By NBC News StaffThe federal government on Thursday issued new rules to help protect the health of Americans from potential harm from medical devices.
The new rules include limits on the kinds of devices that can be implanted and the ways that doctors can administer them.
They also require hospitals to report to the government when doctors administer the devices, a move that will prevent devices from being used to treat or prevent cancer.
The rules apply to medical devices such as pacemakers, coronary pacemaking machines, colonoscopies and catheters, which are typically implanted under the skin and can cause pain and swelling.
They are also designed to protect against accidents, infections and accidental overdoses.
“The goal is to protect Americans from the potential harm that a medical device can cause,” Health and Human Services Secretary Sylvia Mathews Burwell said in a statement.
The guidelines are a continuation of the Obama administration’s “No Device Needed” policy, which was aimed at encouraging hospitals to use safer devices and to limit the amount of money doctors can charge.
They include a provision that says doctors cannot use a medical instrument to treat cancer, or treat a disease that is caused by it, if the device is being used for other purposes.
Patients, patients’ families, doctors and other health care providers can file comments on the rules, which will go into effect in February 2019.
They must be submitted online by the end of March.
The regulations also require that hospitals report information about patients, doctors, devices and hospitalizations.
The guidelines say that doctors cannot administer devices to patients for a diagnosis or treatment unless there is a need for the device.
They cannot prescribe or dispense a medical tool that is intended for another purpose, or provide it to a patient unless it is to be used for an indication other than a treatment.
Doctors are also forbidden from giving the device to a person who is not in a condition to receive a diagnosis.
And they cannot administer a device to someone who is sick or injured, unless the patient has a serious medical condition that requires immediate care.
Hospitals have been under increased scrutiny in recent years.
Health care providers have reported an increase in serious infections linked to medical device use, including pneumonia, sepsis and bloodstream infections.
The Obama administration said the guidelines are necessary to ensure that doctors are not violating patients’ right to choose their own treatments and to protect patients from the risk of harm from devices.
The rule also would require hospitals not to use devices to treat people who are allergic to the device or have been prescribed antibiotics.
The health and human services secretary added that doctors must not knowingly administer a medical service to patients who are unable to receive that service.
They should also not intentionally induce or encourage a patient to give up treatment, including prescribing medications, according to the regulations.
The government is expected to release a final rule on medical device regulations later this month.