October 17, 2013 — This is the third and final article in a series discussing disposable tubing used for irrigation during gastrointestinal (GI) endoscopy. This is the most complete set of published articles that focus on this topic.

First article in series

The reader is directed to the first article in this series of three: “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System“[1]; click here, which focuses on a well-publicized reprocessing mishap identified within the Veterans Health Administration (VHA).

This mishap was associated with the reusable tubing that is a component of a commonly used auxiliary water system intended for irrigation during colonoscopy (and other GI endoscopic procedures).

This article introduced the use of disposable irrigation tubing as an alternative technology to reduce the risk of this mishap’s recurrence during GI endoscopy.

Second article in series

The reader is also directed to the complete version of the second article in this series entitled: “ ‘Disposable’ Irrigation Tubing Used During Gastrointestinal Endoscopy,”[2]— click here.

This article provides a 10-page discussion of this alternative technology, focusing on the features, designs, labeling, and common uses of disposable irrigation tubing used during GI endoscopy.


Update (8-14-2015) — A filed Medical Device Report, or MDR: The following MAUDE report, filed on 8-14-2015, discusses the use of irrigation tubing set and a 24-hour endoscope connector, with focus placed on the potential for cross-infection.

Manufacturer Narrative: The XXX irrigation tubing set was in use with a YYY 24-hour connector, which does not include a check valve. Therefore the only back flow valve was on the XXX irrigation tubing set. It was determined upon testing of the returned device that the valve did not function properly. Subsequent testing of this lot found no other units exhibiting this issue. ZZZ has recommended to the site that they utilize single-use connectors that include back flow valves.

Event Description: A user reported that liquid gastric contents back-flowed into the irrigation tubing during a gastroscopy. There was no patient impact. A TTT gastroscope was in use with YYY 24-hour use irrigation port connector and the XXX irrigation tubing set. Submission of this report does not, in itself, represent a conclusion that medical device caused or contributed to an adverse event.


Third article in series

Featured herein, the third and final article in this series is the only one published, to date, that provides recommendations and guidance for the safe and effective use of both reusable and disposable tubing used for irrigation during GI endoscopy.

Guidance and Recommendations

While its discussion was comprehensive, the second article in this series (see above) did not provide detailed guidance for the safe and effective use of either disposable irrigation tubing or the irrigation tubing used with reusable auxiliary water systems (e.g., the Olympus MAJ-855 water tube).


Article at a Glance.
Article at a Glance.

This article herein—the third and final in this series—provides this guidance. Reader: A review of each of the two previously published articles in this series is recommended for completeness and context.

Whether reusable or disposable, irrigation tubing is routinely used to cleanse the GI tract as is often required to enhance visualization of the gastric and colonic mucosa.

Note: Three companies that market disposable irrigation tubing—Byrne Medical (now MediVators), ERBE USA, and US Endoscopy (now a subsidiary of the STERIS Corporation)—participated in the researching and writing of this series of articles, providing this article’s author (LFM) with samples and/or photographs of their disposable irrigation  tubing and endoscope connectors.


Quality Services and Case Reviews for Hospitals, Manufacturers, Patients:  Click here to read about Dr. Muscarella’s quality services committed to reducing the risk of healthcare-associated infections, including CRE outbreaks linked to contaminated endoscopes and other reusable medical equipment.


 

SECTION 1 – Reusable Auxiliary Water Systems

GI departments that are currently using a reusable auxiliary water system and its associated tubing, flushing pump, water bottle and other accessories—without difficulty, undue inconvenience, or attributable instances of infection—may be inclined to continue doing so, applying the adage that “if it isn’t broken, then don’t try to fix it.”

If it’s not broken, then don’t fix it. — A popular adage

Use of a reusable irrigation system is acceptable, of course, provided, however, that, as Dr. Muscarella recommends, a number of criteria, which are featured in Table 1, below, are met.

Whether disposable irrigation tubing may provide a safe alternative to reusable auxiliary water systems warrants consideration and discussion.—Lawrence F Muscarella, PhD

SECTION 2 – Disposable Irrigation Tubing

GI endoscopy units that prefer instead to use disposable tubing along with an accompanying flushing pump and water bottle to provide similarly for irrigation during GI endoscopy, however, may appreciate some of this alternative tubing’s features.

Click here to read Dr. Muscarella’s related article “Tap Water Used for Irrigation during GI Endoscopy: A Recommendation and Assessment of the Infection Risk.”

Arguably a most convenient feature, the manufacturers of disposable tubing contraindicate its cleaning and high-level disinfection (or sterilization). Additional guidance for the safe and effective use of disposable irrigation tubing is featured in Table 1, below.



Table 1:  Guidance for the safe and effective use of both disposable and reusable irrigation tubing that connect to the GI endoscope’s auxiliary water channel via a port.

— I. — Disposable Tubing and the Reusable Tubing of Auxiliary Water Systems Used for Irrigation during GI Endoscopy:

The following guidance is provided no matter whether using disposable tubing or an auxiliary water system’s  reusable tubing, such as the MAJ-855 auxiliary water tube (or “AWT”; manufacturer: Olympus America), for irrigation of the GI tract’s mucosa during GI endoscopy:

1. Confirm prior to beginning the GI endoscopic procedure that the disposable or reusable irrigation tubing:

[a]  is securely connected to the GI endoscope’s auxiliary water channel (via the correct port) and that none of the other connections or fittings of either type of tubing are loose, disconnected, or leaking water;

[b]  is primed with water (or another type of irrigant);

[c] along with the water bottle, is not contaminated with blood or another potentially infectious fluid or material; and

Attention: Only use disposable or reusable irrigation tubing that is fitted with or otherwise uses a one-way “backflow” valve to prevent the tubing’s contamination and the possibility of patient-to-patient disease transmission due to the backflow of potentially infectious fluids and materials.—Lawrence F Muscarella, PhD

[d]  uses a one-way “backflow” valve (see: Figure 1 and Figure 2 of the first article in this series[1] and Figure 1 and Figure 3 of this series’ second article[2]).

Do not use either type of tubing if it is not fitted (or used) with a one-way valve designed to prevent the backflow of potentially infectious fluids and materials that could result in patient-to-patient disease transmission due to the contamination of the tubing (and the water bottle) during GI endoscopy.—Lawrence F Muscarella, PhD

Attention: Further, do not use the AWT if it is fitted with a green, single-winged connector (that is designed for use with the MH-974 washing tube; manufacturer: Olympus America). The AWT’s correct one-way valve, although also green, is double-winged (refer to Figure 1 of the first article in this series[1]).

Reader’s note: Additional recommendations are available, but are included only in the more complete PDF version of this article of the same title, which may be downloaded by clicking here.

2.  Verify (through documentation and a visual inspection) that the entire GI endoscope, including its auxiliary water channel, is being thoroughly reprocessed (e.g., cleaned and high-level disinfected) after each endoscopic exam.

[a] Click here for instructions by Dr. Muscarella about how to reprocess the GI endoscope’s auxiliary water channel.

Note: More recommendations in this section are available, but are included only in the more complete PDF version of this article of the same title, which may be downloaded by clicking here.


— II. — Reusable Tubing of Auxiliary Water Systems:

If a GI endoscopy department is safely using a reusable auxiliary water system and tubing (such as Olympus America’s reusable AWT) for irrigation without difficulty, confusion, or having identified any significant errors or instances of disease transmission attributed to this tubing’s use, then its continued reuse may be considered.

The following additional guidance is provided for a GI endoscopy department using an auxiliary water system with reusable tubing:

1. Review the reusable auxiliary water system’s setup and operating instructions, which is most likely provided along with (or in) the GI endoscope’s operator’s manual. (Contact the GI endoscope’s manufacturer with questions.)

[a]  Verify this reusable auxiliary water system’s proper setup and use, in accordance with these operating instructions, prior to each endoscopic procedure.

[b] Ensure and document the competency and training of those staffers responsible for the daily setup of the auxiliary water system and its reusable tubing.

[c] Confirm that this auxiliary water system’s reusable tubing is being used with the appropriate endoscope connector (e.g., the one provided with the GI endoscope) for proper connection to the GI endoscope.

If using a reusable water bottle, ensure that it is cleaned and either high-level disinfected or sterilized daily (or, if disposable, that the water bottle is discarded at the end of the day, or sooner if emptied).—Lawrence F Muscarella, PhD

2. Similarly, review the reusable auxiliary water system’s reprocessing instructions.

[a] Ensure that this system’s reusable tubing (e.g., the AWT) is being reprocessed (along with the endoscope connector) after each endoscopic procedure. (Click here to read a related article by Dr. Muscarella that provides instructions on how to reprocess the AWT.)


An in-line disc filter.
Figure 1. An in-line disc filter.

Sidebar:  Does this disc filter (see image on the right) look familiar? Is your GI endoscopy department using them?

These filters can become occluded with debris (without staff’s knowledge) preventing the reprocessing of the internal channels of a contaminated GI endoscope. The result? An increased risk of disease transmission. Read Dr. Muscarella’s article “Factors Affecting the Risk of Infection Associated with an Endoscope Reprocessing Error” that discusses this topic and how to prevent patient harm.


[b] Discard daily (sans reprocessing) those components of this reusable water system that are labeled as single-day (or “reposable”[1]) items—for example, the short OFP irrigation tube and the disposable water bottle.

Reader’s note: More important recommendations in this section are available, but are included only in the more complete PDF version of this article of the same title, which may be downloaded by clicking here.

The proper setup, use, and reprocessing of a reusable auxiliary water system, including its tubing, are crucial to the prevention of disease transmission.—Lawrence F Muscarella, PhD


— III. — Disposable Irrigation Tubing:

Alternatively, a GI endoscopy department may consider using disposable irrigation tubing (along with a flushing pump, a water bottle, and an endoscope connector). Compared to an auxiliary water system’s reusable tubing (e.g., the AWT), some staffers may find disposable irrigation tubing to be easier to use, although its cost may be more expensive.

Moreover, unlike its reusable counterpart, disposable tubing (as its name suggests) is not reprocessed and, therefore, may be preferred by a GI endoscopy department that does not have access to the resources required to clean and high-level disinfect (or sterilize) reusable irrigation tubing.

1. Even though its reuse on multiple patients may be a common practice,1,2 this article suggests that GI endoscopy departments consider the feasibility of using disposable irrigation tubing (along with a single-use endoscope connector; see below) as a single-patient item.

Whether the FDA originally intended “disposable” irrigation tubing to be used only on one patient is not clear and remains unresolved.—Lawrence F Muscarella, PhD

[a] A review of their clearances suggests that the Food and Drug Administration (FDA) may have intended disposable irrigation tubing to be used on one patient only, not reused on multiple patients throughout the day.[1,2]

Indeed, this review did not identify any disposable irrigation tubing used during GI endoscopy whose clearance or “indications for use” specify its reuse.[1.2]

[b] This review’s findings suggest that the labeling on the disposable irrigation tubing’s packaging suggesting a multiple-patient-use indication (e.g., a “24-hour use” claim) may not necessarily be consistent with the tubing’s FDA-cleared indications for use (i.e., single-patient use).[1,2]

2. For those GI endoscopy departments that have determined, however, that to use disposable irrigation tubing only on one patient would be financially prohibitive or is otherwise infeasible, this article suggests that these departments reconsider using the type of auxiliary water system and reusable tubing discussed in section II, above, or discuss with relevant stakeholders the quality and safety of reusing disposable irrigation tubing on multiple patients throughout the day (sans reprocessing).

[a]  These stakeholders would likely include, among possibly others, the medical facility’s risk manager, quality assurance officer, infection control coordinator and the disposable irrigation tubing’s manufacturer.

3. The following guidance is provided for those GI endoscopy departments that, after consultation with these stakeholders, decide to reuse disposable irrigation tubing on multiple patients throughout the day:

[a] Contact the disposable irrigation tubing’s manufacturer and confirm that its reuse is not “off-label.”

Note: Discussed in the second article in this series of three,[2] the off-label use of a device, while not necessarily unsafe, may shift the legal responsibility associated with the device’s use, which is otherwise generally reserved for the device’s manufacturer, onto the healthcare provider or facility. (A device’s off-label reuse could come under particular scrutiny if the device were associated with an adverse event.)

[b] If its manufacturer asserts the safety and regulatory validity of reusing disposable irrigation tubing, then  request from it the maximum number of patients on whom its marketed tubing may be reused daily.

[c] Download directly from the FDA’s website (and keep on file) a copy of the disposable tubing’s 510(k) clearance letter (click here).

  • It is acknowledged that, while arguably not a “best practice,” the reuse of disposable irrigation tubing on multiple patients throughout the day (e.g., during a 24-hour time frame) has not been publicly linked to any reported instances of disease transmission.
  • But it is also acknowledged that while the potential for disease transmission due to the faulty use, setup, or reprocessing of an auxiliary water system’s reusable tubing (e.g., AWT) has been recently reported (refer to the first and second articles in this series1,2), instances of infection attributed to such reusable tubing has not been documented either.
  • Moreover, while seemingly inconsistent with the FDA’s cleared use of disposable irrigation tubing, its reuse on multiple patients (sans reprocessing) appears ironically to be sanctioned by the FDA.[1,2]

Note: More important recommendations in this section are available, but are included only in the more complete PDF version of this article of the same title, which may be downloaded by clicking here.

4. For those GI endoscopy departments that decide to reuse disposable irrigation tubing (fitted with its own primary one-way valve) on multiple patients, this article recommends using this tubing with a single-use endoscope connector (sold by the tubing’s manufacturer) that itself is designed with, or can be connected to and used with, a (secondary) one-way (backflow) valve.

[a]  This article recommends using a single-use connector with a one-way valve (that are discarded after a single patient’s use) as a “best practice” and to improve both quality and safety. (Whereas reusable endoscope connectors sold by the manufacturers of disposable tubing often are not designed with one, these manufacturers’ single-use connectors are generally designed with their own one-way valve.[1,2])

Use of a single-use connector equipped with its own one-way valve (to prevent backflow and the tubing’s contamination) is a recommended “best practice.”—Lawrence F Muscarella, PhD

[b]  Use of disposable tubing with a reusable endoscope connector (which is currently an available option offered by most tubing manufacturers), especially if this reusable endoscope connector is not equipped with a (single-use) one-way valve, is not recommended (unless the endoscope connector is intended and labeled to be reprocessed after each use; see below).

This practice is not recommended because of the concern that the connector and possibly the disposable irrigation tubing (and the tubing’s one-way valve) may become contaminated with blood or another potentially infectious material, posing an increased risk of infection during the tubing’s reuse throughout the day.

  • If the endoscope connector sold by the disposable tubing’s manufacturer is not equipped with one, separately purchase from this manufacturer a single-use, one-way valve (offered as a stand-alone option) that can be manually fitted onto the endoscope connector prior to performing GI endoscopy.
  • As with the disposable tubing, it is acknowledged, however, that instances of disease transmission attributed to the use of a reusable endoscope connector (sans reprocessing) sold by the tubing’s manufacturer, even if the connector were used without a (secondary) one-way (backflow) valve, have not been documented.

The reuse of such disposable items as hypodermic needles and syringes is prohibited and has resulted in patient-to-patient disease transmission.—Lawrence F Muscarella, PhD

Note: More recommendations in this section are available only in the more complete PDF version of this article of the same title, which may be downloaded by clicking here.


— IV. — Miscellaneous Recommendations:

1. Ensure that other types of “disposable” items used during GI endoscopy—for example, hypodermic needles and syringes, intravenous (IV) tubing sets, single-dose medicine vials, and sterile medical gloves—are used only on one patient and are then promptly discarded.

[a] The reuse of these items can result in disease transmission with associated patient morbidity.

2. Confirm that any types of “channel adapters” that might be used with this disposable tubing to provide for irrigation via the GI endoscope’s working (or instrument) channel are used only on one patient and are then discarded, in accordance with the adapter’s instructions.

The FDA is respectfully requested to clarify its definition of “disposable” at it applies to disposable irrigation tubing (e.g., does it define a single-day item?).—Lawrence F Muscarella, PhD

3. Review each of the following related documents:[1,2]

[a] the Veterans Health Administration’s (VHA) patient safety alert, entitled “Improper Setup and Reprocessing of Flexible Endoscope Tubing and Accessories,” dated December 22, 2008, which may be read by clicking here;

[b] the VHA’s directive entitled “Use and Reprocessing of Reusable Medical Equipment in Veterans Health Administration Facilities,” dated February 9, 2009, which may be read by clicking here; and

[c] the first article in this series, which is entitled “Faulty Use of a GI Endoscope’s Auxiliary Water Channel” and may be downloaded as a PDF by clicking here.

A review of this article’s definition of a disposable, reusable, and reposable device is emphasized.—Lawrence F Muscarella, PhD


Legal Reviews for Patients, Hospitals, Manufacturers:  Click here to read about Dr. Muscarella’s expertise and legal assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.


4.  The FDA is requested to clarify for GI endoscopy departments and manufacturers:

[a]  the Agency’s definition of “disposable” at it applies to disposable irrigation tubing (e.g., did the FDA intend this type of disposable irrigation tubing to be a single-patient or single-day item?);

Note: This article defines “disposable” as a single-use device and “reposable” as a single-day device that does not require reprocessing after each use.[1]

[b]  precisely how the Agency intended disposable tubing used for irrigation during GI endoscopy to be marketed (i.e., as a single-use or multiple-use item); and

[c] whether the Agency countenances the reuse of disposable irrigation tubing during GI endoscopy, the tubing’s FDA-clearances notwithstanding.[2]

5. Additional research into the safety of disposable irrigation tubing and its reuse is recommended.

Attention: More recommendations in this section are available only in the more complete PDF version of this article of the same title, which may be downloaded by clicking here.


References

1. Muscarella LF. Faulty use of a GI endoscope’s auxiliary water system. The Q-Net Monthly 2013 Jan-Mar;19(1-3):1-6. Click here.

2. Muscarella LF. “Disposable” irrigation tubing used during GI endoscopy. The X-Net Healthcare Review 2013 Apr-Aug;19(4-8):7-16S2. Click here.

Article by: Lawrence F Muscarella, PhD, president and owner of the think-tank quality and safety company “LFM Healthcare Solutions.” Click here for a list of its services. Article posted: 10/17/2013; updated: 9/19/2015, Rev A.

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