SUDs. Just a mere directive on whether re-use is permitted or not, could lead to unsafe practices effecting patient safety and medical outcomes.