Compliance

Medical Equipment Compliance: Biomedical Standards for Your Facility

8 min read

For the past quarter-century, medicine has changed tremendously from the cut-and-poke, trial-and-error practice that characterized the times before.

Today, doctors are better informed about the human body and the tools they use to save it. Modern medical equipment allows them to open an airway and clamp a vein as deftly as possible, and even to help patients hang on to life where their bodies say otherwise. These advancements that give them mastery also draws to them greater accountability. So, medical facilities today have an important duty to provide reasonable assurance of the safety and effectiveness of their medical devices.

Indeed, the quality of medical equipment can directly bear on the quality of patient care. Thus, facilities must ensure these devices are working and serviced when necessary, because the consequences are all too real and costly where they are not.

On the business side of things, medical facilities don’t even need regulators to require proper management and servicing of medical equipment, though those regulations exist. With a clearly defined and meticulously followed process, a facility can keep accurate inventory and improve operational efficiency.

There is also a lesser frequency of operational issues caused by faulty equipment. All of which helps to avoid unnecessary expenses, typically in ballooning settlement and litigation costs.

UptimeHealth held a webinar on Demystifying Medical Equipment Management that you can watch here. You can also download the webinar deck here.

So, What Does Medical Equipment Compliance Entail?

Medical equipment compliance simply involves keeping with regulatory standards, especially as it relates to equipment inspection, maintenance and repair. These standards mandate facilities to;

  • Reasonable assurances of the safety and effectiveness of medical devices,
  • Understand the number and types of medical devices available in their inventory,
  • Keep accurate records of all service, repair and quality control events, when they were performed and who performed them, and
  • Keep data for the entire life and viability of the device, or in the minimum, only for a period of 3 years.

To keep with compliance standards, medical facilities must generally keep an Equipment Inspection checklist and run periodical service, repair and quality control events. A typical equipment inspection checklist includes but is not limited to;

  • Examination tables and lights,
  • Vitals Monitor,
  • Blood pressure monitors,
  • Nebulizers
  • X-ray systems
  • Ultrasound machines
  • Defibrillators,
  • EKGs
  • Centrifuges,
  • Suction pumps and
  • Inverters and Uninterruptible power sources (UPS)

Etc.

Maintenance and servicing events must also be carried out, for mobile and stationary medical equipment, on ambulances and in the facility. These events include;

Electrical Safety Inspections (ESI)

With these inspections, the technician is testing and confirming the voltage coming through the device and potentially carrying out test runs to verify basic performance. ESIs are required when equipment enters the facility, before patient use, and annually for standard planned inspections.

Just to dispel a common myth here, all NEW devices that plug into an outlet or use electrical power REQUIRE an ESI. The purpose is to ensure that devices are in working condition after they arrive on-site, and that they will not harm a patient.

Calibration and Performance

This involves testing individual devices to determine whether they are calibrated correctly and operating within standards. Calibration can be done with daily use, after a number of cycles, or with a planned maintenance event.

Repairs

Devices not functioning to true performance requirements are taken out of service, and for repairs by a certified Biomed Engineer. It is best practice to have the device tested, post-repair, by a biomedical technician and verified by staff leadership before going back to service.

Quality Control Checks

Quality control checks are also required to make sure the machines are safe for use. They are commonly needed and used for Radiology and Lab equipment, Autoclaves, and AED batteries.

It is a regulatory requirement that medical facilities keep documentation for maintenance and servicing events. One of such documents is a Medical Equipment Management Plan (MEMP), which essentially tells regulatory surveyors how you manage medical devices; outlining your facility’s policies and processes as entailed and carried out by staff anytime a device needs service, repair, and documentation.  

For every repair work, facilities must also keep accurate notes as to the actions performed by the technician and the readings for any test conducted. This documentation must show a definitive statement that the device has passed or failed inspection, and in the event that it failed, what actions were taken and what parts were replaced.

Best Practices for Fulfilling Regulatory and Documentation Requirements

When adding new equipment, always carry out an ESI for devices that plug to an outlet, or use electricity. It is also best to quickly record the service provider contact information for the device, document other important equipment information and store in a common database.

Clear out a definitive space for the equipment and establish a “Do not touch area” there for good measure. You’d be amazed at how many mishaps occur less with the equipment when the manager has to sign off on requests to approve the equipment for use.

It helps to also have a Biomedical engineer in-house, but where you have to source for one, do so upon equipment purchase with referrals from the service provider. UptimeMarketplace and Google are also good sources for reliable, vetted biomedical engineers with great, transparent rates.

Where does UptimeHealth come in?

UptimeHealth helps you unlock the last great hurdle to proper asset (equipment) management –Automation. Using software and data to support repair vs replacement decisions are only logical with the kickbacks they provide. Medical facilities are able to maintain 100% compliance, save precious hours, increase technician response times and reduce costs.

UptimeHealth with its simplicity and scalable technology is built for healthcare facilities by healthcare professionals. We are disruptors in the medical equipment and compliance management industry. Our software simplifies and organizes your facility’s medical equipment inventory and compliance tasks and is versatile enough to do much more.

Let UptimeHealth automate your compliance so you can focus on the patient experience. You can reach out to our team at 857-302-3732 or via our email.

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