As I've also written at my April 2011 post "FDA Decides Regulating Implantable Defibrillator Medical Devices a Political Hot Potato; Demurs", FDA has admitted health IT is a medical device that they shy away from regulating because it's politically expedient not to do so. (The area is a "hot potato" per the Director of FDA's CDRH, the Center for Devices and Radiological Health, so FDA stays away.)
Yet FDA knows of the stakes. As I observed at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks" and elsewhere, patient harm is occurring due to these devices and FDA is aware. Due to admitted impediments to information diffusion, however, even FDA, IOM, The Joint Commission (due to a "dearth of data" as in their 2008 Sentinel Events Alert On Healthcare IT) and others do not know the true magnitude of the problem.
From the FDA internal memo at the preceding FDA memorandum link:
Limitations of the MAUDE [Manufacturer and User Facility Device Experience database] search and final subset of Medical Device Reports (MDRs) include the following:
1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including
... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.
... The results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.
Finally, as I pointed out in my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership", the Office of the National Coordinator for Health IT at HHS (ONC) had published the following with regard to the qualification of those who could "lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States":
Clinician/Public Health Leader: By combining formal clinical or public health training with training in health IT, individuals in this role will be able to lead the successful deployment and use of health IT to achieve transformational improvement in the quality, safety, outcomes, and thus in the value, of health services in the United States. In the health care provider settings, this role may be currently expressed through job titles such as Chief Medical Information Officer (CMIO), Chief Nursing Informatics Officer (CNIO). In public health agencies, this role may be currently expressed through job titles such as Chief Information or Chief Informatics Officer. Training appropriate to this role will require at least one year of study leading to a university-issued certificate or master’s degree in health informatics or health IT, as a complement to the individual’s prior clinical or public health academic training. For this role, the entering trainees may be physicians or other clinical professionals (e.g. advanced-practice nurses, physician assistants) or hold a master’s or doctoral degree(s) in public health or related health field. Individuals could also enter this training while enrolled in programs leading directly to degrees qualifying them to practice as physicians or other clinical professionals, or to master’s or doctoral degrees in public health or related fields (such as epidemiology). Thus, individuals could be supported for training if they already hold or if they are currently enrolled in courses of study leading to physician, other clinical professional, or public-health professional degrees.
Here, though, is a more typical reality in today's hospitals, the background of an EHR deployment leader in one of the most risk-prone and difficult environments in healthcare, the Emergency Department (ED) in a large hospital of which I am aware:
Clinical Systems AnalystJanuary 2004 – PresentProject manager for implementation of an ED EHR [vendor name redacted]
Responsible for all aspects of implementation including build and process design, report build, testing, training, and go-live support.
Extensive knowledge ADT processes, HL7, and CPOE.
Manage software patches and upgrades.
Experience in HTML, SQL and SAP.Financial Systems Analyst
November 2001 – January 2004Project Team Lead for implementation of Patient Accounting system.
Responsible for system development and system build, training, testing, and reporting.Education
[Regional university in the lower 50% of US News rankings in the region, name redacted]
B.S., Management Information Systems
2000 – 2003
[Name redacted] Community CollegeAssociates Degree, Business Administration
- An experimental medical device,
- unregulated by anyone,
- in a field whose qualifications for leadership are unregulated by anyone,
- devices known to be risky,
- but without anyone knowing the magnitude of that risk,
- whose implementation is led by a generic 'clinical' systems analyst "responsible for all aspects of implementation" with a Bachelor's degree in MIS from a second-tier institution, an Associates degree from a community college, and no medical or Medical Informatics education or experience whatsoever.
Further, that project lead jumped from financial systems analyst to 'clinical' analyst/leader of an ED EHR implementation.
One should also ask
- Who was the hiring manager who hired such a person and put them in the role?
- On what credentials and experience was the decision based?
- What were the hiring manager's own credentials?
I leave it to the reader to decide if this is an appropriate arrangement, and if they would place their trust in an ED whose activities center around a cybernetic system implemented in this manner.
Feb. 17, 2012 Addendum:
At least in this case the person has degrees.
Per several prominent healthcare IT recruiters in the past in the article "Who's Growing CIO's" in the journal Healthcare Informatics, as mentioned at my Sept. 2009 post "Correcting historical information from the recruiter component of the Health IT Ecosystem", the School of Hard Knocks was plenty good for health IT leadership roles:
I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.