Right to Repair is a Movement Gaining Momentum Every Day

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Tue Nov 08 2022By Justin Barbour

Right to Repair is a movement gaining momentum every day.  Private property is owned by the purchaser and Right to Repair is the belief that the maintenance and liability assumed for such maintenance should be at the owner’s will. Basically, if you own something, you should be able to take it to whoever you wish to keep that item functioning to meet your needs. This is an argument about private property rights vs intellectual property rights of the manufacturer (OEM).

Generating stronger ties between Biomeds and Manufacturers:

Medical Right to Repair is not about having unfettered access to service literature and parts. It’s about manufacturers offering official training and guidance or oversight in exchange for access to service literature, passcodes and parts to repair equipment at the owner’s discretion. Over the last 10 years, medical equipment manufacturers have increasingly restricted access to parts, service manuals and even telephone tech support while their service departments make record revenue.  OEMs would like you to believe that Medical Right to Repair would lead to increased risk to patients but in reality the issue is about money.

It’s about experience. No training can replace experience:

Most OEMs like to recruit younger, less experienced technicians not only because the lower pay leads to higher profits but also younger technicians are more apt to deal with career on the road as a traveling service technician. Some technician regions cover multiple states. An experienced, hospital employed but Official OEM trained technician is much more likely to make responsible maintenance decisions and respond to a critical situation (compared to a junior OEM technician).

Response Time Is Critical:

Most OEM Technicians respond in 24 to 48 hours of a service request. – Some can take a week or more to respond. The Hospital is at the manufacturer’s mercy.  A trained hospital employee can respond to an incident within minutes. This not only leads to decreased downtime but also a dramatic improvement to patient safety.  Responding while an incident is happening directly assists doctors with patient care and allows for better documentation of the incident to ensure that such a thing never happens again. Every minute is critical.

It takes a sickness to reveal our flaws and strengths:

Covid19 was a learning experience for the entire country and the healthcare industry is no exception.  OEM Service Technicians were limited by state borders, hospital rules, politics and logistics. Locally employed and properly trained technicians do not suffer from most of these limitations. Independent Service Organizations (ISOs) banded together with local hospitals to help alleviate the gaping holes left by a system reliant on manufacturers. ISO’s rolled out tens of thousands of medical devices like ventilators and defibrillators to keep the American Healthcare industry from crumbling like it did in countries across Europe. 3rd Party ISOs were the buffer when OEMs couldn’t keep up with the crisis. Diversification is key to a successful healthcare industry when crisis hits. More qualified maintenance personnel across the country leads to stability.

It’s about regulation and rules:

Manufacturers are fear mongering politicians by saying that ISOs are not regulated and they will offer inferior service because no one’s watching them.

This is not true at all. 1st off, the healthcare industry is the most regulated industry that exists. Most of the reputable ISOs are both FDA regulated and ISO 13485 Certified to ensure quality of work. Medical Device Manufacturers are currently held to 21 CFR 820 standard but it’s the old standard.  ISO 13485 is a more complete standard with more listed responsibilities which the FDA is expected to start utilizing soon.

All medical repair companies are capable of reporting medical device deficiencies to the FDA and all medical repair entities are required to keep detailed records of medical device maintenance.

Medical Right to Repair is meant to cement the bond between those who manufacturer medical equipment and those who maintain that equipment at a local level. Passing legislation on Right to Repair decreases downtime and costs for the American healthcare industry while increasing the quality of medical device maintenance.

We all grew up with 2 simple rules: Follow the money to see who’s profiting and don’t put all of your eggs in one basket – Medical device manufacturers want you to ignore both of those rules. Thank you for your time.

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