March 27, 2015 — On March 26, 2015, the FDA issued a safety communication:
Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes — click here.
This Olympus safety communication — which is directed to users of the Olympus TJF-Q180V including gastroenterologists, endoscopy nurses, reprocessing staff, infection control practitioners, and risk managers — follows in the footsteps of Olympus’ own “urgent safety notification” issued, too, on March 26, 2015.
According to the FDA, Olympus has issued new, validated manual reprocessing instructions for the more effective cleaning of the TJF-Q180V duodenoscope. These instructions replace those provided by Olympus in this endoscope’s original labeling.
For more details about the FDA’s safety communication, the reader is directed to the Los Angeles Times article: “Olympus says new steps needed to clean medical scopes of dangerous bugs” also dated March 27, 2015.
A forthcoming regulatory clearance?
The FDA’s safety communication would appear to imply, perhaps, that the FDA may soon clear the Olympus TJF-Q180V duodenoscope for use in the U.S.
But circumspection is warranted, and there may be more legal implications and safety concerns associated with the FDA’s communication than appreciated at first glance.
Revised reprocessing instructions
According to its safety communication, the FDA has reviewed Olympus’s “new reprocessing instructions and the validation data as part of its ongoing review of the 510(k).”
The FDA is further recommending that any facilities using Olympus’ TJF-Q180V duodenoscope teach its staff members about these new instructions and implement them “as soon as possible.”
But whether the FDA is now poised to grant a 510(k) pre-market regulatory clearance to the Olympus TJF-Q180V duodenoscope, which has been used in the U.S. (without a legal clearance) since 2010, remains unclear – but is certainly possible.
Quality Reviews and Reports for Hospitals, Manufacturers, Patients: 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.
Commentary: Some important considerations
1. — 510(k) clearances are not retroactive
The FDA’s safety communication may have overlooked an important consideration with potentially significant regulatory and safety implications:
Even if the FDA were soon to clear the Olympus TJF-Q180V duodenoscope – based, in part, on these “new” validation data that the manufacturer recently provided to the FDA – this type of endorsement would seemingly not apply to the TJF-Q180V duodenoscopes already in use through the U.S.
In short, because these models of duodenoscopes have been sold by the manufacturer, since 2010, without first receiving a 510(k) pre-market clearance, these specialty endoscope do not comply with the requirements of FDA’s Quality System Regulations (QSR), which impose controls on the manufacturing and marketing of the device and are designed, in part, to prevent a manufacturer from doing that which has now occurred: selling a device (the Olympus TJF-Q180V) without first being granted a 510(k) clearance by the FDA.
The FDA ordinarily considers any medical device sold without a regulatory clearance to be “adulterated and misbranded” (see: “sidebar” immediately below), meaning, in part, that the device’s safety and effectiveness cannot be assured.
Ordinarily, a pre-market (510[k]) clearance — which is a legal letter written by the FDA to the manufacturer — is applicable henceforth, from the date of the letter, and applies only to medical devices that the manufacturer has yet to have sold in the U.S.
In general, a granted 510(k) clearance does not apply to, and would not retroactively render legal and both safe and effective, adulterated and misbranded devices already in use.
The FDA’s typical regulatory remedy for medical devices that are in use, but are without a legal clearance (or pre-market approval), and therefore whose safety cannot be assured, would be to order the manufacturer (often by way of a signed consent decree) to remove the devices from use — that is, to recall the un-cleared device.
The FDA has sanctioned the continued use of the un-cleared Olympus TJF-Q180V duodenoscope. This is an atypical, if not extraordinary, action. — Lawrence F Muscarella, PhD
Sidebar: The Food Drug and Cosmetic (“FD&C”) Act
Briefly, a medical device is “misbranded” if the manufacturer failed to obtain a 510(k) clearance (or, pre-market notification) from the FDA prior to introducing the medical device into interstate commerce.
According to the FDA, Olympus failed to obtain such a clearance in 2010 when the manufacturer first began selling the Olympus TJF-Q180V duodenoscope in the U.S.
This endoscope model is also “adulterated” because neither did its manufacturer receive a premarket approval (or, “PMA”) prior to introducing the device into interstate commerce (i.e., prior to selling the device in the U.S.).
The Food Drug and Cosmetic (“FD&C”) Act expressly prohibits the introduction into interstate commerce (that is, the sale) in the U.S. of any medical device that is adulterated and misbranded, such as (according to the FDA) the un-cleared Olympus TJF-Q180V duodenoscope. Refer to 21 U.S.C. §331(a); and 21 U.S.C. § 351(f)(1)(B).
2. Manual cleaning – additional brushing
According to the FDA’s safety communication, Olympus’ revised reprocessing instructions state, under the heading “Manual cleaning”:
- that “additional brushing of the forceps elevator recess area” is now required; and
- “the revised cleaning procedure requires brushing of the forceps elevator recess with two different-sized brushes. In addition to the brush that is currently used to clean the elevator recess area, the (new, smaller bristle) MAJ-1888 brush (or MAJ-1888 equivalent) will be provided for further cleaning of this area. Olympus anticipates shipping the MAJ-1888 brushes to facilities no later than May 8, 2015.”
Four important considerations, if not concerns arise:
First, cleaning brushes are not considered by the FDA to be medical devices and, therefore, they are not cleared (nor are their effectiveness for removing infectious materials from duodenoscopes reviewed and validated) by the FDA. (This same limitation applies to the detergents that are used to clean reusable medical devices, including duodenoscopes.)
Therefore, assurances that these cleaning brushes (like detergents) will perform safely and effectively during their labeled life-cycle necessarily cannot be provided by the FDA.
Second, Olympus’ urgent safety notice recommends the use of a new, smaller bristled MAJ-1888 brush (“or MAJ-1888 equivalent”) for enhanced cleaning.
Three fair questions are asked: Who decides whether one type of brush is “equivalent” to the likely more expensive MAJ-1888 brush? And, what are the performance specifications of Olympus’ MAJ-1888 (e.g., its size and length?) to better ensure that a comparable brush is as effective as Olympus’ brush?
Further, does not the instruction to use an “equivalent” brush require a subjective assessment of a brush’s equivalency, begetting some confusion and the possible ineffective cleaning of the duodenoscope?
Third, the FDA’s safety communication states that: “Olympus anticipates shipping the MAJ-1888 brushes to facilities no later than May 8, 2015.”
This presents an odd double-standard-of-care dilemma, because patients undergoing ERCP prior to May 8, 2015, using the un-cleared Olympus TJF-Q180V model that is cleaned using the currently available (and deemed inadequate) brush would receive a type of care that is apparently of a lesser quality than those patients who will undergo ERCP using this same Olympus endoscope model after this date, but one that is cleaned using this more effective brush.
Different standards of care for different patients always raise important medical concerns and ethical dilemmas that require further discussion.
And, fourth, in its urgent safety notification, Olympus adds: “Until your facility has received the (new) brushes, you should continue to clean the TJF-Q180V duodenoscope in accordance with the original cleaning instructions.”
This is salient, because — according to the FDA — these original cleaning instructions are inadequate for the removal of superbugs from all of the endoscope’s surfaces.
It always has been my understanding that federal statutes and regulations ordinarily prohibit a manufacturer in the U.S. from recommending the use of a medical device that is without either a legal clearance or a pre-market approval (PMA). — Lawrence F Muscarella PhD
The original and revised (issued May, 2015) reprocessing manuals for the Olympus TJF-Q180V duodenoscope may be downloaded and compared by clicking the highlighted text.
3. Automated reprocessing
According to its safety communication, Olympus’ revised reprocessing instructions state, under the heading “Manual High Level Disinfection”:
- “Additional manual flushing steps and increased flushing volume of each endoscope channel (are required), as well as (of) the elevator recess area.”
This instruction’s latter clause (italics added by this posting’s author) raises another important point that, too, may have been overlooked.
Published studies report that most gastrointestinal (GI) endoscopes, including duodenoscopes, are reprocessed in the U.S. using an automated endoscope reprocessor, or “AER.”
According to a trade magazine, “about 90% of duodenoscopes in use in the United States” are reprocessed sing an AER (click here).
Yet, AERs do not flush a detergent or disinfectant, under pressure, onto, into and around the forceps elevator’s recess area, as the FDA’s safety communication and Olympus’ revised reprocessing manual both instruct, which raises questions about using an AER to reprocess the Olympus TJV-Q180V model.
Compliance with the instruction to “flush” the forceps elevator area with an increased fluid volume would seem to require that the duodenoscope, at least the recessed area around the forceps elevator mechanism, be manually reprocessed using a syringe to direct the flow of the detergent and disinfectant (and rinse water) as the manufacturer’s revised instructions now advise.
Manually reprocessing duodenoscopes is not necessarily an insurmountable problem, but might require clarification and elucidation from the FDA before adopting it.
A March 18, 2015, article in USA TODAY discussing the possible role that AERs may have played in some recent “superbug” outbreaks following ERCP may be read by clicking here.
4. — “EUS” (ultrasound endoscopes) and AERs
While not discussed in the FDA’s safety communication, the same concerns about both the risk of transmission of superbugs and the importance of validation data apply similarly to linear array “EUS” (or ultrasound) GI endoscopes, not only to duodenoscopes — as well as likely to AERs labeled to reprocess the Olympus TJF-Q180V duodenoscope.
The labeling of an AER to reprocess this un-cleared duodenoscope model is salient, because of the instructions stated in a letter by the FDA, dated February 22, 2010: “Letter to Endoscope Manufacturers: Possible Misbranding of Reusable Devices Labeled for Reprocessing by the STERIS System 1 Processor” — click here to read it.
According to this letter, it is the FDA’s conclusion that if a medical device (in this instance, an AER) is labeled to reprocess a type of endoscope that is without a legal clearance (in this second instance, the Olympus TJF-Q180V duodenoscope), then the AER itself would become “misbranded under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act” because it “fail(s) to bear adequate directions for use.”
Refer to Appendix A at the end of this posting.
5. — Investigational device exemptions, or IDEs
In its safety communication, dated March 26, 2015, the FDA recommends that facilities using Olympus’ TJF-Q180V duodenoscope “train staff on the new instructions and implement them as soon as possible.”
Whether the FDA has previously endorsed the labeling and use of another medical device that, like the TJV-Q180V model, is without a legal clearance or approval is unclear.
No matter, however, the use of an uncleared device, absent an investigational device exemption (IDE) overseen by a medical facility’s institutional review board (IRB), may not be consistent with federal law; refer to Appendix A, below.
Interesting facts about the law that governs the use of medical devices without a 510(k) clearance or a pre-market approval (sometimes called “investigational” devices), as well as the provisions associated with an IDE and an IRB are discussed in Appendix A, below.
Closing remarks
It can certainly be argued that the oversight of the Olympus TJF-Q180V duodenoscope has been unnecessarily lax.
Had this device received the expected regulatory oversight during the past five years, a majority of the recent well-publicized “superbug” outbreaks linked to contaminated duodenoscopes might have been averted.
Appendix A: Investigational devices, IDEs and IRBs
From Dr. Muscarella’s peer-reviewed article: “Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices” — click here:
“Adoption of a policy that notifies patients of a potentially significant medical error or infection-control breach may not only improve the quality and trust of health care but also, in addition to minimizing potential conflicts of interest, is the patient’s expectation.
“In some circumstances, however, patient notification may be less of a dilemma than a federal mandate.
“For example, consider a ‘significant risk’ medical device whose design has been modified, but that may be used lawfully in the clinical setting without a regulatory approval or clearance. This modified device (e.g., the Olympus TJF-Q180V duodenoscope) — like those unapproved devices, too, that may be the subject of a clinical study conducted by a manufacturer or sponsor to demonstrate the device’s safety and effectiveness (as required of a pre-market approval, or PMA) or its substantially equivalence to a legally marketed predicate device [as required of a 510(k)] — is referred to as ‘investigational,’ and it may be lawfully used in the US provided a number of criteria are satisfied.
“These criteria are detailed in the Code of Federal Regulations and include, among others:
- obtaining for the device an investigational device exemption (“IDE”) approved by an IRB (and, possibly, by the FDA);
- labeling the device “caution – investigational”; and
- having the IRB additionally monitor the device’s clinical use. This third criterion is a check and balance designed to ensure that the unapproved device’s use does not inadvertently overlook or unduly compromise the patient’s “rights, safety and welfare.”
“From the FDA’s perspective, the safety and effectiveness of a modified, unapproved device (or the device’s substantial equivalence to a legally marketed predicate device) have not been demonstrated and, therefore, the device’s clinical use manifestly poses the potential for patient harm.
“Without an approved IDE, the manufacturer’s shipment and introduction into interstate commerce of this unapproved device, as required for its clinical use, would violate federal law.
“Federal rules and regulations governing the clinical and lawful use of medical devices that are without a regulatory clearance or approval also mandate a fourth criterion: that all affected patients be informed of, and consent to, the device’s use.”
Article by: Lawrence F Muscarella, PhD; posted: 3/27/2015; updated: 6/25/2015, Rev B. Quality healthcare services offered by Dr. Muscarella are listed here.
Bravo! Thank you.
Please, someone needs to be listening. . .Where are the Congressional hearings that were mentioned? If unchallenged FDA’s dangerous precedent in allowing Olympus to flaunt legal obligation places any and all in harm’s way with no way of discovering our risks.