A very important part of the investigation is preserving physical evidence. If the
patient was injured by a defect in a piece of equipment, the proper party to
sue may be the equipment manufacturer. The risk manager must be very
careful to determine if the injury resulted from the design or construction of
equipment rather than from an error by the hospital staff. Defective equipment
can range from a multimillion- dollar X-ray therapy machine to a surgical
needle. The entire hospital staff, both nursing and medical, should be carefully
informed about the product liability issues in medical lawsuits. An extremely
important part of any incident investigation is the recognition of risks that
parties other than the medical care providers are legally responsible for.
The modern hospital acts as both a nursing service and a medical supply house.
The hospital supplies drugs, surgical equipment, diagnostic equipment, toilet
tissue, and an enormous list of other items. In most cases, the hospital passes
these items along to the patient without altering them from their manufactured
state. There is not even much presterilization since the advent of disposable
medical supplies. If an item that the hospital dispenses injures a patient, the
hospital wants the patient to sue the manufacturer of that item rather than the
hospital. If the patient does sue the hospital, the hospital should then sue the
manufacturer for whatever damages the lawsuit causes the hospital to suffer.
The investigator must ensure that the identity of the item that injured the
patient is determined, and that the item is preserved for future testing and
investigation. This should be part of the incident reporting process. The staff
must be encouraged to save the defective item and any packaging material
that has not been destroyed. These items should be sealed in clear plastic
bags and carefully labeled as to the patient and the incident. The risk manager
should immediately determine who the manufacturer is and check the
remaining stock of the item for defects. The remaining units should be
impounded and the manufacturer asked to replace them. It is very important
not to allow a second patient to be injured by the same item. The first injury
may be the manufacturer’s fault, but the second injury will be the hospital’s
fault.
An incident involving a defective product should be brought to the attention of
the hospital’s counsel. While it may be possible to prevent the discovery of
information about the defective product, such prevention is not desirable. The
attorney may need to institute legal action against the product’s manufacturer
to protect the hospital’s interests. The attorney may also want to cooperate
with the patient’s attorney. If the patient’s attorney can sue the manufacturer
of a defective product, that attorney will be more likely to settle with the
hospital. This occurs because it is much simpler (and more lucrative) to litigate
a defective product claim than a medical malpractice claim. To take advantage
of this, the hospital must be prepared to share information with the patient’s
attorney. To make these types of action more effective, the quality control
program must be coordinated with the hospital’s purchasing program. The
purchasing agent should know the manufacturer and distributor for each item
that is purchased. The hospital must avoid purchasing items that have an
unclear origin or are manufactured by a company against which it would be
difficult to obtain a judgment. This may not be important for items such as
tissue paper, but for items with great potential for harm, such as IV
(intravenous) solutions or disposable needles it can be cheap insurance to pay
a few cents more for an item from an established manufacturer. Even if the
two products are equally good, it is to the hospital’s benefit to have a
responsible party to sue if there is a defect.