Introduction
Regulatory bodies such as the FDA have been making their position clear on the risks associated with reusable endoscopes and the need to eradicate these risks from practice. But is this achievable in current industry practice? And are infections from contaminated reusable endoscopes truly avoidable? This article aims to critically evaluate the impact of reprocessing reusable endoscopes on patients, staff and facilities whilst discussing the ongoing impact of these issues and whether single use endoscopy could be the solution the industry requires. This article also features an interview with Professor Tan Arulampalam, a practising clinician with over 25 years of experience in the industry.
Current industry practice
The use of reusable endoscopes has been the industry standard for decades, and with impressive visual abilities and base unit technology, it is easy to understand why these are preferred for screening and diagnostic procedures. Yet current infrastructure requires the reprocessing of every endoscope between every procedure, a process that can feature up to 100 steps and take over one hour of manual input to complete. Although automated endoscope reprocessors (AERs) have been used during the disinfection step in the past few decades, reprocessing still primarily involves manual handling(1). This requires clinicians to think critically about their fleet of current endoscopes. How long have these endoscopes been in use? How often are they serviced and inspected by the manufacturer?
Gastrointestinal endoscopic procedures are performed in body cavities that are heavily colonised with microorganisms, thus, during use, endoscopes become heavily contaminated with bioburdens including blood, body fluids and other potentially infectious materials(1). Because of this, guidelines will recommend immediate reprocessing after use, but this is not always achievable in busy hospital environments. Delays to reprocessing procedures can present an enhanced risk of disease transmission and cause damage to the endoscope. These delays can cause the collected bioburdens to stick to the surface of the endoscope, making reprocessing less effective.
There are many international guidelines that fail to provide any recommendations or best practices for many of the steps involved in reprocessing, including replacement frequency, microbiological surveillance testing and appropriate shelf life. This has caused many clinicians to ask the question: Do I want to continue using reusable endoscopes considering the known risks related to reprocessing? Professor Tan Arulampalam discusses the current impact of reprocessing on his work and his staff.
An interview with Professor Tan Arulampalam – Consultant Colorectal Surgeon at Colchester Hospital and The Oaks Hospital
How often are your reusable devices inspected, serviced and assessed by the device manufacturer?
“In the private sector, endoscopes are usually inspected/serviced once a year. In the NHS, you are looking at anywhere between 6 months to a year, but usually when they break. The servicing is not standardised so may vary from hospital to hospital.”
How do the staff responsible for reprocessing find the task?
“For staff, cleaning is a hazardous job. They wear protection, but all complain about problems with breathing and skin rashes. One colleague has personally experienced headaches, breathlessness and a burn mark/rash that required medical attention. There can also be issues with accessibility. In the public and private sectors, sometimes scopes aren’t cleaned on site, rather, the scopes are cleaned in a central sterile service unit. So if there is a delay to the morning list, you require the porter to get a new lot of scopes from sterile services as clean scopes have a limited shelf life. So no cleaning available near the rooms is a logistical problem for us, not just in terms of flow but also needing staff to transport and carry equipment.”
How often are you left waiting for an endoscope in order to perform an endoscopy? How many endoscopies do you think you could perform in that time? And do these scopes break?
“On average we may lose the time equivalent of about one colonoscope and one gastroscope a day due to delays in getting flow of the scopes. Timelines on some of the machines can be quite erratic for wash cycles, and a lot of cycles end up being aborted for kinked wires or blockages in the scope, even when there aren’t any. On average, preparation of the scopes for procedures take between 2-5 minutes per procedure. So over the course of a day, you could realistically expect to get one extra colonoscopy per room, so if you have two rooms, that’s 2 extra procedures a day. Running 7 days a week that is an extra 14 procedures a week. There are also mechanical failures including the optics failing, wires on the handles getting tight due to over usage that leads to snapping and loss of the up/down or left/right movement.”
The problems of reprocessing
Reprocessing challenges
A useful webinar titled ‘A Journey to Safer Endoscopy’ featured on Single Use Endoscopy (Link) identified some endoscope reprocessing challenges as follows:
- Automated endoscope reprocessors
- Use of non-approved supplies to reprocess and clean
- Improper storage of reusable devices
- Environmental contamination
- Reprocessing personnel inconsistencies
- Varied environmental controls
- Unseen damage to the reprocessing personnel
(2)
The FDA has also identified risks regarding the limitations of reusable endoscopes that pose issues for effective reprocessing:
- Long, narrow interior channels, including those with internal surfaces that are not smooth or too small to permit a brush to pass through
- Hinges
- Sleeves surrounding rods, blades, activators etc.
- Adjacent device surfaces between which debris can be forced or caught during use
- O-Rings
- Valves that regulate the flow of fluid through a device
- Devices with design features that cannot be disassembled for reprocessing
(2)
These challenges feature in all areas of current practice with reusable technology, showing that the issues regarding reprocessing are wider than first expected. Trying to fix all these individual challenges could become a costly and timely process for a facility, not to mention wasted if the current manufacture of these devices still does not allow for successful cleaning.
Impact on staff
It is important not to forget the impact this process has on the facility personnel responsible for it. As previously identified by Professor Arulampalam, many members of staff complain about health problems experienced whilst working on this chemical-heavy process. Although the most important, it is not just health concerns regarding this process, but the added time pressure and use of valuable human resources that present a challenge to hospitals. A study by Ofstead conducted in 2010(3) produced some interesting insights into the functionality of this process. The key points have been highlighted below:
- The article noted 12 steps that were considered ‘most important’ in manual reprocessing, yet it was reported that two or more of these steps were completely skipped in 44.9% of all manual reprocessing cases.
- Although staff members interviewed acknowledged that these were the most important steps, over half of observed cases found bioburden inside the working channel was not fully removed.
- This identified that there is more than a 98% chance that when the scope is grabbed for the next procedure, it’s insufficiently cleaned and may be harbouring dangerous pathogens.
- Reasons the steps were not followed properly by staff were identified as:
- Steps were difficult to complete
- Posture required for reprocessing caused pain or discomfort for those performing the cleaning
- Pressure to complete the reprocessing quicker so that there would be no need to wait for later procedures
- Exposure to HLD chemicals was irritating to the respiratory system
(3)
Cost and time impact on facilities
It is also important to recognise the cost and time implications of reprocessing on hospitals. Besides the sizeable challenge of trying to keep patients safe, reprocessing has drawbacks related to time and money(4). The reprocessing of endoscopes requires its own infrastructure within the hospital environment, a major capital cost for many facilities. But it is not just the initial investment that facilities need to consider; reusable endoscopes are let down by reprocessing costs and the financial impact related to the complications of infection(4). This is then followed by the need for training and managing of staff to run the reprocessing suite efficiently. Even the basic reprocessing steps can be time-intensive for medical staff to carry out properly(4).
Risk of cross-contamination
Probably the most discussed and evident risk of the reprocessing procedure is the risk of cross-contamination. A 2018 study from the American Journal of Infection Control showed that 71% of fully reprocessed endoscopes still contained microbial growth(4). Unfortunately, endoscope contamination due to improper reprocessing is associated with more outbreaks of hospital-acquired infection than any other medical device(1). The FDA has also noted this as a serious risk to practice, providing guidelines to help avoid this issue. But as previously discussed, if staff are unable to perform all steps in the process, and the design of the endoscope itself does not allow for effective cleaning, can cross-contamination ever be avoided?
The ongoing impact of reprocessing issues
Cross-contamination between patients presents ongoing issues for hospitals. Should a patient need to be readmitted for a cross-contamination related illness, the hospital has to deal with:
- Increased length of stay
- Increased cost of care delivery
- Decreased resources available
- Decreased patient satisfaction
(2)
Counteracting the inefficiencies of reprocessing
The webinar ‘A Journey to Safer Endoscopy’ presented some great ideas for counteracting the presented inefficiencies of reprocessing with the introduction of single use endoscopes:
- Single use devices can ensure the availability of a device for all patients regardless of time
- Single use allows bedside endoscopy without the need for transport and subsequent reprocessing
- Single use reduces instrument preparation, post-procedure and eliminates reprocessing
- It offers simplified protocols for equipment handling
- Ideal for widespread clinical use
- Less capital expense
- Eliminate service, maintenance and repair contracts
- Reallocate resources spent on reprocessing and reinvest
(2)
At IQ Endoscopes, we share the vision of introducing single use endoscopy into the market to counteract the inefficiencies of reprocessing. The reprocessing procedure presents too many risks to patients, staff and facilities and single use devices offer an effective solution to this problem. We believe this alone is sufficient reason for change.
To learn more about how you can introduce single use endoscopy into your practice, view our website or contact us today.
Citations
(1) Webinar ‘A Journey to Safer Endoscopy’
(2) Endoscope Reprocessing: Update on Controversial Issues, Hyun Ho Choi & Young-Seok Cho
(4) Single use endoscopes: A trend towards better patient safety