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Table 5.11 External pacemakers

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Summary Proof Table

  • Each individual row of the Summary Proof Table (below) provides a summary of the data collected on a particular manufacturer-model version of this particular device type. Each row of summary data is provided with a "drill down" link (on the third row of each cell in C1) to a Detailed Proof Table that shows a breakdown of the various batches of data that are aggregated into the summary data shown in each row of the table. The link is the abbreviation in the first column (C1) of each row (e.g. EX.PA/ME-5348/12).
  • Columns C2 and C3 show the total amount of data in device-years (the experience base) collected for this particular manufacturer- model and an indication as to whether or not this exceeds the amount of data that the Task Force has (tentatively) set as the minimum acceptable level (see Table 11).
  • Columns C4 through C7 provide data on the likelihood that this manufacturer-model version of this particular device type will experience a failure that is attributable to the deterioration of a component that is scheduled to be restored by one or more device restoration tasks in the manufacturer's recommended PM procedure. During the test period such failures were coded as either an MR1 type of failure when the device was repaired - PM-preventable - (see Section 1.4 of HTM ComDoc 1) or as a PM Code 9 finding (serious physical deterioration) during a routine PM (see Section 1.7 of HTM ComDoc 1). Column C4 expresses this likelihood of the device failing from this particular type of PM-preventable failure as a reliability level (or risk level), based on the number of such failures reported over a substantial test period. The Task Force (tentatively) considers a mean time between failures (MTBF) greater than 75 years to represent an acceptable level of PM-related reliability (see Table 12). Devices showing reliability levels less than this are classified in column C7 as PM Priority 1 devices.
  • Columns C8 through C11 provide data on the likelihood that this manufacturer-model version of this particular device type will experience a hidden failure (see Section 1.6 of HTM ComDoc 1). Hidden failures, which are also described as safety verification (SV) related failures, are discovered during routine PMs and are coded as PM Code F findings (see Section 1.7 of HTM ComDoc 1). Column C8 expresses this likelihood of encountering a hidden failure as a reliability level (or risk level) based on the number of such encounters reported over the same substantial test period.
  • When there is a conflict between the two device risk levels (PM Priority levels) reported in columns C7 and C11, the lowest PM Priority level (which is also asterisked) should be considered to be the device's effective PM Priority level.
  • Column C12. Likelihood of failing (from a PM-preventable cause). Entries in this column provide an indication of whether or not this particular manufacturer-model version of this particular device type has a sufficiently substantial documented test period (i.e. an experience base of more than 50 device-years in column C2) showing an acceptable level of PM-related reliability. For devices with a possible outcome severity at the most serious level (LOS 3), the threshold for acceptable reliability is less than one failure every 75 years (i.e. an MTBF of greater than 75 years). Manufacturer-model versions of the device that do meet this level of reliability, when maintained at the interval indicated, should be considered eligible to be included in an AEM program. They are labeled in column C12 as "Unlikely - (eligible for AEM)"
  • Clicking on the device manufacturer - model link in the C1 cell of each row (e.g. Medtronic 5348) will take you to a direct quotation from the manufacturer's literature regarding the recommended PM interval - if the procedure is available and if there is a specific recommendation.
  • This link to the FDA's Global Universal Device Identification (GUDID) website (https://accessgudid.nlm.nih.gov) is provided here for possible use in the future.


This table was last updated on 10-10-18 (prior versions: None)

C1 C2 C3 C4 C5 C6 C7 C8 C9 C10 C11 C12
External pacemakers Experience base

(device-yrs)
Is the size of the
experience base
acceptable?
(SeeTable 11)
MTBF
for
DR-related reliability
Level of Severity
of
DR-related
failure modes
Is the level of the
DR-related reliability
acceptable?
(See Table 12)
DR-related
Risk Level
(See Table 12)
MTBF
for
SV-related reliability
Level of Severity
of
SV-related
failure modes
Is the level of the
SV-related reliability
acceptable?
(See Table 12)
SV-related
Risk Level
(See Table 12)
Likelihood
of failing

(LOF)
R1 Medtronic 5348
(at M-R? 12m interval)
EX.PA/ME-5348/12
182
device-yrs
Yes
Good
>182
years
LOS 3
(Serious, life-
threatening)
Yes - Very good
DR-related
reliability and safety
PM
Priority
3*
>182
years
LOS 3
(Serious, life-
threatening)
Yes - Very good
SV-related
reliability and safety
PM
Priority
3*
Very unlikely
(eligible
for AEM)
R2 Medtronic 5388
(at M-R? 12m interval)
EX.PA/ME-5388/12
259
device-yrs
Yes
Very good
259
years
LOS 3
(Serious, life-
threatening)
Yes - Very good
DR-related
reliability and safety
PM
Priority
3*
>259
years
LOS 3
(Serious, life-
threatening)
Yes - Very good
SV-related
reliability and safety
PM
Priority
3*
Very unlikely
(eligible
for AEM)
R3 Medtronic 5392
(at M-R 12m interval)
EX.PA/ME-5392/12
187
device-yrs
Yes
Good
>187
years
LOS 3
(Serious, life-
threatening)
Yes - Very good
DR-related
reliability and safety
PM
Priority
3*
>187
years
LOS 3
(Serious, life-
threatening)
Yes - Very good
SV-related
reliability and safety
PM
Priority
3*
Very unlikely
(eligible
for AEM)


Commentary

  • Size of the experience base. There is an adequate amount of data aggregated for each of the devices listed in the table, ranging from 182 device-years to 259 device-years. The Task Force has tentatively set the minimum acceptable size of the relevant experience base at 50 device-years (Table 11)
  • According to the data reported in rows R1, R2 and R3, it appears that these particular devices can be considered PM Priority 3 devices. They are considered to be low PM risk devices (see Table 12) and they qualify for inclusion in an AEM program because they have demonstrated an acceptable level of PM-related reliability. In a properly documented AEM program they can be maintained using a PM procedure or strategy (see HTM ComDoc 10) other than that recommended by the manufacturer. For example, they can be transitioned immediately to a less stringent PM strategy, such as the very cost-efficient light maintenance (run to failure) strategy mentioned in Appendix A of the CMS clarification memo (HTM ComRef 28). At the very least, the manufacture-recommended procedure can be modified, such as by omitting electrical safety checks that have been found to be nonproductive, or by extending the testing interval to make it coincide with more convenient or more efficient routines.
  • It may be prudent to continue to monitor the levels of patient safety (see Section 3.10 of HTM ComDoc 3) being achieved by the current procedures or by any of the more efficient procedures (if they were chosen).
  • Before making any changes to the facility's PM program we also recommend reading the cautionary note that can be found in Section 4.11 of HTM ComDoc 4.


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