DESCO Industry Update                                                                     February 2012

For our Steris System One customers:

The following information was recently published by AAMI, the Association for the Advancement of Medical Instrumentation:

FDA Extends STERIS System 1 Transition Deadline Again

"The U.S. Food and Drug Administration (FDA) has granted hospitals and healthcare facilities another six months to transition from STERIS System 1 to a legally marketed alternative.
Affected facilities now have until Aug. 2, 2012, according to a December notice from the agency. The previous deadline was Feb. 2.

The extension only affects customers who have already placed orders for a product to replace the system and "have provided a properly completed Certificate of Transition," the agency said. In a Dec. 22 letter, STERIS said it would only supply System 1 support and sterilant after Feb. 2 for U.S. customers meeting those same conditions.

In December 2009, the agency told healthcare facility administrators that STERIS had significantly changed the liquid chemical sterilizing system, and that the FDA hadn't verified the modified product's safety and effectiveness.

The FDA recommended that facilities move to an acceptable alternative immediately. If a facility didn't have an alternative available, the agency originally gave them until August 2011 to find one, and has now extended that deadline twice.

Users have said that any transition will take a lot of time and money.

"The FDA does not expect to take regulatory action against healthcare facilities for failing to replace units within the transition period," the agency said. "However, these facilities should be aware that the current System 1 is a misbranded and adulterated medical device because it has not been cleared by the FDA as safe and effective for its labeled claims. As a result, healthcare facilities should transition to alternative reprocessing devices as soon as possible."

To read the FDA notice, click here. For the STERIS letter, click here (PDF). For more information on System 1, including how to find alternatives, click here."

For more information, please contact:

Diagnostic Equipment Service Corporation

124 Main Street

Norfolk, MA  02056

800-845-0606

Information on Endoscope Reprocessing and The Joint Commision by Andrea Bordenca

DESCO Medical has participated in the last five AAMI conferences and heard from The Joint Commission’s (TJC) Standard Interpretation Group Senior Engineer, George Mills.  Mr. Mills provides a detailed conference with a helpful Q&A session.  Recently, he spoke about the current and most important issues surrounding TJC surveys. 

TJC’s focus has shifted over the years from flash sterilization, PM completion rate on life support equipment, dialysis water treatment to endoscope reprocessing.  Endoscope reprocessing has been an important issue discussed during the last two AAMI conferences.  Mr. Mills recommends that TJC surveyors request specific information from the Endoscopy Departments and Biomedical Engineering Departments.  Here is the reasoning:

1.  Scopes (rigid and flexible) are considered medical equipment and for this reason must be included in medical equipment inventory list. 

DESCO is looking to add all scopes to our inventory database and provide a full list of the medical equipment including the scopes.  All scopes will have an ID number.  No ID tag will be attached to the scopes for obvious reasons.

2.  All institutions using scopes should keep records of reprocessing (disinfection process) provided to scopes.  These records should be presented to surveyors upon request.  After every reprocessing procedure a printed record should be obtained from the reprocessing device by the operator and saved in the institution in a way that it could be easy for the operator to retrieve those records upon request.  Every institution implements different ways to keep those records.  We recommend saving them chronologically in a notebook that we can provide.  Usually, the reprocessing devices record the scope number and the patient ID information.  The more information saved the better.  The cleaning and inspection performed by the operator prior to reprocessing is considered a preventive maintenance to the scopes.  As these activities are part of the reprocessing procedure, they are reflected implicitly in the reprocessing records.

3.  All institutions using scopes should keep records of the corrective maintenance provided to reprocessing devices.  These records should be presented to surveyors upon request.  Every time service is provided to the reprocessing devices (corrective or preventive maintenance) a service report should be kept in the institution records to be shown to surveyors upon request.  Every time the unit fails during its normal activity and a printout is produced by the device printer with an error log, a service call should be generated and a service report (repair activity) should be created after the repair is completed.  The service report should state that the unit is fully functional and ready to be used again.  This service report should be saved. 

4.  All institutions using scopes should keep records of the corrective maintenance provided to scopes.  These records should be presented to surveyors upon request.  Similar to # 3 above, every time a scope issue occurs, the same procedure applies.  When the scopes are sent for repair a record should be kept in the book to show that a missing scope is out for repair.  When the scope returns from repair it should come with a service report/work order reflecting the activities performed and this report should be saved.  The scopes should undergo an incoming inspection by the operator after they return from service to check for the integrity and the functionality.  This test should be documented.  There is no TJC requirement to involve Biomedical Engineering technician in this incoming inspection activity.

5.  TJC requires Biomedical Engineering Department to act as an inspection body and provide an inspection of the reprocessing site to check the procedure on a calendar schedule (there was no mention about the required frequency).

To note: TJC surveyors don’t ask the managers during surveys, they ask the end-users about the reprocessing steps, and about their record keeping procedures.

DESCO can provide service to your facility’s scopes and is happy to help you with this process so all are on the same page and TJC-inspection ready.  

For more information, please contact:

Diagnostic Equipment Service Corporation

124 Main Street

Norfolk, MA  02056

800-845-0606

MERA® Awards DESCO Most Responsive Organization 2011

Steris Reaches Settlement in Class-Action Suit Over System 1

If your facility purchased a Steris System 1 unit before January 2009, your company may be entitled to credits or cash. While not a safety issue, Steris and the FDA recommend repaceing the SS1 systems by August of 2011.

""There are no allegations in this case that the SS1 devices create a safety hazard," note the plaintiffs' attorneys, "nor that anyone has been harmed as a result of using the SS1 devices." Steris denies all claims made in the suit. "We thought it was best to settle the suit and provide further incentive to our customers to assist with their System 1 transition, rather than incur legal fees," says Stephen Norton, Steris' director of corporate communications and government affairs, in a statement e-mailed to Outpatient Surgery."

Read the whole article from Outpatient Surgery HERE

Preventive Maintenance Defined:
How Your Costs are Impacted
by Andrea L. Bordenca, DESCO CEO

Among the many facilities and many vendors out there, the terms “Preventive Maintenance (PM) and “Operational Check” are sometimes used interchangeably. This will impact your bottom line.

Understanding what your vendor is doing to your equipment is not a trivial conversation and could translate into thousands of dollars in needless expenditures for healthcare facilities of all kinds. 

Upon contract initiation, ask your vendor candidates to lay out and define the distinctions noted at the end of this month’s DESCO Industry Update.  It is common to use these terms interchangeably, but that is not accurate.  “Preventive Maintenance” is just that: Preventing maintenance, preventing failure, preventing return service calls.

Read the whole article by Andrea Bordenca, DESCO CEO HERE