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FDA Warning Letter to Innovative Sterilization Technologies on ONE TRAY (Part II)

In Part I of this blog (Novo blog #101, August 30, 2019) we reported that the FDA had disclosed on Tuesday, August 20, 2019 that they had issued a warning letter to Innovative Sterilization Technologies (IST) on March 20th of this year. The warring letter expressed significant concerns by the FDA about IST’s promotion of One Tray for “terminal sterile storage and terminal sterile storage with retained moisture.”1

Last fall we published a blog on One Tray (Novo blog #60, October 19, 2018) that contained a number of comments from AAMI members expressing their concerns with the product. The following comments from the AAMI members over the use, applicability and functionality of the One Tray sterilization container system are the comments of the individuals exclusively (2) and do not necessarily reflect the opinions of Novo Surgical.

“I have watched the discussion threads on One Tray for a couple years now. I have seen questions mostly about compliancy, sterility and how it can eliminate the dry time and save time. What I do not see is any concern or questions about what the lack of any dry time will do to the instrumentation. The main reason for the dry cycle has always been for the protection of instruments made of many types of metal alloys. Metals in a moist environment which are not designed for that environment will be damaged.

Medical device manufacturers RELY on the fact that there WILL BE A STANDARD DRY TIME RUN so their devices will not be damaged. We cannot change physics by using One Tray. If the instruments are wet inside the packaging after the cycle is done, over time they will corrode, Period! The fact that the instrumentation is corroded, but still sterile, is beside the point when it does not work, breaks in the field or sluffs off oxidation into the patient.” John ___________ SPD Manager3

I’m not using One Tray and I’m not considering using them. As you know they hold moisture and I would not give anything to the O.R that has moisture in the set. The dry time is shortened and my problem with One Tray is that the device manufacturer’s IFU cannot be followed. You should not have moisture in the tray when they go into the O.R.”
Erika __________SPD Manager4

Since the FDA’s warning letter on One Tray was made public on August 20, a lot of AAMI members have weighed in with comments on One Tray and the claims made by the company. As was the case with the AAMI member comments that we published last fall, the following comments are the opinions of the AAMI members exclusively (5) and do not necessarily reflect the opinions of Novo Surgical.

“I would like to remind everyone that the issues faced by One Tray are not just how long sterilization can be maintained in a moist environment and off label usage. Even though IST has tested how the product will stay sterile, it cannot override the instrument manufacturers’ IFU requiring minimum dry times. So unless every device/instrument manufacturer tests their device and puts it in their IFU that it does not require dry time if used in FDA approved container which can have retained moisture it is a moot point. Not to mention the fact that FDA pointed out in the warning letter that an intended use for a terminal sterilization case approved for storage with moisture DOES NOT EXIST is also a big hurdle. This is why you have not seen other case manufactures try what IST is doing now. For all the studies which are done the fact that dry time are still required by the instrument manufacturers cannot be overlooked.” Jim _______, BMET (5)

Jim makes an excellent point! Almost every surgical instrument manufacturers’ IFUs call for a minimum drying time of 15 to 20 minutes (or even longer in the case of complex instruments with long lumens, dead spaces, deep crevasses, etc.). One Tray simply cannot dismiss the instrument manufacturers’ IFUs.

“Consumers want assurances that the device has been cleared by the FDA. Unfortunately, IST is fighting a two front war. Competitors are voicing their concerns over their expanding shelf life claims since 2005 and the customer is asking for data to support their expanded shelf life claims based on their currently “Cleared” indication for use statement. This is contradictory and nuanced based on IST’s press release
(6) which states that The One Tray’s website also specifically lists shelf life ‘testing of the device and the sterile instruments it holds without a dry time based on performance testing relied upon for clearance.’

I am not sure what ‘relied upon for clearance’ means as it relates to their cleared indication for use statement but an indication for use statement is a medical device company’s right to sell their device and they are confined by the language within their indications for use statement.” Shawn ______ CHL, CIS, CRCST, Manager of Sterile Processing/OR Services (7)

As was pointed out in Part I of this blog, any healthcare facility that is using One Tray for something other than its FDA approved use then that facility could be “in violation of the Federal Food, Drug, and Cosmetic Act.”(8) The FDA has only approved One Tray to hold reusable medical devices while they are flash sterilized for immediate use (IUSS). According to the FDA warning letter, the use of One Tray for terminal sterile storage and/or terminal sterile storage with retained moisture “could result in patient illness, injury, or death.”9

If your facility is using One Tray, please be sure and share this blog and link to the FDA’s Warring Letter with your facility’s Infection Control Manager, your OR manager and your Risk Manager. As the FDA points out in their warring letter, unapproved use of One Tray “could result in patient illness, injury, or death.”10

  1. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innovative-sterilization-technologies-llc-524761-03202019
  2. AAMI Members Discussion Group Digest, September 17, 2018 through October11, 2018
  3. Op. Cite.
  4. Op. Cite.
  5. AAMI Members Discussion Group Digest, August 22, 2019 through September10, 2019
  6. Innovative Sterilization Technologies, LLC, Press Release, August 22, 2019, Dave Billman, Chief Operating Officer
  7. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innovative-sterilization-technologies-llc-524761-03202019
  8. Op. Cite.
  9. Op. Cite.
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