Why is a hospital machine tied to superbugs still in use? Six months ago, the Food and Drug Administration (FDA) said a machine tied to a deadly superbug outbreak should be taken off the market “as soon as possible” to protect public health. Twice. But the machine, which uses water, disinfectant, and sound waves to clean certain surgical instruments, remains in use for some of those instruments after FDA officials backed down. And no one is saying precisely why. The FDA ordered Custom Ultrasonics Inc. to

take its 2,800 System 83 Plus machines out of service. The automated washing machines are used across the U.S. to clean endoscopes including duodenoscopes. The use of the equipment was one of several factors that “likely contributed” to dan- gerous infections spread by inadequately cleaned duodenoscopes, according to a 2016 report by Senate Democratic staff investigating the incidents. In its November 2015 correspondence with

the company demanding a recall, the FDA raised concerns about the device's compatibility with dis- infectants, whether it works with duodenoscopes, and whether it properly eliminates microorganisms from water. In pulling back that recall demand, the regulator now says it’s working with the company to ensure that the machines “are validated in a timely manner,” according to an agency spokes- woman. “Validated” means the company has to prove the devices work as advertised. In the meantime, the machines can still be used to clean instruments including most endoscopes—just not duodenoscopes. With the new FDA position, Custom Ultrasonics

said in a notice posted on its website that it will send hospitals a label to affix to the washers that will warn medical staff not to use the machines to clean duodenoscopes. The FDA's scrutiny of Custom Ultrasonics pre-

dates the recent outbreaks. Inspections as far back as 1991 found “significant violations” of federal rules meant to ensure quality manufacturing and timely reporting of patient harm, according to a 2006 complaint filed by federal prosecutors in Philadelphia. Similar violations were documented in 1992, 1995, 2005, and 2006, according to the lawsuit, which led to a consent decree in January 2007 that remains in force, and was the legal basis for the latest recall. Two letters dated Nov. 12, 2015 and Jan.

29, 2016 indicated that, given the company’s “lengthy regulatory history,” merely trying to fix the machines wouldn’t suffice. The first letter instructed the company to recall all of them, at its own expense, and figure out how hospitals could “transition from the System 83 Plus as soon as possible.” The second letter said the company’s response to the first letter was insufficient because it only offered to correct the machines “rather than to remove those devices from use.” The agency wrote, in bold text, “FDA orders Custom Ultrasonics to immediately recall all System 83 Plus devices by removing them from use.”(Bloomberg)

Uncommon sense CS/SPD certification and training should be

universal, so why isn’t it? by Kara Nadeau

ith greater recognition of the patient safety risks presented by improperly processed surgical instruments and devices, the spotlight on central sterile/sterile processing departments (CS/SPD) grows. Many different parties to the healthcare industry, including hospitals, manufacturers and industry associations, are making concerted efforts to increase CS/SPD education and training, as well as ensure the profession has the resources it needs to suc- cessfully protect patients. In this article, we provide an overview of current CS/SPD state certification require- ments, both bills that have passed and legis- lation currently in progress. We also provide insights from CS/SPD professionals, industry thought leaders and manufacturers on what is needed to advance the profession in terms of establishing a CS/SPD career path, on-the- job training and continuing education. Lastly, we offer resources that CS/SPD professionals can access to expand their knowledge and further their careers in this up-and-coming profession.


The state of certification At the time this article was written (May 2016), Connecticut, New Jersey and New York require new central service technicians entering the profession to obtain certification in order to work in the profession within those states; however, all central service tech- nicians, whether grandfathered in or not, are required to complete a minimum of 10 hours of continuing education annually. Josephine Colacci, Esq., Director of Govern-

ment Affairs for the International Associa- tion of Healthcare Central Service Materiel Management (IAHCSMM), notes how there has been progress on the legislative front in both Massachusetts and Pennsylvania as well. According to Colacci, the Massachusetts legislation regarding certification for central service technicians

Josephine Colacci

successfully passed out of the Joint Health Care Financing Committee on May 5, 2016. This legislation is now before the Senate Rules Committee. In Pennsylvania, IAHCSMM continues to meet with legislators serving


on the House Health Committee to educate them regarding certification for central ser- vice technicians.

“The field of healthcare is constantly

changing, with new procedures and new medical devices being introduced at a rapid rate,” said IAHCSMM’s Education Director Natalie Lind, CRCST, CHL, FCS. “Those changes have a profound impact on the central ser- vice department. All those involved in the reprocessing of medical devices must keep up with changes as they occur. Along with learning about new devices and procedures, we are also evolving in our understanding of the science of sterilization. What was an acceptable practice a few years ago may be unacceptable now. Keeping cur- rent is critical for patient safety.”

Natalie Lind

Grassroots efforts Bob Marrs, Director of Consulting Services/ Field Operations for Aesculap, believes hos- pital leadership in sterile processing, surgical services and administration should be leading the charge for certification.” He states: “Did you know that the person who cuts your hair, works on your car, does

Bob Marrs

your nails, does your taxes and sells your house all require certification? Yet, the folks who clean, decontaminate, inspect for qual- ity and functionality, sterilize, store and transport the surgical instruments that will go into you or your loved ones’ bodies, does not require certification. How did this happen and how does it continue to happen? In the country that boasts the ‘best’ healthcare in the world, our third leading cause of death is medical errors. What are you doing as a CS/ SPD professional to support this effort and to keep the momentum going? Our profes- sion needs this but more importantly, our PATIENTS need this!”

Jo M. Wood, Compliance & Education Supervisor for Boston Medical Center, has taken an active role in supporting the Mas- sachusetts legislative efforts. Wood explains how those working on the Massachusetts leg-

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