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December 13, 2016
More on Double-Booked Surgery
It’s only been two weeks since our last column on double-booked surgery (see our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery”) but already there have been two significant publications regarding the practice.
We previously noted the paucity of evidence in the literature for or against the practice of double-booked surgery. In our November 10, 2015 Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery” we noted Massachusetts General Hospital’s review of its own cases. And in our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we highlighted the study done by Zhang and colleagues at UCSF comparing overlapping cases with non-overlapping cases for a variety of orthopedic surgical procedures performed in an academic ambulatory surgery setting (Zhang 2016). The latter found no difference in patient operating room time, procedure time, and 30-day complication rates between overlapping and non-overlapping surgery.
Now a new retrospective review has compared overlapping surgery with nonoverlapping surgery at the Mayo Clinic (Hyder 2016). Over 10,000 cases of overlapping surgery were matched to a similar number of nonoverlapping surgeries. Adjusted odds ratio for inpatient mortality was greater for nonoverlapping procedures (adjusted odds ratio, OR = 2.14 vs overlapping procedures) and length of stay and morbidity were no different.
That’s reassuring in that it likely means that the overall occurrence of adverse events related to double-booked or overlapping cases is small. The frequency of retained surgical items or wrong-site surgery is also small but that doesn’t mean we don’t need to take steps to prevent such adverse events. The same applies to double-booked or overlapping surgery. The Hyder review also cannot conclude that there were no adverse events related to overalapping surgery since they did not do full case reviews on all cases. And, while they did the best they could in matching overlapping cases to nonoverlapping cases, we don’t know why the latter were done without overlapping. There may well have been a selection bias in which some factor not accounted for in the risk adjustment led the surgeons to schedule these cases as nonoverlapping. And you’ll recall in our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we also described a scenario where as complication that could have been prevented had a post-op debriefing been done for one case of an overlapping surgery actually gets attributed instead to a nonoverlapping case. And, lastly, the results from a single academic center may not be generalizable to other academic centers or to non-teaching venues.
In addition, the Boston Globe (Saltzman 2016) recently noted an unpublished study by an assistant professor of surgery at the University of Toronto found an increased risk for postoperative complications in concurrent surgery for hip fractures. The study, which used data from about 100 hospitals, compared about 1,000 concurrent hip surgeries with 1,000 that were not performed simultaneously from 2009 to 2014. They noted that the longer the overlap, the greater the rate of complications. From the Globe article, however, it is not clear whether these surgeries were concurrent or overlapping, an important distinction as we’ll note below under definitions.
The second, and perhaps more significant, publication comes not from traditional medical literature but rather from the Senate Finance Committee! You may recall that, after the 2015 Boston Globe investigative report (Abelson 2015) on the practice of double-booked surgery, the Senate Finance Committee, which oversees CMS (Centers for Medicare & Medicaid Services), launched an investigation into double-booked surgery. It has just released a report on the findings of that investigation (Senate Finance Committee 2016). That committee solicited responses from 20 academic medical centers regarding a variety of issues surrounding double-booked surgery plus received testimony from CMS, The Joint Commission, the American College of Surgeons (ACS), AHRQ, the HHS OIG, and multiple other stakeholders.
After the American College of Surgeons issued its position/guidance on concurrent and overlapping surgery (ACS 2016) all of the 20 medical centers responding to the Senate committee had either modified their existing policies, adopted new policies, or were in the process of adopting new policies on double-booked surgery. The Senate committee reviewed those policies and other key issues and, while generally comfortable with the progress made to date, had some additional recommendations.
Hereafter, we’ll refer to “overlapping” surgery. The definition of “concurrent” surgery is a practice in which a surgeon is participating in the “critical portion(s)” of 2 cases simultaneously. The ACS and the Senate committee and pretty much all parties agree that “concurrent” surgery should never be performed.
The Senate committee specifically looked to see if the hospital policies conformed to the ACS guidance on the following:
Under the definitions of concurrent and overlapping surgeries, they wanted to see that “concurrent” surgery was defined and specifically prohibited. They also looked to see that hospitals used the ACS definitions for the 2 types of “overlapping” surgeries (see our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” for those definitions from the ACS). Half the respondent hospitals used the ACS definitions but several had used definitions that were more vague.
They drew special attention to one hospital policy that required department chairs allow surgeons to conduct overlapping surgery only after reviewing the surgeons’ outcome and quality data. In our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we recommended that such review be conducted as part of both the credentialing and privileging process for new surgeons and for continuation of privileges for “overlapping” surgeries for current surgeons, keeping in mind that some older surgeons may maintain their surgical skills even as their ability to multitask deteriorates.
As you might expect, there was more variability when it came to defining “critical portions” of overlapping surgeries. Basically, both CMS and the ACS guidance leave that definition up to the individual surgeon. Most of the hospital policies reviewed by the Senate committee either did not define the critical portions or left it up to the attending physician. A few hospitals, however, did develop lists of procedures (usually by department) and their critical components. The report also notes that discussion of the “critical portions” could be part of the pre-op “huddle” or surgical “time out” and could also be written on the OR white board.
The Senate report notes that both CMS and the ACS generally consider opening and closing of the surgical site as not critical. But in our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we gave real-life examples of some instances where circumstances identified after wound closure would likely merit return of the attending surgeon, with resultant increases in patient time under anesthesia.
The Senate report recognizes that the optimal manner of defining “critical portion” is wanting. But it does find merit in the approach where “surgical departments within a hospital’s medical staff develop guidelines that identify critical components of particular procedures while accounting for the individualized clinical judgment of the surgeon”. We feel strongly that there must be definitions that are uniform for each of the surgical procedures done within a department and across departments when the same procedure is done by multiple departments. (Definitions set by the “hospital” would really have to rely upon the expertise of department chairs, anyway.) Likewise, we would hope that each specialty society will help develop such definitions so that regulatory bodies don’t have to step in and develop such for them.
When overlapping surgery is performed, there should be designation of a backup surgeon who will be “immediately available” to intervene if the original attending surgeon is doing other surgery. Defining “immediately available”, as anticipated, was controversial. There was wide variation in the timeframes and locations in the policies of respondent hospitals. A third simply stated the surgeon must be “on campus”, which does not specify how readily he/she could respond. Some did not define immediately available at all. Others noted specific timeframes, such as 5 minutes or 15 minutes. The Senate report notes that neither CMS nor the ACS defined the term adequately. The ACS guidance does state the surgeon should be “reachable through a paging system or other electronic means, and able to return immediately to the operating room.”
The Hyder study (Hyder 2016), in describing overlapping surgery as performed at the Mayo Clinic, noted that “Each surgical specialty operates in dedicated operating room cores with multiple surgeons of the same specialty present throughout the business day; therefore, second surgeons are available to assist when needed.” That’s simply not good enough. A specific surgeon needs to be designated for each such overlapping case and that surgeon must not be doing activities that would preclude him/her from immediately going to the OR case in need of help (nor jeopardizing any other patient he/she may have been involved with prior to the call for help).
The Senate report notes that some hospitals set additional expectations for the backup surgeon. For example, he/she should be credentialed/privileged to perform the procedure being done, be willing to serve as backup, and be fully aware of the responsibility. The ACS apparently testified that some surgical fellows, with appropriate training, could be qualified to serve as the backup surgeon. We especially like what some policies require regarding communication about the backup surgeon:
The section of the Senate committee report dealing with informed consent is quite useful. It makes it clear that patients must be informed that their surgeon will not be in the operating room for parts of their surgery. But their review of informed consent documents found only 3 in which the consent forms explicitly stated the patient was scheduled to have overlapping surgery and that their surgeon would not be present for portions of their surgery. Many hospitals used wording too vague, such as their surgeon “may” be involved in other surgeries. In addition, 6 hospitals had wording that other providers may perform portions of their surgery without mentioning that their attending surgeon might not be present for those portions.
Moreover, it emphasizes that patients must be made aware of this in a manner in which they fully comprehend the implications and have both the ability to ask questions and refuse to have overlapping surgery. They cite an informative Health Affairs Blog by Dr. James Rickert dealing with informed consent in such cases (Rickert 2016). Rickert discusses the problems of ensuring patients truly understand what is told to them during informed consent and suspects that in discussing overlapping surgery “Euphemisms, incomplete information, and oblique discussions will be the norm.” It is clear that this discussion must take place at a time when the patient would have adequate time to digest the information, ask questions, and be able to cancel the surgery if desired. So having the discussion on the day of surgery is a no-go. Some of the hospitals included a specific time period, such as “at least 24 hours prior to the surgery”, but many left the wording vague such as “sufficiently prior to” surgery.
Some hospitals included in their general surgery consent a place for a patient to initial or sign that he/she understands their surgeon may be absent for a portion of their surgery. The report provides an excellent example the specific text of a paragraph one hospital uses on its form that must be signed by patients only in cases where overlapping surgery applies. Rickert notes that when surgery is first discussed, surgeons should tell patients if they practice simultaneous surgery, and explain what this will mean for them in the operating room. Because surgery schedules for elective procedures are usually done weeks or even months ahead of time, patients would then have sufficient time to find another surgeon if they are uncomfortable with the practice of simultaneous surgery. You’ll also recall from our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” the practice at UCSF in the Zhang study (Zhang 2016) typically involved such discussion during a clinic visit, typically a week prior to surgery and in the editorial accompanying the Zhang study, Healy (Healy 2016) recommended obtaining specific informed consent at least 2 weeks prior to the operation.
Our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” also cited a viewpoint on informed consent in concurrent surgery (Langerman 2016) which pointed out the “information asymmetry” involved, where “surgeons know much and our patients know little about what will happen during their operation.” Patients may not understand the implications of potentially spending extra time under anesthesia in the event their surgeon is delayed in responding to something in their case because he/she is doing surgery on another patient. Most patients in academic centers understand that physicians in training will actively participate in the surgery and likely improve the quality of their overall care. But they also likely expect that their primary surgeon will be present to oversee all aspects of their surgery.
We would also like to point out a surgeon should never refuse to perform surgery on a patient who refuses to consent to overlapping surgery. It may be appropriate to let a patient know his/her surgery may not be able to be scheduled as soon if it is not overlapping. But to refuse to do the surgery as a nonoverlapping case would be unethical. We feel that including specific wording to that effect in the informed consent document or the educational materials provided to the patient should be part of every hospital’s policy on overlapping surgery. And hospitals obviously need to make it clear to their staff that such refusal would not be tolerated.
Perhaps the strongest recommendations in the Senate committee report deal with ensuring compliance with policies. The report stresses that developing policies on overlapping surgery are an important first step but that training all staff to ensure they understand the policies and then overseeing that the policies are adhered to are critical steps. They liked language similar to that used by some hospitals:
They also liked language used by some hospitals to describe roles played by others staff in ensuring compliance with the policies:
Monitoring surgeon location and tracking the critical portions of the surgical procedures is also considered important in the Senate committee report. Many hospital policies simply used the CMS billing requirement that the surgeon document in the medical record that he/she was present for the critical portion(s) of the surgery. We previously noted the Massachusetts Board of Registration in Medicine proposal requiring that surgeon presence or absence in the room at various times be documented. We like the latter idea. We actually have proposed hospitals record entry and exit of all OR personnel in attempt to reduce opening and closing of OR doors (which may predispose to infections) as described in our July 26, 2016 Patient Safety Tip of the Week “Confirmed: Keep Your OR Doors Closed”.
In our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we also suggested that you might as part of your quality management program occasionally try to get hold of that “backup” physician and see how long it actually takes for him/her to get to the OR.
The Senate committee was also concerned that hospitals need to specify how complaints about surgeries from patients or staff would be addressed.
Missing from the Senate committee report, from our perspective, is discussion about pre-op huddles/briefings and post-op debriefings. We’ve discussed these important issues in our Patient Safety Tips of the Week for November 10, 2015 “Weighing in on Double-Booked Surgery” and November 29, 2016 “Doubling Down on Double-Booked Surgery”.
The Senate committee report does make mention of the surgical time out only in that the “time out” should include identification of the backup surgeon. It also notes that discussion of the “critical portions” could be part of the pre-op “huddle” or surgical “time out” and could also be written on the OR white board. We also think that the surgeon should announce during both the pre-op “huddle” and surgical “time out” that he/she will be doing an overlapping case and when staff can expect him/her to leave the current case. For the second case, the surgeon obviously needs to be present for the surgical “time out”. But what about the pre-op “huddle” for that second case? Is it skipped? Is it done prior to the first case? And, remember, if you do two pre-op huddles back-to-back you may be vulnerable to transposing information or intents between cases, particularly when the cases are similar procedures.
The Senate committee report tried to get an estimate of the scope of overlapping surgery across the US. But they found such statistics are difficult to come by. At respondent hospitals the percentages of overlapping cases ranged from less than 1% to 33% of all surgeries. The percentage of overlapping cases was even higher for some specific surgeons.
The Senate report also notes that neither CMS nor The Joint Commission has specifically investigated overlapping surgery in their surveys. The HHS OIG has audited billing practices at teaching hospitals and has found several violations over the years, resulting in fines for those hospitals. So the Senate Finance Committee has also recommended that CMS and the HHS OIG review compliance with billing practices related to overlapping surgery. They also note that the CMS billing guidelines only apply to teaching hospitals. The Senate committee recommends that CMS also review whether those billing requirements should also be applied to non-teaching venues where overlapping surgery may be done (private hospitals, ambulatory surgery centers, etc.).
The recent Boston Globe article (Saltzman 2016) also included a comment from the chairman of surgery at the University of Michigan, stating that “the practice benefits only the surgeons who get to do it by increasing their productivity. It is inefficient for all other medical staff, he said, including other surgeons who lose operating room time.” We hadn’t quite thought about it in that way but it is really in keeping with our conviction that the fundamental driving force for double-booked surgery is the financial incentive.
As before, we personally would not consent to any form of double-booked surgery and expect our attending surgeon to be present at our procedure even when portions of the surgery are being performed by residents, fellows, or other personnel. While we would hope most hospitals eliminate or minimize any form of double-booked surgery, we would expect those hospitals allowing overlapping surgery meet the positive elements noted in this column.
For those of you who plan to allow overlapping surgery at your institution, we offer the the “Overlapping Surgery Checklist” to help you plan for safe implementation.
See all our columns on double-booked, concurrent, or overlapping surgery:
Zhang AL, Sing DC, Dang DY, et al. Overlapping Surgery in the Ambulatory Orthopaedic Setting. J Bone Joint Surg Am, 2016; 98 (22): 1859-1867
Hyder JA, Hanson KT, Storlie CB, et al. Safety of Overlapping Surgery at a High-volume Referral Center. Annals of Surgery 2016; Published ahead of print (Post Author Corrections): December 5, 2016
Saltzman J, Abelson J. Senate committee calls for ban on surgeons conducting simultaneous operations. The Boston Globe 2016; December 6, 2016
Abelson J, Saltzman J, Kowalcyzk L, Allen S. Clash in the Name of Care. Boston Globe October 26, 2015
Senate Finance Committee. Concurrent and Overlapping Surgeries: Additional Measures Warranted. A Senate Finance Committee Staff Report 2016; December 6, 2016
ACS (American College of Surgeons). Statements on Principles. Revised April 12, 2016
Rickert J. A Patient-Centered Solution To Simultaneous Surgery. Health Affairs Blog 2016; June 14, 2016
Healy WL. Overlapping Surgery: Do the Right Thing. Commentary on an article by Alan L. Zhang, MD, et al.: “Overlapping Surgery in the Ambulatory Orthopaedic Setting”. J Bone Joint Surg Am, 2016; 98 (22): e101
Langerman A. Concurrent Surgery and Informed Consent. JAMA Surg 2016; 151(7): 601-602
Our own “Overlapping Surgery Checklist”.
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A couple nationwide medication safety campaigns have been in the news lately. Earlier this year ASHP (American Society of Health-System Pharmacists) was awarded a 3-year contract by the FDA to develop standardized concentrations for intravenous and oral liquid medications. ASHP has partnered with ISMP (Institute for Safe Medication Practices), AAMI (Association for the Advancement of Medical Instrumentation), and PPAG (Pediatric Pharmacy Advocacy Group) in this endeavor, the Standardize 4 Safety initiative. The coalition just announced one of its Phase 1 (of 3 Phases) outcomes: a list of recommended standardized concentrations for adult continuous IV infusions. The list includes the standardized concentration(s), dosing units, status of commercial availability, and comments for over 30 of the most commonly infused drugs in adults.
Other activities in Phase 1 will be development and implementation of concentrations and dosing units for compounded oral liquids for adults. Phase II addresses concentrations and dosing units for pediatric continuous IV infusions and standard doses for oral liquid medications. Phase III addresses intermittent IV medications, PCA (patient-controlled analgesia) pumps, epidurals, and standard doses for oral chemotherapy agents.
Another collaborative medication safety campaign, the Just Bag It Campaign, was just launched by the National Comprehensive Cancer Network (NCCN 2016). Vincristine is a chemotherapy agent intended for intravenous use. Yet since the 1960’s there have been numerous incidents where it has been administered intrathecally or via Omaya reservoirs. The results are disastrous, with patients developing quadriplegia, encephalopathy, and usually death. In 2013 ISMP summarized the literature (ISMP 2013) and noted that virtually all cases involved vincristine being prepared in a syringe and that there were no cases when vincristine was prepared in an IV bag. There are, of course, other contributing factors in such incidents. ISMP noted the following contributing factors: mislabeling of syringes; bringing IV and intrathecal medications into a treatment area together; failing to administer vinca alkaloids in a specialty oncology unit or with only experienced, oriented staff familiar with current operational and clinical standards, procedures, or protocols; administering chemotherapy outside of normal hours; not conducting an independent double check or “time out” before intrathecal medication administration; and incomplete or missing warning labels. But, given that all reported incidents occurred when vincristine was in a syringe, ISMP recommended that vincristine instead by diluted in a minibag for infusion and syringes be avoided.
Now the NCCN Just Bag It Campaign has been launched for the safe handling of vincristine, calling for health care professionals to always dilute vincristine in a 50ml mini-IV drip bag and never in a syringe. The campaign comes with Christopher’s Story, the sad story of a patient who died as the result of one of the above vincristine errors. All NCCN member institutions have already adopted this best practice for handling vincristine but the campaign calls on all other oncology providers to do the same.
ASHP (American Society of Health-System Pharmacists). Standardize 4 Safety website.
ASHP (American Society of Health-System Pharmacists). ASHP IV ADULT CONTINUOUS INFUSION GUIDELINES. October 2016
NCCN (National Comprehensive Cancer Network). Just Bag It: The NCCN Campaign for Safe Vincristine Handling. NCCN 2016; accessed November 14, 2016
ISMP (Institute for Safe Medication Practices). Death and neurological devastation from intrathecal vinca alkaloids: Prepared in syringes = 120; Prepared in minibags = 0. ISMP Medication Safety Alert! Acute Care Edition. September 5, 2013
In our November 2015 What's New in the Patient Safety World column “Medications Most Likely to Harm the Elderly Are…” we noted the paucity of evidence in the literature about antibiotic stewardship programs in ambulatory care or other outpatient settings. CDC had previously published on the core elements for hospitals (CDC 2014) and nursing homes (CDC 2015). Now CDC has published the “Core Elements of Outpatient Antibiotic Stewardship” (Sanchez 2016).
The Core Elements of Outpatient Antibiotic Stewardship are:
Regarding commitment, CDC notes that declaring commitment to antibiotic stewardship in a public fashion (eg. posters in examination rooms) has been shown to reduce inappropriate prescription of antibiotics. In larger practices and healthcare organizations, designating a leader for antibiotic stewardship programs is recommended. CDC also recommends not only educating all staff on antibiotic stewardship but also making it part of their job descriptions and evaluation. CDC stresses that all members of the healthcare team have an important role in antibiotic stewardship.
Under Action for policy and practice they recommend adherence to the evidence-based practices recommended in specialty society guidelines. They note that use of delayed prescribing practices or watchful waiting, when appropriate, may be successful strategies. This requires good communication skills and consistent messages. Systems should provide clinical decision support tools for clinicians and have informational printouts available for patients and families. Various triage systems (eg. nurse call lines) should also reinforce principles of appropriate antibiotic prescribing and may help reduce unnecessary office/clinic/ER visits. They also recommend documentation in the medical record of rationale for decisions not to prescribe antibiotics.
Tracking and reporting consists of audit and feedback, which has been shown to reduce inappropriate antibiotic prescribing. Items to track should include whether antibiotics were appropriate, whether the correct antibiotic was prescribed, and whether the duration of therapy recommended was appropriate. Some systems or practices might choose a high priority condition, like acute bronchitis, to monitor. Others might look at percentage of overall visits at which antibiotics are prescribed. Feedback to individual prescribers can be compared to peers. Some systems may also track adverse drug events related to antibiotics.
Education applies both to prescribers and patients. Communication with patients or families should take into account health literacy issues. Continuing educational activities should be available for healthcare providers and timely access to persons with expertise (eg. pharmacists, infectious disease staff) should be made available.
See also our November 2015 What's New in the Patient Safety World column “Medications Most Likely to Harm the Elderly Are…” for other recommendations and links to some of the other studies on antibiotic stewardship in the outpatient setting.
Some of our prior columns on antibiotic stewardship:
CDC. Core elements of hospital antibiotic stewardship programs [Internet]. Atlanta, GA: US Department of Health and Human Services, CDC; 2014; last updated May 25, 2016
CDC. Core elements of antibiotic stewardship for nursing homes [Internet]. Atlanta, GA: US Department of Health and Human Services, CDC; 2015; last updated August 18, 2016
Sanchez GV, Fleming-Dutra KE, Roberts RM, Hicks LA. Core Elements of Outpatient Antibiotic Stewardship. Recommendations and Reports. MMWR 2016; 65(6): 1-12
The Joint Commission has revised for 2017 NPSG.07.06.01, its national patient safety goal for prevention of CAUTI’s (catheter-associated urinary tract infections).
The elements of performance for NPSG.07.06.01 are:
- Limiting use and duration
- Performing hand hygiene prior to catheter insertion or maintenance care
- Using aseptic techniques for site preparation, equipment, and supplies
- Securing catheters for unobstructed urine flow and drainage
- Maintaining the sterility of the urine collection system
- Replacing the urine collection system when required
- Collecting urine samples
(The NPSG acknowledges that there are certain medical conditions, predominantly neurological ones, that require a prolonged use of an indwelling urinary catheter in order to avoid adverse events and promote patient safety.)
- Selecting measures using evidence-based guidelines or best practices
- Having a consistent method for medical record documentation of indwelling urinary catheter use, insertion, and maintenance.
- Monitoring compliance with evidence-based guidelines or best practices
- Evaluating the effectiveness of prevention efforts
(The NPSG notes that surveillance may be targeted to areas with a high volume of patients using in-dwelling catheters, as identified through the hospital’s risk assessment.)
Of course, we are advocates of incorporating your evidence-based criteria into your CPOE system. That can help ensure appropriate use of catheters and may help you meet some of the documentation requirements. Innovative hospitals will also use barcoding to help create documentation for things like time of insertion, review for continuation, etc.
This NPSG and all the other 2017 National Patient Safety Goals are now available on The Joint Commission website (TJC 2016).
Our other columns on urinary catheter-associated UTI’s:
The Joint Commission. Hospital Accreditation Program. National Patient Safety Goals Effective January 2017. Accessed November 18, 2016
ECRI Institute has published its annual list of its Top 10 Health Technology Hazards for 2017 (ECRI 2016). The full report details the risks of each of the technologies and makes very useful recommendations on what your organization should be doing to minimize those risks. Their 2017 list:
As is our usual practice we don’t go into detail about items on their list because we encourage you to go right to their excellent resources on these topics. We’re happy to see that under alarm management they have highlighted failures to communicate alarms effectively to staff, a topic we discussed in detail in our February 9, 2016 Patient Safety Tip of the Week “It was just a matter of time…”.
Go to the ECRI site to download the full report. It is a free download but you’ll need to register to receive it.
ECRI Institute. Top 10 Health Technology Hazards for 2017.
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