How to inactivate an activated medical device or procedure?

From the Guidelines

To inactivate an activated medical device or procedure, reprogramming or deactivating the device is necessary, and this should be done by medical personnel with guidance from industry-employed allied professionals, if needed.

Key Considerations

• Pacemaker-dependent patients should have their device reprogrammed to an asynchronous mode during surgery (VOO or DOO), or a magnet should be placed over the device during surgery 1.
• Implantable cardioverter defibrillator (ICD) devices should have their tachyarrhythmia treatment algorithms programmed off before surgery and turned on after surgery to prevent unwanted shocks due to spurious signals 1.
• Continuous ECG and pulse monitoring should be performed during surgery for all patients with implanted devices 1.
• For patients nearing end of life, pacemaker deactivation should be considered, and patients or their legally defined surrogates have the right to refuse or request withdrawal of any medical treatment or intervention, including pacemakers 1.

Deactivation Procedure

• Outpatient visit: For patients who are well enough to travel to a clinic with programming capability, an outpatient visit may be acceptable for device deactivation 1.
• On-site deactivation: For patients in long-term facilities without on-site electrophysiological expertise, deactivation should be performed by medical personnel with guidance from industry-employed allied professionals 1.
• Programmer: The attending physician should arrange for a programmer to be brought to the patient, and medical personnel would deactivate the device using the programmer with technical assistance provided by the industry-employed allied professional 1.

From the Research

Inactivation Methods

To inactivate an activated medical device or procedure, various methods can be employed, including:

• Chemical inactivation: using chemicals such as glutaraldehyde 2, Virkon S 3, or isopropyl alcohol 3 to inactivate pathogens
• Physical inactivation: using methods such as autoclaving 4 or gamma-ray irradiation 4 to inactivate pathogens
• Plasma technology: using plasma to inactivate microbial pathogens such as bacteria, fungi, and viruses 5

Pathogen-Specific Inactivation

Different pathogens require different inactivation methods, including:

• Viruses: can be inactivated using glutaraldehyde 2, Virkon S 3, or isopropyl alcohol 3
• Bacteria: can be inactivated using autoclaving 4 or gamma-ray irradiation 4
• Prions: require specialized inactivation methods, such as autoclaving at 121°C for 20 minutes 4 or gamma-ray irradiation, as they are resistant to conventional sterilization procedures

Considerations for Inactivation

When inactivating medical devices or procedures, it is essential to consider the following factors:

• The type of pathogen being inactivated
• The method of inactivation being used
• The concentration and exposure time of the inactivating agent
• The potential for toxicology or breakdown products 6
• The need for proof of inocuity after inactivation 3