Infection Control Today

SEP 2018

ICT delivers to infection preventionists & their colleagues in the operating room, sterile processing/central sterile, environmental services & materials management, timely & relevant news, trends & information impacting the profession & the industry

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28 ICT September 2018 www.infectioncontroltoday.com Staphylococcus aureus) are released from surgical team members and patients into the surrounding OR air and settle onto surgical instruments and into operative incisions. 17-23 Most of the organisms that cause SSIs are shed from skin or are attached to particulate matter of less than 5 microns in size. These particles become transiently airborne and foat on air currents before implanting in the wound. 24-25 The Changing Legal Environment This is an exciting time in healthcare with innovations in medical technology that have the potential to greatly improve patient outcomes and reduce the cost of care. However, advancing change in healthcare, be it product, practice or people, can be challenging. Clinicians can be reticent to be agents of change due to political and organi- zational challenges, lack of resources, fear of failure and/or malpractice. While clinicians may think there is security in adhering to clinical practice guidelines, problems may arise when those guidelines confict with evolving standards of care. Absence of a requirement in clinical guidelines or standards may not be an adequate legal defense for failure to prevent an SSI if the larger body of evidence suggests otherwise. Clinical practice guidelines (CPGs) and evidence-based medicine (EBM) are not the same in the eyes of the court. CPGs can be defned as systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specifc clinical circumstances. 26 CPGs are a combination of contemporary belief and customary practice. All too often it is believed that a failure to adhere to CPGs is equivalent to a failure to meet the standard of care when in fact, following guidelines that are outdated (as they frequently are even on the date of publication) or "guidance" written for the beneft of the author, may prove detrimental to both patient and practi- tioner. For example, while the CDC issued a revision to the Guideline for Prevention of Surgical Site Infection in 2017, the recommendations are not inclusive of certain practices that have become widespread in the prevention of SSI. While these practices are not included in the guideline on the basis that they do not meet the threshold for quality and/or quantity of evidence, the overall body of evidence available to the feld led to widespread adoption of these practices and the related technologies. Even though these practices and technologies are not recommended in the guideline, they are the de-facto standard of care. In contrast, evidence-based medicine (EBM) is the conscientious, explicit and judicious use of current best evidence 27 integrating the best research with clinical expertise and patient values. 28 More simply, EBM is focused on treating the individual patient based upon that patient's unique health state and diagnosis, individual risks and the benefts of potential interventions. 29 To meet the evidence-based standard, clinicians are urged to keep informed with respect to new evidence from patient-centered clinical research even if this invalidates previously accepted guidance in an effort to yield more powerful, accurate, safer and more cost-ef- fective outcomes. Some courts have been moving toward utilizing an evidence-based standard of care because historical customary practice may not necessarily be reasonable or refect the most recent advancements in medical care or technology. At least a part of the legal rationale behind the movement toward an EBM standard of care is based upon the fact that malpractice standards change because of advancements in technology and not changes in the law itself. The issue then becomes whether reasonable care equates to what most medical profes- sionals actually do or what is reasonable to expect given the state of medical knowledge at the time of treatment. It is important to keep in mind that both malpractice standards and evidence-based medicine include a "duty to stay abreast." This means that there is an obligation to be aware of evolving practices in medical care and to make appropriate use of new scientifc knowledge in medicine as it emerges. 30 Clinicians contemplating adoption of new evidence-based products, practices, or technologies, but reluctant to move beyond clinical guidelines may want to investigate Nowatske v. Osterloh where the court ruled that should medical practice fail to keep pace with developments and advances in medical science, adherence to custom might constitute a failure to exercise reasonable care. 31 It also stated that if what passes for customary or usual care lags behind developments in medical science, such care might be negligent, despite its customary nature. 32 Some case law implies that if the relevant practice, product or technology was found acceptable by a reputable subset of the profession it would not be regarded as improper even if few clinicians had adopted it at that time. 33 This fnding lends support to early adoption of technologies that do not place patients at additional risk and credence to the value of smaller, well designed and executed studies. This fnding should encourage manufacturers, product developers and healthcare institutions to pursue smaller studies when large randomized control trials (RCTs) are not feasible. Air Quality in the OR and Malpractice for Orthopedic Surgery With respect to HAIs, medical malpractice cases generally focus upon whether the infection was preventable and/or whether the infection was properly and/or promptly treated. In their evaluation of the merits of a medical malpractice case based upon a patient acquiring a healthcare-associated infection, courts may look at the availability of evidence-based technology which could have prevented the infection with minimal risk, cost, and training in determining whether the standard of care was breached. In the Pennsylvania case of DiMeo v. St. Agnes Hospital, 34 Annette DiMeo underwent a left total knee replacement that subsequently developed into an infected hematoma and progressed into an infected septic knee. Among the plaintiff's causes of action was an allegation for failure to take adequate precautions to prevent operating room infections. The jury awarded DiMeo $1,200,000 in damages. In the New York case of Lugo v. Klein, 35 Lugo underwent knee surgery and subsequently developed a staph infection. He alleged negligence in failure to keep the wound sterile, failure to recognize infection as well as failure to warn of risks of infection resulting from the procedure. Jury awarded Lugo $401,000 for pain and suffering. Interestingly, in the Illinois case of Goldby v. Orthopedic & Spine Surgery Associates, 36 the plaintiff's allegations were based upon failure to properly diagnose and treat an infection following a right forearm injury, but also included negligence based upon closing a dirty wound. While it was not specifcally alleged that the wound became dirty because of the OR conditions, this certainly paves the way for future claims asserting negligence based upon a failure to properly disinfect and/ or inspect the operative feld. A settlement was reached in favor of the plaintiff in the amount of $1.75 million. Allegations in other orthopedic prosthetic joint infections have included failure to properly disinfect the OR and surgical instruments (Dechico v. Hudson Valley Hospital) 37 and failure to inspect the operative feld and clean surgical instruments (Phillips v. Baker). 38 It is suspected that these cases are just the tip of the iceberg in orthopedic SSI litigation, as most malpractice cases are settled long before they get to court and many come with nondisclosure orders preventing release of information related to the case. Thus, it is not possible to estimate the actual number of SSI claims, claims alleging injury due to contam- ination of the OR and/or contamination of the wound, or average costs to healthcare institutions to defend SSI-related litigation.

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