Device failure requires immediate action
February 1, 1998 6 minutes read
Device failure requires immediate action
The failure of a medical device should set off alarm bells in the risk manager’s office, causing you to spring into action with a carefully planned response that will help you deflect liability away from your facility and back at the device manufacturer. That’s the advice from an attorney experienced in defending hospitals involved in medical device malpractice cases.
Lori G. Baer, JD, is an attorney with Alston & Bird in Atlanta, concentrating on medical malpractice and product liability litigation. Her experience with cases involving medical device failures has helped her develop what she sees as the ideal response by a risk manager. She recently explained her suggestions to risk managers attending the annual meeting of the American Society for Healthcare Risk Management in Atlanta.
The key, she says, is to have a plan before the device fails. Once a surgeon calls from the operating room and says a device just misfired and crushed the patient’s aorta, things will happen too fast for you to start wondering what sort of evidence needs to be collected and what needs to be documented. Without a plan, key evidence will be spoiled or overlooked.
And that almost always is bad for the health care facility, Baer says. Unless you have clear evidence that the device failed with no help from your staff, a jury will be more likely to assume the injury was the result of human error. And don’t forget that in a device case, you will be fighting more than just the plaintiff’s attorney. The device manufacturer will have a defense team alleging that the device was perfectly fine and your staff must have misused it.
Collect the evidence immediately
This is how Baer suggests you respond to and report a device failure:
1. Secure the scene.
Identify and isolate the device in question, any witnesses, and all documents related to the incident. This is the crucial first response. It should be done immediately, as soon as you get the report of a device failure. The risk manager should race to the OR or wherever the incident occurred and personally supervise the collection of evidence.
"There is no more critical piece of evidence in the case than the failed device itself," Baer says. "You should also consider securing other identical devices which, while they have not failed, may be helpful in analyzing the failed device."
Before testing the device, consider very carefully what effect that may have on the evidence. Clinical staff often are eager to test the device, simply out of a desire to know what happened and if they did anything wrong. If there is any chance that testing will alter the device in any way, at least wait until after litigation has been filed. If you inadvertently alter evidence before then, you may face a claim for spoliation of evidence.
Take extensive photos of the device and any pertinent surroundings. The goal should be to record exactly how the device, and possibly the patient or the entire scene, looked just after the incident. Be sure to include the date, time, and photographer’s name.
2. Interview the witnesses.
Talk to everyone involved with the incident or who may have witnessed it. Record their observations carefully, but also consider any measures you might be able to take that would give them a shield of confidentiality. Each state’s laws differ on how peer review privileges, self-critical analysis privilege, and other rules confer confidentiality, so discuss these rules with counsel beforehand. What you find out may affect how you go about conducting the interviews.
In particular, you should ask your legal counsel whether the interviews should be conducted by the risk manager or an attorney, whether the interview should be written in a formal report, and whether it should be recorded and transcribed. You also will need to consider whether the involved physicians are independent contractors or agents of the hospital, which will affect how some privileges attach. Also look at whether you have a conflict of interest with the doctor and whether you have separate carriers for hospital professional and products liability coverage.
Baer stresses that witness interviews must be done immediately after the incident, when everyone’s memory is fresh, so the particulars of how to conduct them must be worked out beforehand.
She also advises telling the witnesses not to discuss the incident with anyone but counsel. That warning must be given carefully, however, or you risk the appearance of hiding information. The best way, she says, is to emphasize that discussing the matter with anyone but counsel will result in waiving the privilege of confidentiality.
3. Secure any documents concerning the incident and the device.
Along with the patient record and anything related to the incident itself, you should immediately collect all paperwork concerning the device. That includes marketing literature, product instructions, updates, and bulletins. Quality control testing records can be especially important in proving you exercised due care in maintaining the device. Be sure to collect any relevant reports you have made to regulatory agencies. If any report on the device or the device failure has been made to a regulatory body, you can be sure the opposing counsel will get a copy of it. It is to your advantage to have the same reports in front of you.
4. Don’t lose anything!
It is now a common strategy in malpractice cases, even those not involving a device failure, to charge the defendant with misconduct concerning the evidence. When the case hinges on a medical device, that strategy is very likely if you give the opposing counsel any reason to believe you have not adequately preserved the evidence. In most cases, the court allows a jury to assume that missing or destroyed evidence was detrimental to the party responsible for its loss. No matter how bad the evidence might be for your case, losing it, altering it, or destroying it will only look worse.
5. Report the incident to appropriate parties.
When you suspect a medical device has failed, you are obligated to report the incident to certain parties. And you should report the incident to other parties as you see fit.
In simple terms, a "medical device" is any health care item that is not a drug. This includes items such as hospital beds, catheters, ice packs, and wheelchairs, as well as the more high-tech items such as X-ray machines, heart valves, and respirators. The Safe Medical Device Act of 1990 (SMDA) requires that health care providers report to the device manufacturer and the U.S. Food and Drug Administration in Rockville, MD, whenever a device may have caused or contributed to the death, serious illness, or injury of a patient. The report must be made within 10 working days. (See pp. 21-22 for samples of the forms used to report medical device incidents to the FDA.)
If opposing counsel suggests that the device did not actually fail, it will work to your advantage to be able to show that you took all the required steps to report the failure of a medical device. Reporting the incident to the authorities shows that you knew this injury was caused by a device failure, or at least suspected so, from the very start. That can help dispel any impressions that you latched on to the idea later as a way of denying culpability for the injury.
Though the information may not be admissible as evidence, you should assume that any reports made to the FDA will be available to the opposing counsel. With that in mind, be careful how you write the report. Keep these points in mind:
• The report should be clinical and objective, without statements that might be construed as an admission.
• Reports should avoid legally significant terms such as "defective" and "misuse."
• Include disclaimer language such as, "This report was prepared pursuant to the requirements of the SMDA, is inadmissible as evidence, and is not an admission of liability."
Also, you should look into whether the incident must be reported to insurance carriers. Many insurance policies contain language requiring an insured to report such incidents right away. If you do not comply with whatever stipulations are in the contract, the insurer may be released from liability.
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