Know Your Rights: FDA Requires Availability of Service Manuals
By: Greg Stett, MD Buyline Clinical Analyst
In many cases, it is more cost-effective for hospitals to maintain medical equipment technologies in-house, as opposed to investing in full-service vendor service contracts. Many vendors have a variety of contract offerings (e.g., BMET First Look, parts only, etc.) that give the hospital options when defining their future maintenance needs. Most companies will train in-house personnel at their training schools, for a fee or even for free. However, service revenue can be a large portion of some vendors’ bottom line and we still see cases where a hospital’s request for a manual is denied or held up until the BMET gives up and finds one on his or her own. Here are just a few examples I observed on a biomed listserv:
BMET #1: “I have had an XXXXX person tell me they will not provide service manuals unless I pay for and attend training. I was able to buy a XXXXX service manual for $300 from a third party. I have already saved two service calls by using the manual. When I brought this to the rep’s attention, he said they may be able to provide manuals at a cost but are still working on it.”
BMET #2: “I was told by our local dealer that YYYYYYY’s policy is not to provide service manuals without me paying for and attending training. I then found a part number and bought the manuals from YYYYYYY. We are now in the process of purchasing another product from this dealer and will require manuals.”
BMET #3: “I had this happen recently, where the manufacturer swore no service manuals or documents existed. I ‘gently’ reminded them that federal law, through the FDA among others, requires every step of design, production, and in-house staff training to be documented. The inhouse staff includes assemblers and technical staff. Documents include schematics and functional descriptions. I asked if they had followed federal law and since I assumed they did, those documents would do nicely. Amazingly, they found a real service manual for me. For free. Once you get past the worker ants it gets easier.”
BMET #4: “I start with ‘if service manuals cannot be provide then our policy is to require a five-year warranty,’ and work from there. Again, the only power to negotiate is at the time of sale. The trick is to get your purchasing people to believe.”
So, what recourse does a hospital have when faced with this issue? One vice president of operations and quality for a medical equipment vendor said, “If it is for medical equipment, they must provide manuals (FDA, 21 CFR 820.170). If they tell you they don’t or won’t, call the home office and ask for their regulatory manager.”
For reference, the FDA Code of Federal Regulations reference is below:
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 820_QUALITY SYSTEM REGULATION–Table of Contents
Subpart L – Handling, Storage, Distribution, and Installation
Sec. 820.170 Installation. (a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device. (b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer’s instructions and procedures and shall document the inspection and any test results to demonstrate proper installation.
Another source in the regulations that addresses what operator and maintenance manuals a vendor must provide is NFPA 99, a well-known National Fire Protection Association code. This code may not be the final authority in all states but it is pertinent in many. The reference for this code is NFPA 99, The Health Care Facilities Handbook, Item 9-22.214.171.124 NFPA 99.