Based on the comments of Dr. Koppel and others (including the excellent comments on this blog), there is dire need for these defacto medical devices (CPOE and others) to undergo methodological evaluation for safety and efficacy by the FDA.

The output of the meeting of 13 years ago, mentioned by Dr, Koppel, established a self serving self-regulatory algorithm for HIT vendors’ products. The proposed program and its algorithm gets an “F” in each of the 13 years since it was published.

Each site currently utilizing CPOE devices should be declared an in situ experimental site by the FDA. Data collection on intrinsic device flaws, ergonomic flaws, adverse events, work arounds, vendor conduct, delays in care, and others should begin immediately.

There ought to be a link to the FDA on each CPOE terminal to facilitate the reporting of the errors and defects.

If CPOE devices fail, the risks to the patient are formidable, putting these devices in FDA Class 3. Thus, the rigors of pre-market approval protocols are indicated.

Ultimately, this will be good for the patients, the health care professionals using the devices, and the industry itself.

Perhaps Commissioner Hamburg and the new director of FDA’s CDRH will come to this understanding. ZZ

Think you mean Ross and Scott?

I’ve been vocal re potential harm in EMRs. I and others have reported to senior execs “glitches” in systems that pose clear danger of harm. I saw TDS execs (system studied) respond ethically when errors found, regardless of finanicial impact. This hasn’t been the case since with vendors response most often “shooting the messenger”.

While beauracracy could paralyze us, it’s fightening no regulatory agency sits between some profit driven (apparently soul-less) vendors and hospitals. Some hospitals simply resource strapped and non-software savvy – staff assume no vendor would knowingly ship dangerous code.

With EMR/CDSS and non-FDA regulated medical device middeware, IT drives life-critical data and processes, with push in some cases to eliminate or marginalize the clinician. A Risk is enormous and worsens as we outsource, patch old systems and skimp on analysis, design and QA (cost saving). Glitches are invisible to buyers.

Many vendor and hospital staff expected to meet unrealistic deadlines driven in public companies by quarterly performance demands. ARRA (incentives and timelines) and economy (need for those with jobs to retain them and companies to continue to produce “numbers”) add to perfect storm for errors and misuse of IT. The HCIT industry works on “honor system”. Clinicians who raise issues have short careers.

I’ve documented and presented concerns, had reached out to implore HIMSS and Gartner execs to take leadership role in raising awareness with vendor client members’ CEOs/execs – not knowing who else might wield influence at this level. No response.

Who can/will advocate for clinicians and patients with corporate interests driving healthcare and HCIT?

Russ, you are my hero! Tim, keep em coming! Will be hard to top this interview. Timely to have these discussions!

The non-disclosure clauses need to go. The non-compete clauses need to go. They’re holding back the development in the industry from the normal percolation of ideas and people.