A Healthcare Risk Control (HRC) member recently asked for guidance on policies for managing patient-owned continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) machines. The member notes that the organization currently allows such machines to be used without a waiver during a patient's hospital stay, and asks whether such waivers should be in place and what they should contain.
In our response, ECRI Institute notes that healthcare organizations have a duty to ensure the safety of equipment and devices used in their facilities. When a hospital allows the use of patient-supplied equipment, it may also assume legal responsibility for the equipment's performance and safety. In some states, such legal duty may not be waived under state law.
Another consideration is accreditation requirements. Hospitals accredited by Joint Commission, for example, must comply with the organization's standards for environment of care.
Allowing the use of patient-supplied equipment may place the hospital at risk of liability because the facility has never had control over the equipment's use or evidence of its proper maintenance, repair, or storage. The key question to consider is, "Is there a risk of serious injury or death should the equipment fail?"
Patients' requests for use of patient-supplied medical equipment and devices should be addressed on a case-by-case basis, unless the facility has implemented a blanket policy against their use.
When considering such requests, patient safety issues must always be addressed appropriately and with regard to the particular device and the individual user (patient).
A best practice is to establish a formal written policy regarding the use of patient-supplied medical devices and equipment in the facility's medical equipment management plan.
The following are elements to consider in developing the policy.
- Include clinicians in the review of issues and decisions pertaining to use of patient-supplied medical equipment and devices.
- Obtain physician approval of the suitability of the device for the patient. The physician would not be certifying that the equipment itself is fit for use—only that the equipment is needed for the patient's current condition. When determining whether the patient will be allowed to use the device and what, if any, restrictions will be required, clinicians should consider the patient's training and experience in using the device, the patient's current mental and physical condition, the reason for the current treatment, and the medical or surgical procedures the patient is expected to undergo.
- Notify the respiratory therapy and pulmonology departments (as may be appropriate for the device or equipment) of the request. Verify that these departments agree that the use of the particular patient-supplied equipment is appropriate and that they will make staff available to offer assistance as needed.
- Before use of the equipment, have clinical engineering or respiratory therapy personnel inspect its condition, focusing on general physical condition, cleanliness, and the need for further assessment (e.g., detailed performance inspection). Steps should also be taken to assign responsibility for cleaning and maintaining the equipment.
- For ventilators, have appropriate personnel check to ensure that all alarms are properly set and sufficiently loud and that appropriate staff will be notified by any alarms. If applicable, verify that the ventilator can be configured with the facility's alarm management system. Document all findings.
- Ensure that caregivers are familiar with device operation. At minimum, the nursing staff caring for the patient during all shifts should know what to do or whom to call in the event of a malfunction or problem.
Waivers of liability when the facility allows the use of patient-supplied equipment should be handled as follows:
- Establish a standard release/waiver of liability for patient-supplied medical devices and equipment prepared by or in coordination with legal counsel. The waiver should include, at minimum, a statement that the patient understands and accepts that hospital-performed device inspection of the patient-supplied medical device is not a warranty that the device is safe and free from defects; a statement that the hospital may, at its discretion, replace the device with a substitute; and specific provisions, guided by the advice of legal counsel, that protect the hospital from liability for patient harm associated with the equipment and that require the patient to sign the waiver before he or she is allowed to use the equipment in the facility.
- Be aware that the waiver of liability may not be enforceable under state law. Hospitals have a duty to provide a safe environment of care, and in some states, pursuant to tort law and/or contract law, that duty cannot be waived.
If an organization decides to deny the patient's request to use the device or decides to remove the device during the patient's stay, appropriate personnel should discuss the decision with the patient. The patient and family should understand the reasons behind such a decision. Policy should require that the discussion be documented.
The recommendations contained in Ask HRC do not constitute legal advice. Facilities should consult legal counsel for specific guidance and develop clinical guidance in consultation with their clinical staff.