Three Detroit hospital systems – Beaumont, Oakwood, and Botsford – announce plans to merge into an eight-hospital, $3.8 billion system, citing shared electronic medical records as one of their four goals.
From Tom: “Re: McKesson’s FDA Class 1 recall. The description of their product Anesthesia Care could generically be applied to almost any EMR/EHR/CIS vendor’s AIMS product and yet the FDA’s decision-making clearly does not apply to vendors equally. Also I wonder how the regulation of CDS would affect a hospital who develops their own CDS?” FDA’s highest-level recall of McKesson Anesthesia Care may be sending a message that the agency considers even software-only clinical decision support to be high risk. McKesson defines its product as an anesthesia information management system, which it also calls an “anesthesia EMR.” McKesson sought and received FDA premarket clearance apparently because the system collects data from physiologic monitors. McKesson did a voluntary recall of its product in March 2013 after a customer reported that the software pulled up the wrong patient’s information, with two other customers reporting later that it had lost medical history comments and misconnected to a physiologic monitor, affecting one patient in each instance. Some thoughts:
- McKesson Anesthesia Care is a software-only system that does not control medical devices. It collects and uses information from patient monitors. Other than that, it’s like any other high-acuity, unregulated EHR (surgery, ICU, ED, etc.)
- FDA would not have been involved if the patient monitor connection hadn’t pushed the product into its regulatory arena. FDA regulates software that makes independent patient decisions or connects to regulated devices, with the idea being that those systems are devices working on their own rather than simply providing guidance to users.
- Software vendors usually hide contractually behind the “professional judgment” test that says even if their software gives incorrect information or bad advice that harms patients, the clinical professional who uses the system makes the final decision and is solely responsible for the result.
- The danger to patients is the same as for any other clinical decision support or even EHR software. Mixing up information between patients could be disastrous any time software is presented information or recommending actions. However, high-acuity systems give users less time to make important decisions, so that probably should be a consideration in determining patient risk.
- McKesson planned to announced a Class II recall (meaning the problem wasn’t likely to cause patient harm) but FDA overrode that proposal and initiated a Class I recall indicating that patients could be harmed.
- McKesson notified users almost immediately when the first problem was reported in March 2013, but FDA’s recall didn’t go out until a year later.
- It’s not clear what users of the system should do as an alternative, or what action they may have taken since the …read more