Single-use medical devices also referred to as disposable devices, are the kind of medical devices that are intended to be used only on one patient, during a single procedure only. They are not intended to be reprocessed (cleaned, disinfected or sterilized) or used on another patient. The labelling and manufacturer instructions on the packaging may include suitable instructions and indications for the same. In keeping with infection control best practices, Healthcare providers are increasingly choosing to go for single-use devices. Single-use medical devices could be syringe, gloves, pace maker, catheter etc. Whether used or not used, if you are disposing-off medical devices, there are stringent guidelines to be followed. Here we are going to discuss guidelines for disposal of single-use medical devices as per World Health Organization (WHO).
Disposal of single-use medical devices
Disposal usually means discarding without the intention of retrieval. Disposal of single-use medical devices could be by way of burial, deposit, discharge, dumping, placing or release of any waste material into the air or water or on land. Radioactive waste must be disposed-off in an approved, specified facility (e.g. near-surface or geological repository) or into the environment, if direct discharge is approved. The approval includes all the prior steps and processes of de-commissioning and dismantling of medical devices for recycling.
WHO is concerned about disposal of single-use medical devices in such a way so as to ensure the highest standard of health & safety for all concerned including patient, employee, handlers and environment.
Single-use medical devices by risk class
The various single-use devices are broadly divided into four risk classes. The risk class of a medical device is based on factors such as the degree of invasiveness, the anatomical location as well as the duration of use in the body. Bio-therapeutic products if any, are deemed to be higher risk. Many bio-therapeutic products contain or can become contaminated with viruses during production or processing. The virus in these medical devices need to be eliminated or cleared through a means of inactivation and removal to prevent harming the patient. These products, called viral inactivation devices, are usually rendered safer through viral inactivation. It is widely acceptable to divide single-use medical devices into groups or classes, often labelled A, B, C and D.
Accurate classification of devices is critical for the safety of patients and users. The instructions for use and the intended use of the device as indicated by the manufacturer should be consulted while deciding for disposal too.
| Risk Class | Risk | Devices (Example) |
| A | Low | Syringes, examination gloves, patient hoists, stethoscopes, wheelchairs, IVD diagnostic instruments etc. |
| B | Low-Moderate | Surgical gloves, infusion sets, pregnancy tests |
| C | Moderate- High | Condoms, infusion pumps, neonatal incubators, therapeutic and diagnostic X-Ray, lung ventilators, haemodialysis machines, anesthesia equipment, self-test glucose strips etc. |
| D | High | Pacemakers, implants, angioplasty balloon catheters, spinal needle etc. |
Risks with re-use of single-use medical devices
Single-use medical devices are designed for use on an individual patient during a single procedure only. Still, several single-use medical devices are often known to be re-processes and re-used in hospitals across the world. Reprocessing of medical devices may mean processes which de-contaminate or clean the device including decontamination, cleaning, drying, functional testing, repackaging, relabelling, disinfection and sterilization.
As single-use medical devices are not meant to be re-used, they are expected to be disposed-off. They do not come with instructions for cleaning, disinfection or sterilization after use. There is also no information available regarding their safety and performance parameters if they are reprocessed or refurbished for re-use. Single-use medical devices that have been reprocessed and used more than once may be harmful for patients, as conformity to the original standards for their safety, quality and performance cannot be assured.
Therefore, it is important to know the risks associated with re-processing and re-use of these devices.
The potential health risks associated with reuse of Single-use medical devices are:
- Impairment of the quality of devices, changes in properties or degradation of the device material due to repeated sterilization or impact of high temperatures and harsh chemicals;
- cross-infection
- absorption of residues of chemical cleaning agents by the material of the device that that may result in exposure of patients or users on re-use;
US Food and Drug Administration concerns
The US FDA has published a list of Single-use devices (SUDs) known to be reprocessed. According to USFDA, parties (such as a health care facility or third-party re-processor) are subject to the same regulatory and reporting measures as the original manufacturer of the devices they reprocess. As exposure to reused single-use medical devices may be unsafe for patients, the liabilities related to their re-use also fall on the party who reprocesses them.
As per US Food and Drug Administration, if a single-use medical device is re-processed in any way, then the party or facility that reprocesses the single-use device as such, becomes the manufacturer of the re-processed device and is responsible for ensuring that it is safe and effective for reuse and adhere to all regulations applicable for the original device.
The re-processor needs to demonstrate that the single-use medical device can be adequately cleaned and disinfected or sterilized and that the characteristics or quality of the device will not be adversely affected by these processes.
The re-processor should put in place a tracking system to enable prompt location of devices for recall in the event that corrective action or notifications to the device is necessary.
If removal of the device is required for any reason such as for any correction, repair, modification, adjustment, relabelling, destruction or inspection, it shall be reported to the regulating body by the re-processor.
Disposal of medical devices by approved agencies
As mentioned before, disposal could be by way of burial, deposit, discharge, dumping, placing or release of any waste material into the air or water or on land. Disposal of medical devices must be handled by agencies approved by the state pollution control board for bio-medical waste management.
Such approved parties have facilities for safe collection, transportation, temporary storage, proper treatment and disposal of bio-medical waste. The treatment of waste includes facilities such as incinerator, autoclave, dis-infection tanks, shredders, effluent treatment plants etc. The disposal of the treated waste material could be to land-fill or recycling depending on the type of material.
Healthcare providers must go through proper processes for condemnation of medical equipment as per NABH guidelines. Read more.. https://www.primedeq.com/blog/medical-equipment-disposal-approval-of-appropriate-authority/
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